Scientific Paper Max J@Ablation System

SCIENTIFIC PAPER MAX J@ABLATION SYSTEM

www.max-more.com SCIENTIFIC PAPER MAX J@ABLATION SYSTEM

1. MaxMore Joint Ablation (J@Ablation) is a manually rotating MaxMore Joint Ablation (J@Ablation) closes the gap between ablation and denervation system for the treatment of one or unsuccessful conservative, minimally invasive therapy and more facet joints by performing a “Manual rotating ablation surgical therapy through long-term pain relief to avoid or delay procedure” for capsule and bone ablation with endoscopic surgical therapy. denervation of the capsule and the dorsal ramus, using radio frequency. 7. See study MD Scott Haufe (Appendix 1) See study Egypt (Appendix 2) 2. Pain from the vertebral joints of the lumbar, cervical and thoracic spine, status after facet inflation. 7.a. Study Testimonials X-ray MRI classification Fujiwara type 1-4 (X-ray), NIC Guidelines British Spine Society Pathria grade 0-3 (CT) (https://www.nice.org.uk/guidance/ipg8) no randomized perspective study available 3. M40-M57 diseases of the spine and back, taking into account Application study Egypt evidence class A2 the DKR 1806G chronic, therapy-resistant pain, tumor pain, the main diagnosis from the area of M54 back pain can be 7.b. All common measuring instruments such as VAS Score, assigned. ODI, EQ5 are used.

Example: VAS: https://www.physio-pedia.com/Visual_Analogue_Scale M54.2 Cervical neuralgia, M54.6 pain in the area of the (it goes through all of the details of the VAS and then states at thoracic spine, M54.4 low back pain, this also includes facet the bottom that it is available at no cost and can be obtained syndrome in spondyloarthritis / facet joint arthrosis of the from Scott & Huskisson or here: lumbar spine / BWS / HWS M47.86, M47.84, M47.82 http: // www.amda.com/tools/library/whitepapers/ hospiceinltc/appendix-a.pdf. There are also clinical references 4. Pain of the lumbar, cervical and thoracic spine from the at the bottom of the page that cites clinical testing of the vertebral joints, status after facet inflation. validity of the VAS)

X-ray MRI classification Fujiwara type 1-4 (X-ray), Pathria ODI: https://www.physio-pedia.com/Oswestry_Disability_ grade 0-3 (CT) Index. It was developed by Dr. Jeremy Fairbank at Cambridge University and is specific as a measurement tool for low back 5. Degenerative spinal disease in a special case pain. There are many clinical articles that use the ODI and spondylarthrosis or spondylarthropathia deformans, a very here is the reference that is sometimes used at the end of common disease of the spine. About 80% of diseases occur in the questionnaire: Fairbank JC, Pynsent PB. The Oswestry the area of the lumbar spine, 20% in the area of the cervical Disability Index. Spine 2000 Nov 15; 25 (22): 2940-52; spine. Prevalence from the available literature is between discussion 52. 1% and 1.9%. With approximately 80 million German citizens, there is a potential number of 800,000 to 1.6 million There are norm values from the population for the commonly potential patients. used measurement scores. The measurement scores we use are used in most studies, one example - Egyptian study - 6. Beginning conservative therapy with appropriate physiotherapy, i.e. non-invasive therapy, then vertebral 8. The risk of the MaxMore Joint Ablation (J@Ablation) joint infiltration, as well as minimally invasive therapy of the method is vry low if it is performed by an experienced person. vertebral joints with cryo-denervation, thermo-denervation To ensure this, we did a study on animals first. See( Appendix 3). or RF therapy, if there is no improvement surgical therapy i.S. Stabilization of the spine with removal of the pain generators, vertebral joint. Int. J. Med. Sci. 2010, 7 120

International Journal of Medical Sciences 2010; 7(3):120-123 © Ivyspring International Publisher. All rights reserved Research Paper Endoscopic Facet Debridement for the treatment of facet arthritic pain – a novel new technique Scott M.W. Haufe 1,3 and Anthony R. Mork 2,3

1. Chief of Pain Medicine and Anesthesiology 2. Chief of Spine Surgery 3. MicroSpine, DeFuniak Springs, FL 32435, USA

Corresponding author: Scott M.W. Haufe, M.D., 101 MicroSpine Way, DeFuniak Springs, FL 32435. Phone: 888-642-7677; Fax: 850-892-4212; Email: [email protected]

Received: 2010.03.29; Accepted: 2010.05.24; Published: 2010.05.25

Abstract Study design: Retrospective, observational, open label. Objective: We investigated the efficacy of facet debridement for the treatment of facet joint pain. Summary of background data: Facet joint disease, often due to degenerative arthritis, is common cause of chronic back pain. In patients that don’t respond to conservative measures, nerve ablation may provide significant improvement. Due to the ability of peripheral nerves to regenerate, ablative techniques of the dorsal nerve roots often provide only temporary relief. In theory, ablation of the nerve end plates in the facet joint capsule should prevent reinner- vation. Methods: All patients treated with endoscopic facet debridement at our clinic from 2003-2007 with at least 3 years follow-up were included in the analysis. Primary outcome measure was percent change in facet-related pain as measured by Visual Analog Scale (VAS) score at final follow-up visit. Results: A total of 174 people (77 women, 97 men; mean age 64, range 22-89) were included. Location of facet pain was cervical in 45, thoracic in 15, and lumbar in 114 patients. At final follow-up, 77%, 73%, and 68% of patients with cervical, thoracic, or lumbar disease, respectively, showed at least 50% improvement in pain. Mean operating time per joint was 17 minutes (range, 10-42). Mean blood loss was 40 ml (range, 10-100). Complications included suture failure in two patients, requiring reclosure of the incision. No infection or nerve damage beyond what was intended occurred. Conclusions: Our results demonstrate a comparable efficacy of endoscopic facet debridement compared to radiofrequency ablation of the dorsal nerve branch, with durable results. Large scale, randomized trials are warranted to further evaluate the relative efficacy of this surgical treatment in patients with facet joint disease.

Key words: vertebral arthritis, facet syndrome, back pain, minimally invasive, nerve ablation

INTRODUCTION Facet joint disease, often due to degenerative surveys, 40-45% of patients had evidence of facet joint arthritis, is common cause of chronic back pain. pain based on anesthetic nerve blocks 9 10. Among low back pain patients, facet joint disease is Conservative therapy for facet joint pain consists present in an estimated 7 to 75% 6. In epidemiological of rest, physical therapy, and short-term use of non-

http://www.medsci.org Int. J. Med. Sci. 2010, 7 121 steroidal anti-inflammatory drugs or oral steroids 18. the skin at the entry site. A guide wire is inserted Local steroid injections and trigger point injects may down to the facet joint and then secured into the joint provide rapid relief that continues to improve over surface. A dilation system is inserted over the guide 5-7 days, but lacks evidence in the form of well de- wire and used to dilate the tissues and to allow ade- signed clinical trials 6 18 14 16 4. With steroid injection, quate working environment. Various final dilation pain relief can last anywhere from 2 months to 2 sizes were utilized during the study with a range of 7 years, but a subset of patients will have no significant to 14mm. The various sizes were utilized to determine benefit 18. the minimal size needed to achieve the procedure. In patients with continued pain despite these Through the final dilation portal, pituitaries are then measures, nerve ablation may provide significant re- used to remove the capsular tissue under direct ob- lief. Rhizotomy is commonly performed by radiofre- servation via a standard laparoscopic scope system. quency ablation (RFA); cryo-denervation has been The scope size varied based on the size of the portal reported in Europe 2 17 1. Ablation of the dorsal nerve and ranged from 2.7 to 7mm in diameter. Electrocau- roots supplying the painful facet joint provides sig- tery and holmium lasers are also used to complete the nificant relief, but due the innate ability of peripheral denuding of the joint surface to insure that the com- nerves to regenerate, improvement is impermanent. plete capsular region was removed. Once the joint is Theoretically, removal of the capsular tissue within completely denuded of capsular tissue, the dilation the joint, which contains the peripheral nerve system is removed and the site closed with subcuta- endplate receptors, should prevent nerve regenera- neous sutures. Each joint takes approximately 15 to 20 tion. Without endplate receptors present within the minutes to properly treat. A maximum of 6 joints joint, dorsal root axons should be incapable of were treated at any time; most patients required re-innervating the joint. treatment of 4 joints: 116 people had 4 joints treated In this study we investigate the long-term effi- (bilateral joints times two levels), 32 had 6 joints or 3 cacy of facet debridement for the treatment of chronic levels bilateral, and 26 had one level bilateral or two back pain originating in the facet joint. joints treated. The reason the maximum treated joints was 6 is due to time restraints of the surgery. MATERIALS AND METHODS Patient enrollment and evaluation RESULTS All patients treated with endoscopic facet de- A total of 174 people (77 women, 97 men; mean bridement at our institution from 2003-2007 with at age 64, range 22-89) were included. Length of fol- least 3 years follow-up were included in the analysis. low-up was at least 3 years with a maximum of 6 Patients were diagnosed based on response to facet years. Location of facet pain was cervical in 45, tho- injections as follows: 1 ml of 0.25% bupivacaine was racic in 15, and lumbar in 114 patients. injected using a 22 gauge needle with fluoroscopic Surgical times varied based on the number of guidance into the joints near their reported pain. Pa- joints treated. Mean operating time per joint was 17 tients with at least 75% improvement in their back minutes (range, 10-42). Mean blood loss was 40 ml pain immediately following injection were diagnosed (range, 10-100). Complications included suture failure in two patients, requiring re-closure of the incision. with facet pain. No infection or nerve damage beyond what was in- Primary outcome measure was percent change tended occurred. in facet-related pain as measured by Visual Analog Table 1 reports percent change in VAS at fol- Scale (VAS) score at final follow-up visit. Secondary low-up. A total of 77%, 73%, and 68% of patients with outcome was change in OSWESTRY disability index cervical, thoracic, or lumbar disease, respectively, from preoperative evaluation to final follow-up. showed at least 50% improvement in pain at last fol- Surgical procedure low-up. Table 2 reports change in Oswestry score The procedure commenced as follows: the pa- from preoperative evaluation to final follow-up. tient is appropriately prepped and draped. Using Overall, 76%, 60%, and 75% of patients with cervical, fluoroscopic guidance, the facet joints are identified. thoracic, or lumbar facet disease, respectively, had at An incision of between ½ to ¾ of an inch is made in least 50% improvement.

http://www.medsci.org Int. J. Med. Sci. 2010, 7 122

Table 1. Percent change in VAS pain score at long-term follow-up according to location of facet joint pain.

% Change VAS No Change (N) 1-24% (N) 25-49% (N) 50-74% (N) 75-100% (N) Total (N) Cervical 5 3 2 2 33 45 Thoracic 4 0 0 3 8 15 Lumbar 11 11 15 15 62 114

Table 2. Percent change in Oswestry Disability Index at long-term follow-up according to location of facet joint pain.

% Change Oswestry -1-25% No Change (N) 1-24% (N) 25-49% (N) 50-74% (N) 75-100% (N) Totals (N) Cervical 1 3 2 5 8 26 45 Thoracic 0 5 1 0 3 6 15 Lumbar 1 8 7 13 17 68 114

In comparison of the endoscopic surgery ap- patients with cervical facet disease and 35% of pa- proach to conventional facet joint therapies, out of the tients with lumber disease after a mean follow-up of 114 lumbar facet patients, 72 patients underwent facet 13.7 months. Iwatsuki et al. 5 reported significant pain injections elsewhere as treatment prior to considering relief in 71% of 21 patients at one year follow-up with the endoscopic option. The facet injections in these 72 laser denervation of the dorsal facet capsule. Li et al. 8 patients gave 50 to 100% relief of their pain in 86% of treated 5 patients with RFA of the dorsal rami. Three the patients with a median relief period of 3 months. patients had durable response after 6 to 16 months The range of relief varied from zero days to up to 13 follow-up; two patients had no pain relief. Other au- months for the facet injection group. None of the thors have reported similar success rates but with lumbar facet injection patients received permanent limited or no follow-up data 7 12 15 11. relief. Of the 114 lumbar facet patients, 26 underwent Cryorhizotomy is reported in to be of similar ef- radiofrequency lesioning of the dorsal rami nerves ficacy. In a study of 76 patients treated via CT-guided prior to considering the endoscopic surgery option. Of cryorhizotomy of the dorsal nerve medial branch, these 26 patients, 14 patients had 50 to 100% relief Staender et al. 17 reported a mean VAS pain score re- with a median period of pain relief being 5 months. duction of 3.3 at six months follow-up; 40% of patients The range of relief for the radiofrequency group was had relief for at least 12 months, and mean duration of from zero days to 16 months for all 26 patients who pain relief was 14 months. Barlocher et al. 1 treated 50 underwent the radiofrequency procedure. Of the 14 patients with cryorhizotomy of the medial branch. At patients who revealed 50% or greater improvement 1-year follow up, 62% had good results. from the radiofrequency procedure, the length of im- Our results are similar to those reported with provement varied from 3 months to 16 months. RFA and cryorhizotomy. Importantly, the majority of Again, no one in the radiofrequency group developed our patients reported significant pain improvement permanent relief of their pain. Thus, the endoscopic for at least 36 months postoperatively. This durable facet procedure offered long-term relief beyond what effect is particularly promising, given the propensity was seen when the patients underwent facet injections for facet joint pain to return following dorsal root or rhizotomy procedures. rhizotomy. We speculate that the direct visualization of the joint allows better de-innervation of the joint DISCUSSION and removal of the entire end-plate receptors that Studies of radiofrequency ablation (RFA) for fa- adhere to the bone and capsular tissue. cet pain report rapid symptomatic relief. Success rates Limitations of the current study include a lack of range from 21-71%. However, most studies are small comparison group and lack of blinding. A rando- in size, do not include a control group, and have li- mized, controlled clinical trial would be ideal to fur- mited follow-up. Because of the capacity for peri- ther verify the efficacy we report here. We chose to pheral nerves to regenerate, long term outcome fol- include only patients with long-term follow-up in lowing ablation of the dorsal nerve root or its order to provide data on the duration of pain relief. branches should be evaluated. Cho et al. 3 reported a The exclusion of patients with less than 3 years fol- 71% success rate in 324 patients at a mean follow-up low-up may bias our results, as patients with unsuc- of 22.5 months. Tzaan et al. 19 reported good results at cessful results may have left our clinic and received a mean follow-up of 5 months in 41% of 90 patients. therapy elsewhere. Schaerer 13 reported good to excellent results in 50% of In conclusion, facet joint pain is a significant

http://www.medsci.org Int. J. Med. Sci. 2010, 7 123 source of chronic back pain and responds well to 19. Tzaan WC, Tasker RR. Percutaeous radiofrequency facet nerve ablation techniques. Our results demonstrate rhizotomy--experience with 118 procdedures and reappraisal of its value. Can J Neurol Sci 2000;27:125-30. efficacy of endoscopic facet debridement comparable to the more commonly used RFA, with results durable for at least 3 years. Larger scale trials with a control group are warranted to further evaluate the relative efficacy of this surgical treatment in patients with facet joint disease. Conflict of Interest The authors have declared that no conflict of interest exists. References 1. Barlocher CB, Krauss JK, Seiler RW. Kryorhizotomy: an alternative technique for lumbar medial branch rhizotomy in lumbar facet syndrome. J Neurosurg 2003;98:14-20. 2. Birkenmaier C, Veihelmann A, Trouillier HH, et al. Medial branch blocks versus pericapsular blocks in selecting patients for percutaneous cryodenervation of lumbar facet joints. Reg Anesth Pain Med 2007;32:27-33. 3. Cho J, Park YG, Chung SS. Percutaneous radiofrequency lumbar facet rhizotomy in mechanical low back pain syndrome. Stereotact Funct Neurosurg 1997;68:212-7. 4. Gorbach C, Schmid MR, Elfering A, et al. Therapeutic efficacy of facet joint blocks. AJR Am J Roentgenol 2006;186:1228-33. 5. Iwatsuki K, Yoshimine T, Awazu K. Alternative denervation using laser irradiation in lumbar facet syndrome. Lasers Surg Med 2007;39:225-9. 6. Kalichman L, Hunter DJ. Lumbar facet joint osteoarthritis: a review. Semin Arthritis Rheum 2007;37:69-80. 7. Koizuka S, Saito S, Kawauchi C, et al. Percutaneous radiofrequency lumbar facet rhizotomy guided by computed tomography fluoroscopy. J Anesth 2005;19:167-9. 8. Li G, Patil C, Adler JR, et al. CyberKnife rhizotomy for facetogenic back pain: a pilot study. Neurosurg Focus 2007;23:E2. 9. Manchikanti L, Pampati V, Fellows B, et al. Prevalence of lumbar facet joint pain in chronic low back pain. Pain Physician 1999;2:59-64. 10. Manchikanti L, Pampati V, Fellows B, et al. The diagnostic validity and therapeutic value of lumbar facet joint nerve blocks with or without adjuvant agents. Curr Rev Pain 2000;4:337-44. 11. Ogsbury JS3rd, Simon RH, Lehman RA. Facet "denervation" in the treatment of low back syndrome. Pain 1977;3:257-63. 12. Savitz MH. Percutaneous radiofrequency rhizotomy of the lumbar facets: ten years' experience. Mt Sinai J Med 1991;58:177-8. 13. Schaerer JP. Radiofrequency facet rhizotomy in the treatment of chronic neck and low back pain. Int Surg 1978;63:53-9. 14. Schwarzer AC, Aprill CN, Bogduk N. The sacroiliac joint in chronic low back pain. Spine (Phila Pa 1976) 1995;20:31-7. 15. Silvers HR. Lumbar percutaneous facet rhizotomy. Spine (Phila Pa 1976) 1990;15:36-40. 16. Slipman CW, Lipetz JS, Plastaras CT, et al. Fluoroscopically guided therapeutic sacroiliac joint injections for sacroiliac joint syndrome. Am J Phys Med Rehabil 2001;80:425-32. 17. Staender M, Maerz U, Tonn JC, et al. Computerized tomography-guided kryorhizotomy in 76 patients with lumbar facet joint syndrome. J Neurosurg Spine 2005;3:444-9. 18. Stone JA, Bartynski WS. Treatment of facet and sacroiliac joint arthropathy: steroid injections and radiofrequency ablation. Tech Vasc Interv Radiol 2009;12:22-32.

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MEDOVEX DenerveX Rotational Ablation Denervation System

Clinical Evaluation Report Via Literature Review Revision B

MEDOVEX Corporation 1950 Airport Road, Ste A Atlanta, GA 30341

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Table of Contents

TABLE OF CONTENTS ...... 2

1. DEVICE NAME/MODEL ...... 4

2. DEVICE DESCRIPTION ...... 4

2.1. CLINICAL BACKGROUND ...... 4

2.2. DEVICE OVERVIEW ...... 4 2.3. COMPONENTS ...... 5 2.4. USE ENVIRONMENT ...... 5 2.5. INDICATIONS FOR USE ...... 5 2.6. CLINICAL PROCEDURE STEPS...... 5

2.7. PROPOSED REGULATORY CLASSIFICATION ...... 8

3. OBJECTIVES OF REPORT ...... 8

4. SCOPE OF LITERATURE SEARCH ...... 8

5. METHODS ...... 8

6. OUTPUTS ...... 10

7. LITERATURE SUMMARY ...... 10 7.1. SUMMARY OF OUTCOMES ...... 11 7.2. SUMMARY OF RADIOFREQUENCY DEVICE TYPES ...... 11 7.3. SUMMARY OF ROTATIONAL AND MECHANICAL TISSUE DESTRUCTION DEVICE TYPES ...... 11 7.4. NARRATIVE SUMMARY OF INCLUDED LITERATURE ...... 63

7.4.1. RANDOMIZED CONTROLLED TRIAL (RCT) ...... 63

7.4.2. PROSPECTIVE TRIAL...... 68

7.4.3. RETROSPECTIVE TRIAL ...... 82

7.4.4. CASE REPORT ...... 94

7.4.5. LITERATURE SEARCH...... 96

7.4.1. TECHNICAL NOTE ...... 99

8. APPLICABILITY OF EXISTING DATA TO THE DENERVEX DEVICE ...... 101

9. DISCUSSION ...... 108

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9.1. CLINICAL OUTCOMES ...... 108 9.2. PROCEDURAL COMPLICATIONS AND ADVERSE EFFECTS ...... 109

9.3. PROPOSED SAFETY MEASURES FOR PATIENTS AND MEDICAL STAFF ...... 112

10. CONCLUSION ...... 113

APPENDIX A: LITERATURE SEARCH PROCESS ...... 114

APPENDIX B. ACCEPTED ARTICLES AND STUDIES FOR LITERATURE SEARCH ...... 115

APPENDIX C: PUB MED LITERATURE SEARCH RESULT ...... 123

APPENDIX D. DR. HAUFE’S CV ...... 167

APPENDIX E. COMPARATIVE DEVICE PROMOTIONAL LITERATURE ...... 168

APPENDIX F. DENERVEX INSTRUCTIONS FOR USE (IFU) DOCUMENT ...... 169

APPENDIX G. QUALITY ASSESSMENT OF ARTICLES INCLUDED IN LITERATURE REVIEW (MEDDEV 2.7.1 REV 3) ...... 170

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1. DEVICE NAME/MODEL The product name during development is the MEDOVEX DenerveX Rotational Ablation Denervation System which consist of two parts, the first a dedicated power generator; the DenerveX Rotational Ablation Denervation Generator-Pro-40 (Hereby referred to as the Pro-40 Power Generator) and second, the DenerveX Rotational Ablation Denervation Kit (hereafter referred to as the DenerveX Device or DenerveX Kit). Product number MDVX-DenerveX-01 for the Denervex Kit and MDVX-Pro-40 for the DenerveX Generator.

2. DEVICE DESCRIPTION

2.1. Clinical Background

Facet joint syndrome is a condition in which the zygapophysial joints in the back of the spine degenerate and subsequently cause pain. Treatment options, which have been in use in the 1960s, include injection of anesthetics or anti-inflammatory agents and application of radiofrequency energy to the area of pain. The latter technique has been described using a variety of terms, including radiofrequency lesioning, rhizotomy, and neurotomy. Regardless of the term used to describe the RF based procedure, the intent is to destroy the dorsal ramil nerve at the site of pain. Pain relief is achieved by creating defined lesions on pain-conducting nerve fibers and surrounding capsular tissue.

2.2. The DenerveX Device Overview The DenerveX device is a rotational RF ablation denervation device, designed to treat the nerve and capsular tissue on the posterior surface of the zygapophysial (facet) joint. The DenerveX Device probe is attached to the Pro-40 Power Generator (an electrosurgical generator) using a unique 6-pin connector that can only be used with the Pro-40 Power Generator and incorporates an electrically-powered motor (powered by the generator) to provide rotation. When activated, the atraumatic probe delivers controlled radiofrequency energy while slowly rotating at a pre-set speed of approximately 45 rpm. The speed of rotation is not adjustable by the user. Denervation of the facet joint capsule is achieved through the delivery the RF energy and with tissue debris removed from the site via the rotating action of the probe. Figure 1 below depict the device.

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Portal tube, Procedure Dilator, K-wire Rotational Radiofrequency electrode

DenerveX Device/Hand Piece

Figure 1. DenerveX Device Kit and Access Components

2.3. DenerveX Kit Components Each DenerveX Rotational Ablation Denervation Device Kit will include the DenerveX Device or Hand piece (probe) and accessories: a K-wire, Procedure Dilator, Tissue Stabilizer, Portal Driver and Portal Tube. The DenerveX Device Kit is designed for single-use and is provided sterile. After use, the device and accessories are disposable.

2.4. Use environment As with the current therapies, pain management specialists, orthopedic surgeons performing spinal procedures, interventional radiologists and neurosurgeons will most typically use the DenerveX device. The DenerveX Device is intended for transient use (<60 minutes), and one device is used per patient procedure. The device has a controlled and limited activation time of 30 seconds per use on a single facet joint and may activated multiple times in order to treat multiple facet joints in one patient. Indications for Use:

The DenerveX Device, in combination with the DenerveX Pro-40 Generator unit, is intended for ablation of soft tissues in spinal applications for selective denervation, which may be performed on the lumbar, thoracic and cervical regions (C2-C7) of the peripheral nerves and nerve roots for the relief of pain associated with the facet joint syndrome.

2.5. Clinical Procedure Steps I. Place the patient in a prone position, drape and prepare the treatment site(s) following standard techniques. II. Place a return electrode underneath either the thigh or abdomen, connect the return electrode cord to the Pro-40 power generator. III. Determine desired treatment location via fluoroscopy and mark skin.

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IV. Make a 10-15mm incision in a location that takes into account the angle of approach required to reach the targeted facet joint. V. Using fluoroscopic guidance, advance the K-wire into the incision until it reaches the facet joint. Tap the wire gently into the bone using a small hammer. VI. Insert the procedure dilator over the K-wire until at least two K-wire upper marker bands are visible.

VII. Insert the Portal Tube over the Procedure Dilator/K-wire. VIII. Attach the Portal Driver and further advance the Portal Tube as far as possible. Ensure that the large Procedure Dilator marker band is visible, extending past the top face of the driver. IX. Remove the Portal Driver and check to ensure that at least two K-wire upper marker bands are visible. X. Connect standard suction tubing to the side port of the tissue stabilizer. XI. Advance the tissue stabilizer with standard suction tubing over the Portal Tube and maintain position using firm hand pressure for the remainder of the procedure. (During all steps from XI- XX)

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Note: If the Portal Tube is not fully advanced, the Portal Driver may be reattached and used to further advance the Portal Tube. If full advancement is not possible, a new access point may be necessary. XII. Establish a flow rate of at least 40LPM. XIII. Connect the DenerveX Device to the DenerveX Pro-40 Generator and select the desired treatment “Effect” on the Pro-40 power generator. Note: In general, Effect 3 should be used when treating individuals with high BMI and Effect 1 for those with low BMI subjects. XIV. Reconfirm that the K-wire is still positioned over the facet joint and adjust position if necessary. XV. Gently remove the procedure Dilator and K-wire with one hand, while maintaining the position of the Portal Tube with the other hand. XVI. Insert the DenerveX Device into the Portal Tube. XVII. Depress and hold the trigger to activate rotation and delivery of RF energy. Note: Visually verify that the shaft of the device is rotating during activation. XVIII. Gently guide the device through the tissue, without rocking or pivoting, until tactile feedback with bone is determined. XIX. Maintain gentle downward pressure on the DenerveX Device for duration of the treatment. Note: Energy delivery and rotation will stop after 30 seconds or when the trigger is released. An audible alarm sounding like an intermittent Activation Tone from the DenerveX Pro-40 generator when the 30 second time has been reached. Depressing the Reset Button on the generator is required to allow the generator to activate for the next 30 second period. XX. Remove the DenerveX device from the Portal Tube. XXI. Remove the Portal Tube and close the incision using standard techniques.

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XXII. Clean the debris from the hand piece electrode using cautery pads after treatment of each joint. XXIII. Move to the next treatment location and repeat steps I-XXII

2.6. Proposed Regulatory Classification Based on a review of the classification rules described in Annex IX of MDD 93/42/EEC, DenerveX is an active, transient use, surgically invasive device that administers energy in a potentially hazardous way. As a result, rule 9 applies, and the device is considered to fall within Class IIb.

3. OBJECTIVES OF REPORT The objective of this report is to evaluate the scientific literature to determine the clinical performance, safety, risks and benefits of radiofrequency facet joint denervation.

4. SCOPE OF LITERATURE SEARCH The scope of the clinical literature search encompassed published scientific and medical journal articles, reports of adverse events from post market surveillance, and device recalls. All searches focused on identification of safety and performance data from nerve and tissue ablation devices and mechanical tissue destruction specific to the spinal region. The process that was used to develop the literature search is documented in a flowchart in Appendix A.

5. METHODS Searches 1 and 2 were conducted on June 12, 2014 and June 13, 2014 by Julie Tapper, Regulatory Affairs Manager, at Medpace Medical Device in Blaine, Minnesota. Searches 3 through 6 were conducted on April 18, 2016 by Marin Olson, Associate Project Manager, at Medpace Medical Device located in Blaine, Minnesota. PubMed was the primary scientific literature database for the search. It is a widely recognized database with citations from MEDLINE, life science journals, and online books. Bibliographies of articles retrieved were screened for any additional relevant literature. After the initial PubMed search, the search terms used in selected articles were checked to determine if any additional relevant search terms were available that captured more literature. However, no new, relevant search terms were identified as a result, nor were additional articles located as a result of the review of the bibliographies of the “included” articles. Table 1 - Summary of PubMed Search Strings and Criteria

PUBMED SEARCH STRINGS Inclusion Criteria Exclusion Criteria Date Range

Search #1: • Non-English Publications 15-JUN-2004 Terms entered into PubMed: (facet • Non-human studies through 12-JUN- joint radiofrequency AND safety) 2014 OR (“facet joint radiofrequency” AND effectiveness) OR (facet joint rhizotomy)

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PUBMED SEARCH STRINGS

Search #2: • Non-English Publications 15-JUN-2004 Terms entered into PubMed: (facet • Non-human studies through 13-JUN- joint radiofrequency AND adverse 2014 events) OR (facet joint radiofrequency AND adverse effects) OR (facet joint rhizotomy AND adverse events) OR (facet joint rhizotomy AND adverse effects) NOT (facet joint radiofrequency AND effectiveness) NOT (facet joint radiofrequency AND safety)

Search 3: (facet joint • Non-human clinical trials 15-JUN-2014 radiofrequency AND safety) OR • Non-English literature through 15-APR- (facet joint radiofrequency AND 2016 • Systematic literature reviews effectiveness) OR (facet joint • Personal Narratives rhizotomy) • Letters • Opinion/Critique articles • Case reports will be excluded from the overall analysis, but were included for labeling considerations

Search 4: (facet joint • Non-human clinical trials 15-JUN-2014 radiofrequency AND adverse • Non-English literature through 15-APR- events) OR (facet joint 2016 • Systematic literature reviews radiofrequency AND adverse • Personal Narratives effects) OR (facet joint rhizotomy AND adverse events) OR (facet • Letters joint rhizotomy AND adverse • Opinion/Critique articles effects) NOT (facet joint rhizotomy • Case reports will be excluded from the overall AND effectiveness) NOT (facet analysis, but were included for labeling joint radiofrequency AND safety) considerations

Search 5: (minimally invasive • Non-human clinical trials 15-JUN-2004 treatment spinal stenosis OR • Non-English literature through 15-APR- minimally invasive lumbar 2016 • Systematic literature reviews decompression OR flexible micro • Personal Narratives blade shaving OR minimally invasive facet joint treatment OR • Letters spinal decompression) AND • Opinion/Critique articles (effectiveness OR adverse event • Case reports will be excluded from the overall OR safety) NOT fusion analysis, but were included for labeling considerations

Search 6: (io-Flex OR rongeur OR • Non-human clinical trials Unrestricted spine shaver OR ultrasonic scalpel • Non-English literature OR Sonopet) NOT fusion AND • Systematic literature reviews

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PUBMED SEARCH STRINGS

spine • Personal Narratives • Letters • Opinion/Critique articles • Case reports will be excluded from the overall analysis, but were included for labeling considerations

6. OUTPUTS Each retrieved article was assessed to determine its suitability for inclusion in the literature search. A complete list of accepted articles and studies that have been included within the literature summary is provided in Appendix B. If an article was determined to be unsuitable, an exclusion rationale was provided. Refer to Appendix C for the complete result from the PubMed search. The listing provided within Appendix C includes all articles that were retrieved with the search, indicates which were included and excluded from the literature summary, and provides the rationale for excluded articles.

7. LITERATURE SUMMARY The types of included studies and the total number in each category are summarized in Table 2, below. Table 2. Summary of Included Study Types Number of Study Type Retrieved Articles Randomized controlled trials 14 Prospective trials 35 Retrospective trials 30 Case reports 9 Systematic literature review 17 Technical notes 2 Total 107

The included articles reported on 8,383 unique patients in 78 trials (randomized, prospective and retrospective). Subjects discussed in case reports, technical notes, and systematic literature reviews were excluded from the total patient count; however, any discussion of adverse events presented in case reports was considered. The majority of studies included both men and women, and were completed on subjects who were, on average, over 40 years old. The subjects’ etiologies included facet joint syndrome, neck pain, neck pain with headaches, chronic headaches, thoracic facet joint pain, low back pain, low back pain with intractable leg pain, low back pain with right upper buttock pain, lower back with radicular pain, lumbar facet pain, lumbar facet syndrome, recurrent thoracolumbar facet joint pain, zygapophysial joint and sacroiliac joint pain, recurrent lumbar pain after radiofrequency neurotomy, and advanced lumbar spondylosis.

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Treatments were administered along the length of the cervical, thoracic, lumbar and sacral spine, although most were in the lumbar region. Scott Haufe, MD, participated in the review of this document, and provided input regarding the articles that were retrieved in the searches. A copy of Dr. Haufe’s CV is in Appendix D. A summary of the articles accepted from the literature search is provided below, in Table 3.

7.1. Summary of Outcomes Treatment results (outcomes) reported included assessment of pain, quality of life, disability, activities of daily living and work status. Validated assessment tools were the norm for most studies. The clinical outcome of radiofrequency denervation generally included pain relief, which was measured using a Visual Analog Scale (VAS), a pain scale that is a patient-designated measurement of pain, usually from 0 (no pain) to 10 (worst pain imaginable). Other measured clinical outcomes included relief from disability, reduction in analgesic use, and improved quality of life. Five standardized assessments were utilized to assess patient outcomes pre-procedure and at follow-up, as follows: 1. The RMQ (Roland-Morris Questionnaire), which consists of 24 yes/no questions and is designed to assess back pain that has occurred within the last 24 hours. The RMQ consists of 24 items reflecting a variety of daily living activities; each item is scored 1 if declared applicable to the respondent and 0 if not, and so the total score can vary from 0 (no disability) to 24 (severe disability). 2. The NASS (North American Spine Society) Patient Satisfaction Questionnaire, which measures satisfaction with the procedure performed. 3. The EQ-5D (Euro QOL in 5 dimensions), which measures quality of life. 4. The (PDQ-S) Pain Disability Questionnaire – Spine, which measures functional status. 5. The (OSW) Oswestry Low Back Pain and Disability Questionnaire and associated (ODI) Oswestry Disability Index, which quantifies disability for low back pain and evaluates intensity of pain, physical ability and quality of life in several categories. The ODI is a self-administered, 10-item questionnaire. The first section rates the intensity of pain, and the others describe its disabling effect on typical daily activities. The score for each item ranges from 0 to 5, and the sum of the 10 scores is expressed as a percentage of the maximum score and thus ranges from 0 (no disability) to 100 (maximum disability).

7.2. Summary of Radiofrequency Device Types A variety of radiofrequency generators and RF electrode configurations were included in the reported studies, which can generally be described as applying RF energy directly to the facet joint using either a monopolar or bipolar electrode. Over time, the shape of the electrodes used in the treatment of facet joint syndrome has evolved from off-the-shelf non-specific electrodes (Cosman RRE TC Electrode) to those that are specifically designed for this indication (CE-marked Stryker Venom). A comprehensive review of the methods and materials used in the reviewed studies is provided in Section 8.

7.3. Summary of Rotational and Mechanical Tissue Destruction Device Types There are a number of mechanical devices used for bone and tissue removal included in the reported studies. Long used methods of bone and tissue removal such as a high speed drill (Medtronic Midas Rex) or a Kerrison Rongeur are heavily represented in the included studies. There are also more refined tools

Page 11 of 178 Clinical Literature Review, Revision B Radiofrequency Facet Joint Denervation 09 December 2016 Page 12 used for mechanical tissue removal in the spine, such as the MILD device used for spinal decompression of the lumbar and the Io-Flex saw. A comprehensive review of the methods and materials used in the reviewed studies is also provided in Section 8.

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Table 3a. Summary of Included Literature (results literature searches 1-4) Citation # Citation Type of Study # of Patients Etiology Intervention Primary Outcome Results and Clinical Outcome Complications or Adverse Effects (from Primary Measurements Appendix Author B) Randomized Controlled Trial (RCT) 1 Lakemeier S Randomized 56 subjects: Low back pain of facet Steroid injection, radiofrequency Roland-Morris Pain relief and functional improvement were No major adverse events reported during the controlled trial 29 steroid origin denervation Questionnaire at baseline observed in both groups. There were no 6 month observation period injection arm, and 6 months significant differences between the 2 groups 27 denervation for the primary end point (95% confidence arm interval [CI], −3 to 4)

2 Civelek E Randomized 100 subjects: Chronic low back pain Lumbar facet joint interventions Visual Numeric Pain In early post-op VNS, the FJI group showed There were no cases of infection, or new controlled trial 50 Facet Joint (FJI or FJRF) Scale (VNS), North better results, however at 1 month, 6 months motor or sensory deficit after the FJI and Injections American Spine Society and 1 year, FJRF showed better results FJRF procedures at early or long-term (FJI), 50 Facet patient satisfaction (p<0.001). NASS patient satisfaction scores follow-ups. There have been rare complaints Joint questionnaire (NASS), were not significantly different in the 1st of small superficial burns after RF. In FJRF Radiofrequenc Euro QOL in 5 month (p=1) and 6th month (p=0.13) follow- group, observed burning-like sensation in the y (FJRF) dimensions (EQ-5D) ups, however there was significant difference lesion area and increase in severity of low Denervation at the 12th month (p=0.04). There was no back pain in two patients at early follow-up. significant difference with respect to 1st After neuropathy medication, all complaints month (p=0.17), 6th month (p=0.22) and resolved after 6-8 weeks and no additional 12th month (p=0.11) post-procedure follow- procedure was required. ups in EQ-5D. At the short term FJI was more effective than FJRF however in midterm follow-up FJRF had more satisfying results than FJI.

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Citation # Citation Type of Study # of Patients Etiology Intervention Primary Outcome Results and Clinical Outcome Complications or Adverse Effects (from Primary Measurements Appendix Author B) 3 Cohen S Randomized Multicenter Suspected lumbar Radiofrequency denervation >= 50% pain relief Success at 3 months: Two patients, one each in group 0 and 2, controlled trial trial, facet pain coupled with positive Group 0: 33% experienced significant worsening (2-point randomized global perceived effect Group 1: 16% increase in numerical rating scale pain score 1:1:1 persisting for 3 months Group 2: 22% at rest and 4 point increase in Oswestry 151 subjects Disability Index score) back pain 1 month received (P<0.001) after denervation. One patient experienced radiofrequency the new development of radiating pain into denervation the lower leg at the first follow-up visit, Group 0: based which was not accompanied by on clinical corresponding magnetic resonance imaging findings pathology. These symptoms were all Group 1: after resolved by 3 months. positive response to single diagnostic block Group 2: after positive response to comparitive blocks with lidocane and bupivacaine 4 Dobrogowski J Randomized 45 subjects Chronic lumbar Radiofrequency neurolysis of Pain intensity, summed The 50% reduction of pain intensity was Severe local tenderness reported in 26.7% controlled trial zygapo-physial joint lumbar medial branch with pain intensity difference, achieved in 80% of patients one week after (n=4) of the saline group. In 1:1:1 pain – transient intraoperative injection of minimum 50% reduction the procedure, and at 6 months such results methylprednisolone group 20% (n=3) radiofrequency postopera-tive pain methylprednisolone or of pain intensity, Patients were reported by 60% of patients. There was patients reported mild tenderness, pentoxi- neurotomy pentoxifylline in comparison with Satisfaction Score, and a significant reduction of pain intensity in all fylline group 13.3% (n=2) reported mild with addition placebo local tenderness three groups at all time points compared to tenderness. No other complications were of baseline (p < 0.001), however, there were no noted in any of the patients. methylpredni- differences between the three groups. There solone, was a significant difference in local pentoxifylline tenderness as a measure of postoperative pain or saline indicating effectiveness of both, methylprednisolone and pentoxifylline.

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Citation # Citation Type of Study # of Patients Etiology Intervention Primary Outcome Results and Clinical Outcome Complications or Adverse Effects (from Primary Measurements Appendix Author B) 5 Joo Y Randomized 40 subjects Recurrent Radiofrequency ablation (RFA) or Recurrence rate of pain Without recurring pain at 24 month follow- Injection site pain in both groups (n=5 in controlled trial 1:1 thoracolumbar facet alcohol ablation (AA) and adverse events up RFA and n=7 in AA) randomization joint pain RFA: 1 to AA: 17 radiofrequency Median effective periods (p <0.000) ablation vs. RFA: 10.7 months alcohol AA: 24 months ablation 6 Ma K Double-blind 66 subjects Lumbar facet pain Diclofenac sodium for the relief of Pain visual analgesia VAS in groups B and C was less than in Nausea n=1 (A), n=3 (B), n=3 (C) randomized pain after CRF denervation score (VAS) at baseline, group A at 1 and 7 days post-treatment (P < vomiting n=2 (B), n=3 (C) controlled trial 1:1:1 1, 7, 14, 30 and 60 days 0.05 and 0.01, respectively). Diarrhea n=1 (A), n=3 (B) randomization post-treatment Edema n=1 (A), n=2 (B), n=4 (C) to placebo PSS in groups B and C was significantly Anaphylactoid n=2 (B), n=1 (C) (group A), Oswestry Disability better than in group A at 30 and 60 days after Erythra n=1 (B) diclofenac Index (ODI) and treatment (P < 0.05). sodium for 3 Patients’ Satisfaction All resolved at 30 days post procedure. days (group B) Score (PSS) at baseline, The rate of side effects was similar among or 7 days 30 and 60 days post- the three groups at all times (P > 0.05). (group C) treatment. The cost of analgesic administration in group Cost of administering B was significantly less than in groups A and diclofenac sodium C (P < 0.05). 7 Kroll H Randomized, 50 subjects Lumbar facet Continuous (CRF) versus pulsed Visual analog scale No significant differences in the relative None double-blind (ASA physical syndrome (PRF) radiofrequency (VAS) pain assessment percentage improvement were noted between prospective status I, II and and Oswestry Low Back groups in either VAS (P=0.46) or OSW study III) Pain and Disability scores (P=0.35). Questionnaire (OSW) were administered at Within the PRF group, comparisons of the baseline and then at three relative change over time for both VAS (P = months. Comparisons 0.21) and OSW scores (P = 0.61) were not between groups and significant. However, within the CRF group, within groups were made VAS (P = 0.02) and OSW scores (P = 0.03) of the relative percentage showed significant improvement. improvement in VAS and OSW scores.

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Citation # Citation Type of Study # of Patients Etiology Intervention Primary Outcome Results and Clinical Outcome Complications or Adverse Effects (from Primary Measurements Appendix Author B) 8 Tekin I Randomized, 60 subjects Continuous low back Conventional (CRF) vs. Pulsed Pain relief was evaluated Mean preprocedural VAS and ODI scores None double-blind pain (PRF) radiofrequency denervation by visual analog scale were higher than all postprocedural scores in sham lesion 1:1:1 (VAS) and Oswestry all groups (p<0.001). VAS and ODI scores controlled trial randomization Disability Index (ODI) at were lower in PRF and CRF groups than the to conventional preprocedure, at control group at postprocedure evaluation. or pulsed procedure, at 6 months Although the decrease in the VAS score and radiofrequency and 1 year after the ODI was maintained in the CRF group at 6 denervation vs. procedure months, this was not achieved in the PRF sham treatment group. At 1 year, mean VAS score was similar in control and PRF groups but lower in CRF group compared to the others (p<0.001). Mean ODI was lower in RF groups than control group at 1 year. 9 Van Wijk R Randomized, 81 subjects Chronic low back pain Radiofrequency facet joint Success of treatment The combined outcome measure showed no None double-blind denervation vs. sham treatment defined as: 1) reduction differences between radiofrequency facet sham lesion of median VAS-back of joint denervation (n = 40; success 27.5%) controlled trial drop in and sham (n = 41; success 29.3%) (P = 0.86). daily activities and/or The VAS in both groups improved (P , rise≥50%, in analgesicwith no intake; 0.001). Global perceived effect improved or 2) a reduction of after radiofrequency facet joint denervation - (P , 0.05). The authors do conclude that the treatment had an effect on certain subjects. simultaneous≥25% of median rise VAS in dailyback, acwithtivities of and drop in analgesic intake of ≥25%

≥25%. Every outcome in which these criteria were not met was defined as failure.

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Citation # Citation Type of Study # of Patients Etiology Intervention Primary Outcome Results and Clinical Outcome Complications or Adverse Effects (from Primary Measurements Appendix Author B) 45 Zhen-Zhou Li Randomized 58 Pain originating from Endoscopic rhizotomy (surgery Low back pain or Operation group--low back pain and referred No complications observed through follow Controlled n=45 surgery base of superior group) OR NSAIDs, PT, cognitive- referred pain was pain showed a lower score at any time point up. During operation, anatomical variants of Trial group articular processes behavioral therapy (conservative measured on a visual postoperatively (P < 0.01), as compared to the dorsal ramus of the spinal nerve, n=13 (SAP) and the group). Device used not described. analog scale (VAS). the VAS pain score obtained before medial including the number, the thickness and the conservative transverse process MacNab score was also branch neurotomy (MBB), while showed no positioning of the dorsal ramus were group obtained for QOL statistical difference (P > 0.05) as compared observed. to the VAS pain score obtained after MBB. Conservative group--low back pain and referred pain showed a lower score at any time point postoperatively (P < 0.01), as compared to the VAS pain score obtained before MBB, while showed a higher score (P > 0.05) as compared to the VAS pain score obtained after MBB. The VAS back or referred pain score in the two groups was not statistically different at any time point postoperatively (P > 0.05). Therapeutic procedural characteristics--not statistically different degree of pain relief (back/referred) after MBB in either group. The relief of pain (back/referred) at any time point postoperatively in the operation group was higher in comparison to that in the conservative group (t test, all P < 0.01). Excellent or good McNab outcomes of the 1 year postoperative evaluation in the operation group were 97.8%, which was significantly higher than that in the conservative group which recorded 0% (P < 0.01).

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Citation # Citation Type of Study # of Patients Etiology Intervention Primary Outcome Results and Clinical Outcome Complications or Adverse Effects (from Primary Measurements Appendix Author B) 107 Moussa, Randomized 120 Chronic lower back All three treatment groups received Visual Analog Score All three groups experienced significant pain None WMM Controlled pain a local injection of anesthetic and (VAS) was used to relief at the 3 month time point (P<0.05). The Trial steroid at the beginning of the determine pain relief control group lost improvement by 1-year procedure. Then RF denervation of across the three groups follow-up (P=0.017). At three years follow- the facet joint capsule, or RF for up to 3 years post up, the joint capsule denervation group denervation of the medial dorsal procedure. maintained significant improvement branch supplying the facet joint. A (P=0.033) whereas the medial branch third (control group) had the denervation group lost its significant effect electrodes and thermocouple probe (P=0.479). Only the joint capsule positioned, but the RF current was denervation group kept significant never engaged. Patients were improvement (P=0.026) guaranteed that in the case they experienced no pain relief after the control treatment, a RF treatment would be offered. Prospective Trials 10 MacVicar J Prospective, 104 subjects Chronic neck pain Cervical medial branch Complete or at least 80% 74% and 61% of patients achieved a None outcome study treated with radiofrequency neurotomy relief of pain for at least successful outcome. Relief lasted 17–20 radiofrequency 6 months with complete months from the first RFN, and 15 months neurotomy restoration of activities for repeat treatments. Allowing for repeat of daily living, no need treatment, patients maintained relief for a for any further health median duration of 20–26 months, with some care, and return to work. 60% still having relief at follow-up.

11 Masala S Prospective 92 subjects Facet joint syndrome Pulsed radiofrequency medial Pain improvement Mean pain reduction, comprising all FBSS None study received branch dorsal ramus neurotmy (reduction of pain at 1, 6 and non-FBSS patients and patients double medial branch and 12 months) and treated, was statistically significant neurotomy, 12 quality of life visual (p<0.005). VAS before treatment was mean with failed analog scale (VAS) and 8.2±2.0 SD, and at 1 year follow up was back surgery the Oswestry Disability mean 2.1±0.5 SD. The ODI before treatment syndrome Index (ODI) was mean 48%±21% SD and at 1 year follow (FBSS) up was mean 26%±10% SD. 12 Tomé-Bermejo Prospective 86 subjects Chronic low back Percutaneous rhizolysis Reduction in lumbar pain Lumbar pain improved significantly (P = None F study facet joint pain and disability using the 0.0001). Oswestry Low Back Pain A total of 89% of patients experienced Disability Questionnaire significant relief from pain after rhizolysis, with this relief lasting 6 months or more in Page 18 of 178 Clinical Literature Review, Revision B Radiofrequency Facet Joint Denervation 09 December 2016 Page 19

Citation # Citation Type of Study # of Patients Etiology Intervention Primary Outcome Results and Clinical Outcome Complications or Adverse Effects (from Primary Measurements Appendix Author B) 66%, and a minimum of 1 year in 50% of cases. 13 Rambaransingh Prospective 104 subjects: Chronic neck or back Repeat radiofrequency neurotomy Pain Disability Pain intensity, pain frequency, and patient- None B study 73 (1st RFN) pain (RFN) Questionnaire-Spine specific disability measures were 73 (2nd RFN) (PDQ-S) significantly improved post-initial, second, 36 (3rd RFN) and third RFN. Moreover, there was no statistically significant difference among the PDQ-S scores post-RFN 1, 2, and 3. There was no statistical significance between the duration of pain relief post-RFN 1 and pain relief post-RFD 2.

Repeated cervical and lumbar RFN reduces pain and disability with equal effectiveness for approximately 10 months in patients with facetogenic chronic neck and back pain. 14 Lang J K Prospective 31 subjects (61 Chronic headaches Radiofrequency neurotomy Pain relief rated by VAS, Pain relief of at least 70% was observed in all n=31, numbness in the neck or occipital study radiofrequency (>12 months) due to verbal rating scale subjects. The mean duration of pain relief region decreasing over time. neurotomies): irritation of the (VRS), and numerical until recurrence of 50% of pre-procedure n=21, history zygapophysial joint rating scale (NRS): pain was 125.11 days (range 6-732 days ). n=1, burning dysesthesia over a coagulated of cervical C3/4 First day after treatment Duration of pain relief after radiofrequency facet (not requiring medical treatment) fusions recurrence of 50% of neruotomy in cervical fusions or fractures (followed by pre-coagulation pain was significantly longer than in patients with pesudoarthrosis arthritis (p < 0.005) ) n=4, history of traumatic cervical fractures (not fused) n=6, history of arthritis 15 Iwatsuki K Prospective 21 subjects Persistent low back Laser denervation to the dorsal Greater than 70% pain One year after laser denervation, 17 patients Post-procedure discomfort in an unspecified study pain surface of the facet capsule reduction after 1 year (81%) experienced complete or greater than number of subjects 70% pain reduction (P<0.01)

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Citation # Citation Type of Study # of Patients Etiology Intervention Primary Outcome Results and Clinical Outcome Complications or Adverse Effects (from Primary Measurements Appendix Author B) 16 Shabat S Prospective 58 subjects Chronic mechanical Radiofrequency ablation of the Clinically significant Pain relief at: Minor transient discomfort and burning pain study received low back pain medial branch of the dorsal ramus reduction in pain at 1, 3 1 month: 74% were reported in 19% (n=11) of patients. radiofrequency and 6 months and 1 year 3 months: 66% heat lesion measured by a visual 6 months: 57% Spontaneously resolved at 1 month post analaog scale (VAS) and 12 months: 52% procedure Oswestry Disability Index (ODI) Oswestry Disability Index was significantly improved at 1 year (P <0.05) 17 Speldewinde Prospective 282 patients Zygapophysial joint Radiofrequency thermal neurotomy At least 50% reduction of An average of 72% subjects obtained an Similar adverse side effects were noted in 25 study received 379 and sacroiliac joint pain, for at least 2 average of 86% reduction in pain for a period of the 272 successful procedures (9.1%), and procedures pain months, in the region of 12 months or more of ongoing relief. The in 14 of the 110 unsuccessful procedures relevant to the joint or results were highly significant by t-test, and (12.7%). No infections were reported. joints treated the effect size was large as determined by the Cohen’s d. Clinical outcomes were In those patients with a successful outcome, associated with highly significant the side effects were increased pain (n=10), improvements in psychological distress and or headache (n=5), or neuralgia (n=6), nausea physical function. (n=3), numbness (n=5), spasms (n=2), disturbed balance (n=1). Often, these symptoms were short-lived, but sometimes they persisted. Retrospective Trials 18 Klessinger S Restrospective 34 patients Chronic zygapophysial Treatment with radiofrequency 50% pain reduction 58.8% of patients achieved at least 50% None audit were treated joint pain neurotomy enduring for 6 months reduction in pain for a minimum of 6 months Practice chart with review radiofrequency neurotomy

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Citation # Citation Type of Study # of Patients Etiology Intervention Primary Outcome Results and Clinical Outcome Complications or Adverse Effects (from Primary Measurements Appendix Author B) 19 Schofferman J Retrospective 20 subjects Recurrence of lumbar Repeat treatment with Success rates and Second radiofrequency neurotomy: 85% None chart review 2 neurotomies pain after radiofrequency neurotomy duration of relief success, mean duration of relief was 11.6 (2 subjects) radiofrequency months, relief continuing in one. 3 neurotomies neurotomy (6 subjects) Third radiofrequency neurotomy: 94% 4 neurotomies success, mean duration of relief in nine of the (5 subjects) 15 was 11.2 months, relief continuing in six. 5 neurotomies Fourth radiofrequency neurotomy: 87.5% (3 subjects) success, mean duration of relief was 9 7 or more months, relief continuing in the other four. neurotomies (4 subjects) None of these differences significant. The frequency of success and durations of relief remained consistent after each subsequent radiofrequency neurotomy. 20 Kornick C Retrospective 92 subjects, Chronic low back pain Facet joint radiofrequency Complications within 8 1.0% overall incidence of minor 3 cases of localized pain > 2 weeks chart review 616 denervation weeks of procedure complications per radiofrequency site 3 cases of neuritic pain < 2 weeks radiofrequency No infection, new motor deficits or new lesions (116 Electrode placement within the L1 sensory deficits were identified. denervation transverse process and sacral ala procedures) 21 Haufe S Retrospective, 174 subjects: Facet joint disease Endoscopic facet debridement % change in facet-related 77%, 73%, and 68% of patients with Suture failure (2 subjects) observational, Cervical (45 pain as measured by cervical, thoracic, or lumbar disease, open label subjects) Visual Analog Scale respectively, showed at least 50% Thoracic (15 (VAS) at final follow-up improvement in pain. subjects) visit Lumbar (114 subjects) 22 Yilmaz C Retrospective 50 subjects Lumbar facet Lumbar facet joint neruotomy Pain, disability and 48% of patients received at least 70% None syndrome treatment satisfaction at reduction in pain and 85% obtained at least 12 months using VAS 60% reduction in pain at 12 months and EQ-5D

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Citation # Citation Type of Study # of Patients Etiology Intervention Primary Outcome Results and Clinical Outcome Complications or Adverse Effects (from Primary Measurements Appendix Author B) 46 Tsukasa Retrospective 55 subjects Chronic pain from the Radiofrequency neurotomy of facet The Japanese Orthopedic The patient success rate was 75% (41/55) at Two cases had minor postoperative Kanchiku Review fixed groove between joints. Electrode contact with the Association (JOA) 1 week, 71% (39/55) at 3 months, 60% complications, which were localized burning the mammillary and medial branch of the dorsal ramus scoring system for back (33/55) at 6 months, and 51% (28/55) at 12 pain lasting <1 week at the site of electrode accessory processes and denervation of this branch pain was used for clinical months after treatment. No significant insertion. (MA groove) confirmed by monitoring assessment. difference was observed in age, sex, duration compound muscle action potentials Improvement=excellent of illness, number of affected intervertebral (CMAPs) from the multifidus when the improvement joints, or preoperative JOA scores between muscle group on electrical rate was ≥70%, good the patients with excellent or good stimulation through an electrode. If when it was 40%–70%, improvement rates and those with poor CMAPs were not provoked at and poor when it was improvement. The results of this study 5mA, the cautery needle was <40%. In this study, indicated that this is a reliable method for judged to be improperly placed. excellent and good lumbar medial branch denervation and long- The cautery needle was held where improvement term pain relief. The CMAP monitor could CMAPs could be provoked at the rates=successful be useful as an objective index for facet lowest possible stimulus. The outcomes, and poor denervation. Therefore, this therapy is an reproducibility of symptoms improvement effective alternative for the treatment of confirmed and CMAPs recorded rates=unsuccessful chronic back pain because of lumbar simultaneously. After outcomes. intervertebral arthropathy that resists thermocoagulation, electrical conservative treatments and impacts daily stimulation of the same intensity living. applied and absence of CMAPs confirmed, completing the procedure. 47 Massimo Retrospective 30 subjects Chronic pain from the RF neurotomy on 30 patients; Cohort was selected due No aberrant activation of stimulators No adverse reactions were recorded due to Barbieri Review lumbar facet joints, study is reviewing for interference to the presence of detected; No AE were recorded due to electrical interaction or due to clinical events. intervertebral discs, or complication due to interference implanted medical electrical interaction or clinical events. sacroiliac joint and between RF neurotomy and devices. Adverse events peripheral nerves. implanted device associated with RF Mostly lumbar, a few ablation and implantable occipital nerve cases. device interference (pacemaker (PM), spinal cord stimulator (SCS) or implantable cardioverter- defibrillator (ICD))

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Citation # Citation Type of Study # of Patients Etiology Intervention Primary Outcome Results and Clinical Outcome Complications or Adverse Effects (from Primary Measurements Appendix Author B) Case Report 23 Osborne M Case report 1 subject Advanced lumbar Radiofrequency neurotomy to Safety guidelines for No atypical symptoms. Back pain relieved None spondylosis lumbar facet joints radiofrequency 70% for >6 months bilaterally neurotomy in patients with deep brain stimulators 24 Terao T Case report 1 subject Low back pain and RF denervation of lumbar facet Pain relief Lower back pain relief almost entirely, leg None intractible leg pain joint for back pain and spinal cord pain reduced approximately 50% stimulation for leg pain 25 Burnham R Case report 1 subject Low back and right Bipolar radiofrequency strip Pain relief Complete pain relief and restoration of 4 days of increased discomfort post- upper buttock pain for thermal lesions around the function for 16 months postprocedure procedure 16 years posterior pseudoarthrosis articular margin 26 Abbott Z Case report 1 subject Low back pain Radiofrequency neurotomy of the N/A Irreversible injury of non-target nerves New right leg pain and parasthesias due to medial branches of the dorsal rami L5 sensory radiculopathy treated with spinal (L3, L4 and bilateral L5) cord stimulator 27 Smith M Case report 1 subject Neck pain and Left C2, C2-3, C3 and C4 cervical N/A Post-procedural MRI revealed apparent Severe neck pain headaches medial branch radiofrequency paraspinal muscle abscess which after later denervation MRI may have represented post-procedure granulation tissue 48 David Walega Case Report 1 subject T1–4 medial branch Cooled radiofrequency ablation (C- Time to heal N/A Third Degree Burn: During lesioning of the nerve pain RFA) T2 MBN on the T3 transverse process, skin blanching 15 mm in diameter was noted around the introducer needle with patient complaints of severe, localized pain. Post procedurally the skin injury at this level worsened in appearance, with a 20 mm 9 4mm skin defect, which took nearly 5 months to heal.

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Systematic Literature Review 28 Falco F Literature 11 randomized Chronic low back pain Lumbar facet joint interventions Pain relief Evidence for radiofrequency neurotomy is N/A review trials and 14 Short-term relief: up to 6 good and fair to good for lumbar facet joint observational months nerve blocks for short- and long-term studies Long-term relief: 12 improvement months 29 Falco F Literature 4 randomized Chronic neck pain Cervical facet joint interventions Pain relief Evidence for cervical radiofrequency N/A review trials and 6 Short-term relief: up to 6 neurotomy is fair observational months Evidence for cervical medial branch blocks is studies Long-term relief: > 6 fair months 30 Falco F Literature N/A Facet Joint pain Cervical facet joint interventions Pain relief Evidence for radiofrequency neruotomy in N/A review Short-term relief: up to 6 the cervical spine is Level II-1 or II-2 months (Quality of evidence based on US Long-term relief: > 6 Preventative Services Task Force) months

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Citation # Citation Type of Study # of Patients Etiology Intervention Primary Outcome Results and Clinical Outcome Complications or Adverse Effects (from Primary Measurements Appendix Author B) 31 Atluri S Literature N/A Chronic thoracic facet Theraputic thoracic facet joint Pain relief All neuotomy studies were excluded from N/A review joint pain interventions Short-term relief: up to 6 analysis due to low methodological quality months Long-term relief: > 6 months

32 Boswell M Literature N/A Chronic facet- Theraputic facet interventions Intraarticular facet joint Evidence for short- and long-term pain relief: N/A review mediated spinal pain injections: Radiofrequency neurotomy of cervical and Pain relief lumbar medial branch nerves: moderate Short-term relief: < 6 Thoracic facet neurotomy: indeterminate weeks Moderate Long-term relief: > 6 weeks

Medial Branch Radiofrequency Neurotomy: Pain relief Short-term relief: up to 3 months Long-term relief: > 3 months

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Citation # Citation Type of Study # of Patients Etiology Intervention Primary Outcome Results and Clinical Outcome Complications or Adverse Effects (from Primary Measurements Appendix Author B) 33 Hooten W M Literature N/A Low back pain Radiofrequency neurotomy Outline the procedural Significant dissonance exists between the N/A review limitations of primary RF literature and the procedure that randomized controlled was actually performed in the three RCTs [1– trials 3]. This compromises any conclusions that can be drawn from the results of these trials.

34 Manchikanti L Literature N/A Chronic spinal pain N/A Body of evidence Lumbar spine: N/A review The evidence for therapeutic facet joint interventions is good for conventional radiofrequency, limited for pulsed radiofrequency

Cervical spine: The evidence for therapeutic cervical facet joint interventions is fair for conventional cervical radiofrequency neurotomy

Thoracic spine: The evidence for therapeutic thoracic facet joint nerve blocks is fair, limited for radiofrequency neurotomy

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Citation # Citation Type of Study # of Patients Etiology Intervention Primary Outcome Results and Clinical Outcome Complications or Adverse Effects (from Primary Measurements Appendix Author B) 35 Van Kleef M Literature 7 controlled Facet joint pain Radiofrequency treatment N/A RF treatment of the facet joints can provide Transient, localized burning pain and self- review studies intermediate-term benefit in carefully limiting back pain lasting longer than 2 selected patients weeks, each occurring with a frequency of 2.5% per procedure Meta-analysis: when including the 6 randomized controlled trials, RF was significantly better than placebo. Even when only the 2 trials without shortcomings were included, the difference in favor of RF treatment remained significant

36 Manchikanti L Literature N/A Low back pain Theraputic interventions Body of evidence Fair evidence for therapeutic radiofrequency N/A review neurotomy 37 Chou R Literature N/A Low back and Nonsurgical interventional Body of evidence Insufficient evidence from randomized trials One trial reported a case of mild, subjective, review radicular pain therapies to reach reliable conclusions regarding and transient lower limb weakness following radiofrequency denervation because the trials radiofrequency denervation. Two other trials evaluated technically inadequate procedures. found no difference in adverse events between radiofrequency denervation and sham, though radiofrequency treatment was associated with trends toward increased postprocedural pain. 38 Datta S Literature N/A Chronic low back pain Lumbar facet joint interventions Pain relief The indicated level of evidence for N/A review Short-term relief: up to 6 therapeutic lumbar facet joint interventions is months Level II-2 or II-3 evidence for Long-term relief: > 6 radiofrequency neurotomy months 39 Cetas J Literature N/A Nonmalignant pain Destructive procedures Quality of evidence Modest long-term improvement in pain N/A review scores was reported after radiofrequency rhizotomy for lumbar facet syndrome. 40 Carragee E Literature N/A Neck pain Percutaneous injections and Body of evidence Radiofrequency neurotomy is not supported N/A review surgical interventions by current evidence.

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Citation # Citation Type of Study # of Patients Etiology Intervention Primary Outcome Results and Clinical Outcome Complications or Adverse Effects (from Primary Measurements Appendix Author B) 41 Markman J Literature Two Spinal pain Radiofrequency neurotomy 50% reduction in pain or Improvement in disability and reduction in Minor complications at a rate of 1% per review prospective, >2 point reduction on opioid use. lesion site double- numeric rating scale blinded, High placebo-responder rate which could Localized pain >2 weeks (0.5%) randomized, reduce the likelihood of demonstrating controlled statistical superiority. trials 42 Cohen S Literature Five placebo- Lumbar zygapophysial Radiofrequency denervation Varies In carefully selected patients, radiofrequency Transient numbness and/or dysthesias, rare review controlled joint pain denervation is a treatment option burns, <5% neuritis studies have been conducted evaluating radiofrequency denervation for l-z joint pain 43 Boswell M Literature N/A Chronic low back pain Interventional techniques Quality of evidence The evidence for medial branch neurotomy is Painful cutaneous dysesthesias, increased review moderate pain due to neuritis or neurogenic inflammation, anesthesia dolorosa, cutaneous hyperesthesia, pneumothorax, and deafferentation pain 44 Murtagh J Literature N/A Chronic low back pain Radiofrequency neurotomy Quality of evidence Four systematic reviews reached divergent Painful cutaneous dysesthesias, neuritis or review conclusions; two found moderate efficacy, neurogenic inflammation pain, anesthesia one found strong evidence for short- and dolorosa, cutaneous hyperesthesia, long-term pain relief and one found pneumothorax, and deafferentation pain, conflicting evidence on the short-term effect. treatment-related pain, transient neuropathic pain, transient leg pain, dysesthesia, and subjective leg weakness

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Table 3b – Summary of citations using rotational and tissue removal devices (results of literature searches 5-6) Citation # Citation Type of # of Intervention Anatomical Visual Field Follow- Primary Outcomes Results and Clinical Outcome Complications and (from Primary Study patients and Device Location of or Up Measurements Adverse Events Appendix Author and Used Procedure Percutaneous B) Year 50 Hiroaki Prospective 92 Comparison of C3-C7 Visual Field >1 year Surgical duration, blood loss, Two of the 46 cases in the open-door group were There were no Nakashima, Randomized the surgical perioperative complications, excluded from the study because they did not complete perioperative complications 2014 results between neurological assessment using the a 1-year follow-up assessment. The remaining cases in open- and Japanese Orthopedic Association both groups were all followed up at least 12 months French-door score, and recovery rate. Radiological after surgery. The mean follow-up period was 29.3 laminoplasty. evaluations included assessment of months in the French-door group and 28.4 months in Device was not the cervical lordotic angle and the open-door group. There were no significant described. cervical range of motion. In addition, differences in sex percentages, age range, types of the ratio of postoperative spinal diseases, or preoperative JOA scores between the 2 lamina opening was evaluated by groups, there were no significant differences between magnetic resonance imaging. the 2 groups for postoperative JOA scores. The differences between pre- and postoperative cervical lordotic angles were not statistically significant, The mean decrease in the cervical lordotic angle (from preoperative to postoperative) was significantly greater in the open-door group (Frenchdoor group, 3.0° ± 4.0°; open-door group, 5.6° ± 3.9°; P = 0.003). Regarding preoperative cervical ROM, no significant differences were found ; however, postoperative cervical ROM was significantly lower in the open-door group (19.3° ± 5.9°) than in the French-door group (26.0° ± 8.7°; P < 0.001). The rate of decrease in the cervical ROM was significantly higher in the open-door group (38.4% ± 11.4%) than in the French-door group (26.0% ± 14.4%; P < 0.001). The decrease in cervical ROM occurred primarily during cervical extension; the postoperative extension angle and the rate of decrease in the extension angle were significantly worse in the open- door group (postoperative extension angle: Frenchdoor group, 14.1° ± 8.7°; open-door group, 7.9° ± 3.5°; P < 0.001; rate of decrease in extension angle: French-door group, 24.9% ± 23.6%; open-door group, 43.8% ± 20.8%; P = 0.001). The spinal canal enlargement rate was significantly greater in the open-door group than in the French-door group (French-door group, 213.5% ± 69.8%; open-door group, 256.6% ± 77.6%; P = 0.007). The postoperative spinal lamina/vertebral body ratio was significantly higher in the open-door group than in the French-door group (French-door group, 74.5% ± Page 29 of 178 Clinical Literature Review, Revision B Radiofrequency Facet Joint Denervation 09 December 2016 Page 30

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Citation # Citation Type of # of Intervention Anatomical Visual Field Follow- Primary Outcomes Results and Clinical Outcome Complications and (from Primary Study patients and Device Location of or Up Measurements Adverse Events Appendix Author and Used Procedure Percutaneous B) Year 51 Youn-Kwan Park, Retrospective 79 The study sought Cervical Visual Field 12 months Time-dependent changes in hinges A total of 125 CT scans of 79 patients were available Hinge Fracture (HF) 2012 Review to evaluate the post surgery observed on computed tomography (Table 1), of 32 patients at 1 week after surgery, of 52 status and time (CT) were used to measure the patients at 4 months after surgery, in 20 patients at 1 course of bony radiological outcome. the Japan year, and in 21 patients at 2 years. the fixation that healing of the Orthopedic Association (JOA) score, open-door laminoplasty provides on the open side may hinge gutter and Neck Disability Index (NDI) and 0- to not be sufficiently stable to allow successful primary to determine the 10-point visual analog scales for arm healing. The probability of delayed fracture was closely effect on (VASa) and neck (VASn) pain were associated with the initial status of the hinge (p<.0001, postoperative successfully collected before and 12 chi-square). Delayed fractures developed mainly in the clinical course of months after surgery. hinges of C4 (50–57%) and C3 (45–47%), with relatively plate-only, open- few developing in the other levels (C5 and C6). For door cervical interpreter reliability, the kappa coefficients for hinge laminoplasty. A 2- status at each observation (1 week, 4 month, and 1 year mm cutting burr or later) were 0.6, 0.77, and 0.67, respectively. Kappa was used on the coefficients of 0.6 to 0.77 suggest good agreement open side and a among the observers. After surgery, the JOAs and VASa 3-mm burr on the were significantly improved, but the VASn and NDI were hinge side. largely unimproved. The mean rate of recovery for the JOA score was 53 +/- 25%. The decrease in cervical curvature after surgery was small, but the difference was statistically significant. Regarding the VASn, approximately two-thirds of patients experienced an improvement. However, 28 patients (39%) reported worsening, and 8 of them (11%) worsened by more than 3 points. A similar number of patients (36%) reported worsening of the NDI, and 17% worsened by more than 6 points. The worsening of VASn was weakly but significantly correlated with C2 or C7 involvement (p=.013, rs=0.29) and the numbers of HF (p=.033, rs=0.25). However, the worsening of NDI was not significantly correlated with either of them (p=.26 and .13,respectively). Compared with patients with 2 HFs or less (n=58), patients with 3 or more (n=15) experienced significant worsening of both VASn and NDI (p=.006 and .018, respectively). Additional attention should be paid to the hinged side to prevent delayed fracture in the early postoperative period and to reduce postoperative axial pain.

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53 Riu Gao, 2011 Retrospective 75 Posterior Thoracic Visual Field The mean Modified Japanese Orthopedic Clinical Features: The mean number of involved levels None discussed Review laminectomy was follow-up Association (JOA) scale and the was 4.6, with a range from 3 to 10. Of these patients, performed in all was 35.7 recovery rate. 73.3% presented with contiguous OLF, whereas 26.7% patients for months (12– showed noncontiguous OLF. Of the total 345 ossified thoracic 96 months) levels, the most common involved levels were T10/T11 myelopathy (15.4%), T9/T10 (13.3%), and T11/T12 (12.5%). Of these caused by 75 patients, the most common involved thoracic areas multilevel (three were lower thoracic spine (17 patients, 22.7%) and or more levels) middle-lower thoracic spine (17 patients, 22.7%). ossification of the Neurological assessment and surgical results: The ligamentum myelopathy was classified as mild (JOA score >=7), flavum (OLF) . moderate (JOA score 4–6), or severe (JOA score <=3). Of The spinous the patients, 37.3% had mild myelopathy and 53.3% processes were had moderate myelopathy, whereas 9.3% had severe resected during myelopathy. The mean preoperative JOA score was 5.8 the operation, +/- 1.7, ranged from 3 to 9. The mean JOA score at the and end of follow-up was 8.2 +/- 2.1 (3–11). The recovery laminectomies rate was 51.2% +/- 28.0%. No improvement or were performed symptom aggravation was found in 7 patients, and a by using a high- recovery rate of more than 50% was observed in 40 speed drill. patients. Postoperative JOA score increased significantly (p=.000). Univariate analysis revealed that gender, age, intramedullary signal change, shape of OLF, type of OLF, and combined spinal disorders were not related to the surgical outcome. However, patients with long duration of symptoms (>24 months), long levels involved (>=5), or low preoperative JOA score (<=3) were significantly prone to have poor surgical outcomes. Furthermore, multiple regression analysis showed that preoperative duration of symptoms and preoperative JOA score were important predictors of surgical outcome.

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Citation # Citation Type of # of Intervention Anatomical Visual Field Follow- Primary Outcomes Results and Clinical Outcome Complications and (from Primary Study patients and Device Location of or Up Measurements Adverse Events Appendix Author and Used Procedure Percutaneous B) Year 54 Bohdan W. Retrospective 45 Mild lumbar Percutaneous 1 week, 6 Outcome measures included the Patients experienced a statistically significant No major device or Chopko, 2013 Review percutaneous months, and Visual Analog Scale (VAS), Oswestry improvement in VAS from an average of 7.2 (95% intraprocedural adverse lumbar 1-year Disability Index, and Zurich confidence interval [CI] ± 0.6) at baseline to a mean of events were reported at the decompression, Claudication Questionnaire. 4.8 (95% CI ± 0.8) at 2-year follow-up, an improvement time of treatment, or at any the mild of 2.4 points (ANOVA, P < 0.0001). The Responder time during 2-year follow- technique uses a group improved from an average of 7.9 (95% CI +/- up. dorsal approach 0.64) at baseline to a mean of 4.1 (95% CI +/- 0.96) at 2- to remove small year follow-up, a pain reduction of nearly 50% (3.8 portions of points). Improvement from baseline at each interim ligament and follow-up was found to be statistically significant lamina. Mild (Turkey HSD test, P<0.01). ODI values for the cohort device (Vertos population showed statistically significant improvement Medical Inc., from baseline average of 48.4 (95% CI +/- 4.4) to an Aliso Viejo, CA) average at year 2 of 39.8 (95% CI +/- 5.6), improving 8.6 points (ANOVA, P<0.0001). ODI values for the Responders showed significant improvement from a baseline average of 50.5 (95% CI +/- 5.33) to an average at year 2 of 38.9 (95% CI +/- 7.35), an improvement of 11.6 points. Similar to VAS results, ODI improvement from baseline at each interim follow-up was found to be statistically significant (Tukey HSD test, P<0.01). All ZCQ domains showed statistically significant improvement at 2-year follow-up, including the Physical Function domain (P=0.0006), and both the Pain subdomain (P=0.0001), and the Neuroischemic subdomain (P=0.0002). Further, the overall Symptom Severity scale was significantly improved at 2 years compared with baseline (P<0.0001).

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56 Cort D. Lawton, Retrospective 38 Patients operated Cervical Percutaneous Patients questionnaires consisting of a visual The mean 1 year follow-up scores all showed One complication was 2014 Review with on for Cervical were analog scale for the neck (VASN) and statistically significant improvements: NDI (P = 0.0019), reported in this study prospective microendoscopic followed for arm (VASA), and a neck disability VASN (P = 0.0017), VASA (P <= 0.0001). Similar results consisting of duratomy, questionnaires foraminotomy an average index (NDI) form. Operative time, were seen at 2-year follow-up: NDI (P = 0.0011), VASN which required no further (CMEF) or of 24.47 estimated blood loss, and (P = 0.0022), and VASA (P <= 0.0001); and at 3- to 6- intervention. posterolateral 12.84 hospitalization stay also were year follow-up: NDI (P = 0.0015), VASN (P = 0.0200), and disk herniation in months collected. VASA (P = 0.0034). The average operation time, the cervical spine, (range, 8-61 hospitalization stay, and estimated blood loss were Cervical months) 154.27 +/- 26.79 minutes, 21.22 +/- 14.23 hours, and microendoscopic 27.92 mL, respectively. diskectomy (CMED). A drill with a long endoscopic bit is used.

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58 Robert M. Levy, Retrospective 373 Percutaneous Lumbar Percutaneous 1 yr Oswestry Disability Index scores were Subjects from 5 studies (NCT00956631, NCT01082159, no reports of major device 2012 safety review lumbar used to document baseline functional NCT01076244, NCT00995371, and NCT00749073) were or procedure-related decompression disability, and visual analog scale combined from 31 centers. There were no major adverse events, and there (Mild device, values deﬁned the intensity of device- or procedure-related AEs and no mortality in were no mortalities. Vertos Medical baseline back and leg pain. Treatment any of the studies compared. Inc., Aliso Viejo, outcomes of patients who reached 1- CA) year follow-up were also included.

59 Memduh Retrospective 80 Single posterior Lumbar Visual Field 6 mo, 1 yr Oswestry Disability Index (ODI) The improvement from baseline to both 6th and 12th 10 procedure related Kaymaz, 2011 Review decompressive month in mean ODI scores was statistically significant complications including laminectomy, (p<.0001). Change in baseline ODI scores at the end of wound hematoma (n=5), Midas Rex drill the 6th month did not significantly differ between additional neurological (Medtronic) patients regarding number of levels requiring surgery deficit (n=2) and (p=0.895), severity of stenosis (p=0.070), preoperative unintended dural laceration ASA score (p=0.631), patient gender (p=0.754) or body (n=2) mass index (p=0.874).

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61 Nagy Mekhail, Prospective 40 Percutaneous lumbar Percutaneous 1 year The Pain Disability Index (PDI) and At twelve months, both PDI and Roland-Morris showed No significant device- or 2012 Non- lumbar Roland-Morris Disability significant improvement of 22.6 points (ANOVA, P < procedure related adverse Randomized decompression Questionnaire. Pre- and post 0.0001) and 7.7 points (ANOVA, P < 0.0001), events were reported. (Mild device, procedure Standing Time, Walking respectively. Walking Distance, Standing Time, and VAS Vertos Medical Distance, and Visual Analog Score improvements were also statistically significant, Inc., Aliso Viejo, (VAS) were also monitored. increasing from 246 to 3,956 feet (ANOVA, P < 0.0001), CA) 8 to 56 minutes (ANOVA, P < 0.0001), and 7.1 to 3.6 points (ANOVA, P < 0.0001), respectively. Tukey HSD test found improvement in all 5-outcome measures to be significant from baseline at each follow-up interval.

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65 Masaaki Prospective 520 double-door Cervical: C2-C3 Visual Field >1 year: The The severity of myelopathy before The mean JOA score was 10.4± 2.8 points 9 patients (1.73%) had Machino, 2013 Non- laminoplasty in to C7-T1 average and after surgery was evaluated preoperatively and 13.6± 2.5 points at ﬁnal follow-up. intraoperative dural tear, Randomized patients with follow-up according to Japanese Orthopedic The mean achieved JOA score was 3.3± 2.1 points which required repair, and 2 cervical period was Association for cervical myelopathy postoperatively whereas the mean RR of the JOA score patients (0.38%) showed spondylotic 33.3 ± 15.7 (JOA score). Functional improvement was 51.2± 29.0%. On the basis of RR, the patients were deep infection, which myelopathy months. was expressed by the recovery rate classiﬁed into the following 5 groups: 131 patients developed under the deep (CSM). The (RR) of the JOA score. (25.2%) in excellent, 156 patients (30.0%) in good, 152 fascia and muscles laminae is cut patients (29.2%) in fair, 74 patients (14.2%) in postoperatively. using a high- unchanged, and 7 patients (1.3%) in worse (reasons speed drill (no that were unrelated to CSM). further device description).

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67 Sanghamitra Single site 27 Mild lumbar lumbar Percutaneous 6 months Visual Analog Scale, Oswestry At 6-months, Visual Analog Scale showed a statistically There were no significant Basu, 2012 prospective decompression Disability Index, and Zurich significant improvement of 5.2 points (2-tail t test, mild device or procedure- procedure (Mild Claudication Questionnaire (ZCQ) P<.0001). Oswestry Disability Index also showed related adverse events device, Vertos statistically significant improvement of 24.0 points (2- observed or reported. Medical Inc., tail t test, P<.0004). Improvement in all ZCQ domains Aliso Viejo, CA) was statistically significant (2-tail t test, P<0.001), and the average ZCQ Patient Satisfaction score was 1.86 at 6-month follow-up

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70 Yasuyuki Case Study 1 posterior Far-out Visual Field 1 yr None 29 yo male subject presented with right L5 nerve root No adverse events or Miyoshi, 2011 decompression foraminal compression and significant pain from far-out foraminal complications reported for radicular pain stenosis of the stenosis due to osteophyte formation at sacral/L5 caused by far-ou L5 spinal nerve foramina. Osteophyte was removed using high-speed foraminal drill and rongeurs and pain immediately subsided with stenosis. High full pain relief 1 month post surgery. He remained speed drill was symptom free at 1 year post surgery used.

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73 Bohdan Chopko, Prospective 75 Percutaneous Lumbar spine Percutaneous 6-weeks Visual Analog Score (VAS), Oswestry Significant improvement from baseline to 6-week No major device or 2010 Non- lumbar Disability Index (ODI), Zurich follow-up for all primary outcomes: VAS, ODI, ZCQ procedure related Randomized decompression Claudication Questionnaire (ZCQ), (P<0.001). SF-12v2 was significantly improved at 95% complications reported for (Mild device, and SF-12v2 CI. this study. Minor Vertos Medical complications were not Inc., Aliso Viejo, recorded. CA)

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75 Timothy R. Deer, Retrospective 90 Percutaneous Lumbar spine Percutaneous None Adverse events or complications Of 90 procedures reviewed, there were no major None 2009 Review lumbar device or procedure related adverse events or complications related to the devices decompression or procedure. No incidents of dural puncture or tear, (Mild device, blood transfusion, nerve injury, epidural bleeding, or Vertos Medical hematoma were observed. Inc., Aliso Viejo, CA)

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77 Murat Kutlay, Prospective 18 A modified lumbar Visual Field The mean Patients were also reviewed for At the latest follow-up examinations, outcomes using There were no 2008 Non- combined follow-up evaluation of their final neurological the Macnab classification were excellent in 13 patients intraoperative or Randomized intertransverse– period was status according to the Macnab (72.2 %), good in four (22.2%) and fair in one (5.5%). postoperative interlaminar 62.6 months criteria. Outcome was defined as The mean preoperative radicular pain VAS score complications, except approach was the (range 36–96 excellent (no pain and full recovery of improved from 7.9 to 1.2 postoperatively. transient dysesthesia in one surgical months). motor function), good (occasional (5.5%) patient. intervention for symptoms and partial motor lateral lumbar recovery), fair (moderate disc herniation radiculopathy or findings that caused occurring into the patient to curtail or modify work and/or outside or leisure activities) and poor the intervertebral (unchanged or worse). Radicular pain foramen. A high was assessed using a visual analogue speed drill was scale (VAS) ranging from 0 to10 in used. both the preoperative and postoperative period along follow-up time.

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79 Jwo-Luen Pao, Prospective 60 enrolled, 53 Double-door Cervical Percutaneous Average Clinical outcomes were evaluated ODI scores improved from 64.3 ± 20.0 to 16.7 ± 20.0 at There were 11 surgical 2008 Non- functionally laminoplasty in follow-up with the Oswestry disability index final follow up. The average improvement was 47.6 ± complications: dural tear in Randomized evaluable patients with period of (ODI) and the Japanese Orthopedic 27.5. Forty-three patients (86.0%) got signiﬁcant 5, wrong level operation in cervical 15.7 months Association (JOA) score. improvement. The JOA score improved from 9.4 ± 6.1 2, and transient neuralgia in spondylotic (12–24) to 24.2 ± 6.0. The improvement rate was 73.9 ± 30.7% 4 patients. No wound- myelopathy and 40 patients (80%) had good or excellent results. related complication was (CSM). The Success of treatment was achieved in 45 patients (90%). noted. laminae is cut Of the 53 patients who completed follow-up, 45 using a high- patients (84.9%) stated they were satisﬁed with the speed drill (no treatment result. further device description).

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80b Halit Ҫavuşoğlu, Prospective 100 unilateral Lumbar spine Visual 3 months Oswestry Disability Index (ODI) and Mean ODI scores decreased by 16.92 points by 3 mo 3 incidental durotomies 2008 Non- laminectomy and 4-7 Short Form 36 Health Survey (SF-36) F/U and an additional .20 points at 4-7 year F/U (p < occurred in laminectomy Randomized versus years 0.0001) in laminectomy group and 17.4 points at 3 mo group and 2 in laminotomy laminotomy, F/U and then increased by .24 points at 4-7 year F/U for group. kerrison rongeur laminotomy group. No significant difference between or high-speed either group in regards to pain during walking, standing, burr and sitting positions identified. No significant difference between any SF-36 domains found, but all significantly improved (with the exception of emotional role).

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82 David S. Rosen, Prospective 57 Minimally lumbar Percutaneous median demographic information, pre- and Fifty patients had sufﬁcient outcomes data for analysis. No major complications or 2006 Non- invasive lumbar follow-up postoperative Visual Analog Scale The mean back VAS pain score was 5.7 before surgery perioperative deaths Randomized spine period, 7 pain scores, Oswestry Disability Index and decreased to 2.2 after surgery (P < 0.001).Visual occurred, although one decompression, mo; mean scores, and Short-Form 36 scores Analog Scale pain scores decreased from 5.7 to 2.2 for patient died of pneumonia 8 device not follow-up back pain and from 5.7 to 2.3 for symptomatic leg pain months after surgery. There described period, 10 (P < 0.05). The mean ODI was 48 before surgery and were no wound infections. mo improved signiﬁcantly to 27 after surgery (P < 0.001). The most common The mean SF-36 Physical Function score was 26 before complications were urinary surgery and increased to 48 after surgery (P < 0.001). retention and transient The longitudinal analysis demonstrated durability of delirium, which were the symptom relief. The mean preoperative SF-36 typically associated with Bodily Pain score was 28 and increased to 54 after postoperative narcotic use. surgery (P < 0.001). Both VAS and ODI results showed statistically significant change three months after surgery, and had no significant change after 3 months (P = 0.005 and P = 0.03 respectively), indicating results were long lasting.

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84 Claudius Thome, Prospective 120 Patients with a lumbar Percutaneous The Perioperative parameters and Surgical decompression resulted in a dramatic There were no 2005 Randomized diagnosis of minimum complications were documented. reduction of overall pain in all three groups (p < 0.001). perioperative deaths. Of all lumbar stenosis follow up of Symptoms and scores, such as visual Residual pain was lowest in Group 1 (VAS score 2.3 +/- surgically treated levels without 12 months analog scale (VAS), Roland–Morris 2.4 and 4 +/- 1 in Group 3; p < 0.05 and 3.6 +/- 2.7 in unintended durotomy herniated discs or was Scale, Short Form–36 (SF-36), and Group 2; p < 0.05). The Roland–Morris Scale score occurred in 3.2% (Group 1, instability were obtained in patient satisfaction were assessed improved from 17 +/- 4.3 before surgery to 8.1 +/- 7, two levels), 7% (Group 2, randomized to 94% of preoperatively and at 3, 6, and 12 8.5 +/- 7.3, and 10.9 +/- 7.5 (Groups 1–3, respectively; p five levels), and 11% (Group three treatment patients. months after surgery. < 0.001 compared with preoperative). Patient 3, eight levels). One wound groups (bilateral satisfaction was significantly superior in Group 1, with infection was noted in a laminotomy 3, 27, and 26% of patients unsatisfied (in Groups 1, 2, laminectomy-treated [Group 1], and 3, respectively; p = 0.01). patient after evacuation of unilateral an epidural hematoma laminotomy requiring a second [Group 2], and reoperation and antibiotic laminectomy therapy. [Group 3]). High- speed burrs and Kerrison rongeurs were used in all procedures.

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87 Klaus Galiano, Prospective 23 patients had Laminectomy for lumbar Not specified >18 months Comorbidity was assessed using the The mean of the Cumulative Illness Rating Scale for In 3 cases, a general state of 2005 Non- a total of 41 lumbar spinal Cumulative Illness Rating Scale for Geriatrics total score was 7.7 +/- 4.3, reﬂecting the mental confusion was Randomized laminectomies stenosis in Geriatrics. At follow-up, all patients normative comorbidity-values of octogenarians. At observed after surgery for (L2, n = 4; L3, n = octogenarians, completed a questionnaire containing follow-up, 4 patients had died. The Oswestry Disability several days but was fully 6; L4, n = 18; L5, device not the Visual Analog Pain Scale and the Index for the remaining patients was 36.4 +/- 28%. The reversible. One female n = 13), including described. Oswestry Disability Index. daily nonsteroidal anti-inﬂammatory medication had patient had a bladder 9 single-level, 9 decreased from 1.9 to 0.1 equivalent analgesic doses dysfunction, which required two-level, and 5 and the amount of morphine from 0.6 to 0.2 equivalent catheterization for 3 three-level narcotic doses. The Pain Score on the Visual Analog Pain months. We experienced no laminectomies Scale decreased from 85 to 39. After surgery no patient permanent morbidity or had claudication. At follow up the decrease in pain or perioperative death. analgesics consumption strongly correlated with an excellent ODI (r = -0.75, P < 0.001).

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89 Kyeong-Seok lee, Case Study 1 Transient Cervical, Not specified Approx. 6 To describe a case of transient The authors hypothesize that anesthesia below the Three hours after a second 2003 paraparesis after Thoracic months Paraparesis After Laminectomy in a level of the nipple (T4) and spontaneous recovery decompressive decompressive Patient with Multi-Level Ossification suggested that vascular compromise of the borderlines laminectomy of thoracic laminectomy, of the Spinal Ligament of the arterial supply by microthrombi might be region and laminoplasty of device not responsible for the paraparesis. lower cervical spine the described patient became paraplegic, without any changes in his vital signs. He could not move his toes and he was anesthetic below the level of the nipple. Surprisingly, he could move his legs spontaneously, about five hours later (eight hours after the second operation).

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92 Carl Lauryssen, Retrospective 67 Lumbar spinal lumbar Visual Field average of VAS for leg and back pain was used. In a subset of 16 patients (treated by the author) the Inadvertent durotomies 2010 Review stenosis 3.5 month VAS pain decreasing from a mean (range) of 7.5 (5– 8) occurred at 7 levels; 6 decompression follow-up before surgery to 1.7 (0 –5) after surgery at an average during access to the central surgery using a of 3.5 month follow-up. All 67 patients from this canal with traditional ﬂexible retrospective study have remained clinically stable and surgical instruments, and 1 microblade no patient has undergone additional surgery as of the at the axilla of the L5 nerve shaver system, last follow-up time point. root after introduction of iO-Flex (Baxano the shaver. Inc., San Jose, CA).

93 Carl Lauryssen, Literature 2011 Review included in article, not used here.

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Citation # Citation Type of # of Intervention Anatomical Visual Field Follow- Primary Outcomes Results and Clinical Outcome Complications and (from Primary Study patients and Device Location of or Up Measurements Adverse Events Appendix Author and Used Procedure Percutaneous B) Year 94 Masashi Takaso, Prospective 50 Modified spinous lumbar Visual Field The average A distinction was made between leg The average preoperative leg pain level was 6.7 (range, Intraoperative 2011 Non- process follow-up and back pain, each of which was 4–10). The average leg pain level was 1.0 (range, 0–2) at complications occurred in Randomized osteotomy period was scored subjectively for severity on the two years after surgery and the last follow-up was 0.7 two patients, both of which decompressive 6.7 years visual analogue scale (VAS). Walking (range, 0–2). At two years after surgery, 80% (40/50) of were dural tears (one by the procedure (range, five tolerance was described in terms of the patients reported that leg pain had resolved; 20% corresponding author and (MSPO) for to eight distance. CT scans were performed to (10/50) judged the pain to be better. At the last follow- one by a chief resident). All degenerative years) determine the fate of the up, 90% (45/50) of the patients reported that leg pain tears were a result of lumbar spinal osteotomised spinous process at had resolved; 10% (5/50) believed the pain to be better. Kerrison rongeur work and stenosis, device three months, six months, nine The average preoperative low back pain level was 1.5 repaired immediately not described months and 12 months after surgery (range, 0–3). The average low back pain level was 0.7 without clinical sequelae. and at the last follow-up. (range, 0–2) at two years after surgery and at the last No postoperative follow-up it was 0.5 (range, 0–2). At two years after complication occurred in surgery, 40% (18/45) of the patients reported back pain any of our series. There was was absent; 40% (18/45) believed the pain was no re-operation during the improved; 20% (9/45) stated no change in the level of follow-up period. pain. At the last follow-up, 60% (27/45) of the patients reported back pain was absent; 40% (18/45) believed the pain was improved. CT scans demonstrated the osteotomised spinous process united with the contralateral retained laminar bridge in 10% (5/50) of the patients at three months after surgery, in 80% (40/50) at six months after surgery and in 100% (50/50) at nine months after surgery.

95 Kiyoshi Ito, 2008 Prospective non- 12 Laminoplastic Cervical, Visual Field 5-10 months The purpose of the report is to The scalpel-type ultrasonic bone curette is useful for There were no major Randomized laminotomy and Thoracic, describe the effectiveness and cutting bone and effective for reconstruction of the procedure-related hemilaminotomy Lumbar surgical pitfalls of an ultrasonic bone laminae. Laminotomy with an ultrasonic bone curette is complications such as cord for removal of curette in laminoplastic laminotomy safe and minimally invasive. The width of the tip was injury. In 1 patient with the spinal cord and hemilaminotomy. narrow enough for resected laminae to be fused calcified dura mater tumor using the postoperatively, and spinal instability did not occur in associated with tumor, scalpel type all cases. To prevent dural tear, the authors recommend dural tear occurred. ultrasonic bone drilling laminae to make the bone thin as the first step, curette. A followed by cutting the remaining laminae using a bone SONOPET UST- curette especially in cases with calcified or tense dura 2001 ultrasonic mater. bone curette with HB-05S hand pieces (M and M Co, Ltd, Tokyo, Japan).

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97 Kyongsong Kim, Retrospective 6 Report on Cervical, Visual Field Not Description of patients who There were five instances of dural puncture and one None of the affected 2005 Review encountered Thoracic, Applicable underwent microscopic spinal spinal cord injury. All dural tears occurred when the patients developed operative spinal Lumbar surgeries using a high-speed drill and dura mater was aspirated into the tip of the SONOPET. postoperative clinical surgery the SONOPET instrument. The authors conclude that the transient spinal cord complications because complications injury occurred because the vibration emanating from cerebrospinal fluid leakage thought to be the SONOPET was transmitted directly to the spinal was avoided by appropriate attributable to cord. Some patients experienced damage to the closure. the use of the epidural venous plexus for similar reasons. The authors SONOPET suggest that to prevent dural tears and venous plexus (SONOPET OST- injury, cotton be placed between the SONOPET and 2001, Miwatec important structures. Furthermore, to avoid spinal cord Co. Ltd., injury, the SONOPET should be inserted horizontal with Kawasaki, Japan) the dura mater to avoid the direct transmission of vibrations emanating from the instrument to the spinal cord.

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Citation # Citation Type of # of Intervention Anatomical Visual Field Follow- Primary Outcomes Results and Clinical Outcome Complications and (from Primary Study patients and Device Location of or Up Measurements Adverse Events Appendix Author and Used Procedure Percutaneous B) Year 100 Kazuhiko Retrospective 204 Cervical unilateral Cervical Visual Field A subset of Postoperative complications and their Recovery rate of clinical symptoms was 62.1% at the Occurrence rate of Satomi, 2001 Review open-door 80 patients outcomes were examined clinically in final follow-up. Rates were 63.6% for cervical complications, such as laminoplasty were 204 patients, and causes of motor spondylosis, 87.1% for cervical disk herniation, and muscle weakness, deep followed for paresis were sought with 61.3% for ossification of the posterior longitudinal infection, closure of opened 5 years or postoperative computed tomography ligament. There was no significant difference between laminae, and others, was longer after myelography. Postoperative pathologies. Patient age younger than 60 years at the 10.8%. Muscle weakness (average, 8 improvement of clinical symptoms time of operation and less than 1 year’s duration of was observed in 7.8% of the years; range, was assessed by recovery rate symptoms before surgery were significantly associated patients. 5–17 years) calculated with the scores of the with recovery rate of clinical symptoms. At the final Japanese Orthopaedic Scoring System follow-up examination, average recovery rate from in 80 patients. symptoms was significantly lower (P< .0001) in patients 60 years or older (41.3%; range, 15.4–100%) than in patients younger than 60 years (76.3%; range, 12.5– 100%). The rate of recovery was also significantly lower (p=.0003) in the patients whose symptoms lasted 1 year or longer before surgery (53.2%, range, 15.4–100%) than in the patients whose symptoms lasted less than 1 year (79.1%; range, 28.6–100%). Recovery rate was not correlated with either preoperative function judged by the Japanese Orthopaedic Association score or spinal sagittal diameter.

101 E.H. Frank, 2003 Prospective 10 Lumbar spinal Lumbar Percutaneous Not This instrument allows one to The curved endoscopic Kerrison rongeur adequately fits No cerebrospinal fluid leaks Non- stenosis Applicable visualize and decompress structures into the lateral recess. It could be easily advanced or nerve root injuries Randomized decompression within the lateral recess that may through the foamenas bone/ligament was removed. occurred while using the surgery, a small have required more extensive The cured instrument allowed the entire recesses and instrument. curved Kerrison removal of portions of the facet foramen to be reached. The device allowed the rongeur that joints. ligamentum to be removed from underneath the bone contains a 10000- (facet joint) much more easily than by using an pixel endoscope operative microscope or magnifying loops. Suction was applied to keep the instrument lens clear and allowed suction removal of the material dissected without having to remove and reinsert the instrument.

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103 Rafid Al- Prospective 62 The Misonix Cervical, Visual Field Not specified To evaluate the use of the Misonix The clinical advantages of the MBS are a reduced There was one case of blood Mahfoudh, 2014 Non- Ultrasonic Bone Thoracic, lumbar Ultrasonic Bone scalpel in spinal incidence of iatrogenic durotomy and neural injury. loss greater than 500 ml Randomized Scalpel (MBS) surgery Almost two-thirds of cases (74%) were completed in (1.6%). There were four was used in an less than 2 h, and surgeons using the MBS did feel that iatrogenic dural lesions array of spinal overall it reduced the time spent on operating. Use of (6.5%), three of which were surgeries. the bone cutter appears to be associated with less as a result of bone punches blood loss. This was most apparent to the senior and one was caused by the authors during corpectomies: both cervical and MBS (1.6%). Two patients thoracic. In the latter, MBS also protects spinal cord developed wound infections blood supply by preservation of radicular arteries in (3.2%). spite of a wide trench decompression.

104 Kiyoshi Prospective 40 Expansive open- Cervical Visual Field up to 4.5 Recovery Rate as measured by: A recovery rate of 66%, calculated from pre- and post- There has been no case Hirabayashi, Non- door years Activities of Daliy Life (ADL) points = operative disability points in A.D.L., determined by the undergoing this procedure 1983 Randomized laminoplasty for (Postoperative condition - pre- Japanese Orthopaedic Association. The width of the in which postoperative cervical spinal operative condition/Normal condition spinal canal increased 3-4 mm on average when malalignment of the cervical stenotic - Preoperative condition) x 100. compared with the preoperative AP diameter on lateral spinal lateral curvature was myelopathy, air roentgenogram. The relationship between AP diameter noted. In two failed cases in drill using a widening and the clinical recovery rate showed that which the laminar doors did cutting burr, and widening of the AP diameter by approximately 4 or 5 not remain open, open-door a diamond burr in mm is sufficient for obtaining good operative results. laminectomies were done the final stage as reoperations.

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106 Lawrence D. prospective 59 subjects facet-sparing L2-S1 Visual Field Not specified Subject demographics, details of the Operative time, blood loss, demographics, and length of Three operative Dickinson, 2012 observational enrolled. A decompression procedure, and operation, including stay were similar to or less than that seen in the complications were study historical for subjects adverse events were collected. historical control; no statistical significance was found reported, all dural tears comparison diagnosed with Preoperative and postoperative except for that the iO-Flex System cohort had a (5.1%). These dural tears cohort (n=133) lumbar spinal computed tomography scans and significantly shorter length of stay than the SPORT occurred before was selected stenosis were plain radiographs were obtained from cohort (P < 0.0001). As observed in the subset of introduction of the flexible from the Spine recruited into this a subset of 12 subjects and patients who had a CT scan there was a statistically decompression system. Patient study. Subjects quantitatively assessed for bone significant increase in mean widest foraminal width Outcomes underwent removal and preservation of from 7.9 (± 1.4 SD) preoperative to 8.3 mm (± 1.5 SD) Research Trial decompression stabilizing structures. post operative; P = 0.015. The mean subarticular space (SPORT) with the iO-Flex diameter significantly increased from 5.3 to 5.9 mm System (Baxano (11.2%, P = 0.016) post procedure. The superior facet Inc., San Jose, cross-sectional area showed a significant decrease of CA), a flexible 8.4 mm square (5.8%, P = 0.001) postoperatively. The microblade data suggests that decompression with the flexible decompression microblade shaver system is technically effective and system. tissue sparing.

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7.4. Narrative Summary of Included Literature

7.4.1. Randomized Controlled Trial (RCT) Citation #1 Lakemeier et al randomized 56 adult subjects (52 included in analysis) with Lumbar Facet Joint (LFJ)-related low back pain for ≥24 months with at least 50% pain reduction after test injection of local anesthetics into the L3/L4-L5/S1 LFJs. The groups received either steroid injection (26 subjects, mean age 56.3 +/- 10.8, 38.5% female) or radiofrequency (RF) denervation (26 subjects, mean age 57.6 +/- 12.8, 34.6% female). 20-G curved RF needles with 100-mm active tips (BMC RF Cannula; Baylis Medical) were placed at the site of the dorsal ramus medial branch of the relevant L3/L4-L5/S1 LFJs and placement was confirmed. In the steroid injection arm, 3 mg of betamethasone was injected. In both arms, the RF probe was inserted into the cannula and the denervation process (80° for 90 seconds) was begun, but in the steroid injection arm, the electrodes were not connected to the pain generator device (Baylis Medical Pain Management Generator 115V; Baylis Medical). Health status was measured using the Roland-Morris Questionnaire (RMQ) at baseline and 6 months. The RMQ improved in both groups; however, there was no significant (P = 0.90; 95% CI, −3 to 4) difference between the 2 groups. No major adverse events were reported. The authors concluded that there was no significant difference in pain relief and functional outcome between intraarticular steroid injection and RF after 6 months. Citation #2 Civelek et al randomized 100 adult subjects (70.8% female) with a mean age of 56.5 (+/- 17.7) with chronic low back pain not responsive to traditional conservative treatment to either facet joint injection (FJI) (50) or facet joint radiofrequency (FJRF) denervation (50). Subjects randomized to FJI were treated with a medial branch block of the posterior primary ramus with 1 cc of methylprednisolone acetate (40 mg) (diluted with 1 cc SF) combined with 2 cc bupivacaine hydrochloride (diluted with 2 cc SF). The FJRF arm was treated with radiofrequency denervation at 80° C for 120 seconds. Treatment outcomes were measured using the Visual Numeric Pain Scale (VNS), North American Spine Society (NASS) patient satisfaction questionnaire and (Euro-QOL in 5 dimensions) EQ-5D. In early post-op VNS, the FJI group showed better results, however at 1 month, 6 months and 1 year, FJRF showed better results (p<0.001). NASS patient satisfaction scores were not significantly different in the 1st month (p=1) and 6th month (p=0.13) follow-ups, however there was significant difference at the 12th month (p=0.04). There was no significant difference with respect to 1st month (p=0.17), 6th month (p=0.22) and 12th month (p=0.11) post-procedure follow-ups in EQ- 5D. Rare complaints of superficial burns and burning-like sensation in the lesion-performed region and two cases of increase in severe back pain were reported and resolved after 6-8 weeks. The authors concluded that the success rate seems to be significantly better in FJRF. In the short term, FJI seems to be more effective than FJRF but in mid-term follow-up FJRF had more satisfying results than FJI. Citation #3 Cohen et al randomized 151 adult subjects with suspected lumbar facetogenic pain to three groups. Group 0 (51 subjects, mean age 41.0 (range 22.0-72.0), 39.2% female) received radiofrequency denervation based solely on clinical findings; group 1 (50 subjects, mean age 44.0 (range 23.0-66.0), 48% female) underwent denervation contingent on a positive response to a single diagnostic block; and group 2 (50 subjects, mean age 41.0 (range 26.0-73.0), 46% female) proceeded to denervation only if they obtained a positive response to comparative blocks done with lidocaine and bupivacaine. Denervation was performed on the L5 dorsal rami using 20-gauge curved radiofrequency needles with 10-mm active tips (BMC RF Cannula; Baylis Medical) at 80° C for 90 seconds using a radiofrequency generator (Electrothermal 20S Spine System; Smith and Nephew, Andover, MA; Baylis Medical Pain Management Generator 115V; Baylis Medical; or Radionics RF Lesion

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Generator System, Model RFG-3C; Radionics, Valleylab). A positive outcome was predesignated as 50% pain relief coupled with a positive global perceived effect persisting for 3 months. In group 0, 17 patients (33%) obtained a successful outcome at 3 months versus eight patients (16%) in group 1 and 11 (22%) patients in group 2. Denervation success rates in groups 0, 1, and 2 were 33, 39, and 64%, respectively. Pain scores and functional capacity were significantly lower at 3 months but not at 1 month in group 2 subjects who proceeded to denervation compared with patients in groups 0 and 1. The costs per successful treatment in groups 0, 1, and 2 were $6,286, $17,142, and $15,241, respectively. Few complications were noted. Two patients, one each in group 0 and 2, experienced significant worsening (2-point increase in numerical rating scale pain score at rest and 4 point increase in Oswestry Disability Index score) back pain 1 month after denervation. One patient experienced the new development of radiating pain into the lower leg at the first follow-up visit, which was not accompanied by corresponding magnetic resonance imaging pathology. These symptoms were all resolved by 3 months.The authors concluded that, using current reimbursement scales, proceeding to radiofrequency denervation without a diagnostic block is the most cost- effective treatment paradigm. Citation #4 Dorogowski et al randomized 45 adult subjects (48.8% female) with a mean age of 66.4 +/- 8.94 with chronic lumbar zygapophysial joint pain to three groups. The subjects received radiofrequency neurotomy with methylprednisolone, pentoxifylline or saline added. Neurotomy was performed using 10 mm pole needles and a radiofrequency generator (Neuro Therm Radio Frequency Lesion Generator model JK2 RDG Medical). A lesion was created by raising the needle tip temperature to 85° for 60 seconds. After lesioning, one of the three drugs was injected. Subjects were observed for 6 months. Pain intensity, summed pain intensity difference, minimum 50% reduction of pain intensity, Patients Satisfaction Score, and local tenderness were determined. The 50% reduction of pain intensity was achieved in 80% of patients one week after the procedure, and at 6 months such results were reported by 60% of patients. There was a significant reduction of pain intensity in all three groups at all time points compared to baseline, however, there were no differences between the three groups. There was a significant difference in local tenderness as a measure of postoperative pain indicating effectiveness of both, methylprednisolone and pentoxifylline. No other complications were noted in any of the patients. The authors concluded that radiofrequency neurotomy is a safe and effective method to treat patients with zygapophysial joint pain. An addition of pentoxifylline and methylprednisolone can reduce postoperative pain commonly appearing within a short time after the procedure, however, neither pentoxifylline nor methylprednisolone influences long-term follow-up results. Citation #5 Joo et al randomized 40 adult subjects with recurrent thoracolumbar facet joint pain after successful thermal radiofrequency ablation (RFA) to two groups receiving either RFA (20 subjects, mean age 67.8 +/- 18.2, 55% female) or alcohol ablation (AA) (20 subjects, mean age 68.7 +/- 15.5, 60% female). Radiofrequency ablation of the medial branch of the posterior ramus was performed using RFDE-10, 22-gauge, 10-cm disposable electrode with a 10-mm exposed tip (NeuroTherm) and NT1100 or NT500 RF Generator (NeuroTherm) at 90°C for 90 seconds. During the 24-month follow-up after RFA and AA, one and 17 patients, respectively, were without recurring thoracolumbar facet joint pain. The median effective periods in the RFA and AA groups were 10.7 (range 5.4–24) and 24 (range 16.8–24) months, respectively (p < 0.000). No significant complications were observed with the exception of injection site pain, which occurred in both groups. The authors concluded that in this cohort, alcohol ablation in medial branch neurotomy provided a longer period of pain relief and better quality of life than repeated radiofrequency medial branch neurotomy in the treatment of recurrent thoracolumbar facet joint pain syndrome after successful thermal RFA.

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Citation #6 Ma et al randomized 66 adult subjects with pain after conventional radiofrequency (CRF) denervation for lumbar facet pain to three groups. Group A (22 subjects, mean age 72.4 +/- 14.9, 72.7% female) received placebo for 7 days, group B (22 subjects, mean age 62.3 +/- 16.1, 59.1% female) received diclofenac sodium for 3 days and group C (22 subjects, mean age 68.8 +/- 11.7, 59.1% female) received diclofenac sodium for 7 days. CRF of the L5 dorsal primary ramus was done using a 21-gauge straight sharp RF cannula with a 5-mm exposed tip (PMC21-100-5) and Pain Management Generator (PM-230, Baylis Medical Company) at 70°C for 90 seconds or 80°C for 120 seconds. Pain visual analgesia score (VAS) and side effect were recorded at baseline 1, 7, 14, 30, and 60 days after treatment. Oswestry Disability Index (ODI), Patients’ Satisfaction Score (PSS), and dosage and cost of the drugs used for pain management were recorded at baseline, 30 and 60 days after treatment. VAS in groups B and C both was less than that in group A at 1 and 7 days after treatment (P < 0.05 and 0.01, respectively). PSS in groups B and C was significantly better than in group A at 30 and 60 days after treatment (P < 0.05). Edema (13.6%) and nausea (9.1%) in group C were the most frequently reported complications. Edema occurred at the lower extremity or face, mostly at the ankle. Anaphyactoid (erythra, pruritus, etc.) were seen in two patients (9.1%) in group B and in one patient (4.5%) in group C 7 days after treatment. The incidence of side-effect rate was similar in the three groups at all observation times (P > 0.05). The cost of analgesic administration in group B was significantly less than in groups A and C (P < 0.05). The authors concluded that diclofenac sodium administration improves analgesia and the PSS after CRF denervation. Compared to a 7-day dosage, a 3-day diclofenac sodium therapy has similar efficacy and less cost for the treatment of pain after CRF neurotomy. Citation #7 Kroll et al randomized 50 adult subjects, 26 of which completed follow-up, with lumbar facet syndrome to either continuous radiofrequency (CRF) thermocoagulation at 80°C for 75 seconds (mean age 57.0 +/- 8.4, 61.5% female) or pulsed radiofrequency (PRF) at 42°C at a pulse duration of 20 ms and pulse rate of 2Hz for 120 seconds (mean age 59.5 +/-11.6, 46.1% female). L3-S1, L4-S1 or L4-L5 were treated. Straight radiofrequency cannulae, either 21-gauge, 100-mm length, 5 mm active tip (Model PMC21-100-5; Baylis Medical Co.) or 20-guage, 145-mm length, 5 mm active tip (Model PMC20-145-5, Baylis Medical Co.) along with a Baylis Pain Management Generator (Model PMG-115) with either 100-mm length (Model PMP21-100) or 145-mm (Model PMP-20-145) radiofrequency probes. Visual analog scale (VAS) pain assessment and Oswestry Low Back Pain and Disability Questionnaire (OSW) were administered at baseline and then at three months. Comparisons between groups and within groups were made of the relative percentage improvement in VAS and OSW scores at baseline and 3 months. No significant differences in the relative percentage improvement were noted between groups in either VAS (P=0.46) or OSW scores (P=0.35).Within the PRF group, comparisons of the relative change over time for both VAS (P = 0.21) and OSW scores (P = 0.61) were not significant. However, within the CRF group, VAS (P = 0.02) and OSW scores (P = 0.03) showed significant improvement. No adverse events were encountered during CRF or PRF lesioning, and no complications were documented three months postprocedure.The authors concluded that although there was no significant difference between CRF and PRF therapy in long-term outcome in the treatment of lumbar facet syndrome, there was a greater improvement over time noted within the CRF group. Citation #8 Tekin et al randomized 60 adult subjects with continuous low back pain with or without radiating pain with focal tenderness over the facet joints, pain on hyperextension, absence of neurologic defect, unresponsiveness to conservative treatment, no radicular syndrome, and no indication for low back surgery, to three groups. One group received 80°C conventional radiofrequency (CRF) denervation for 90 seconds (mean age 57.9 +/- 9.3, 55% female), another received 2 Hz pulsed

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radiofrequency (PRF) denervation for 4 minutes (45V/42°C) (mean age 59.6 +/-7.7, 60% female) and a third (control) received local anesthetic (mean age 60.5 +/- 8.5, 55% female). Denervation of the segmental medial branches of L3, L4, and L5 nerve roots was done using an RF generator (RFG 3C Plus, Radionics) and cannulas (CRF group (n=20): 10-cm 22-gauge SMKC10 electrode, 10-mm active tip (Radionics); PRF group (n=20): 10-cm 22-gauge SMK-C10 electrode, 2-mm active tip). RF current was not switched on in the control group. Pain relief was evaluated by visual analog scale (VAS) and Oswestry Disability Index (ODI) at preprocedure, at procedure, at 6 months and 1 year after the procedure. Mean preprocedural VAS and ODI scores were higher than all postprocedural scores in all groups (p<0.001). VAS and ODI scores were lower in PRF and CRF groups than the control group at postprocedure evaluation. Although the decrease in the VAS score and ODI was maintained in the CRF group at 6 months, this was not achieved in the PRF group. At 1 year, mean VAS score was similar in control and PRF groups but lower in CRF group compared to the others (p<0.001). Mean ODI was lower in RF groups than control group at 1 year. No complications were reported. The authors concluded that CRF and PRF are both safe and useful interventions in the treatment of chronic facet joint pain with minimal complication rate. However, PRF is not long lasting as CRF. Citation #9 van Wijk et al randomized 81 adult subjects with chronic low back pain to either radiofrequency facet joint denervation (40 subjects, mean age 46.9 +/- 11.5, 75% female) or sham treatment (41 subjects, mean age 48.1 +/- 12.6, 68.3% female). RF treatment of joints between Th12–L2, L2–L4, or L4–S1 was performed using a RF generator using a thermocouple with 10-cm electrodes (RFG- 3C; 22G SMK-C10 electrode, 5-mm active tip (Radionics). The generator was not switched on in the control group. RF lesions were generated at 80°C for 60 seconds. Primary outcome combined pain visual analog scale (VAS), physical activities and analgesic intake at one year. The combined outcome measure showed no differences between radiofrequency facet joint denervation (n = 40; success 27.5%) and sham (n = 41; success 29.3%) (P = 0.86). The combined outcome measure and VAS showed no difference between radiofrequency and sham, though in both groups, significant VAS improvement occurred. The global perceived effect was in favor of radiofrequency. No complications were reported. The authors concluded that in selected patients, radiofrequency facet joint denervation appears to be more effective than sham treatment. Citation #45 OBJECTIVE: To study the effectiveness of surgical dorsal endoscopic rhizotomy for the treatment of facetogenic chronic low back pain. METHODS: From April 2011 to November 2011, 58 patients who were diagnosed with lumbar facetogenic chronic low back pain (CLBP) and thereafter experienced >80% reliefs of pain with two comparative lumbar medial branch blocks were recruited in the study. Of those 58 patients, 45 cases (the operation group) received dorsal endoscopic rhizotomy, and the remaining 13 cases (the conservative group) received conservative treatment. Patients' preoperative and postoperative VAS score, percentage of pain relief and the MacNab score were analyzed and compared. Anatomic variations and any possible complications were recorded. RESULTS: In the operation group, VAS scores of pain (low back/referred) at any time point postoperatively were significantly lower than that before MBB (P<0.05), which, however, showed no significant difference as compared to the scores after MBB (P>0.05). In the conservative group, VAS scores of pain (low back/referred) at any time point postoperatively with conservative treatment decreased significantly compared with that before MBB (P<0.05) and were significantly higher than that after MBB (P<0.05). Percentage of pain relief in the operation group at any time point postoperatively were significantly higher than that in the conservative group (P<0.01). The MacNab scores of 1 year follow-up in the operation group were higher than that in the conservative group. In addition, four separate newly identified anatomical variations of medial branch anatomy

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were observed and reported. CONCLUSION: Dorsal endoscopic rhizotomy is safe and effective for the facetogenic CLBP, and can achieve better clinical outcome than the conservative treatment. Citation #50 STUDY DESIGN: Prospective randomized study. OBJECTIVE: This study aimed to prospectively compare the surgical results of the open- and French-door laminoplasty. SUMMARY OF BACKGROUND DATA: Cervical laminoplasty is a common surgical procedure for the treatment of cervical compressive myelopathy. These procedures are primarily classified as either open- or French-door laminoplasties. Only few prospective studies comparing the surgical results of the 2 procedures are available. METHODS: A total of 92 patients with cervical compressive myelopathy who underwent cervical laminoplasty were prospectively enrolled and randomized into the following 2 groups according to the type of laminoplasty: open-door and French-door groups. A single attending spine surgeon performed all surgical procedures. The following factors were evaluated: surgical duration, blood loss, perioperative complications, neurological assessment using the Japanese Orthopedic Association score, and recovery rate. Radiological evaluations included assessment of the cervical lordotic angle and cervical range of motion. In addition, the ratio of postoperative spinal lamina opening was evaluated by magnetic resonance imaging. RESULTS: There were no differences in perioperative complications and neurological outcomes between the 2 groups. The mean reduction in cervical lordotic angle after surgery was significantly greater in the open-door group than the French-door group (3.0° vs. 5.6°). Postoperative cervical range of motion significantly decreased in the open-door group than in the French-door group (19.3° vs. 26.0°). Postoperative cervical lordotic angle in the extension position significantly diminished in the open- door group than in the French-door group (7.9° vs. 14.1°). The ratio of opening of the spinal lamina after surgery was significantly larger in the open-door group than in the French-door group. CONCLUSION: The 2 laminoplasty methods showed almost the same neurological recovery as well as perioperative complications. In cases of open-door laminoplasty, postoperative cervical alignment became more kyphotic and cervical range of motion was more restricted than that in French-door laminoplasty cases after surgery. French-door laminoplasty is preferable to open-door laminoplasty for postoperative cervical alignments. LEVEL OF EVIDENCE: 1. Citation #71 OBJECTIVE: To assess the influence of different hinge positions on clinical results of expansive open-door laminoplasty (EOLP) for cervical spondylotic myelopathy (CSM). METHODS: A total of 102 CSM patients who underwent EOLP from February 2006 to February 2007 were enrolled in this randomized controlled trial. Using a random digits table, 57 patients with the hinge located at the inner margin of the lateral mass were classified as wide-open group, while 45 patients with the hinge positioned at the lamina margin served as narrow-open group. All patients were observed over 24 months, and the clinical and radiological results were analyzed statistically. RESULTS: There were no significant differences in operation duration, intraoperative bleeding volume, Japanese Orthopaedic Association (JOA) scores, cervical curvature index, range of motion and neural function recovery rate. The neural functions were satisfactorily improved after surgery in both groups, while the severity of axial symptoms was significantly lower in the narrow-open group than in the wide- open group (P equal to 0.003). The incidence of C(5) palsy in the wide-open group was higher than that in the narrow-open group (5.3% vs 0), even though the difference did not reach statistical significance (one tailed Fisher's exact test, P equal to 0.17). CONCLUSIONS: Proper inward shift of the hinge can ensure effectiveness of surgical decompression, avoid an excessive backward shift of the spinal cord, decrease the incidence of C(5) palsy and alleviate the severity of axial symptoms. Citation #84 OBJECT: Recently, limited decompression procedures have been proposed in the treatment of lumbar stenosis. The authors undertook a prospective study to compare the safety and outcome of

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unilateral and bilateral laminotomy with laminectomy. METHODS: One hundred twenty consecutive patients with 207 levels of lumbar stenosis without herniated discs or instability were randomized to three treatment groups (bilateral laminotomy [Group 1], unilateral laminotomy [Group 2], and laminectomy [Group 3]). Perioperative parameters and complications were documented. Symptoms and scores, such as visual analog scale (VAS), Roland-Morris Scale, Short Form-36 (SF-36), and patient satisfaction were assessed preoperatively and at 3, 6, and 12 months after surgery. Adequate decompression was achieved in all patients. The overall complication rate was lowest in patients who had undergone bilateral laminotomy (Group 1). The minimum follow up of 12 months was obtained in 94% of patients. Residual pain was lowest in Group 1 (VAS score 2.3 +/- 2.4 and 4 +/- 1 in Group 3; p < 0.05 and 3.6 +/- 2.7 in Group 2; p < 0.05). The Roland-Morris Scale score improved from 17 +/- 4.3 before surgery to 8.1 +/- 7, 8.5 +/- 7.3, and 10.9 +/- 7.5 (Groups 1-3, respectively; p < 0.001 compared with preoperative) corresponding to a dramatic increase in walking distance. Examination of SF-36 scores demonstrated marked improvement, most pronounced in Group 1. The number of repeated operations did not differ among groups. Patient satisfaction was significantly superior in Group 1, with 3, 27, and 26% of patients unsatisfied (in Groups 1, 2, and 3, respectively; p < 0.01). CONCLUSIONS: Bilateral and unilateral laminotomy allowed adequate and safe decompression of lumbar stenosis, resulted in a highly significant reduction of symptoms and disability, and improved health-related quality of life. Outcome after unilateral laminotomy was comparable with that after laminectomy. In most outcome parameters, bilateral laminotomy was associated with a significant benefit and thus constitutes a promising treatment alternative. Citation #107 Objectives: Percutaneous radiofrequency denervation of the medial dorsal branch is often used in chronic low back pain of intervertebral facet etiology, which is sometimes difficult to perform and recurrence of pain often ensues. We theorized that shifting the target of RF coagulation to the facet joint capsule would provide an easier target and a longer-lived pain relieving response. Patients and Methods: A prospective randomized controlled trial where 120 patients diagnosed with CLBP of a confirmed facet origin were randomly divided into three equal groups, the first was submitted to percutaneous radiofrequency coagulation of the facet joint capsule, the second underwent percutaneous denervation of the medial dorsal branch and the third did not receive radiofrequency lesioning. All the three groups received local injection of a mixture of local anesthetic and steroid. Cases were followed for up to 3 years. Results: 87(72.5%) patients were females. By 3 months' post procedure, improvement in VAS was significantly better than pretreatment levels in all groups (p<0.05). The control group lost improvement by 1-year follow-up (p=0.017). At 2 years' follow-up, the joint capsule denervation group maintained significant improvement (p=0.033) whereas the medial branch denervation group lost its significant effect (p=0.479). By the end of follow-up period, only joint capsule denervation group kept significant improvement (p=0.026). Conclusion: In CLBP of facet origin, shifting the target of percutaneous radiofrequency to the facet joint capsule provides an easier technique with an extended period of pain relief compared to the medial dorsal branch of the facet joint.

7.4.2. Prospective Trial Citation #10 Mac Vicar et al treated 104 adult patients with chronic neck pain which was completely relieved by controlled diagnostic medial branch blocks at two practice groups, A (40 subjects, median age 48 (range 27-71), 67.5% female) and B (64 subjects, median age 48 (range 22-80), 46.9% female). All patients underwent cervical medial branch radiofrequency neurotomy (RFN) with 10-cm 16-gauge

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(1.6 mmdiameter) CosmanRRE “Ray” electrodes with 5-mm exposed tips. The electrodes were placed parallel to the medial branches and sufficient lesions were created in the sagittal plane and in an oblique plane 30° to sagittal to cover the likely location of the nerves. The temperature for the oblique lesions was 80° and the temperature for the sagittal lesions was 85°, and these temperatures were maintained for 90 seconds for each lesion. Outcome was defined as complete relief of pain, or at least 80% relief, for at least 6 months, with complete restoration of activities of daily living, no need for any further health care, and return to work. The success rate in Practice A was 74% and that in Practice B was 61%. The median duration of complete relief of pain following the first successful RFN was 17 months in Practice A (interquartile range: 12–29 months) and 20 months (12–30 months) in Practice B. After repeat treatment, Practice A achieved an aggregate of 959 months of complete relief of pain, in 31 patients, using 51 treatments, which amounts to a median duration of cumulative relief of 29 (16–42) months, and a median duration of 15 months per treatment or an average of 19 months complete relief per treatment. Practice B achieved an aggregate of 1,276 months of relief in 40 patients, using 65 treatments, which amounts to a median cumulative relief of 26 (18–45) months, with a median duration of 15 months per treatment or an average of 20 months per treatment. Allowing for repeat treatment, patients maintained relief for a median duration of 20– 26 months and 60% of subjects had pain relief at follow-up. No complications were reported. The authors concluded that in selected patients, cervical medial branch radiofrequency neurotomy can temporarily but completely relieve chronic neck pain. Citation #11 Masala et al treated 92 adult patients (54.3% female) with mean age of 63.6 years +/- 5.7 with facet joint syndrome with medial branch radiofrequency neurotomy. 20-G 100-mm long cannula with 10- mm tip hug (Stryker Instruments) were used at 80°C for 70 seconds to create a lesion. Outcome was defined as pain reduction at 1, 6 and 12 months. Mean pain reduction was statistically significant (p<0.005). No complications were reported. The authors concluded that medial branch radiofrequency neurotomy can be effective in treating pain and improving quality of life. Citation #12 Tomé-Bermejo et al treated 86 adult patients with mean age of 49.87 years with chronic lumbar pain (mean duration 7.12 years (range 1-40 years)) specific to facet joint pain with rhizolysis. A 22- gauge, 100-mm spinal cannulae with a 5-mm exposed tip (Radionics, Inc.) was used to perform facet denervation bilaterally at 2 levels (L4-L5 and L5-S1) of the vertebral column in all cases using thermocoagulation with the electrode (Radionics RFG-3C Plus Lesion Generator (Radionics, Inc.)) at 80°C for 90 seconds. Outcome was defined as reduction in lumbar pain using the Visual Analog Scale (VAS) and the Oswestry Low Back Pain Disability Questionnaire (ODQ) at 1 year. Significant improvement was shown in VAS (P = 0.0001) after rhizolysis. 89% of patients experienced significant pain relief lasting 6 months or more in 66% and a minimum of 1 year in 50%. No complications were reported. The authors concluded that rhizolysis can achieve long- lasting results by reducing impact on daily activities. Citation #13 Rambarasingh et al treated 104 adult patients, 45.2% female with mean age 51.5 years (range 23-79) with repeat radiofrequency neurotomy for chronic neck or back pain. Patients underwent 1 treatment (73 subjects), 2 treatments (73 subjects) or 3 treatements (36 subjects). Outcome was measured using the Pain Disability Questionnaire-Spine (PDQ-S). Pain intensity, pain frequency, and patient-specific disability measures were significantly improved post-initial, second, and third RFN. There was no statistically significant difference among the PDQ-S scores post-RFN 1, 2, and 3. There was no statistical significance between the duration of pain relief post-RFN 1 and pain relief post-RFN 2. No complications were reported. The authors concluded that the amount and duration of pain relief and reduction of disability remains consistent with subsequent RFNs

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Citation #14 Lang and Buchfelder treated 31 adult patients (38.7% female, median age 46 years) with chronic headaches due to zygapophyseial joint irritation lasting for at least 12 months with 61 radiofrequency neurotomies of the third occipital nerve and the medial branches of the cervical dorsal rami of C3 and C4 at 80°C for 90 seconds. Outcome was measured by pain relief on the first day and then duration of pain relief until recurrence of 50% of pre-procedure pain. Pain relief of at least 70% was observed in all subjects. The mean duration of pain relief until recurrence of 50% of pre-procedure pain was 125.11 days (range 6-732 days). Duration of pain relief after radiofrequency neruotomy in cervical fusions or fractures was significantly longer than in patients with arthritis (p < 0.005). Numbness in the neck or occipital region was reported to be decreasing over time and burning dysesthesia over a coagulated facet was reported. The authors concluded that radiofrequency neurotomy is effective in patients with primarily degenerative diseases. Citation #15 Iwatsuki et al treated 21 adult patients (19% female, mean age 46.4 years (range 30-70)) with persistent low back pain with laser denervation to the dorsal surface of the facet capsule. A 23-gauge needle was used to deliver a 805 nm diode laser (UDL-60, Diomed Limited Co. Ltd) with output of 15 watts at the tip. Laser energy was delivered in 1.0-second pulses with 1.0 second pauses for a total of 600 J irradiation energy. Success was measured by pain reduction >70% at 1 year. After 1 year, 81% experienced complete or >70% pain reduction. Only post-procedure discomfort was reported. The authors noted that the dorsal surface of the facet capsule might be an alternative target for facet denervation. Citation #16 Shabat et al treated 58 adult patients (at least 80 years) with chronic mechanical back pain of spinal origin with radiofrequency ablation of the medial branch of the dorsal ramus. Ablation was performed using SMK-10 and SMK-15 electrodes with a 10 mm active tip and an RFG-3C generator (Cosman Medical, Inc.) at 80°C for 90 seconds. Outcomes at 1, 3, 6 and 12 months were measured by pain on the visual analog scale (VAS) and functional outcome using the Oswestry Disability Index (ODI). At 3 months, 66% of patients had clinically significant pain relief; at 6 months, 57% had pain relief and at 12 months, 52% had pain relief while the other 48% had no effect. ODI was significantly improved at 1 year (P <0.05). Minor transient discomfort and burning pain were reported in 19% of patients and spontaneously resolved by one month post-procedure. The authors concluded that radiofrequency ablation is safe and partially effective in treating mechanical back pain in elderly patients due to facet syndrome. Citation #17 Speldewinde evaluates the analgesic, physical, and psychological outcomes of percutaneous radiofrequency neurotomy for persistent zygapophysial and sacroiliac joint pain. A prospective evaluation of 379 consecutive neurotomies on 282 patients in a single specialist practice between the years 2001–2010 in Australia was completed. The male-to-female ratio was 45:55. The age range was 22–87 years. Typical duration of pain was 2–4 years. A “successful outcome” was defined as at least 50% reduction of pain, for at least 2 months, in the region relevant to the joint or joints treated. All RF neurotomy procedures were performed under local anaesthesia and fluoroscopic imaging. For the first cohort, during the first seven years (196 patients), 22 G cannulae with a10 mm tip were used for the cervical, thoracic and sacroiliac regions, and 20 G cannulae with 10 mm tips were used for the lumbar region. In each region, a minimum of three contiguous “burns” to each target nerve (third occipital nerve, medial branch nerve, lateral branch nerves) were applied at 80°C for 90 seconds each. Zygapophysial joint pain was diagnosed by medial branch blocks, and was treated by medial branch neurotomy. Sacroiliac joint pain was diagnosed by intra-articular blocks, but treated by coagulating the L5 dorsal ramus and the lateral branches of the S1, S2, and S3 dorsal rami by three evenly-spaced vertical placements. For the second cohort, during the final two years (185 patients),

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the technique was modified to use larger cannulae (18 G), with shorter durations of thermal coagulation (60 seconds) but still at 80°C. Side-effects included increased pain or headache, or neuralgic pain. In this study, spinal pain was reduced by an average of 86% in 72% of candidates for an average duration of 12 months or more of ongoing relief. This was associated with highly significant improvements in psychological distress and physical function. Citation #57 BACKGROUND: Symptomatic lumbar spinal stenosis (LSS) patients often suffer from multiple etiologies, and patient symptoms must be differentiated and identified as either neurogenic claudication, radicular pain, or both. The most common symptom associated with LSS is neurogenic claudication, which has been reported to occur in 91% to 100% of the LSS patient population. Neurogenic claudication symptoms are described as pain radiating to the lower extremities that begins and worsens as the patient ambulates. Neurogenic claudication symptoms worsen over time and can eventually result in significant life-altering functional limitations. Symptomatic LSS patients may also suffer from radicular pain, which is a persistent pain transmitted through neural pathways, and is associated with inflammation of the exiting nerve root. OBJECTIVE: To assess patient safety, pain reduction, and functional status of patients treated with percutaneous lumbar decompression. STUDY DESIGN: Single-center, prospective clinical study of 46 consecutive patients with neurogenic claudication symptoms related to lumbar spinal stenosis. SETTING: US interventional pain management practice. METHODS: From March 2010 to January 2011, 46 LSS patients suffering from neurogenic claudication underwent mild percutaneous lumbar decompression. Of these, 12-week, 6-month and one-year follow-up was available for 35 patients. OUTCOME ASSESSMENT: Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and Zurich Claudication Questionnaire (ZCQ). Outcomes were assessed at baseline, 12-week, 6-month and one- year follow-ups. RESULTS: One-year follow-up patients in this study experienced statistically and clinically significant improvement in physical function, as well as reduction of pain intensity. The initial improvement in these patients, which was significant, was sustained through one year, with no significant differences among the interim follow-up visit periods. These results demonstrate early improvement following treatment with a high degree of durability over time. There were no serious device or procedure-related complications reported in this study. LIMITATIONS: Single-center study with no control group. CONCLUSIONS: In this study, the mild procedure was shown to be safe. In addition, patients experienced significant improvement in mobility and reduction of pain one year after the procedure. One-year outcomes were not significantly different from interim results, indicating that the significant improvement following treatment, occurring as early as 12 weeks, was maintained through one year. This high degree of consistency over time indicates the durability of percutaneous lumbar decompression in the treatment of neurogenic claudication in symptomatic LSS. Citation #61 BACKGROUND: Neurogenic claudication due to symptomatic lumbar spinal stenosis (LSS) is a painful condition causing significant functional disability. While the cause of LSS is multifactorial, thickened ligamentum flavum (LF) accounts for up to 85% of spinal canal narrowing. mild percutaneous lumbar decompression allows debulking of the hypertrophic LF while avoiding the morbidities frequently associated with more invasive surgical procedures. METHODS: In this prospective case series study, consecutive LSS patients presenting with neurogenic claudication were treated with percutaneous lumbar decompression. Efficacy was evaluated using the Pain Disability Index (PDI) and Roland-Morris Disability Questionnaire. Pre- and postprocedure Standing Time, Walking Distance, and Visual Analog Score (VAS) were also monitored. Significant device- or procedure-related adverse events were reported. RESULTS: The mild procedure was successfully performed on forty patients. At twelve months, both PDI and Roland-Morris showed

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significant improvement of 22.6 points (ANOVA, P<0.0001) and 7.7 points (ANOVA, P<0.0001), respectively. Walking Distance, Standing Time, and VAS improvements were also statistically significant, increasing from 246 to 3,956 feet (ANOVA, P<0.0001), 8 to 56 minutes (ANOVA, P<0.0001), and 7.1 to 3.6 points (ANOVA, P<0.0001), respectively. Tukey HSD test found improvement in all 5-outcome measures to be significant from baseline at each follow-up interval. No significant device- or procedure-related adverse events were reported. CONCLUSION: This study demonstrated significant functional improvement as well as decreased disability secondary to neurogenic claudication after mild procedure. Safety, cost-effectiveness, and quality-of-life outcomes are best compared with comprehensive medical management in a randomized controlled fashion and, where ethical, to open lumbar decompression surgery. Citation #62 BACKGROUND: Percutaneous remodeling of the ligamentum flavum and lamina (PRLL), commercially known as minimally invasive lumbar decompression (mild technique), relies on fluoroscopy and epidural contrast to direct surgical instruments via a 6-mm cannula. OBJECTIVE: To evaluate the safety and efficacy of PRLL and present, to our knowledge, the first reported imaging findings after PRLL. METHODS: We performed a prospective study of PRLL for neurogenic claudication. Primary outcomes were Oswestry Disability Index, Short-Form 12 version 2.0 health survey, and visual analog scale for pain at 26 weeks. Analgesic use was also assessed. Postoperative magnetic resonance imaging was performed at 12 weeks. Long-term failure, defined as the poststudy need for secondary surgery, was assessed up to 18 months. RESULTS: Ten subjects with an average age of 64 years (range, 41-81 years) were treated between September 2008 and January 2009. There were no major adverse events. Mean postoperative visual analog scale score remained significantly reduced throughout 26 weeks (P =.015, analysis of variance). Mean postoperative Oswestry Disability Index was also improved by 1 week and remained significant throughout 26 weeks (P = .024; analysis of variance). However, there was a trend toward increased reliance on narcotic type medications postoperatively. Imaging studies did not show significant decompression of the spinal canal in any patient. In the poststudy period, recurrent claudication requiring laminectomy developed in 6 patients (60%). CONCLUSION: Throughout 26 weeks, pain and disability scores were decreased; however, PRLL did not improve the degree of stenosis on imaging studies. Although PRLL appears to be safe in this small cohort of patients, poststudy outcomes indicate that the failure rate is unacceptably high. Citation #63 OBJECTIVE: To test the equivalence for clinical effectiveness between microdecompression and laminectomy in patients with central lumbar spinal stenosis. DESIGN: Multicentre observational study. SETTING: Prospective data from the Norwegian Registry for Spine Surgery. PARTICIPANTS: 885 patients with central stenosis of the lumbar spine who underwent surgery at 34 Norwegian orthopaedic or neurosurgical departments. Patients were treated from October 2006 to December 2011. INTERVENTIONS: Laminectomy and microdecompression. MAIN OUTCOME MEASURES: The primary outcome was change in Oswestry disability index score one year after surgery. Secondary endpoints were quality of life (EuroQol EQ-5D), perioperative complications, and duration of surgical procedures and hospital stays. A blinded biostatistician performed predefined statistical analyses in unmatched and propensity matched cohorts. RESULTS: The study was powered to detect a difference between the groups of eight points on the Oswestry disability index at one year. 721 patients (81%) completed the one year follow-up. Equivalence between microdecompression and laminectomy was shown for the Oswestry disability index (difference 1.3 points, 95% confidence interval -1.36 to 3.92, P<0.001 for equivalence). Equivalence was confirmed in the propensity matched cohort and full information regression analyses. No difference was found between groups in quality of life (EQ-5D) one year after surgery. The number of patients with

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complications was higher in the laminectomy group (15.0% v 9.8%, P=0.018), but after propensity matching for complications the groups did not differ (P=0.23). The duration of surgery for single level decompression was shorter in the microdecompression group (difference 11.2 minutes, 95% confidence interval 4.9 to 17.5, P<0.001), but after propensity matching the groups did not differ (P=0.15). Patients in the microdecompression group had shorter hospital stays, both for single level decompression (difference 1.5 days, 95% confidence interval 1.7 to 2.6, P<0.001) and two level decompression (0.8 days, 1.0 to 2.2, P=0.003). CONCLUSION: At one year the effectiveness of microdecompression is equivalent to laminectomy in the surgical treatment of central stenosis of the lumbar spine. Favourable outcomes were observed at one year in both treatment groups.Trial registration ClinicalTrials.gov NCT02006901. Citation #65 STUDY DESIGN: This is a prospective study on surgical outcomes of double-door laminoplasty in patients with cervical spondylotic myelopathy (CSM). OBJECTIVE: The purpose of this study was to report the efficacy and safety of modified double-door laminoplasty in a large series of patients with CSM. SUMMARY OF BACKGROUND DATA: Laminoplasty is an established procedure for the decompression of multisegmental CSM. However, no report has described the clinical outcomes of laminoplasty for a large number of patients with CSM (>500 patients). METHODS: Between April 1995 and December 2006, 520 consecutive patients (331 male and 189 female) with CSM who underwent double-door laminoplasty and were followed-up for more than 1 year were enrolled in this study. The mean age was 62.2 years (23 to 93 y), and the mean duration of disease was 20.1 ± 32.0 months. The severity of myelopathy before and after surgery was evaluated according to a scoring system proposed by the Japanese Orthopedic Association for cervical myelopathy (JOA score). Functional improvement was expressed by the recovery rate (RR) of the JOA score. RESULTS: The average surgery time for laminoplasty was 75.2 ± 23.3 minutes, and the average blood loss was 72.6 ± 84.6 mL. The average follow-up period was 33.3 ± 15.7 months. The mean JOA score was 10.4 ± 2.8 points preoperatively and 13.6 ± 2.5 points at final follow-up. The mean RR was 51.2 ± 2 9.0%. On the basis of RR, we found that the conditions of 493 patients (94.8%) improved (RR, >1%), 20 patients (3.8%) showed no change (RR, 0%), and 7 patients (1.3%) in worse condition (RR, < 0%). The 7 patients deteriorated for reasons (lumbar spinal canal stenosis and cerebral infarction) that were unrelated to CSM. CONCLUSIONS: Modified double-door laminoplasty is a safe, reliable, and effective procedure for patients with CSM. Citation #67 OBJECTIVE: The mild lumbar decompression procedure is a minimally invasive therapy for the treatment of symptomatic lumbar spinal stenosis (LSS). Mild offers LSS patients an early alternative after failed conservative therapy and before open surgery. This report describes 6-month safety and efficacy of mild patients treated at a single center. METHODS: From November 2009 through June 2010, 27 consecutive patients were enrolled in a prospective Study at a single center. Efficacy of the mild procedure was evaluated by comparing the Visual Analog Scale, Oswestry Disability Index, and Zurich Claudication Questionnaire (ZCQ) at baseline and 6-month follow-up. Significant mild device or procedure-related adverse events were tracked and patient outcomes reported. RESULTS: There were no significant mild device or procedure-related adverse events observed or reported. No patients required more than 24 hours postoperative observation. At 6-months, Visual Analog Scale showed a statistically significant improvement of 5.2 points. Oswestry Disability Index also showed statistically significant improvement of 24.0 points. Improvement in all ZCQ domains was statistically significant, and the average ZCQ Patient Satisfaction score was 1.86 at 6-month follow- up indicating that patients were "satisfied" to "very satisfied" with the treatment. DISCUSSION: The safety profile of mild, combined with the significant improvement in quality of life for these patients at 6-months is remarkable. Having failed conservative therapy, the high level of effectiveness of the

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mild procedure is particularly important in this patient population. In this series, mild has been shown to be a safe, effective, and cost-effective treatment for LSS patients with neurogenic claudication. Citation #68 STUDY DESIGN: A prospective study. OBJECTIVE: To evaluate the effectiveness of prophylactic C4/C5 microforaminotomy with open-door laminoplasty for cervical myelopathy in preventing postoperative C5 palsy. SUMMARY OF BACKGROUND DATA: Postoperative C5 palsy is a common complication of cervical laminoplasty. Although the etiology of C5 palsy and preventive measures remain unclear, we hypothesize that C5 palsy is caused by C5 nerve root impairment induced by potential C4/C5 foraminal stenosis and posterior shifting of the spinal cord after laminoplasty. METHODS: The study included 141 consecutive patients with cervical myelopathy (103 men and 38 women) who underwent open-door laminoplasty with prophylactic bilateral C4/C5 foraminotomy between 2009 and 2010. These were designated as the foraminotomy group (FG). One hundred forty-one consecutive patients (100 men and 41 women) who underwent open-door laminoplasty without prophylactic foraminotomy during 2006 to 2008 served as a control group. This was the nonforaminotomy group (NFG). The incidence of C5 palsy, operation time, blood loss, and the number of decompressed disc levels were recorded. RESULTS: The incidence of C5 palsy was 1.4% (2 of 141 cases) in the FG, and 6.4% (9 of 141 cases) in the NFG. The mean operation times were 129 and 102 minutes, respectively. There were significant differences in the incidence of C5 palsy and operation time (both comparisons, P < 0.05). There were no significant differences in blood loss or the number of decompressed disc levels (both comparisons, P > 0.05). CONCLUSION: Prophylactic bilateral C4/C5 microforaminotomy significantly decreased the incidence of postoperative C5 palsy. These results suggest that the main etiology of C5 palsy was C5 root impairment. However, 2 patients experienced C5 palsy despite undergoing prophylactic foraminotomy, which indicated that other factors including spinal cord impairment after acute decompression against cervical canal stenosis may also be considered as minor etiologies of C5 palsy. We conclude that prophylactic C4/C5 foraminotomy was an effective preventive measure against postoperative C5 palsy after laminoplasty. Citation #69 BACKGROUND: Lumbar spinal stenosis (LSS) generally occurs from a combination of degenerative changes occurring in the lumbar spine. These include hypertrophy of ligamentum flavum, facet joint arthritic changes and bulging of the intervertebral disk. Spinal stenosis leads to compression of the lumbar neural elements (cauda equina), which manifests as low back and leg pain especially on standing and walking known as "neurogenic claudication." Current treatment options for LSS are varied. Conservative management, including physical therapy with/without epidural steroid injections, may be adequate for mild stenosis. Surgical decompression is reserved for severe cases and results in variable degrees of success. Patients with moderate-to-severe LSS having ligamentum flavum hypertrophy as a key contributor are generally inappropriately treated or undertreated. This is due to ineffectiveness of conservative therapy and possibility that major surgical compression might be too aggressive. Percutaneous decompression offers a possible solution for this patient population. METHODS: One-year follow-up study was conducted at 11 U.S. sites. Study cohort included 58 mild(®) percutaneous decompression patients who underwent 170 procedures, the majority treated bilaterally at one or two lumbar levels. Outcome measures included the visual analog scale (VAS), Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ), and SF-12v2(®) Health Survey. RESULTS: No major mild(®) device or procedure-related complications were reported. One-year data showed significant reduction of pain as measured by VAS. Improvement in physical functionality, mobility, and disability was significant as measured by ZCQ, SF-12v2, and ODI. CONCLUSIONS: At 1 year this 58-patient cohort demonstrated continued

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excellent safety profile of the mild(®) procedure and equally important, showed long-term pain relief and improved functionality. Citation #72 STUDY DESIGN: Prospective clinical series. OBJECTIVE: To evaluate the ability of plate-only laminoplasty to achieve stable laminar arch reconstruction and to determine the rate and time course with which bony healing occurs in such constructs. SUMMARY OF BACKGROUND DATA: Reconstruction of a stable laminar arch with sufficient room for the decompressed spinal cord is a desired goal when performing cervical laminoplasty for myelopathy. Traditional forms of laminoplasty fixation, such as sutures, bone struts, and ceramic spacers, may be associated with complications including loss of fixation, dislodgement with neurologic compromise, and premature laminoplasty closure. Plates, in contrast, provide more rigid fixation. Plate-only laminoplasty is gaining popularity as a method of laminoplasty fixation, but there is little data on its effectiveness. METHODS: Fifty-four patients who underwent open door laminoplasty for cervical myelopathy and had available postoperative computed tomography (CT) scans formed the basis of this study. In all cases, a 4-mm round burr was used to create the hinge at the junction of the lateral mass and lamina by completely removing the dorsal cortex and thinning the ventral cortex until a greenstick deformation of the hinge could be produced. Laminoplasty plates were used as the sole method of fixation. No supplemental bone graft struts were used on the plated side, and the hinge side was not bone grafted. Axial CT scans obtained at 3, 6, and 12 months postoperatively were assessed for plate complications and bony healing of the hinge. RESULTS: No plate failures, dislodgements, or premature closures occurred in any of the levels at any time postoperatively. Computed tomography scan review demonstrated that 55% of levels were healed at 3 months, 77% at 6 months, and 93% at 12 months. At each timepoint, C6 and C7 had the highest hinge healing rates. Laminar screw backout was seen in 5/217 (2.3%) of levels, but was not associated with plate dislodgement, laminoplasty closure, or neurologic consequences, and did not occur in any case in which 2 laminar screws had been placed. CONCLUSION: Plate-only laminoplasty provided stable reconstruction of an expanded laminar arch with no failures, dislodgements, adverse neurologic consequences, or premature closures in 217 levels. Ninety-three percent of hinges demonstrated radiographic union at 12 months, and even those that did not heal by CT scan criteria maintained patent expansion of the spinal canal without adverse neurologic consequences. Supplemental bone graft does not appear necessary when plated laminoplasty is performed. Citation #73 BACKGROUND: Neurogenic claudication due to lumbar spinal stenosis is a common problem that can be caused by many factors including hypertrophic ligamentum flavum, facet hypertrophy, and disc protrusion. When standard medical therapies such as pain medication, epidural steroid injections, and physical therapy fail, or when the patient is unwilling, unable, or not severe enough to advance to more invasive surgical procedures, both physicians and patients are often left with a treatment dilemma. Patients in this study were treated with mild, an ultra-minimally invasive lumbar decompression procedure using a dorsal approach. The mild procedure is performed under fluoroscopic imaging to resect bone adjacent to, and achieve partial resection of, the hypertrophic ligamentum flavum with minimal disruption of surrounding muscular and skeletal structure. OBJECTIVE: To assess the clinical application and patient safety and functional outcomes of the mild lumbar decompression procedure in the treatment of symptomatic central canal spinal stenosis. STUDY DESIGN: Multi-center, non-blinded, prospective clinical study. SETTING: Fourteen US spine specialist practices. METHODS: Between July 2008 and January 2010, 78 patients were enrolled in the MiDAS I Study and treated with the mild procedure for lumbar decompression. Of these patients, 6-week follow-up was available for 75 patients. OUTCOME ASSESSMENT: Visual Analog Score (VAS), Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ),

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and SF-12v2 Health Survey. Outcomes were assessed at baseline and 6 weeks post-treatment. RESULTS: There were no major device or procedure-related complications reported in this patient cohort. At 6 weeks, the MiDAS I Study showed statistically and clinically significant reduction of pain as measured by VAS, ZCQ, and SF-12v2. In addition, improvement in physical function and mobility as measured by ODI, ZCQ, and SF-12v2 was statistically and clinically significant in this study. LIMITATIONS: This is a preliminary report encompassing 6-week follow-up. There was no control group. CONCLUSIONS: In this 75-patient series, and in keeping with a previously published 90-patient safety cohort, the mild procedure proved to be safe. Further, based on near-term follow-up, the mild procedure demonstrated efficacy in improving mobility and reducing pain associated with lumbar spinal canal stenosis. Citation 76 OBJECTIVE: We describe a prospective cohort study that investigated the effectiveness of microsurgical bilateral decompression using unilateral laminotomy for lumbar spinal stenosis and assessed the factors influencing the outcome. METHODS: A total of 165 consecutive patients underwent decompression for lumbar spinal stenosis. They were divided into 3 age groups: A (<65 years), B (65-75 years), and C (>75 years). Further classification was performed according to body mass index (BMI): BMI 1 (<26), BMI 2 (26-30), and BMI 3 (>30), anesthesiological risk factors (American Society of Anesthesiologists), and the number of levels decompressed. The outcome was monitored by an independent observer at 1 week, 3 months, and 1 year after surgery. The following parameters were evaluated: pain (visual analog scale and analgesic consumption), functional improvement (Neurogenic Claudication Outcome Score), and walking performance, defined as walking distance x speed (treadmill). RESULTS: One week after surgery, pain decreased in 85.9% of patients, and a comparison of the pre- and postoperative use of analgesics showed that 38% of nonopioid use and 74% of opioid use were discontinued, whereas nonsteroidal anti-inflammatory drug consumption increased 13%. One year after surgery, pain remained decreased in 83.9% of patients, Neurogenic Claudication Outcome Score increased in 90.3% of patients, and walking performance improved in 92.2% of patients. BMI greater than 30 was the only negative prognostic factor for pain reduction (P = 0.012) and Neurogenic Claudication Outcome Score improvement (P = 0.019). Surprisingly, patients who underwent multilevel decompression benefitted more from surgery than those who underwent single-level decompression. CONCLUSION: Microsurgical bilateral decompression using unilateral laminotomy is an effective surgical option for lumbar spinal stenosis, even in high-risk patients with multilevel stenosis. Citation #77 Large lumbosacral disc herniations causing bi-radicular symptoms are very rare clinical entities and may present a surgical challenge. This study was undertaken to evaluate the effectiveness of the simply modified combined lateral and interlaminar approach for the treatment of these unique disc herniations. Between 2000 and 2005, 18 patients with bi-radicular symptoms secondary to large disc herniations of the lumbar spine underwent surgery. There were 13 men and five women, ranging in age between 25 and 64 years (mean 54.3 years). In this three-step operation, the osseous areas that are not essential for the facet joint were removed and both upper and lower nerve roots were decompressed. There were no intraoperative or postoperative complications, except transient dysesthesia in one (5.5%) patient. The mean follow-up period was 62.6 months (range 36-96 months). At the latest follow-up examination, outcomes using the Macnab classification were excellent in 13 patients (72.2 %), good in four (22.2%) and fair in one (5.5%). Recurrent disc herniations and/or instability, either symptomatic or radiographic, have not occurred as a result of the procedure during the follow-up period. The combined approach described here is a safe and effective procedure in the surgical treatment of this subtype of disc herniations with bi-radicular

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involvement. It permits optimum decompression of both nerve roots, avoiding the risk of secondary spinal instability. Citation #79 The goal of surgical treatment for degenerative lumbar spinal stenosis (LSS) is to effectively relieve the neural structures by various decompressive techniques. Microendoscopic decompressive laminotomy (MEDL) is an attractive option because of its minimally invasive nature. The aim of prospective study was to investigate the effectiveness of MEDL by evaluating the clinical outcomes with patient-oriented scoring systems. Sixty consecutive patients receiving MEDL between December 2005 and April 2007 were enrolled. The indications of surgery were moderate to severe stenosis, persistent neurological symptoms, and failure of conservative treatment. The patients with mechanical back pain, more than grade I spondylolisthesis, or radiographic signs of instability were not included. A total of 53 patients (36 women and 17 men, mean age 62.0) were included. Forty- five patients (84.9%) were satisfied with the treatment result after a follow-up period of 15.7 months (12-24). The clinical outcomes were evaluated with the Oswestry disability index (ODI) and the Japanese Orthopedic Association (JOA) score. Of the 50 patients providing sufficient data for analysis, the ODI improved from 64.3 +/- 20.0 to 16.7 +/- 20.0. The JOA score improved from 9.4 +/- 6.1 to 24.2 +/- 6.0. The improvement rate was 73.9 +/- 30.7% and 40 patients (80%) had good or excellent results. There were 11 surgical complications: dural tear in 5, wrong level operation in 2, and transient neuralgia in 4 patients. No wound-related complication was noted. Although the prevalence of pre-operative comorbidities was very high (69.8%), there was no serious medical complication. There was no post-operative instability at the operated segment as evaluated with dynamic radiographs at final follow-up. We concluded that MEDL is a safe and very effective minimally invasive technique for degenerative LSS. With an appropriate patient selection, the risk of post-operative instability is minimal. Citation #80a OBJECTIVE: We have conducted a prospective study to evaluate the results and effectiveness of bilateral decompression via a unilateral laminectomy in 50 patients with 98 levels of degenerative lumbar spinal stenosis without instability. METHODS: Clinical outcomes were assessed using the Visual Analog Scale, Oswestry Disability Index, Short Form-36, and subjective Satisfaction Measurement. RESULTS: Adequate decompression was achieved in all patients. The mean follow- up time was 22.8 months (range 19 - 47 months). Surgical decompression resulted in a dramatic reduction of overall pain in all patients (late postoperative VAS score was 2.16 +/- 0.81). The ODI scores decreased significantly in early and late follow-up evaluations and the SF-36 scores demonstrated significant improvement in late follow-up results in our series. Patient satisfaction rate was 94%, and its improvement rate was 96%. CONCLUSION: For degenerative lumbar spinal stenosis with or without mild degenerative spondylolisthesis, the unilateral approach allowed sufficient and safe decompression of the neural structures and adequate preservation of vertebral stability, resulted in a highly significant reduction of symptoms and disability, and improved health- related quality of life. Citation #80b The aim of our study is to evaluate the results and effectiveness of bilateral decompression via a unilateral approach in the treatment of degenerative lumbar spinal stenosis. We have conducted a prospective study to compare the midterm outcome of unilateral laminotomy with unilateral laminectomy. One hundred patients with 269 levels of lumbar stenosis without instability were randomized to two treatment groups: unilateral laminectomy (Group 1), and laminotomy (Group 2). Clinical outcomes were assessed with the Oswestry Disability Index (ODI) and Short Form-36 Health Survey (SF-36). Spinal canal size was measured pre- and postoperatively. The spinal canal was increased to 4-6.1-fold (mean 5.1 +/- SD 0.8-fold) the preoperative size in Group 1, and 3.3-5.9-

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fold (mean 4.7 +/- SD 1.1-fold) the preoperative size in Group 2. The mean follow-up time was 5.4 years (range 4-7 years). The ODI scores decreased significantly in both early and late follow-up evaluations and the SF-36 scores demonstrated significant improvement in late follow-up results in our series. Analysis of clinical outcome showed no statistical differences between two groups. For degenerative lumbar spinal stenosis unilateral approaches allowed sufficient and safe decompression of the neural structures and adequate preservation of vertebral stability, resulted in a highly significant reduction of symptoms and disability, and improved health-related quality of life. Citation #81 Anterior cervical discectomy (ACD) is standard practice for cervical radiculopathy. Irrespective of the precise method used, it involves more or less complete disc removal with resultant anatomical and biomechanical derangements, and frequently the insertion of a bone or prosthetic graft. Anterior cervical foramenotomy is an alternative procedure that allows effective anterior decompression of the nerve root and lateral spinal cord, whilst conserving the native disc, preserving normal anatomy and movement, and protecting against later degeneration at adjacent spaces as far as possible. The aim of the study was to determine the safety and efficacy of anterior cervical foramenotomy in the treatment of cervical radiculopathy and took the form of a prospective study of 21 cases under the care of a single surgeon. All patients had a single level or two level anterior cervical foramenotomy. All had pre- and postoperative visual analogue scores for arm and neck pain, arm strength, sensation and overall use. A comparison between patients' perceptions and surgeon's observations was also made. Patients were followed up for between 10 and 36 months. Sixty-eight per cent completed full pre- and postoperative assessments. Twenty-eight per cent of the responders had complete arm pain resolution. There were statistically significant reductions in arm and neck pain, and overall disability. The surgeon's impression of improvement paralleled that of the patients. There was one complication with discitis. Anterior cervical foramenotomy is a safe and effective treatment for cervical radiculopathy caused by posterolateral cervical disc prolapse or uncovertebral osteophyte, and might also reduce adjacent segment degeneration. Citation #82 OBJECTIVE: Lumbar spinal stenosis and spondylosis are major causes of morbidity among the elderly. Surgical decompression is an effective treatment, but many elderly patients are not considered as candidates for surgery based on age or comorbidities. Minimally invasive surgical techniques have recently been developed and used successfully for the treatment of lumbar spinal disease. Our objective was to examine the safety and efficacy of minimally invasive lumbar spinal surgery for elderly patients. METHODS: We reviewed demographic information, pre- and postoperative Visual Analog Scale pain scores, Oswestry Disability Index scores, and Short-Form 36 scores of prospectively accrued patients who underwent minimally invasive decompression of lumbar degenerative disease at two institutions between January 2002 and December 2005. Data from patients who were at least 75 years old were selected. Statistical analysis methods included paired t test, multiple linear regression, and linear mixed effects modeling. RESULTS: Fifty-seven patients with a mean age of 81 years met the study criteria (median follow-up period, 7 mo; mean follow-up period, 10 mo). No major complications or deaths occurred. Fifty patients had sufficient outcomes data for analysis. Visual Analog Scale pain scores decreased from 5.7 to 2.2 for back pain and from 5.7 to 2.3 for symptomatic leg pain (P < 0.05). Oswestry Disability Index scores decreased from 48 to 27; Short-Form 36 Body Pain and Physical Function scores also showed statistically significant improvements after surgery (P < 0.05). The longitudinal analysis demonstrated durability of the symptom relief. CONCLUSION: Minimally invasive lumbar spine decompression is a safe and efficacious treatment for elderly patients with spinal stenosis and spondylosis. Elderly patients should be considered good candidates for lumbar surgical decompression using minimally invasive techniques.

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Citation #83 OBJECT: The authors evaluated the efficacy and safety of so-called chimney sublaminar decompression, a new technique to decompress the degenerative stenotic lumbar spinal canal without stripping of the paravertebral muscles. METHODS: Eighteen patients (nine men and nine women whose mean age was 67 years) with symptoms of claudication were selected to undergo chimney sublaminar decompression. The duration of symptoms was greater than 6 months in 17 patients. Two lumbar segments were involved in seven patients, three in eight, and four in the remaining three patients. Central canal stenosis was present in 13 patients, and lateral recess stenosis in five patients. Mild spondylolisthesis was noted in seven patients. All the patients underwent chimney sublaminar decompression. After surgery, mild wound pain developed in 14 patients, moderate wound pain in two, and severe wound pain in two. The postoperative hospital stay was 4 days or fewer in 14 patients. At follow-up examination, excellent, good, and fair outcomes were achieved in 11, five, and two patients, respectively. No patient required a body brace, and no worsening of preexisting spondylolisthesis was detected. The spinal canal was increased to two- to 6.8-fold (mean 4.2-fold) the preoperative size. CONCLUSIONS: Compared with laminectomy or endoscopic surgery, the aforementioned chimney sublaminar decompression technique was an equally effective and less invasive technique in the treatment of degenerative lumbar canal stenosis. Citation #87 STUDY DESIGN: Cohort study with follow-up after at least 1.5 years. OBJECTIVES: The purpose of this study was to determine long-term safety and efficacy of laminectomy in octogenarians. SUMMARY OF BACKGROUND DATA: This is the first study evaluating the outcome in octogenarians with well-defined lumbar spinal stenosis. This study was designed to provide some guidance in clinical-practical decisions in the treatment of aged patients with lumbar stenosis. METHODS: We evaluated long-term outcome after laminectomy in 23 consecutive patients affected by lumbar spinal stenosis. Comorbidity was assessed using the Cumulative Illness Rating Scale for Geriatrics. At follow-up, all patients completed a questionnaire containing the Visual Analog Pain Scale and the Oswestry Disability Index. The use of analgesics was assessed from chart review of their family physician. RESULTS: The average age at the time of surgery was 82.2 +/- 2.6 years; the mean follow-up was 2.7 +/- 1.2 years. The mean of the Cumulative Illness Rating Scale for Geriatrics total score was 7.7 +/- 4.3, reflecting the normative comorbidity-values of octogenarians. At follow-up, 4 patients had died. The Oswestry Disability Index for the remaining patients was 36.4 +/- 28%. The daily nonsteroidal anti-inflammatory medication had decreased from 1.9 to 0.1 equivalent analgesic doses and the amount of morphine from 0.6 to 0.2 equivalent narcotic doses. The Pain Score on the Visual Analog Pain Scale decreased from 85 to 39. After surgery no patient had claudication. CONCLUSION: On the long-term, decompressive laminectomy in selected octogenarians results in decreased disability, decline of analgesics usage, and increased quality of life. Citation #91 STUDY DESIGN: Literature review, technique overview, prospective and retrospective data analysis. OBJECTIVE: To review current minimally invasive surgery (MIS) methods of decompression for lumbar spinal stenosis and present a decompression technique using a flexible microblade shaver system. SUMMARY OF BACKGROUND DATA: Several MIS decompression techniques for stenosis have been developed to minimize damage to soft tissues and reduce the amount of posterior element resection. Decompression using linearly configured instruments may not be able to adequately address stenosis in the neural foramen. A flexible microblade shaver system is able to traverse the foramen, removing bone and ligament, using a ventral to dorsal approach, rather than medial to lateral. This enables it to effectively decompress the lateral recess and neural foramen while sparing posterior structures. METHODS: Brief literature review of current

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MIS decompression techniques is presented. MIS decompression using a flexible microblade shaver system is described with 1 year outcomes from a small pilot study and a retrospective chart review at 2 centers. RESULTS: A small postmarket pilot study (n = 9) with 1 year results showed positive patient outcomes using Visual Analog Scale (decrease by 73%), Oswestry Disability Index(50% improvement), Zurich Claudication Questionnaire physical function and symptom severity (improved by 72% and 31%, respectively), and Short-Form 36 (SF-36) Physical Component Score (36% improvement). Sixty-seven patients from a retrospective chart review at 2 centers had an average of 2 levels per patient decompressed using a flexible microblade shaver system. No patient has returned for additional surgery and there have been no cases of neurologic impairment. CONCLUSION: Current decompression techniques may result in inadequate decompression of the neural foramen or excessive resection of the facet joint. MIS decompression using a flexible microblade shaver system represents a way to perform an effective, facet-preserving decompression for patients with lumbar spinal stenosis. Citation #94 This article presents the clinical and radiological results of the modified spinous process osteotomy decompressive procedure (MSPO), which affords excellent visualisation and provides wide access for Kerrison rongeur use and angulation while minimising destruction of tissues not directly involved in the pathological process. A total of 50 patients with degenerative lumbar spinal stenosis underwent MSPO between 2002 and 2005. The minimum follow-up period was five years. Patient's walking distance ability was 85.4 m (5-180 m) preoperatively and 2,560 m (1500-8000 m) at the last follow-up. Leg pain improved in 100% of the patients and back pain improved in 89% at the last follow-up. The overall results were good to excellent in 90% of the patients, fair in 16% and all patients were satisfied with the outcome at the last follow-up. The osteotomised spinous process eventually united with the retained laminar bridge in all patients within nine months after surgery. Degenerative lumbar spinal stenosis can be adequately decompressed with less violation of the integrity of the posterior elements using MSPO. The described technique of MSPO yielded promising results with few complications. The authors believe MSPO is less technically demanding and appropriate for general orthopaedic surgeons, occasional spine surgeons and chief residents. Citation #95 BACKGROUND: Ultrasonic surgical aspirators have been used mainly for removing brain tumors. Because of their longitudinal and torsional tip, they are used for cutting the bone structures in spinal surgery installing a scalpel-type tip. The purpose of this report is to describe the effectiveness and surgical pitfalls of an ultrasonic bone curette in laminoplastic laminotomy and hemilaminotomy. METHODS: We present 12 patients who underwent laminoplastic laminotomy and hemilaminotomy. We used a SONOPET UST-2001 ultrasonic bone curette with HB-05S handpieces (M and M Co, Ltd, Tokyo, Japan). After a tumor was removed, titanium plates were used for the laminoplastic laminotomy and hemilaminotomy. The technical advantage of an ultrasonic bone curette and procedure-related complication were examined. RESULTS: There were no major procedure-related complications such as cord injury. Wound infection and subcutaneous fluid collection caused by cerebrospinal fluid leakage did not occur for reconstruction of posterior bony structure. In 1 patient with calcified dura mater associated with tumor, dural tear occurred. The width of the tip was narrow enough for resected laminae to be fused postoperatively, and spinal instability did not occur in all cases. CONCLUSION: The scalpel-type ultrasonic bone curette is useful for cutting bone and effective for reconstruction of the laminae. Laminotomy with an ultrasonic bone curette is safe and minimally invasive. To prevent dural tear, we recommend drilling laminae to make the bone thin as the first step, followed by cutting the remaining laminae using a bone curette especially in cases with calcified or tense dura mater. Citation #101

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OBJECTIVE: Adequate neural decompression with minimal structural alteration is the goal of lumbar stenosis surgery. Often because of limited visualization significant parts of the facet joints are removed enhancing the potential for developing instability. To overcome this problem we have developed a small curved Kerrison rongeur that contains a 10 000-pixel endoscope. This instrument allows one to visualize and decompress structures within the lateral recess that may have required more extensive removal of portions of the facet joints. METHODS: Ten patients with symptomatic lumbar spinal stenosis were decompressed using the endoscopic rongeur. RESULTS: Compression of the lateral dura and nerve root by the facet and ligamentum could easily be identified. In all cases the ligament could be easily removed and the facet joint was undercut only enough to decompress the nerve. CONCLUSION: This instrument has the potential for less invasive decompression of spinal stenosis and further study of its utility is planned. Citation #102 STUDY DESIGN: Fifteen patients with lumbar spinal stenosis were treated by a new technique, inverse laminoplasty, and the results were evaluated clinically and radiologically. OBJECTIVE: To present the advantages of inverse laminoplasty over laminectomy for the treatment of lumbar spinal stenosis. SUMMARY AND BACKGROUND DATA: Laminectomy has been used widely in the treatment of lumbar spinal stenosis. Destruction of the spinal bony structure, instability, and peridural scar formation are the main problems with this procedure. To overcome these disadvantages, a practical technique is presented here. MATERIAL AND METHODS: In a prospective study, 15 patients who underwent surgery with the inverse laminoplasty technique were evaluated clinically and radiologically. The Oswestry Disability Index was used for clinical assessment. L4-L5 spinal stenosis was detected in all patients. As the operative technique, the L4 lamina was elevated en bloc using a high-speed drill and rongeur. After removal of the ligamentum flavum, the roof of the foramina, and/or disc, the lamina was rotated 180 degrees, rested on facets, and reattached by use of a titanium miniplate. RESULTS: All patients improved clinically and neurologically after this procedure. The mean Oswestry Disability Score was 38.33 preoperatively and 7.0 postoperatively. The mean follow-up time was 17.3 months. Spinal canal diameters were calculated by preoperative and postoperative computed tomography, and the mean enlargement was 77.8%. No complications were observed. CONCLUSION: With this technique, the important integrity of the spinal osseous structures is preserved, and a significant enlargement of the spinal canal area is achieved. This technique prevents peridural scar formation after laminectomy caused by a mechanical barrier effect. Long-term follow-up is needed to evaluate spinal stability in these patients. Citation #103 OBJECTIVE: To present our experience with the Misonix Ultrasonic Bone scalpel in spinal surgery, highlighting its potential applications and advantages. METHODS: Between March and December 2011, a total of 937 spinal cases were performed at a single centre. The Misonix Bone Scalpel (MBS) was used in 62 of these cases. Data were collected prospectively using the Spine Tango registry. Patient demographics, disease type, surgery performed and complications were all recorded along with pre- and post-operative core measures outcome index (COMI). RESULTS: The majority of cases were for spinal degenerative disorders, in particular, revision cases. The bone cutter was also used to achieve laminotomies for access to intradural tumours, corpectomies and a mixture of other pathologies. Of the 62 patients only 1 (1.6%) experienced a blood loss greater than 500 ml, and there was only 1 dural tear (1.6%) as a direct result of the MBS. Four illustrative cases are discussed. CONCLUSIONS: The MBS is a useful adjunct in spinal surgery with particular value in revision cases where scar tissue distorts the normal anatomy. There was a low complication rate with a trend to reduced blood loss. This was most apparent to the senior authors during cervical and thoracic corpectomies.

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Citation #104 Although the operative results have been improving since the air drill was introduced for cervical laminectomy instead of an ordinary rongeur, post-laminectomy complications, such as postoperative fragility of the cervical spine to acute neck trauma, posterior spur formation at the vertebral body, and malalignment of the lateral curvature have still remained as unsolved problems. In order to avoid these disadvantages, a new surgical technique called "expansive open-door laminoplasty" was devised by the author in 1977, which is relatively easier, safer, and better than the ordinary laminectomy from the standpoint of structural mechanics of the cervical spine. The operative procedure is described in detail. Operative results in the patients with cervical OPLL, spondylosis, and canal stenosis were satisfactory, and optimal widening of the AP diameter of the spinal canal is considered to be over 4 mm. From this procedure a bilateral, open-door laminoplasty has been devised for extensive exploration at the intradural space. Citation #106 STUDY DESIGN: This is a detailed description of a facet-sparing decompression technique and a prospective observational study of 59 subjects. OBJECTIVE: To describe a facet-sparing decompression technique, quantify operative parameters, adverse events, and anatomic changes following decompression with a flexible microblade shaving system. SUMMARY OF BACKGROUND DATA: Decompression in patients with lumbar spinal stenosis is a common surgical procedure. However, obtaining a thorough decompression while leaving enough tissue to avoid destabilization can be challenging. Decompression with a flexible, through-the-foramen system may mitigate some of these challenges. MATERIALS AND METHODS: Fifty-nine subjects diagnosed with lumbar spinal stenosis were recruited into this study. Subjects underwent decompression with a flexible, microblade decompression system at a total of 88 levels between L2 and S1. Subject demographics, details of the procedure, and operation, including adverse events were collected. Preoperative and postoperative computed tomography scans and plain radiographs were obtained from a subset of 12 subjects and quantitatively assessed for bone removal and preservation of stabilizing structures. RESULTS: Fifty-nine subjects had 88 levels treated, 51% single-level and 49% 2-level with L4-L5 being the most commonly decompressed level. Operative time, blood loss, and length of stay were similar to or less than that seen in the historical control. The system was successfully used for decompression in 95.8% of the attempted foramina. Three operative complications were reported, all dural tears (5.1%). These dural tears occurred before introduction of the flexible decompression system. Computed tomography scans from 12 subjects demonstrate access to the lateral recess and foramen with removal of <6% of the superior facet cross-sectional area. CONCLUSIONS: The flexible microblade shaving system provided thorough decompression with few intraoperative complications. Operative variables were favorable compared to the literature and radiographic decompression was achieved to a great extent while allowing for the preservation of the facet joints and midline structures.

7.4.3. Retrospective Trial Citation #18 Klessinger treated 34 patients (41.2% female, mean age 53 years (range 27-77)) with persistent back pain after surgery with radiofrequency neurotomy. A NeuroTherm JK3 generator (NeuroTherm) was used along with cannulae (20-gauge with a 10-mm active tip). The total time of the lesion at 80°C was 60 seconds. Success was defined as at least 50% pain reduction for 6 months. 58.8% of patients achieved a successful outcome. The author concluded that medial branch radiofrequency neurotomy can provide pain relief in select patients.

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Citation #19 Schofferman and Kine treated 20 subjects (80% female, mean age 48 years (range 26-63) with recurrent lumbar facet pain after radiofrequency neurotomy with repeat radiofrequency neurotomies (2, 3, 4, 5 or 7+). Outcome was measured by mean duration of relief. Mean duration of relief after a second radiofrequency neurotomy was 11.6 months (85% success, relief continuing in one), after a third, 11.2 months (95% success, relief continuing in 6); after a fourth, 9 months (87.5% success, relief continuing in 4). The authors concluded that mean duration of pain relief from radiofrequency neurotomy was 10.5 months and the procedure was successful 85% of the time. No significant differences were seen. The frequency of success and durations of relief remained consistent after each subsequent radiofrequency neurotomy. Citation #20 Kornick et al treated 92 patients (54% female) with chronic low back pain during 116 denervation procedures. 22-gauge 10-cm Sluijter-Mehta cannulas with 5-mm active tips (SMK-SC10; Radionics, Inc) were used along with RF electrodes (Radionics SMK-STC) placed between the L1 transverse process and the ala of the sacrum. Denervation was performed using an RFG-3CF lesioning generator (Radionics, Inc) at 80°C for 90 seconds. Outcome measured the incidence of complications within 8 weeks of the procedure. 3 cases of localized pain > 2 weeks, 3 cases of neuritic pain < 2 weeks and no infection, new motor deficits or new sensory deficits were identified. An overall 1.0% incidence of minor complications was reported per lesion site. Citation #21 Haufe and Mork treated 174 patients (44.3% female, mean age 64 (range 22-89)) with facet joint pain with endoscopic facet debridement. Patients had cervical (25.9%), thoracic (8.6%) or lumbar (65.5%) disease. Pituitaries were used to remove the capsular tissue and electrocautery and holmium lasers were also used to complete the denuding of the joint surface. Primary outcome was measured by percent change in facet-related pain as measured by Visual Analog Scale (VAS) at final follow up > 3 years. At final follow-up, 77%, 73% and 68% of subjects with cervical, thoracic or lumbar disease respectively had at least 50% improvement in pain. Suture failure was reported in 2 subjects. The authors concluded that endoscopic facet debridement was comparable to radiofrequency ablation. Citation #22 Yilmaz et al treated 50 patients (70% female, mean age 51.82 +/- 16.99 years) with lumbar facet joint syndrome with facet joint neurotomy. Lesioning was performed at 80 degrees for 100 to 120 seconds. Outcomes were assessed at 12 months postoperatively using VAS and EQ-5D measures of pain, disability and treatment satisfaction. 48% of patients had at least 70% reduction in pain (VAS) and 86% had at least 60% reduction in pain (VAS). No complications were reported. The authors noted that radiofrequency is effective, easy and safe treatment modality for facet joint syndrome. Citation #46 STUDY DESIGN: A retrospective review. OBJECTIVE: The aim of this study was to study the effectiveness of percutaneous radiofrequency neurotomy of facet joints by monitoring compound muscle action potentials (CMAPs) of the multifidus muscle group as an objective index of treatment efficacy. SUMMARY OF BACKGROUND: Percutaneous radiofrequency neurotomy of the medial branches of the dorsal rami of the lumbar nerves is a widely accepted treatment for chronic lumbar intervertebral joint pain. However, its success rate has varied in different studies because an objective method for evaluating the facet joint denervation is lacking. METHODS: Fifty-five patients (age range, 19-76 y; mean age, 55 y) with low back pain persisting for ≥3 months, in whom facet block and/or block of the medial branch of the dorsal ramus were only temporarily effective, were included. The Japanese Orthopaedic Association (JOA) scoring system for back pain was used for clinical assessment. JOA scores were measured before treatment and 1 week, 3 months, 6

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months, and 12 months afterward. The improvement rate was calculated with ≥40% improvement rate defined as successful, and the success rate was subsequently evaluated. RESULTS: The patient success rate was 75% (41/55) at 1 week, 71% (39/55) at 3 months, 60% (33/55) at 6 months, and 51% (28/55) at 12 months after treatment. Two cases had minor postoperative complications, which were localized burning pain lasting <1 week at the site of electrode insertion. CONCLUSIONS: Our results suggest that percutaneous radiofrequency facet joint denervation with CMAPs monitoring is a safe, long-lasting, and effective treatment for chronic facet joint pain. CMAP monitoring may be useful as an objective index for facet denervation. Citation #47 BACKGROUND: Radiofrequency is widely used in the treatment of chronic pain for its efficacy and low incidence of side effects and complications. Despite this, it is commonly believed that this kind of treatment could interfere with medical implantable devices. Potential interference between implanted devices such as pacemakers, defibrillators and spinal cord stimulators and the radiofrequency of neurotomy is an important concern for physicians caring for patients with these devices. METHODS: A retrospective study was conducted on 30 radiofrequency-treated patients, collected in five years out of more than 1,000 patients treated. Our cohort was selected due to the presence of implanted medical devices. Treatments include the radiofrequency neurotomy of the lumbar facet joints, intervertebral discs, sacroiliac joint and peripheral nerves. RESULTS: Out of 30 patients and 68 treatments, global radiofrequency ablation was considered safe, due to the absence of any problem during or after the procedure. In particular, procedures were never interrupted because of electrical interference with the implanted devices or for problems attributable to an aberrant activation of them. Neurological and physical exam did not show any alteration after the procedure. CONCLUSION: There are several theoretical concerns about radiofrequency treatments in patients with implantable electrical medical devices. However, there is no experimental evidence of electrical interference with the implanted devices. Our long experience strongly suggests that by following simple precautions, patients can benefit from radiofrequency pain-relieving procedures without any adverse events. Citation #51 BACKGROUND CONTEXT: Among the various forms of laminoplasty fixation, plate augmentation provides a semirigid arch reconstruction and is gaining popularity as the result of its safety and effectiveness. However, the effects of this procedure on hinge status and subsequent bony healing remain unclear. PURPOSE: We sought to evaluate the status and time course of bony healing of the hinge gutter and to determine the effect on postoperative clinical course of plate-only, open-door cervical laminoplasty. STUDY DESIGN: This was a retrospective clinical series. PATIENT SAMPLE: A total of 79 adult men and women undergoing cervical laminoplasty in a university hospital setting were studied. OUTCOME MEASURES: Time-dependent changes in hinges observed on computed tomography (CT) were used to measure the radiological outcome. A numerical rating scale of axial neck pain and arm pain was used to evaluate the clinical outcome. METHODS: Patients who underwent plate-only, open-door laminoplasty for cervical myelopathy and had available postoperative CT scans were enrolled in this study. Neck pain intensity before and 1 year after surgery was assessed with questionnaires. CT scans (n=125) obtained after surgery were assessed in terms of bony healing of the hinge. RESULTS: Most of the hinges were initially well- bent. Only 9% were found to be "fractured" or "in danger of fracture" at 1 week. Primary healing without callus formation, which is the next step of bony healing of well-bent hinges, was observed in 62% of cases at month 4. The remaining 38% were classified as "fractured" or in the process of "secondary healing." A similar number of hinges was classified as "secondarily healed" after 1 or 2 years of follow-up. All except one hinge were well united and incorporated at the final follow-up, and the number of hinges classified as "fractured or secondarily healed" related to postoperative

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axial neck pain with respect to the 1-year visual analog scale for the neck and the Neck Disability Index. CONCLUSIONS: Although plate-only, open-door laminoplasty is a safe and reliable surgery for decompression of multilevel cervical disease, the fixation that it provides on the open side may not be sufficiently stable to allow successful primary healing. Additional attention should be paid to the hinged side to prevent delayed fracture in the early postoperative period and to reduce postoperative axial pain. Copyright © 2014 Elsevier Inc. All rights reserved. Citation #52 OBJECT: Unintended durotomies are a common complication of spine surgery and are often correlated with increased postoperative morbidity. Recently, ultrasonic bone curettes have been introduced in spine surgery as a possible alternative to the conventional high-speed drill, offering the potential for greater bone-cutting precision and less damage to surrounding soft tissues. To date, however, few studies have investigated the safety and efficacy of the ultrasonic bone curette in reducing the rates of incidental durotomy compared with the high-speed drill. METHODS: The authors retrospectively reviewed the records of 337 consecutive patients who underwent posterior cervical or thoracic decompression at a single institution between January 2009 and September 2011. Preoperative pathologies, the location and extent of spinal decompression, and the use of an ultrasonic bone curette versus the high-speed drill were noted. The rates of incidental durotomy, as well as hospital length of stay (LOS) and perioperative outcomes, were compared between patients who were treated using the ultrasonic bone curette and those treated using a high-speed drill. RESULTS: Among 88 patients who were treated using an ultrasonic bone curette and 249 who were treated using a high-speed drill, 5 (5.7%) and 9 (3.6%) patients had an unintentional durotomy, respectively. This finding was not statistically significant (p = 0.40). No patients in either cohort experienced statistically higher rates of perioperative complications, although patients treated using an ultrasonic bone curette tended to have a longer hospital LOS. This difference may be attributed to the fact that this series contained a statistically higher number of metastatic tumor cases (p < 0.0001) in the ultrasonic bone curette cohort, likely increasing the LOS for that patient population. In 13 patients, the dural defect was repaired intraoperatively. No patients who experienced an incidental durotomy had new-onset or permanent neurological deficits postoperatively. CONCLUSIONS: The safety and efficacy of ultrasonic bone curettes in spine surgery has not been well established. This study shows that the ultrasonic bone curette has a similar safety profile compared with the high- speed drill, although both are capable of causing iatrogenic dural tears during spine surgery. Citation #53 BACKGROUND CONTEXT: Thoracic myelopathy caused by multilevel (three or more levels) ossification of the ligamentum flavum (OLF) is rare. Little is known about its clinical features, and the surgical outcomes along with its related factors are also unclear. PURPOSE: To describe the clinical features, assess the safety and effectiveness of surgical decompression, and determine the prognostic factors relevant for patients with thoracic myelopathy caused by multilevel OLF. STUDY DESIGN/SETTING: A retrospective clinical study. PATIENT SAMPLE: Seventy-five consecutive multilevel OLF patients who underwent surgical decompression were analyzed. OUTCOME MEASURES: Modified Japanese Orthopedic Association (JOA) scale and the recovery rate. METHODS: Patients who underwent surgical decompression for symptomatic multilevel OLF during January 1996 to June 2010 were all included. Clinical data were collected from medical and operative records; patients were evaluated by using the JOA scale preoperatively and during the follow-up. Correlations between the surgical outcome and various factors were also analyzed. RESULTS: Forty-three men and 32 women with a mean age of 54.7 years (range 36-78 years) were included. The mean number of involved levels is 4.6 and contiguous OLF presented in 73.3% of these patients. The most common involved levels were T10/T11 (15.4%), T9/T10 (13.3%), and T11/T12 (12.5%). Coexisting spinal disorders were found in 41 patients (54.7%). Preoperative

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evaluation showed the mean JOA score was 5.8±1.7; 37.3% of these patients had mild myelopathy, 53.3% had moderate myelopathy, and 9.3% had severe myelopathy. All patients received posterior laminectomy. The JOA score (mean 8.2±2.1) significantly increased postoperatively (p<.05), and multiple regression analysis showed that preoperative duration of symptoms and preoperative JOA score were important predictors of surgical outcome. CONCLUSIONS: Laminectomy with partially internal fixation is safe and effective in treatment of patients with symptomatic multilevel OLF. The results of our study show that preoperative JOA score and preoperative duration of symptoms were important predictors for the clinical outcome. Citation #54 OBJECTIVE: The aim of this report was to evaluate the long-term effectiveness and safety of mild lumbar decompression for the treatment of neurogenic claudication associated with lumbar spinal stenosis. This technique uses a percutaneous dorsal approach to remove small portions of ligament and lamina, thereby restoring space and decompressing the spinal canal. MATERIALS AND METHODS: Two-year data are reported for 45 patients treated with mild decompression at 11 US sites. Outcome measures included the Visual Analog Scale (VAS), Oswestry Disability Index, and Zurich Claudication Questionnaire. Safety was monitored throughout the procedural and follow-up period for all patients. Interim data are included for these patients at 1 week, 6 months, and 1-year follow-up. RESULTS: Seventy-one percent of patients reported improvement in VAS at the end of the reporting period. At 2 years, patients demonstrated a statistically significant reduction of pain as measured by VAS, and improvement in physical function and mobility was significant as measured by Zurich Claudication Questionnaire and Oswestry Disability Index. Tukey honestly significant different test found significant improvement in all outcome measures from baseline to each follow- up interval. Further, major improvement occurred by 1-week follow-up and showed no difference between each subsequent follow-up, signifying considerable stability and durability of the initial result over time. No major device or intraprocedural adverse events were reported. DISCUSSION: In this report of 2-year follow-up on 45 patients treated with mild percutaneous lumbar decompression, patients experienced statistically significant pain relief and improved functionality. Citation #55 BACKGROUND: Minimally invasive posterior spinal endoscopic surgery has increased in popularity. However, a steep learning curve may result in a high frequency of complications. Additionally, device failure may occur during routine use. We retrospectively investigated the incidence of such safety issues in a population of patients undergoing endoscopic spinal surgery at our institution. PATIENTS/MATERIALS AND METHODS: A total of 611 cases were included. Underlying diseases that required endoscopic surgery were lumbar disc herniation in 382 patients, lumbar spinal stenosis in 123 patients, lumbar degenerated spondylolisthesis in 100 patients, and lumbar facet joint cysts in 6 patients. Surgical complications, anatomic abnormality, and mechanical failure and/or damage of surgical instruments were considered adverse events associated with the surgery. The time period was divided into first and second halves in order to investigate the effects of the learning curve. RESULTS AND CONCLUSION: Complications were divided into perioperative and postoperative complications. Due to operator inexperience, complications such as intraoperative dural tear, wrong disc level surgery, and contralateral symptoms due to lack of nerve decompression were more common during the first 5 years. In contrast, no improvement was seen in the frequency of epidural hematoma in the late phase. This report indicates that during endoscopic spinal surgery, some safety issues and surgical complications are independent of surgeon experience, and may include radicular anomaly, postoperative hematoma, and mechanical damage of instruments. Citation #56

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OBJECTIVE: Few reports have addressed long-term outcomes, as well as the safety and efficacy of the cervical microendoscopic foraminotomy (CMEF) and cervical microendoscopic diskectomy (CMED) procedures used in modern spine practice to treat degenerative disease of the cervical spine. Accordingly, we present long-term outcomes from a cohort of patients treated for foraminal stenosis or disk herniation with the CMEF or CMED procedure, respectively. METHODS: A total of 38 patients were included in the study, with a mean follow-up of 24.47 ± 12.84 months. Patients were monitored prospectively with questionnaires consisting of a visual analog scale for the neck (VASN) and arm (VASA), and a neck disability index (NDI) form. Operative time, estimated blood loss, and hospitalization stay also were collected. Data were analyzed with Microsoft Office Excel 2007. RESULTS: The mean 1 year follow-up scores all showed statistically significant improvements: NDI (P = 0.0019), VASN (P = 0.0017), VASA (P ≤ 0.0001). Similar results were seen at 2-year follow-up: NDI (P = 0.0011), VASN (P = 0.0022), and VASA (P ≤ 0.0001); and at 3- to 6-year follow-up: NDI (P = 0.0015), VASN (P = 0.0200), and VASA (P = 0.0034). The average operation time, hospitalization stay, and estimated blood loss were 154.27 ± 26.79 minutes, 21.22 ± 14.23 hours, and 27.92 mL, respectively. There were no statistically significant differences when patients were compared by age (over 50 vs. under 50), operative level (above C6 vs. below C6), or sex. One complication was reported in this study consisting of duratomy, which required no further intervention. CONCLUSION: Posterior CMEF and CMED are safe and effective procedures for minimally invasive decompression in the cervical spine. Citation #58 OBJECTIVE: This systematic safety review reports multicenter safety results of symptomatic lumbar spinal stenosis (LSS) patients treated with percutaneous lumbar decompression. DESIGN: All percutaneous lumbar decompression institutional review board-approved study patients, as well as a retrospective safety survey, were included in this review. METHODS: All study centers followed the same widely accepted and standardized procedure for percutaneous decompression and utilized the same criteria when observing and reporting device- or procedure-related adverse events. OUTCOME MEASURES: In addition to safety data, Oswestry Disability Index scores were used to document baseline functional disability, and visual analog scale values defined the intensity of baseline back and leg pain. Treatment outcomes of patients who reached 1-year follow-up were also included. RESULTS: Of the 373 patients included in this safety review, there were no reports of major device- or procedure-related adverse events, and there were no mortalities. Major complications were defined as any device- or procedure-related event that required intervention, including events such as incidental durotomy, epidural hematoma, infection, or bleeding that required transfusion. One-year efficacy data showed statistically significant improvement in pain and mobility, further supporting the excellent safety profile of percutaneous lumbar decompression. CONCLUSIONS: In this safety review, percutaneous lumbar decompression proved to be a safe procedure. Compared with other more invasive lumbar decompression techniques, percutaneous lumbar decompression has demonstrated significantly better safety. This high level of safety is particularly vital for the rapidly growing elderly LSS patient population with increased treatment risks related to comorbid medical issues. Citation #59 AIM: The best method for surgical intervention in symptomatic lumbar stenosis is not clear. The present study aims to assess first year outcomes and complication rates of patients treated with single posterior decompressive laminectomy. MATERIAL AND METHODS: Patients requiring surgery for severe, symptomatic, lumbar spinal stenosis were evaluated retrospectively. Oswestry disability index scores as well as the complications attributable to surgery were recorded before, at the sixth month and at the twelfth month of the surgery. RESULTS: Eighty patients were enrolled to the study. The mean age of the population was 63,14 ± 11,57. Neurogenic claudication was the most

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common finding (65%). Of the patients, 67.5% had severe spinal stenosis. The mean ODI score at the baseline was relatively high than in the literature and was measured as 74.30 ± 5.38. At the end of the 6 months follow-up period, all patients' ODI scores significantly improved. Moreover, this improvement continued till the end of the 12 month. The mean change in ODI at the end of the first year was 41.80% ± 12.73. CONCLUSION: In selected cases of symptomatic lumbar spinal stenosis, single posterior decompression using laminectomy is safe and effective. Citation #60 OBJECTIVE: To compare clinical outcomes and surgical-related adverse events in patients with multilevel cervical myelopathy (MCM) undergoing simple anterior, simple posterior, or 1-stage posterior-anterior surgical decompression strategies. SUMMARY OF BACKGROUND DATA: Simple anterior, simple posterior, and 1-stage posterior-anterior surgical decompression strategies have been advocated for MCM treatment in both Western and Chinese populations. However, there is limited evidence on whether 1-stage posterior-anterior strategy may offer equal or more advantages than the other 2 strategies for patients with MCM. METHODS: A retrospective review of medical records was conducted for 255 patients with MCM who had undergone surgical decompression in 3 Chinese spinal centers from 1999 to 2010. Neurological status, perioperative variables, and surgical complications were assessed. Multiple linear regression was used to evaluate factors associated with the outcomes of each strategy. RESULTS: Analyses were conducted on a total of 229 patients with MCM undergoing surgical decompression via 1-stage posterior-anterior (68 patients), simple anterior (102 patients), and simple posterior approaches (59 patients). One- stage posterior-anterior approach had the highest Japanese Orthopaedic Association recovery rate after adjusted for age and sex (adjusted mean ± SD: 50.0 ± 3.2, P < 0.001) and additionally adjusted for smoking, duration from onset of symptoms to surgery, comorbidities, preoperative Japanese Orthopaedic Association score, Ishihara's curvature index and Pavlov ratio, operative blood loss, operating time, anterior operated disc levels, and posterior operated levels (adjusted mean ± SD: 51.6 ± 11.6, P < 0.01). Anterior approach had the largest difference between the pre- and postoperative Ishihara's curvature indexes after adjusted for age and sex (adjusted mean ± SD: 5.3 ± 1.0, P < 0.01) and after multivariable adjustment (adjusted mean ± SD: 6.5 ± 2.8, P = 0.003). CONCLUSION: One-stage posterior-anterior strategy can be a reliable and effective treatment strategy for MCM in a subgroup of patients with anterior and posterior compression on spinal cord simultaneously. Citation #64 OBJECTIVE: To determine the effectiveness of C2 nerve root decompression and C2 dorsal root ganglionectomy for intractable occipital neuralgia (ON) and C2 ganglionectomy after pain recurrence following initial decompression. METHODS: A retrospective review was performed of the medical records of patients undergoing surgery for ON. Pain relief at the time of the most recent follow-up was rated as excellent (headache relieved), good (headache improved), or poor (headache unchanged or worse). Telephone contact supplemented chart review, and patients rated their preoperative and postoperative pain on a 10-point numeric scale. Patient satisfaction and disability were also examined. RESULTS: Of 43 patients, 29 were available for follow-up after C2 nerve root decompression (n = 11), C2 dorsal root ganglionectomy (n = 10), or decompression followed by ganglionectomy (n = 8). Overall, 19 of 29 patients (66%) experienced a good or excellent outcome at most recent follow-up. Among the 19 patients who completed the telephone questionnaire (mean follow-up 5.6 years), patients undergoing decompression, ganglionectomy, or decompression followed by ganglionectomy experienced similar outcomes, with mean pain reduction ratings of 5 ± 4.0, 4.5 ± 4.1, and 5.7 ± 3.5. Of 19 telephone responders, 13 (68%) rated overall operative results as very good or satisfactory. CONCLUSIONS: In the third largest series of surgical intervention for ON, most patients experienced favorable postoperative pain relief. For patients with pain recurrence

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after C2 decompression, salvage C2 ganglionectomy is a viable surgical option and should be offered with the potential for complete pain relief and improved quality of life (QOL). Citation #66 BACKGROUND: Cervical laminoplasty is often used for the decompression of multilevel cervical spondylotic myelopathy without creating spinal instability and kyphosis. OBJECTIVE: To assess the axial pain, quality of life, sagittal alignment, and extent of decompression after standard cervical laminectomy or laminoplasty. We further evaluate whether the sagittal alignment changes over time after both procedures and whether axial pain depends on sagittal alignment. METHODS: We reviewed 268 patients with cervical radiculopathy or myelopathy who had undergone standard cervical laminectomy or laminoplasty between January 1999 and January 2009. The clinical outcome was analyzed by visual analog scale for neck pain. The quality of life was analyzed by EQ- 5D questionnaire. The degree of deformity and extent of decompression were assessed using the Ishihara index and Pavlov's ratio, respectively. RESULTS: Laminoplasty was associated with more neck pain and worse quality of life when 4 or more levels were decompressed compared with the laminectomy group. For operations of 3 or fewer levels, there was no difference. Interestingly, the radiological effectiveness of decompression was greater in the laminoplasty group. CONCLUSION: Laminoplasty for 4 or more cervical levels was associated with more axial pain and consequently poorer quality of life than laminectomy. There was a similar loss of sagittal alignment in both the laminectomy and laminoplasty groups over time. Our results suggest there is no clear benefit of laminoplasty over laminectomy in patients who do not have spinal instability. Citation #74 OBJECTIVE: We performed a retrospective patient chart review to determine the feasibility and safety of en bloc resection of lamina and ossified ligamentum flavum in the treatment of thoracic ossification of ligamentum flavum (OLF). METHODS: From January 2000 to June 2006, 36 patients with thoracic OLF underwent en bloc resection of lamina and ossified ligamentum flavum by a burr- grinding technique. The range of resection included one lamina superior and one lamina inferior to the diseased segments. Ossified dura mater was removed if present, and simultaneous repair was carried out. RESULTS: The mean preoperative Japanese Orthopedic Association (JOA) score (an evaluation system for thoracic myelopathy with a total score of 11 points) was 5 points (range, 3-9 points). The mean JOA score at the last follow-up visit (mean follow-up period, 3.9 years) was 8.44 points (range, 6-11 points). The range of improvement was from 2 to 6 points, and the mean improvement rate was 60.5% (range, 33.3%-100%). No postoperative aggravation of neurological dysfunction, leakage of cerebrospinal fluid (CSF), wound infection, kyphosis, or recurrence occurred. A CSF cyst found in one patient 3 weeks postoperatively was absorbed automatically after 10 months. CONCLUSION: The en bloc resection technique described here is both safe and effective. Citation #75 BACKGROUND AND OBJECTIVES: Lumbar canal stenosis is a common source of chronic low back and leg pain. Minimally Invasive Lumbar Decompression (mild(R)) is a new minimally invasive treatment for pain relief from symptomatic central lumbar canal stenosis. The procedure involves limited percutaneous laminotomy and thinning of the ligamentum flavum in order to increase the critical diameter of the stenosed spinal canal. The objective of this technical report is to evaluate the acute safety of the mild procedure. METHODS: Manual and electronic chart survey was conducted by 14 treating physicians located in 9 U.S. states on 90 consecutive patients who underwent the mild procedure. Patients within local geographical practice areas were selected in keeping with product Instructions For Use. Those patients requiring lumbar decompression via tissue resection at the perilaminar space, within the interlaminar space and at the ventral aspect of the lamina were treated. Data collected included any complications and/or adverse events occurring

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during or immediately following the procedure prior to discharge. RESULTS: Of 90 procedures reviewed, there were no major adverse events or complications related to the devices or procedure. No incidents of dural puncture or tear, blood transfusion, nerve injury, epidural bleeding, or hematoma were observed. LIMITATIONS: Data were not specifically collected; however, regardless of difficulty, in this series none of the procedures were aborted and none resulted in adverse events. Efficacy parameters were not collected in this safety survey. CONCLUSIONS: This review demonstrates the acute safety of the mild procedure with no report of significant or unusual patient complications. To establish complication frequency and longer-term safety profile associated with the treatment, additional studies are currently being conducted. Survey data on file at Vertos Medical, Inc. Citation #78 OBJECTIVE: Laminoplasty has become a common alternative to laminectomy for cervical spondylotic myelopathy or radiculopathy. The procedures have been compared before, but data on functional recovery are limited. We aim to compare the safety and short-term clinical and functional outcomes of cervical laminoplasty and cervical laminectomy. METHODS: We performed a retrospective analysis of the outcome of 72 patients who had laminoplasty and 49 patients who had laminectomy at our hospital from 1999 to 2005. Patients had cervical spondylotic myelopathy or radiculopathy. All of the patients were similar in age and pre-operative functional status. All patients were assessed pre-operatively and 4 months post-operatively with the Rankin disability score, Glasgow outcome scale and Karnofsky and Nurick scales. RESULTS: Laminoplasty resulted in greater improvement than laminectomy on the Rankin scale (p<0.0001, chi-square test), GOS (p<0.0027, chi-square test) and Karnofsky scores (p<0.01, Wilcoxon test). Nurick scores improved in both groups without a significant difference (p<0.62, Wilcoxon test). The proportion of patients who improved on all scales tended to be greater in the laminoplasty group. Patients spent 1.8 fewer days in the hospital after laminoplasty (p=0.04, Wilcoxon rank-sum test). There was no mortality or permanent morbidity for either procedure. CONCLUSION: Both cervical laminectomy and laminoplasty are safe and effective for the treatment of cervical myelopathy or radiculopathy. Cervical laminoplasty results in a shorter hospital stay and greater functional improvement at 4 months follow-up. Citation #85 A retrospective study to investigate the relationship between the surgical levels and decompression effects was performed in patients with cervical myelopathy who had undergone Tension-band laminoplasty (TBL) with/without simultaneous C1 laminectomy. One hundred and sixty-eight patients (115 males, 53 females; age: 31-80 years, average 58.9 years; follow-up period: 12-120 months, average 20 months) were divided into three groups according to the range of the surgical levels: seventy-two patients in group A underwent TBL at the C2-C7 levels with C1 laminectomy; 60 patients in group B underwent TBL at the C2-C7 levels; 36 patients in group C underwent TBL at the C3-C7 levels. Neurological evaluation was performed by using the Japanese Orthopedic Association (JOA) scoring system. The alignment changes of the spinal column and the spinal cord were analyzed using pre- and post-operative roentgenograms and MRIs. The differences in the pre- and post-operative anterior subarachnoid spaces (D-ASAS), the spinal cord diameters (D-CORD), and the dural sleeve diameters (D-DURA) at the C1-C7 levels were also analyzed by using MRIs. The JOA scores improved in all groups. As for the spinal alignment, neither significant changes between pre- and post-operation in any group nor significant differences among the three groups were found. The lordosis of the cervical spinal cord was decreased in all groups. D-ASAS of group A was larger than that of group B at the C1-C5 levels (P<0.05), as were those of D-CORD and D- DURA at the C1-C2 and C4-C5 levels (P<0.05). D-ASAS of group A was larger than that of group C at the C1-C4 levels (P<0.05), as were those of D-CORD and D-DURA at the C1-C5 levels

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(P<0.05). In conclusion, laminoplasty including the C2-C7 levels with simultaneous C1 laminectomy was proven to allow the most posterior shift of the spinal cord within the widened dural sleeve at C5 or higher levels without significantly changing the spinal alignment. Citation #86 OBJECT: The authors discuss the safety and efficacy of an ultrasonic bone curette in various spinal surgeries and report its advantages in clinical application. METHODS: Between April 2002 and September 2003, 76 patients with various spinal diseases (29 cervical, five thoracic, 40 lumbosacral, and two foramen magnum regions) were treated microsurgically by using a Sonopet ultrasonic bone curette with longitudinal and torsional tips and lightweight handpieces. The operations were performed successfully and the device was easy to handle. There were no instrument-related complications or -induced damage to any structure even when removing osseous spurs or ossified lesions near the dura mater, nerves, and vessels. CONCLUSIONS: The ultrasonic curette is a useful instrument for procedures performed near the dura mater or other neural tissue without excessive heat production or mechanical injury. This device is recommended for various spinal surgeries in addition to high-speed drills or other tools. Citation #88 BACKGROUND CONTEXT: It is known that postoperative motor palsy at the C5 level occurs with anterior decompression or posterior decompression and has a relatively good prognosis, but the pathogenesis and possible prophylactic measures of the palsy remain unknown. PURPOSE: The purpose of this study was to evaluate the effectiveness of bilateral partial foraminotomy for preventing C5 palsy from occurring after cervical decompression surgery. STUDY DESIGN: A retrospective review was performed concerning the risk factors of the C5 palsy based on the preoperative clinical findings. To investigate the prophylactic effect of the partial foraminotomy, we examined a difference of an incidence of the C5 palsy by performing concurrent partial foraminotomy with expansive laminoplasty. PATIENT SAMPLE: A total of 305 cases of cervical expansive laminoplasty performed for spondylotic myelopathy or ossification of the posterior longitudinal ligament were reviewed. METHODS: We analyzed 305 cases of cervical expansive laminoplasty to investigate the preoperative risk factors that may cause postoperative C5 palsy. To clarify the relationship of the foraminotomy and development of the C5 palsy, we examined 230 patients in whom foraminotomy could be confirmed by operative records. RESULTS: Of the 305 patients, postoperative C5 palsy occurred in 13 patients (4.3%): 10 patients had radicular pain (77%), and 8 patients had sensory disturbances (62%). We assessed all neurological findings and X- ray, computed tomography and electromyographic findings, but no statistical differences were found in any of the preoperative clinical findings relative to the occurrence of postoperative C5 palsy. For the open side, 108 cases underwent foraminotomy and 122 cases did not, whereas on the hinge side, 54 cases received foraminotomy and 176 cases did not. In order to investigate the prophylactic effect of foraminotomy, we totaled the open side and hinge side, and calculated the number of bone gutters: 162 gutters had concurrent foraminotomy and 298 gutters did not. Postoperatively, C5 palsy occurred in 1 gutter (0.6%) in the former group and in 12 gutters (4.0%) in the latter group (p<.05, Fisher's direct method). CONCLUSIONS: There were no specific risk factors among the preoperative clinical findings related to C5 palsy. Bilateral partial foraminotomy was effective for preventing C5 palsy. Citation #90 BACKGROUND: In patients with cervical spondylotic myelopathy (CSM), laminectomy is usually performed with a Kerrison rongeur or a high speed drill (HSD).The HSD, which is most often selected for laminectomy, may cause complications such as duratomy, thermal and mechanical neural injuries. With an ultrasonic bone scalpel (UBS), a less traumatic laminectomy can be performed in a shorter time. The aim of this study was to compare the results of laminectomies using

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HSD and UBS. METHODS: Evaluation was made in 46 patients who were operated on for CSM. Cervical laminectomy was performed on 23 patients using the UBS (group I) and to 23 using the HSD (group II). A comparison was made of the 2 groups in respect of demographic characteristics, laminectomy levels, mean laminectomy duration, bleeding rates, and surgical complications. RESULTS: In group I, the mean laminectomy time was 2.2 ± 0.4 min/level, mean blood loss was 180 mL, hospitalization was 3.0 ± 0.0 days, and C5 radiculopathy was seen in 1 patient. In group II, the mean laminectomy time was 7.4 ± 2.6 min/level, mean blood loss was 380 mL, hospitalization was 3.7 ± 1.3 days, C5 radiculopathy was seen in 1 patient and dura injuries in 3 patients. The recovery rate was determined as 47.6% in group I and 48.8% in group II. CONCLUSIONS: For patients with CSM, laminectomy using the UBS provides a safe, rapid, and effective decompression with a lesser blood loss. The low rate of complications lessens the postoperative morbidity rates and shortens hospital stay. Citation #92 & #93 STUDY DESIGN: Literature review, technique overview, prospective and retrospective data analysis. OBJECTIVE: To review current minimally invasive surgery (MIS) methods of decompression for lumbar spinal stenosis and present a decompression technique using a flexible microblade shaver system. SUMMARY OF BACKGROUND DATA: Several MIS decompression techniques for stenosis have been developed to minimize damage to soft tissues and reduce the amount of posterior element resection. Decompression using linearly configured instruments may not be able to adequately address stenosis in the neural foramen. A flexible microblade shaver system is able to traverse the foramen, removing bone and ligament, using a ventral to dorsal approach, rather than medial to lateral. This enables it to effectively decompress the lateral recess and neural foramen while sparing posterior structures. METHODS: Brief literature review of current MIS decompression techniques is presented. MIS decompression using a flexible microblade shaver system is described with 1 year outcomes from a small pilot study and a retrospective chart review at 2 centers. RESULTS: A small postmarket pilot study (n = 9) with 1 year results showed positive patient outcomes using Visual Analog Scale (decrease by 73%), Oswestry Disability Index(50% improvement), Zurich Claudication Questionnaire physical function and symptom severity (improved by 72% and 31%, respectively), and Short-Form 36 (SF-36) Physical Component Score (36% improvement). Sixty-seven patients from a retrospective chart review at 2 centers had an average of 2 levels per patient decompressed using a flexible microblade shaver system. No patient has returned for additional surgery and there have been no cases of neurologic impairment. CONCLUSION: Current decompression techniques may result in inadequate decompression of the neural foramen or excessive resection of the facet joint. MIS decompression using a flexible microblade shaver system represents a way to perform an effective, facet-preserving decompression for patients with lumbar spinal stenosis. Citation #97 OBJECTIVE: We report our experience with the SONOPET ultrasonic bone curette. METHODS: Between September 2001 and July 2005, 546 patients underwent microscopic spinal surgeries using a high-speed drill and the SONOPET instrument. RESULTS: We encountered operative complications thought to be attributable to the use of the SONOPET in six patients (1.1%). There were five instances of dural puncture and one spinal cord injury. All dural tears occurred when the dura mater was aspirated into the tip of the SONOPET. None of the affected patients developed postoperative clinical complications because cerebrospinal fluid leakage was avoided by appropriate closure. We think that the transient spinal cord injury occurred because the vibration emanating from the SONOPET was transmitted directly to the spinal cord. Some patients experienced damage to the epidural venous plexus for reasons similar to those described above. CONCLUSION: SONOPET facilitates the removal of bone in a narrow field, such as that encountered during keyhole surgery. It

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aids in the removal of the lateral edge of bone and is especially useful for expanding the foramen intervertebrale or opening the lateral recess. However, its use is not without risk. To prevent dural tears and venous plexus injury, we recommend that cotton be placed between the SONOPET and important structures. To avoid spinal cord injury, we suggest that the SONOPET be inserted horizontal with the dura mater to avoid the direct transmission of vibrations emanating from the instrument to the spinal cord. SONOPET is suitable for decompression on the lateral side, but not for decompression above the spinal cord. Citation #98 OBJECT: The author describes a clinical applications, procedure, and efficacy of ultrasonic bone curette (UBC) (bone-removal bar) in spinal surgery. METHODS: From July 2003 to March 2005, we operated on 98 consecutive spinal disorders by using UBC, Sonopet UST-2001; Chiari type-1 malformation (6 cases), cervical disorders (64 cases), thoracic disorders (5 cases), and lumbar disorders (23 cases). The instrument was devoid of any spinning parts, and the risk of grabbing cotton pledgets and damaging normal tissue was thereby avoided. Support from assistants for irrigation and suction was not required. FINDINGS: In this series, there were no iatrogenically induced injuries for example, direct or heat damage to surrounding soft tissues, including nerves, vessels, spinal cord, and dura matter. Considering potential complications of mechanical injuries by ultrasonic technique, intermittent usage and cotton protection during use under an operating microscope are recommended. We found that the ultrasonic device is easy to handle; however, it is time consuming for removing a large amount of bone and ossified lesions. Therefore, we recommend the combined use of this method with standard drilling. CONCLUSIONS: This system appears to be versatile, safe, and efficient in spinal surgery and could be improved by the development of a better handpiece. Citation #100 BACKGROUND CONTEXT: Laminoplasty has been reported to achieve good operative results for treatment of cervical stenotic myelopathy. However, long-term results and prognostic factors have not been well documented. Among postoperative complications, weakness of the shoulder girdle muscles has been reported as a particular complication of laminoplasty, but the cause is still poorly understood. PURPOSE: Our aim was to clarify the short-term complications and long-term operative results after unilateral open-door laminoplasty and to identify the predictors for operative outcome. STUDY DESIGN: We retrospectively reviewed short-term complications and long-term operative results associated with cervical stenotic myelopathy treated by unilateral open-door laminoplasty. PATIENT SAMPLE: There were 162 men and 42 women with an average age of 57 years who were treated by unilateral open-door laminoplasty in the two institutions. Pathogenesis of myelopathy was cervical spondylosis in 88 patients, cervical disk herniation with a narrow spinal canal in 10, and ossification of the posterior longitudinal ligament in 106. OUTCOME MEASURES: Postoperative complications and their outcomes were examined clinically in 204 patients, and causes of motor paresis were sought with postoperative computed tomography after myelography. Postoperative improvement of clinical symptoms was assessed by recovery rate calculated with the scores of the Japanese Orthopaedic Scoring System in 80 patients. METHODS: The occurrence rate of short-term postoperative complications, causes of motor paresis, and their outcomes were reviewed in 204 patients. Clinical condition was assessed with the Japanese Orthopaedic Scoring System, recovery rate was calculated with the score, and prognostic factors for outcome were studied in 80 patients who were followed up for 5 years or longer (average, 8 years; range, 5-17 years). RESULTS: Occurrence rate of complications, such as muscle weakness, deep infection, closure of opened laminae, and others, was 10.8%. Muscle weakness was observed in 7.8% of the patients. However, this rate decreased in recent years. The cause of motor paresis is not known with certainty, but it may be secondary to operative trauma, posterior shift of the spinal cord, or to displacement of the lamina

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in the hinge side. Recovery rate of clinical symptoms was 62.1% at the final follow-up. Rates were 63.6% for cervical spondylosis, 87.1% for cervical disk herniation, and 61.3% for ossification of the posterior longitudinal ligament. There was no significant difference between pathologies. Patient age younger than 60 years at the time of operation and less than 1 year's duration of symptoms before surgery were significantly associated with recovery rate of clinical symptoms. Recovery rate was not correlated with either preoperative function judged by the Japanese Orthopaedic Association score or spinal sagittal diameter. CONCLUSIONS: The main cause of postoperative motor paresis of upper extremities is thought to be operative trauma, resulting from such procedures as air-drill and Kerrison rongeur handling. Short-term complications may decrease with the use of nontraumatic procedures. Better operative outcomes may be achieved with careful operative procedures and early operative treatment in the patients with myelopathy. Citation #105 INTRODUCTION: The ultrasonic BoneScalpel is a tissue-specific device that allows the surgeon to make precise osteotomies while protecting collateral or adjacent soft tissue structures. The device is comprised of a blunt ultrasonic blade that oscillates at over 22,500 cycles/s with an imperceptible microscopic amplitude. The recurring impacts pulverize the noncompliant crystalline structure resulting in a precise cut. The more compliant adjacent soft tissue is not affected by the ultrasonic oscillation. The purpose of this study is to report the experience and safety of using this ultrasonic osteotome device in a variety of spine surgeries. METHODS: Data were retrospectively collected from medical charts and surgical reports for each surgery in which the ultrasonic scalpel was used to perform any type of osteotomy (facetectomy, laminotomy, laminectomy, en bloc resection, Smith Petersen osteotomy, pedicle subtraction osteotomy, etc.). The majority of patients had spinal stenosis, degenerative or adolescent scoliosis, pseudoarthrosis, adjacent segment degeneration, and spondylolisthesis et al. Intra-operative complications were also recorded. RESULTS: A total of 128 consecutive patients (73 female, 55 male) beginning with our first case experience were included in this study. The mean age of the patients was 58 years (range 12-85 years). Eighty patients (62.5 %) had previous spine surgery and/or spinal deformity. The ultrasonic scalpel was used at all levels of the spine and the average levels operated on each patient were 5. The mean operation time (skin to skin) was 4.3 h and the mean blood loss was 425.4 ml. In all cases, the ultrasonic scalpel was used to create the needed osteotomies to facilitate the surgical procedure without any percussion on the spinal column or injury to the underlying nerves. There was a noticeable absence of bleeding from the cut end of the bone consistent with the ultrasonic application. There were 11 instances of dural injuries (8.6 %) and two of which were directly associated with the use of ultrasonic device. In no procedure was the use of the ultrasonic scalpel abandoned for use of another instrument due to difficulty in using the device or failure to achieve the desired osteotomy. CONCLUSIONS: Overall, the ultrasonic scalpel was safe and performed as desired when used as a bone cutting device to facilitate osteotomies in a variety of spine surgeries. However, caution should be taken to avoid potential thermal injury and dural tear. If used properly, this device may decrease the risk of soft tissue injury associated with the use of high speed burrs and oscillating saws during spine surgery.

7.4.4. Case Report Citation #23 Osborne discuss the treatment of a 67-year-old male with intractable back pain due to advanced lumbar spondylosis and a history of advanced Parkinson’s Disease requiring two deep brain stimulators with radiofrequency neurotomy to the lumbar facet joints. The subject’s back pain was relieved by 70% for > 6 months bilaterally. Radiofrequency neurotomy of the left L4-5 & L5-S1 facet joints was pursued using an 18-gauge 10 cm cannula with a 10-mm, angled, active tip—heating

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to 80°C for 90 seconds. Six weeks later this protocol was repeated on the right L3-4, L4-5 & L5-S1 facet joints No complications were reported. Citation #24 Terao et al discuss the treatment of an 81-year-old woman with failed back surgery syndrome (FBSS) using radiofrequency (RF) lumbar zygapophysial joint denervation for back pain and epidural spinal cord stimultation (SCS) for leg pain. The combination of the two therapies relieved back pain almost entirely and leg pain by approximately 50%. No complications were reported. The author noted that this combination of minimally invasive interventions is effective for severe leg and lower back pain in elderly or medically compromised patients and those with FBSS. Citation #25 Burnham discusses the treatment of a 56-year old female with low back and right upper buttock pain for 16 years and incomplete relief from L4/5 facet joint radiofrequency ablation. Bipolar radiofrequency strip thermal lesions were created around the posterior pseudarthrosis articular margin. The subject reported increased discomfort post-procedure, which resolved within 4 days. Complete pain relief and restoration of function was achieved for 16 months post-procedure. Citation #26 Abbot et al discuss the treatment of a 33-year-old woman with low back pain treated with radiofrequency neurotomy. The patient sustained a right L5 nerve root injury during the procedure and experienced new right leg pain and paresthesias. She was diagnosed with right L5 sensory radiculopathy was treated with spinal cord stimulator which provided 90% pain relief. The authors noted that irreversible injury of non-target nerves is a possible complication of radiofrequency neurotomy and can be avoided by following proper procedural protocol. Citation #27 Smith et al discuss the treatment of a 35-year-old female who underwent cervical radiofrequency denervation due to neck pain and headaches. The patient was admitted to the hospital 7 days post- procedure with severe neck pain, possibly evidential of paraspinal muscle abscess. The subject did not develop systemic signs of infection and tests were negative. A 6-week follow-up MRI revealed persistent minimal left paraspinal enhancement possibly representing post-procedure granulation tissue. At 7 months post-procedure, the subject continued to improve slowly with less baseline discomfort and migraine-type headaches. Citation #48 Radiofrequency ablation of medial branch nerves is considered a safe and effective treatment for chronic facet joint pain in the cervical, thoracic, and lumbosacral spine. Cooled radiofrequency ablation (C-RFA) is gaining popularity over conventional thermal radiofrequency ablation (RFA) in pain management. However, complications of C-RFA have not been reported in the literature. We present a first report of third-degree skin burn resulting from C-RFA electrode use for the treatment of facet syndrome. A 61-year-old woman (BMI of 21.8 kg/m(2) ) with thoracic facet syndrome underwent C-RFA of the T1-4 medial branch nerves (Thoracool System, Baylis Medical Company, Montreal, QC, Canada). Lesioning at the superior-lateral aspect of the thoracic transverse processes at each level was performed. During lesioning of the T2 MBN on the T3 transverse process, skin blanching 15 mm in diameter was noted around the introducer needle with patient complaints of severe, localized pain. Postprocedurally the skin injury at this level worsened in appearance, with a 20 mm × 4 mm skin defect, which took nearly 5 months to heal. With C-RFA, internally cooled electrodes are capable of creating large volume spherical lesions, a size advantage over conventional RFA. Although C-RFA lesion size may overcome the anatomic variability of target nerve location and potentially improve pain outcomes, added vigilance is required in thin patients and in anatomic regions of minimal subcutaneous tissue between the lesion target and the dermis. Skin burns at the site of the RF electrode are a potential risk under such conditions.

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Citation #49 STUDY DESIGN: A systematic review and meta-analysis of randomized controlled trials. OBJECTIVE: To assess treatment effects (benefits and harms) of radiofrequency denervation for patients with facet joint-related chronic low back pain. SUMMARY OF BACKGROUND DATA: There is no consensus regarding the treatment efficacy of facet joint radiofrequency denervation (FJRD) and how it compares with nerve blockades and joint infiltration with anesthetics and/or corticosteroids. METHODS: We searched the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and LILACS for randomized controlled trials that compared FJRD with blockades, infiltrations, or placebo. Primary outcomes were pain, functional status, and quality of life. Secondary outcomes were cost-effectiveness and complications. RESULTS: Fifteen studies were selected and 9 were eligible. Overall quality of evidence was rated low to moderate. The evidence favored FJRD regarding pain control. There was no sufficient evidence for cost- effectiveness and complications. CONCLUSION: The available evidence reviewed in this study should be interpreted with caution. The data indicate that FJRD is more effective than placebo in pain control and functional improvement and is also possibly more effective than steroid injections in pain control. Complications and adverse effects were not sufficiently reported to allow comparisons, and there was no evidence for cost-effectiveness. High-quality randomized controlled trials addressing pain, function, quality of life, complications, and cost-effectiveness are urgently needed. Citation #70 A 29-year-old man presented with a rare case of far-out foraminal stenosis with radiculopathy caused by osteophyte formation secondary to an anomalous articulation between the transverse process and the sacral ala. Diagnosis of unilateral far-out foraminal entrapment of the L5 spinal nerve below a transitional vertebra (TV) depended on selective radiculography and nerve root block. Computed tomography after selective radiculography clearly demonstrated foraminal entrapment of the L5 nerve root via the osteophytes. The patient underwent posterior decompression by resection of the osteophytes using an operating microscope and experienced good relief of radicular pain. This case illustrates the effectiveness and some refinements of posterior decompression for radicular pain caused by far-out foraminal stenosis below a TV and compression of the L5 spinal nerve. Citation #89 Acute neurologic deterioration is not a rare event in the surgical decompression for thoracic spinal stenosis. We report a case of transient paraparesis after decompressive laminectomy in a 50-yr-old male patient with multi-level thoracic ossification of the ligamentum flavum and cervical ossification of the posterior longitudinal ligament. Decompressive laminectomy from T9 to T11 was performed without gross neurological improvement. Two weeks after the first operation, laminoplasty from C4 to C6 and additional decompressive laminectomies of T3, T4, T6, and T8 were performed. Paraparesis developed 3 hr after the second operation, which recovered spontaneously 5 hr thereafter. CT and MRI were immediately performed, but there were no corresponding lesions. Vascular compromise of the borderlines of the arterial supply by microthrombi might be responsible for the paraparesis.

7.4.5. Literature Search Citation #28 Falco et al performed a systematic review of literature on therapeutic lumbar facet joint interventions for treatment of chronic low back pain. 11 randomized trials and 14 observational studies were reviewed. The authors concluded that the evidence for conventional radiofrequency neurotomy is

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good for short- and long-term pain relief and functional improvement and the evidence for pulsed radiofrequency neurotomy is limited. Citation #29 Falco et al performed a systematic review of literature on facet joint interventions in therapeutic management of cervical facet joint pain. 4 randomized trials and 6 observational studies were reviewed. One randomized, sham-controlled, double-blind trial and 5 observational trials studied radiofrequency neurotomy. The authors concluded that the evidence for cervical radiofrequency neurotomy is fair. Citation #30 Falco et al performed a systematic review of literature on cervical facet joint interventions. 14 manuscripts were included in this review. The authors concluded that the evidence for cervical radiofrequency neurotomy is Level II-1: Evidence obtained from at least one properly conducted diagnostic accuracy study of adequate size, or II-2: Evidence obtained from at least one properly designed small diagnostic accuracy study. Citation #31 Atluri et al did a systematic review of diagnostic and therapeutic thoracic facet joint interventions. 2 radiofrequency neurotomy studies and 2 systemic reviews were included. Both studies were excluded due to low methodologic quality. Citation #32 Boswell et al performed a systematic review of facet joint interventions for managing chronic spinal pain. Two randomized trials and 5 observational studies were included in this review. The authors concluded that for medial branch neurotomy, the evidence is moderate for short- and long-term pain relief. Citation #33 Hooten et al performed a systematic review of randomized controlled trials of radiofrequency neurotomy for low back pain in order to outline procedural limitations of the trials. Three trials and two systematic reviews were included. The authors identified substantial shortcomings in all three trials which were not identified in previous literature reviews. The authors provided evidence-based procedural guidelines for developing criteria for multi-site studies. Citation #34 Manchikanti et al performed a systematic review of the literature for treatment of chronic spinal pain. 2 systematic reviews, 1 randomized trial and 1 observational study of lumbar medial branch radiofrequency neurotomy were included. One randomized controlled trial and 5 observational studies of cervical facet joint interventions were included. Two observational studies of thoracic facet joint interventions were included. The authors noted that complications are exceedingly rare, but reported complications include: “a worsening of the usual pain, burning or dysesthesias, decreased sensation and allodynia in the paravertebral skin or the facets denervated, transient pain, persistent weakness, and inadvertent lesioning of the spinal nerve or ventral ramus resulting in motor deficits, sensory loss, and possible deafferentation pain.” The authors concluded that the evidence for therapeutic lumbar facet joint interventions is good for conventional radiofrequency neurotomy and limited for pulsed radiofrequency. The evidence for therapeutic cervical facet joint interventions is fair for conventional radiofrequency neurotomy. The evidence for therapeutic thoracic facet joint interventions is limited for radiofrequency neurotomy. Citation #35 Van Kleef et al performed a systematic review of 7 controlled studies of radiofrequency treatment of the facet joints. Only two trials were without shortcomings in methodology. Possible complications included transient, localized burning pain and self-limiting back pain lasting longer than 2 weeks,

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each occurring with a frequency of 2.5% per procedure. The authors concluded that even excluding the trials with shortcomings, radiofrequency treatment can provide immediate-term benefit in selected patients. Citation #36 Manchikanti et al performed a systematic review of therapeutic interventions for low back pain. 7 randomized studies evaluated radiofrequency neurotomy or lumbar facet joint nerves, but only one study met the inclusion criteria. One systematic review was considered high quality evidence. For radiofrequency neurotomy, 4 of the 5 studies were positive for short-term relief whereas for long- term relief 1 of the 2 studies was shown to be positive. The authors concluded that there was fair evidence for radiofrequency neurotomy. Citation #37 Chou et al performed a systematic review of nonsurgical interventional therapies for low back and radicular pain. 9 randomized controlled trials and 5 systematic reviews of radiofrequency denervation were assessed. One trial reported a case of mild, subjective, and transient lower limb weakness following radiofrequency denervation. Two other trials found no difference in adverse events between radiofrequency denervation and sham, though radiofrequency treatment was associated with trends toward increased postprocedural pain. The authors found insufficient evidence from randomized trials to reach reliable conclusions regarding radiofrequency denervation because the trials evaluated technically inadequate procedures. Citation #38 Datta et al performed a systematic review of diagnostic and therapeutic lumbar facet joint interventions. 7 randomized controlled trials (one included in the analysis) and 8 observational studies (two included in the analysis) of radiofrequency neurotomy were reviewed. The authors concluded that evidence for lumbar radiofrequency neurotomy was of Level II-2 (Evidence obtained from at least one properly designed small diagnostic accuracy study) to II-3 (Evidence obtained from diagnostic studies of uncertainty). Citation #39 Cetas et al performed a systematic review of destructive procedures for nonmalignant pain. 14 studies evaluated radiofrequency rhizotomy for treatment of lumbar facet syndrome. Complications were noted to be minimal. The authors concluded that the studies showed a modest treatment effect. Citation #40 Caragee et al performed a systematic review of percutaneous and open surgical interventions for neck pain. 31 studies were analyzed. None of the studies of radiofrequency neurotomy for suspected facet pain were considered admissible. One study of radiofrequency heating of the cervical spine dorsal root was considered admissible. This study noted a slight improvement in the treatment group at 6 weeks, but at 3 months, a higher percentage of the placebo group reported feeling “better.” The authors concluded that radiofrequency neruotomy is not supported by current evidence. Citation #41 Markman and Philip discussed interventional strategies for pain management. The authors cite two prospective, double-blinded, randomized trials, one small prospective trial and one large retrospective series study of percutaneous radiofrequency neurotomy for treatment of chronic low back pain. Minor complications were noted at the rate of 1% per lesion site, including localized pain at the needle entry site lasting more than 2 weeks (0.5%). The authors noted that these trials demonstrated improvement in disability and reduction in opioid use. The authors noted that there was a high placebo-responder rate in the interventional trials which could reduce the likelihood of demonstrating statistical superiority.

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Citation #42 Cohen and Raja discussed pathogenesis, diagnosis and treatment of lumber zygapophysial joint pain. Reported complications include self-limiting, transient numbness and dysthesias, rare burns due to electrical faults, electrode insulation breaks and generator malfunctions and neuritis (<5%). The authors concluded that in carefully selected patients who fail conservative treatments such as physical and pharmacologic therapies, radiofrequency denervation is a treatment option. Citation #43 Boswell et al discuss their formulation of evidence-based clinical practice guidelines for interventional techniques in the treatment of chronic spinal pain. Three systematic reviews, two randomized trials and 15 observational studies were included in the analysis. Rare, but potential side effects include painful cutaneous dysthesias, increased pain due to neuritis or neurogenic inflammation, anesthesia dolorosa, cutaneous hyperesthesia, pneumothorax and deafferentation pain. The authors concluded that the evidence for the evidence for radiofrequency neurotomy of medial branches is strong for short-term and moderate for long-term relief. Citation #44 Murtagh and Foerster discuss the use of radiofrequency neurotomy for lumbar pain. Four systematic reviews reached divergent conclusions; two found moderate efficacy, one found strong evidence for short- and long-term pain relief and one found conflicting evidence on the short-term effect. Possible adverse effects (AEs) of medial branch RFN include painful cutaneous dysesthesias, neuritis or neurogenic inflammation pain, anesthesia dolorosa, cutaneous hyperesthesia, pneumothorax, and deafferentation pain. AEs reported in two studies included treatment-related pain, transient neuropathic pain, transient leg pain, dysesthesia, and subjective leg weakness; the other studies reported no AEs. One centre performing lumbar medial branch RFN estimated the incidence of minor AEs at 1% per lesion site.

7.4.1. Technical Note Citation #96 BACKGROUND: We report our experience with the Aesculap Pneumatic Powered Kerrison Rongeur (Aesculap AG Company) Tuttlingen, Germany. METHODS: Between February 2007 and January 2008, 125 patients underwent spinal surgery for the treatment of spinal stenosis, spinal tumors, degenerative disk disease, and herniated disks in the cervical, thoracic, and lumbar areas using the pneumatic-powered Kerrison rongeur for bone and tissue removal. RESULTS: All bone removal for procedures ranging from cervical and lumbar microdiscectomies to extensive multilevel laminectomies was carried out with no complications from instrument design or malfunction. Most importantly, the manual labor required to forcefully squeeze and bite bone was virtually eliminated. The learning curve for instrument application was negligible. Operating room personnel similarly had no difficulty with the simplified tubing connections to an air supply and the Kerrison handle with interchangeable, multisized shafts. CONCLUSION: The new pneumatically powered Kerrison rongeur not only is safe and easy to use but also virtually eliminates the manual fatigue and, at times, pain associated with prolonged bone removal from the use of standard Kerrison rongeurs. Citation #99 STUDY DESIGN: Direct removal of an ossified mass via an anterior approach carries good decompression, to one- or two-level ossification of the posterior longitudinal ligament (OPLL) of the cervical spine. Ossification occasionally involves not only the posterior longitudinal ligament (PLL) but also the underlying dura mater. Defect of the dura mater by resection of the dural ossification (DO) can cause cerebrospinal fluid leakage or neural injury. The technique of resection of OPLL with

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floating of DO provides satisfactory decompression and avoids dural defect or neural injury in OPLL associated with DO. METHODS: Four patients developed cervical myelopathy. Radiological examination revealed cord compression due to OPLL associated with DO. RESULTS: All patients underwent anterior procedures. After the necessary discectomies and corpectomies, OPLL was resected using a high-speed drill with a 4-mm steel burr and then with a 4-mm diamond burr. When the OPLL became paper-thin, it was separated from the dura mater using a microdissector and a Kerrison rongeur. There was a thin layer of the nonossified degenerated PLL between the residual OPLL and DO. Meticulous dissection of the residual OPLL over the DO was performed without removing the DO at this layer. Fixation was performed with a titanium cylindrical cage. CONCLUSION: This technical note describes the successful decompression of the spinal cord by removing OPLL only, and avoidance of dural defect or neural injury in cases of OPLL associated with DO.

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8. APPLICABILITY OF EXISTING DATA TO THE DENERVEX DEVICE The radiofrequency denervation devices used in the publications of this report are equivalent, but not identical to the DenerveX device. This section provides a comparison between relevant characteristics of the DenerveX device and existing devices of the same type in order for a conclusion to be made that the existing clinical literature supports the safety and performance of the DenerveX device. The guidance document, NB-MED/2.7/Rec1, titled, Guidance on clinicals Chapter 2.7 Clinical investigations, clinical evaluation, was considered during the development of this comparison. The NB-MED guidance states that, “Unless safety and performance can be adequately demonstrated in other ways (e.g., convincing experience from previous use), clinical investigation of a medical device is likely to be required in the following [four] circumstances.” Each of the four circumstances is provided, as follows, along with DenerveX device information which demonstrates that none of the circumstances apply. 1. Where a completely new device is proposed for the market, whose components, features and/or method of action are previously unknown. Components/Component Materials of Construction The DenerveX device is a new device proposed for the market. The DenerveX design includes components (RF electrode, access tube, dilator, and K-wire) that are common to devices of the same type, and the clinical setting in which the device will be used. The blood contacting components include the electrode shaft, which is constructed of PEEK, and the electrode tip, which is 304 stainless steel. There are included accessories (also blood contacting) which include the PEEK access tube and stainless steel RF electrode, dilator and K-wire. All DenerveX device components are well characterized and understood medical device materials. Additionally, biocompatibility testing will be fully assessed in accordance with ISO 10993 to confirm that the device is biologically safe. Features/Mechanism of Action A variety of radiofrequency generators and RF electrode configurations were included in the reported studies, which can generally be described as applying RF energy directly to the facet joint using either a monopolar or bipolar electrode. Over time, the shape of the electrodes used in the treatment of facet joint syndrome has evolved from off- the-shelf non-specific electrodes (Cosman RRE TC Electrode) to those that are specifically designed for this indication (Stryker Venom). Electrodes are available in a variety of designs and geometries; however, the main function of the electrodes is the same—to radiate RF energy to tissue to achieve tissue ablation. Because the electrodes function in the same manner, the differences in electrode designs is considered to be irrelevant to the safety and performance of the RF devices. The DenerveX device mechanism of action is similar to other devices of the same type. Specifically, DenerveX will be used in conjunction with an electrosurgical generator unit to create RF lesions in the nerve tissue. The DenerveX device applies temperature controlled, RF energy into a target area via a circular rotating electrode probe to destroy the nerve tissue and the capsule on the posterior surface of the facet joint. Pain relief is achieved by creating defined lesions on pain-conducting nerve fibers and surrounding capsular tissue. The rotating action of the electrode is ancillary to the electrode’s primary function of radiating RF energy to tissue, and functions to remove treated tissue debris from the target site. The probe rotates at a fixed speed of 45 RPM whenever the device is activated, the user cannot adjust the speed of the probe’s rotation. The probe can be activated for a maximum of 30 seconds per user- triggered activation.

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Comparison of relevant device design and operational settings of the DenerveX device and other devices of the same type is provided in Tables 4a and 4b, below. Table 4a: Comparison of the DenerveX Device to Reviewed Radiofrequency Denervation Devices Comments or Clinical Literature Overview DenerveX Device Rationale RF Electrode 10 mm pole needle Specially designed monopolar Electrodes are Configuration electrode available in a 16 gauge 5 mm exposed tip, 10 cm length variety of designs

electrode by Cosman RRE“Ray” and geometries, (Brochure in .) Appendix E however, the function of all electrodes is the same—to heat the target tissue by delivering RF energy.

18 -22 gauge needle electrodes with2, 5 or 10 mm active tips (Brochure in Appendix E.)

Stryker Venom Catheter1 (Brochure and IFU for CE marked product in Appendix E.)

1 Note: The Stryker Venom Catheter was not specifically discussed in the cited literature; however, a comparison is provided in this table for two reasons: 1) to show the evolution of electrode design; and 2) because the Stryker Venom Cahteter has a CE mark for the indication for use under consideration for DenerveX.

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Comments or Clinical Literature Overview DenerveX Device Rationale Indications for The Stryker RF electrodes and cannulae, DenerveX, in combination The proposed Use in combination with the Stryker RF with commercially available indications for use Generator are intended for the coagulation electrosurgical generator units, represent a subset of soft tissues in orthopedic, arthroscopy, is intended for coagulation of of those of the CE- spinal and neurosurgical applications. soft tissues in spinal marked Venom These products are also used for select applications for selective Catheter. denervation and tissue destruction denervation (rhizotomy) and procedures which may be performed on tissue destruction procedures, the lumbar, thoracic and cervical regions which may be performed on of the peripheral nerves, and nerve root the lumbar, thoracic and for the relief of pain. Examples include, cervical regions (C2-C7) of but are not limited to, Facet Denervation, the peripheral nerves and Trigeminus Neuralgia, Peripheral nerve roots for the relief of Neuralgia and Rhizotomy. pain associated with the facet joint. Representative Baylis Medical Pain Management Electrosurgical RF generator Even though RF Generator Generator 115V (Baylis Medical) with similar energy output commercial RF (Brochure in Appendix E.) characteristics to generators have a commercially available units variety of NT1100 or NT500 RF Generator manufacturers, they (NeuroTherm) (Brochure in Appendix all have the same .) E mechanism of NeuroTherm Radio Frequency Lesion action, and are Generator model JK2 (RDG Medical) designed to be compatible with the same types of RF electrodes.2 Representative RF needles placed at the site of the dorsal An incision is created above There are no Procedure ramus medial branch of the relevant the facet joint to be treated. A significant Description L3/L4–L5/S1 lumbar facet joints. Correct dilator/cannula is inserted differences between placement was confirmed using through the incision and the DenerveX electrostimulation at 50 and 2 Hz for advanced to the surface above clinical procedures sensory and motor function, respectively. the facet joint. The electrode and procedures Then, 1 mL of 0.5% bupivacaine was is advanced through the described in the injected through the cannula to decrease cannula and treatment is clinical studies as treatment-related pain, increase lesion initiated. During treatment, all involve the size, and prevent postoperative neuritis. the electrode body slowly application of RF The RF probe was then reinserted into the rotates and acts to remove the energy to the area cannula and lesioning was performed. tissue debris from the target around the facet site. joint. The needle was placed parallel to the nerve; multiple lesions were made in parallel for each medial branch. Each neurotomy was performed with fluoroscopic visualization using established techniques.

2 Note: The completed technical file and final clinical literature review will include a thorough comparison of the output characteristics and provide guidance regarding the types of generators that may be used in conjunction with the DenerveX catheter.

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Comments or Clinical Literature Overview DenerveX Device Rationale The cannula was introduced until bone contact and then advanced forward up to the posterior–inferior border of the foramen. Sensory stimulation was performed by 50 Hz 0.2-0.7 V pulses followed by 2 Hz, 1 V pulses. 1mL 0.5% bupivacaine was injected to anesthetize the target area and lesioning was performed. Representative Dorsal ramus medial branch of from The DenerveX device is The DenerveX Electrode C3/C4 through S1 facet joints intended to be used in the electrode placement Placement cervical, thoracic and lumbar locations are Location regions of the spine. comparable to the devices used during the clinical studies. Device Continuous or pulsed RF delivery The DenerveX device will use The DenerveX Settings commercially available device settings are RF setting between 42°C and 90°C for 60, electrosurgical RF generators comparable to the 70, 75, 90 or 120 seconds that provide similar devices used during Treatment times ranging from 60 seconds continuous output of RF the clinical studies. up to 4 minutes energy.

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Table 4b: Comparison of the DenerveX Device to Rotational and Mechanical Tissue Removal Devices Comments or Clinical Literature Overview DenerveX Device Rationale Rotational or Midas Rex high speed drill with cutting burr Specially designed monopolar Surgical tissue removal attachment electrode with rotational function devices with device intended to remove coagulations rotational or (Brochure for electric model in Appendix E) mechanism of soft tissue as a result of mechanical denervation using RF energy. tissue removal are commonly used in spinal decompression surgery, laminectomy, and laminoplasty among other spinal procedures. All are CE marked devices.

Kerrison Rongeur (Brochure in Appendix E)

MILD (Brochure in Appendix E)

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Comments or Clinical Literature Overview DenerveX Device Rationale Sonopet with RF generator (Brochure in Appendix E)

Io-Flex saw (Brochure in Appendix E)

Indications for The devices in this table are CE marked and widely DenerveX, in combination with The proposed Use used in practice of spinal surgery with the ultimate goal commercially available indications for of pain relief for the patient. These devices are used in electrosurgical generator units, is use represent a the tissue destruction procedures involved with spinal intended for coagulation of soft subset of those decompression, laminoplasty, laminectomy, spinal tissues in spinal applications for of the CE- fusion, and rhizotomy. Respectively, each of these selective denervation marked devices are used in surgical procedures equal to or (rhizotomy) and tissue devices listed more invasive than the DenerveX indication. destruction procedures, which in this table. may be performed on the lumbar, thoracic and cervical regions (C2-C7) of the peripheral nerves and nerve roots for the relief of pain associated with the facet joint. Tissue The Kerrison Rongeur, MILD and Io-Flex devices rely The rotational aspect of the Though the Destruction on manual force for function. DenerveX probe is intended to energy sources Energy Source remove coagulated soft tissues vary in this The Midas Rex rotational drill can be powered by from the intended surgical site. group of either a pneumatic piston or a high-speed electric The rotation of the probe of the devices, all are motor. DenerveX is fixed at 45 RPM designed to The Sonopet tissue destruction device uses focused RF and does not contain any sort of remove tissue energy to remove tissue and bone. “cutting blades”. in the pursuit of pain mitigation through tissue destruction and removal.

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Comments or Clinical Literature Overview DenerveX Device Rationale Representative The Midas Rex drill is used at high speeds (up to An incision is created above the There are no Procedure 75,000 RPM) to cut or shave bone and other hard facet joint to be treated. A significant Description tissues in procedures such as laminectomy. Procedures dilator/cannula is inserted differences involving a Midas Rex drill occur in a direct visual through the incision and between the field. advanced to the surface above DenerveX the facet joint. The electrode is clinical Kerrison Rongeurs are used to remove bone and hard advanced through the cannula procedures tissue one “bite” at a time using mechanical force. and treatment is initiated. and These devices can be operated by compressing the During treatment, the electrode procedures handles together by manual force by the surgeon, or body slowly rotates and acts to described in they can be pneumatically powered. Kerrison Rongeurs remove the tissue debris from the the clinical are often used in spinal surgeries, especially when target site. studies as all spinal discs are to be reduced in size. Kerrison involve the Rongeurs can be used percutaneously or in a direct application of visual filed. RF energy to The MILD device is a set of surgical equipment used the area for spinal decompression of the lumbar. The device is around the used in conjunction with a specific surgical procedure facet joint. intended to relieve lower back pain caused by compressed nerves in the facet joint region of the lumbar. The Sonopet is often referenced as an ultrasonic bone knife. Using intensely focused RF energy, a Sonopet device can cut through bone and other hard tissues in the spine, however unlike a cutting burr, surgical knife, or rongeur the Sonopet will not affect soft tissue by mistake, thus significantly reducing the risk of dural tear. The iO-Flex bone saw is used to manually cut though ligament and bone of the lateral recess and foraminal stenosis while preserving the facet joint integrity and stability. The decompression achieved with the iO-Flex in the lumbar region is assessed by comparing lateral fluoroscopic images. Device The speed of the Midas Rex drill is adjustable by the The rotational aspect of the The Probe Settings user from 200 -75,000 RPM DenerveX device is active when rotates at a the RF component of the device fixed speed of The Kerrison Rongeur and the Mild Device require is activated. The rotation of the 45 RPM; the manual operation which may lead to inherent device is intended only to clear speed cannot variability in force and treatment area. the surgical area of coagulated be adjusted by The Sonopet uses an RF generator which can be set to soft tissue. the user. continuous or pulsed cutting energy delivery. The iO-Flex saw is manually operated by pulling a wire manually and thus grating away bone or ligament with each manually pulled pass.

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2. Where an existing device is modified and the modification might significantly affect the clinical safety and performance. Since the DenerveX device is a new device, this circumstance does not apply. 3. Where a previously established device is proposed for a new indication. Since the DenerveX device is a new device, this circumstance does not apply. 4. Where a device incorporates new materials, previously unknown, coming into contact with the human body or existing materials applied in a location not previously exposed to that material, and for which there is no convincing prior clinical experience, or that the device will be used for a significantly longer time. Device Materials of Construction The blood contacting components include the electrode shaft, which is constructed of polyether ether keytone (PEEK), and the electrode tip, which is 304 stainless steel. There are included accessories (also blood contacting) which include the PEEK access tube and stainless steel RF electrode, dilator and K- wire. All DenerveX device components are well characterized and understood medical device materials. Additionally, biocompatibility testing has been assessed in accordance with ISO 10993, and confirmation of biological safety has been confirmed. Device Duration of Use The DenerveX device is intended for transient use (<60 minutes), and one device is used per patient procedure. The device is active for 30 seconds per activation, and may activated multiple times in order to treat multiple facet joints in one patient. The duration of use is consistent with other devices of the same type.

9. DISCUSSION Using PubMed to conduct searches of published literature (searches 1-4), 49 studies were obtained that describe radiofrequency denervation procedure safety and effectiveness in patients suffering from spinal pain. The studies were conducted over the past 12 years. In these combined, randomized, retrospective and prospective studies, a total of 1,940 patients were treated with radiofrequency denervation. Note: The case reports and systematic literature review studies were not included in calculating the patient total.

9.1. Clinical Outcomes The clinical outcome of radiofrequency denervation generally included pain relief, which was measured using a Visual Analog Scale (VAS), a pain scale that is a patient-designated measurement of pain, usually from 0 (no pain) to 10 (worst pain imaginable). Other measured clinical outcomes included relief from disability, reduction in analgesic use, and improved quality of life. Five standardized assessments were sometimes utilized to assess patient outcomes pre-procedure and at follow-up, as follows: 1. The RMQ (Roland-Morris Questionnaire), which consists of 24 yes/no questions and is designed to assess back pain that has occurred within the last 24 hours. The RMQ consists of 24 items reflecting a variety of daily living activities; each item is scored 1 if declared applicable to the respondent and 0 if not, and so the total score can vary from 0 (no disability) to 24 (severe disability). 2. The NASS (North American Spine Society) Patient Satisfaction Questionnaire, which measures satisfaction with the procedure performed. 3. The EQ-5D (Euro QOL in 5 dimensions), which measures quality of life. 4. The (PDQ-S) Pain Disability Questionnaire – Spine, which measures functional status.

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5. The (OSW) Oswestry Low Back Pain and Disability Questionnaire and associated (ODI) Oswestry Disability Index, which quantifies disability for low back pain and evaluates intensity of pain, physical ability and quality of life in several categories. The ODI is a self-administered, 10-item questionnaire. The first section rates the intensity of pain, and the others describe its disabling effect on typical daily activities. The score for each item ranges from 0 to 5, and the sum of the 10 scores is expressed as a percentage of the maximum score and thus ranges from 0 (no disability) to 100 (maximum disability). All of the studies included some period of follow-up with patients after performing the RF denervation procedures, ranging from several days to 24 months. Overall, the study results were favorable, and concluded that RF denervation was successful in achieving clinically and statistically significant pain relief and functional improvement for patients. Adverse effects (discussed in detail in Section 9.2, below) were categorized as minor or moderate, and were in most cases resolved by the 3 month follow-up time point. Several studies reported that there were no adverse effects. No deaths or serious adverse effects were reported in any of the studies. One limitation in some of these studies was the lack of placebo groups as controls. However, more than one author asserted that comparing RF denervation to placebo presented ethical concerns considering the existing clinical studies that determined RF denervation was clearly superior to placebo.

9.2. Procedural Complications and Adverse Effects No procedural complications that may have been related to radiofrequency denervation itself were presented in the searched literature. There were adverse effects presented in some studies, however, no adverse effects were reported as being serious in nature, and there were no deaths reported. Several studies reported that there were no adverse effects1, 7, 8, 9, 10, 11, 12, 13, 18, 19, 22, 45, 47, 50, 53, 54, 58, 60, 61, 64, 66, 67, 69, 70, 73, 75, 78, 86, 96, 97, 98, 102, 107. The most common effect from RF procedures was numbness after the procedure (n=36 subjects out of 1,940 total subjects). Of these 36, n=31 were reported in a study that had 31 subjects, by Lang and Buchfelder14. In the Lang and Buchfelder study, all subjects reported numbness in the neck or occipital region after undergoing standard radiofrequency neurotomy of the third occipital nerve and medial branches of the cervical dorsal rami of C3 and C4. None of the subjects reported the numbness as being disabling. The authors noted that the numbness decreased in all subjects over time, persisting for a longer period for four subjects. The other study in which subjects reported numbness was by Speldewinde17. Spelwinde reported that two subjects (n=2) reported numbness after undergoing radiofrequency neurotomy in the cervical region and three subjects (n=3) reported numbness after undergoing radiofrequency neurotomy in the lumbar region. Speldewinde reported that, in total, the side effects were usually short lived, but sometimes persisted. The most common effect from rotational and mechanical tissue destruction devices was dural tear (n=101 out of 6,462 subjects). Because the DenerveX device is not intended for use near the dura of the spinal cord (only rhizotomy of the peripheral nerve and nerve root), it is exceedingly unlikely that a dural tear would ever be associated with the DenerveX device. Still, dural tear has a very low complication rate of 0.016% across the literature reviewed. Mechanical tissue destruction devices also often require repetitive actions which can lead to fatigue on the part of the surgeon, thus increasing the likelihood of user error96. The DenerveX device does not require many repetitive actions in comparison to a Kerrison Rongeur.

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Table 5a. Summary of Adverse Effects in Included Studies Related to RF Incidence Procedure (number Related or Effect Description reported/rate3) RF Related Outcome Numbness after procedure14, 36/0.019 Procedure or Numbness generally decreased 17 RF over time Mild local 21/0.011 Procedure or Resolved 4 weeks after procedure. tenderness/burning4, 16,46 RF Worsening pain after 13/0.007 RF Resolved by 3 months, maximum procedure3, 17, 25 Nausea6, 17 10/0.005 Procedure Resolved maximum 30 days after Related procedure Nerve pain17, 20 9/0.005 RF Resolved maximum 5 months post procedure Edema6 7/0.004 Procedure Resolved 30 days after procedure Injection site pain5 5/0.003 Procedure Resolved 24 hours after procedure Related Headache17 5/0.003 Not related Resolved maximum 4 weeks post procedure Vomiting6 5/0.003 Procedure Resolved 30 days after procedure Severe local tenderness4 4/0.002 Procedure or Resolved 4 weeks after procedure RF in 3 of 4 subjects, in 4th subject the pain was mild. Diarrhea6 4/0.002 Not related Resolved 30 days after procedure Anaphylactoid6 3/0.002 Not related Resolved 30 days after procedure Burning-like sensation in 2/0.001 Procedure or Medication for neuropathy given, lesion area and increased RF resolved after 6-8 weeks back pain after procedure2 Spasms after procedure17 2/0.001 Procedure or Not described RF Suture failure20 2/0.001 Procedure Not described Related New pain (radiating into 1/<0.001 Procedure or Resolved by 3 months after lower leg) after procedure3 RF procedure Burning dysethesia14 1/<0.001 RF Did not require medical treatment Erythra6 1/<0.001 Procedure Resolved 30 days after procedure Disturbed balance17 1/<0.001 Not related Resolved days after procedure Severe third degree burn48 1/<0.001 RF Related Resolved after 5 months

3 The rate was calculated using a total number of subjects: 1,947 = Total of 1,940 total subjects from randomized, prospective and retrospective trials + 7 case study subjects.

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Table 5b. Summary of Adverse Effects in Included Studies Related to using rotational and tissue removal devices Incidence Procedure Related (number or Device Related Effect Description reported/rate4) Outcome Dural Tear 56, 59, 63, 65, 76, 79, 101/0.016 Device Related Repair was done 80a, 80b, 83, 84, 90, 92,94, 95, 99, 103, intraoperatively 105, 106

Muscle weakness100 16/0.002 Device related Resolved with therapy Infection 65, 76, 103 8/0.001 Procedure related Appropriate treatment was given to cure infection Reoperation required due 7/0.001 Procedure Related Reoperation occurred to insufficient decompression 76 Neuralgia/nerve pain 78, 88, 6/0.001 Procedure or device Resolved within several 91 related months of procedure Implanted hardware 5/0.001 Device Related – Not Hardware had to be malfunction 72 applicable to explanted or repaired DenerveX Mental confusion59, 87 5/0.001 Not related Resolved spontaneously after several hours Hematoma 59 5/0.001 Procedure Related Hematoma was resolved Neurogenic caudation 62 3/<0.001 Procedure or device Resolution was not related discussed Surgery on wrong level or 2/<0.001 Procedure Related Repeat surgery required wrong side79 Paralysis below level of 1/<0.001 Procedure or device Resolved spontaneously nipples89 related after 5 hours Dysesthesia 77 1/<0.001 Procedure or device Resolution was not related discussed Bladder dysfunction 87 1/<0.001 Procedure or device catheterization for 3 months related required Blood loss >500 mL 1/<0.001 Procedure Related Transfusion required

Tables 6a and 6b contain a listing of reported device Adverse Events from the Manufacturer and User Facility Device Experience (MAUDE database) database maintained by the FDA. The MAUDE search covered 5 years (September 2011 – September 2016). This search was conducted as a deviation from the approved protocol in that:

4 The rate was calculated using a total number of subjects: 6,462 = Total of 6,331 total subjects from randomized, prospective and retrospective trials + 2 case study subjects +129 subjects from Technical Notes.

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• Searching based on the defined product classification codes did not yield applicable results; therefore, the search was modified to include specific product names as reflected in tables 6a and 6b • Searching the TPLC databases using either methods did not result in applicable outputs Inclusion of this data is intended to show that there are relatively few AEs reported for the devices included in this Clinical Evaluation Report. Table 6a. Summary of Manufacturer and User Facility Device Experience (MAUDE database) Results for RF Tissue Destruction Devices and Generators

Stryker NeuroTherm NeruoTherm Baylis RF AE Venom NT1100 NT500 Generator Total Device Failure 6 0 1 2 9 Electric Shock 0 2 0 0 2 User Error 2 0 0 0 2 Total 8 2 1 2 13

Table 6b. Summary of Manufacturer and User Facility Device Experience (MAUDE database) Results for Rotational and Mechanical Tissue Destruction Devices Midas Rex MILD iO-Flex AE Drill Kit Saw Sonopet Total Bleeding 0 0 2 0 2 Device Failure 12 2 11 3 28 Dural Tear 0 3 16 0 19 Accessory 36 0 0 4 40 Air Hose Failure 2 0 0 0 2 Foot Drop 0 0 2 0 2 Fracture 0 0 8 0 8 RF Generator Malfunction 0 0 0 1 1 Hematoma 0 1 14 0 15 Incomplete Report 0 0 1 0 1 Infection 1 0 3 0 4 Over Heating (device) 7 0 0 5 12 Patient Complaint 0 1 0 0 1 Transient weakness/pain 0 1 9 0 10 User Error 5 1 1 0 7 Total 63 9 67 13 152

9.3. Proposed Safety Measures for Patients and Medical Staff

A cross correlation analysis has been performed of adverse events found in the included literature and what is listed in the Instructions For Use (IFU) document (appendix F). Based upon the complications and precautions listed; we believe that adequate notification to the user about potential complications

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associated with the DenerveX Device and procedure have been addressed. There are a few additional AEs from the literature that are not listed in the IFU document, these include the following with explanation:

• Headache, vomiting, diarrhea, nausea, confusion. These symptoms are associated with any post- surgical recovery. From the literature, they resolved within a reasonable amount of time and we do not believe they would be associated with the DenerveX Device.

• Hematoma/Blood loss. Because the DenerveX Device uses RF ablation, a cauterizing effect is realized and there is essentially no likelihood of either hematoma or inter-operative blood loss.

• Paralysis and Bladder dysfunction. These were respectively observed in a single individual who underwent full laminectomy; both outcomes resolved spontaneously. We do not believe these outcomes could occur with facet joint rhizotomy using the DenerveX Device.

All risks identified in the review of literature were compared with risks identified in the risk management files. No discrepancies were noted.

10. Conclusion The DenerveX device is a new medical device that will be used in conjunction with an electrosurgical generator unit to create RF lesions in the nerve tissue. The DenerveX device applies RF energy into a target area to destroy the nerve tissue and the capsule on the posterior surface of the facet joint. Pain relief is achieved by creating defined lesions on pain-conducting nerve fibers and surrounding capsular tissue. The DenerveX device also has a rotational aspect which removes tissue debris from the RF lesion site via the rotation action of the probe. This literature review supports the safety and performance of RF denervation in patients with spinal pain, specifically facet joint syndrome. There is extensive prior clinical experience using this clinical procedure and similar device technology. Overall, the clinical outcomes are favorable and demonstrate that RF denervation is effective at relieving spinal pain. The procedural complications are essentially nonexistent in the searched literature, and both short and long-term complications are exceedingly infrequent (<0.02%) and generally minor. Based on the cumulative data from the literature cited within this report, it is evident that RF denervation in the lumbar, thoracic and cervical regions of the peripheral nerves and nerve roots is predictable, safe, and effective for the relief of facet joint syndrome pain. Recognizing that the RF denervation procedures described in the initial literature presented did not incorporate rotational elements, our expanded review of the literature examined powered and manual mechanical bone and tissue destruction devices. The results of this search support a conclusion that incorporation of a rotational element will not dramatically reduce or compromise the safety of the DenerveX device. In relation to the DenerveX device, the mechanical devices discussed in this document are more disruptive than the slow rotation of the DenerveX probe (45 RPM). Furthermore, unlike the rotational and mechanical devices discussed, the DenerveX device is intended to be used only on the facet joints, and not directly adjacent to the spinal cord. Therefore, the safety profile of these mechanical devices can be considered to over-estimate the adverse event rate, e.g., the safety profile of DenerveX will be no worse than the cited literature. There were no apparent difference in clinical outcome, technical success, or safety based on the manufacturer, type of generator, or electrode configuration, which suggest that the results observed in these studies will be applicable to the DenerveX device. As a result, the available literature is sufficient to support the safety and clinical performance of the DenerveX device in the treatment of facet joint syndrome and that a reasonable risk/benefit profile exists.

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Appendix A: Literature Search Process

*Searches 3 and 4 are updates to the original searches 1 and 2 expanding date range only.

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Appendix B. Accepted Articles and Studies for Literature Search

—Randomized Controlled Trials— 1) Lakemeier S, Lind M, Schultz W, Fuchs-Winkelmann S, Timmesfeld N, Foelsch C, Peterlein CD. (2013) A comparison of intraarticular lumbar facet joint steroid injections and lumbar facet joint radiofrequency denervation in the treatment of low back pain: a randomized, controlled, double- blind trial. Anesth Analg. 117(1):228-35. 2) Civelek E, Cansever T, Kabatas S, Kircelli A, Yilmaz C, Musluman M, Ofluoglu D, Caner H. (2012) Comparison of effectiveness of facet joint injection and radiofrequency denervation in chronic low back pain. Turk Neurosurg. 22(2):200-6. 3) Cohen SP, Williams KA, Kurihara C, Nguyen C, Shields C, Kim P, Griffith SR, Larkin TM, Crooks M, Williams N, Morlando B, Strassels SA. (2010) Multicenter, randomized, comparative cost-effectiveness study comparing 0, 1, and 2 diagnostic medial branch (facet joint nerve) block treatment paradigms before lumbar facet radiofrequency denervation. Anesthesiology. 113(2):395-405. 4) Dobrogowski J, Wrzosek A, Wordliczek J. (2005) Radiofrequency denervation with or without addition of pentoxifylline or methylprednisolone for chronic lumbar zygapophysial joint pain. Pharmacol Rep. 57(4):475-80. 5) Joo YC, Park JY, Kim KH. (2013) Comparison of alcohol ablation with repeated thermal radiofrequency ablation in medial branch neurotomy for the treatment of recurrent thoracolumbar facet joint pain. J Anesth. 27(3):390-5. 6) Ma K, Yiqun M, Wu T, Wang W, Liu X, Huang X, Wang Y. (2011) Efficacy of diclofenac sodium in pain relief after conventional radiofrequency denervation for chronic facet joint pain: a double-blind randomized controlled trial. Pain Med. 12(1):27-35. 7) Kroll HR, Kim D, Danic MJ, Sankey SS, Gariwala M, Brown M. (2008) A randomized, double- blind, prospective study comparing the efficacy of continuous versus pulsed radiofrequency in the treatment of lumbar facet syndrome. J Clin Anesth. 20(7):534-7. 8) Tekin I, Mirzai H, Ok G, Erbuyun K, Vatansever D. (2007) A comparison of conventional and pulsed radiofrequency denervation in the treatment of chronic facet joint pain. Clin J Pain. 23(6):524-9. 9) van Wijk RM, Geurts JW, Wynne HJ, Hammink E, Buskens E, Lousberg R, Knape JT, Groen GJ. (2005) Radiofrequency denervation of lumbar facet joints in the treatment of chronic low back pain: a randomized, double-blind, sham lesion-controlled trial. Clin J Pain. 21(4):335-44. Erratum in: Clin J Pain. 21(5):462. 45) Li ZZ, Hou SX, Shang WL, Song KR, Wu WW. Evaluation of endoscopic dorsal ramus rhizotomy in managing facetogenic chronic low back pain. Clin Neurol Neurosurg. 2014 Nov;126:11-7. doi: 10.1016/j.clineuro.2014.08.014. Epub 2014 Aug 18. 46) Wan J, Xu TT, Shen QF, Li HN, Xia YP. Influence of hinge position on the effectiveness of open-door expansive laminoplasty for cervical spondylotic myelopathy. Chin J Traumatol. 2011 Feb 1;14(1):36-41. 47) Thomé C, Zevgaridis D, Leheta O, Bäzner H, Pöckler-Schöniger C, Wöhrle J, Schmiedek P. Outcome after less-invasive decompression of lumbar spinal stenosis: a randomized comparison

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of unilateral laminotomy, bilateral laminotomy, and laminectomy. J Neurosurg Spine. 2005 Aug;3(2):129-41. 48) Nakashima H, Kato F, Yukawa Y, Imagama S, Ito K, Machino M, Ishiguro N. Comparative effectiveness of open-door laminoplasty versus French-door laminoplasty in cervical compressive myelopathy. Spine (Phila Pa 1976). 2014 Apr 15;39(8):642-7. doi: 10.1097/BRS.0000000000000252. 107) Moussa WM, Khedr W. (2016) Percutaneous radiofrequency facet capsule denervation as an alternative target in lumbar facet syndrome. Clin Neurol Neurosurg. 2016 Nov;150:96-104. doi: 10.1016/j.clineuro.2016.09.004. Epub 2016 Sep 5.

—Prospective Trials— 10) MacVicar J, Borowczyk JM, MacVicar AM, Loughnan BM, Bogduk N. (2012) Cervical medial branch radiofrequency neurotomy in New Zealand. Pain Med. 13(5):647-54. 11) Masala S, Nano G, Mammucari M, Marcia S, Simonetti G. (2012) Medial branch neurotomy in low back pain. Neuroradiology. 54(7):737-44. 12) Tomé-Bermejo F, Barriga-Martín A, Martín JL. (2011) Identifying patients with chronic low back pain likely to benefit from lumbar facet radiofrequency denervation: a prospective study. J Spinal Disord Tech. 24(2):69-75. 13) Rambaransingh B, Stanford G, Burnham R. (2010) The effect of repeated zygapophysial joint radiofrequency neurotomy on pain, disability, and improvement duration. Pain Med. 11(9):1343- 7. 14) Lang JK, Buchfelder M. (2010) Radiofrequency neurotomy for headache stemming from the zygapophysial joints C2/3 and C3/4. Cent Eur Neurosurg. 71(2):75-9. 15) Iwatsuki K, Yoshimine T, Awazu K. (2007) Alternative denervation using laser irradiation in lumbar facet syndrome. Lasers Surg Med. 39(3):225-9. 16) Shabat S, Leitner Y, Bartal G, Folman Y. (2013) Radiofrequency treatment has a beneficial role in reducing low back pain due to facet syndrome in octogenarians or older. Clin Interv Aging. 8:737-40. 17) Speldewinde GC. (2011) Outcomes of percutaneous zygapophysial and sacroiliac joint neurotomy in a community setting. Pain Med. 12(2):209-18. 49) Rhee JM, Register B, Hamasaki T, Franklin B. Plate-only open door laminoplasty maintains stable spinal canal expansion with high rates of hinge union and no plate failures. Spine (Phila Pa 1976). 2011 Jan 1;36(1):9-14. doi: 10.1097/BRS.0b013e3181fea49c. 50) Chopko B, Caraway DL. MiDAS I (mild Decompression Alternative to Open Surgery): a preliminary report of a prospective, multi-center clinical study. Pain Physician. 2010 Jul- Aug;13(4):369-78. Erratum in: Pain Physician. 2012 Jul-Aug;15(4):349. 51) Papavero L, Thiel M, Fritzsche E, Kunze C, Westphal M, Kothe R. Lumbar spinal stenosis: prognostic factors for bilateral microsurgical decompression using a unilateral approach. Neurosurgery. 2009 Dec;65(6 Suppl):182-7; discussion187. doi: 10.1227/01.NEU.0000341906.65696.08.

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52) Kutlay M, Topuz K, Colak A, Simşek H, Cetinkal A, Demircan MN. Management of disc herniations with bi-radicular symptoms via combined lateral and interlaminar approach. Neurosurg Rev. 2010 Jan;33(1):97-105. doi: 10.1007/s10143-009-0218-0. 53) Pao JL, Chen WC, Chen PQ. Clinical outcomes of microendoscopic decompressive laminotomy for degenerative lumbar spinal stenosis. Eur Spine J. 2009 May;18(5):672-8. doi: 10.1007/s00586-009-0903-2. Epub 2009 Feb 24. 54a) Cavuşoğlu H, Türkmenoğlu O, Kaya RA, Tuncer C, Colak I, Sahin Y, Aydin Y. Efficacy of unilateral laminectomy for bilateral decompression in lumbar spinal stenosis. Turk Neurosurg. 2007 Apr;17(2):100-8. 54b) Cavuşoğlu H, Kaya RA, Türkmenoglu ON, Tuncer C, Colak I, Aydin Y. Midterm outcome after unilateral approach for bilateral decompression of lumbar spinal stenosis: 5-year prospective study. Eur Spine J. 2007 Dec;16(12):2133-42. Epub 2007 Aug 22. 55) White BD, Buxton N, Fitzgerald JJ. Anterior cervical foramenotomy for cervical radiculopathy. Br J Neurosurg. 2007 Aug;21(4):370-4. 56) Rosen DS, O'Toole JE, Eichholz KM, Hrubes M, Huo D, Sandhu FA, Fessler RG. Minimally invasive lumbar spinal decompression in the elderly: outcomes of 50 patients aged 75 years and older. Neurosurgery. 2007 Mar;60(3):503-9; discussion 509-10. 57) Lin SM, Tseng SH, Yang JC, Tu CC. Chimney sublaminar decompression for degenerative lumbar spinal stenosis. J Neurosurg Spine. 2006 May;4(5):359-64. 58) Galiano K, Obwegeser AA, Gabl MV, Bauer R, Twerdy K. Long-term outcome of laminectomy for spinal stenosis in octogenarians. Spine (Phila Pa 1976). 2005 Feb 1;30(3):332-5. 59) Deer TR, Kim CK, Bowman RG 2nd, Ranson MT, Yee BS. Study of percutaneous lumbar decompression and treatment algorithm for patients suffering from neurogenic claudication. Pain Physician. 2012 Nov-Dec;15(6):451-60. 60) Mekhail N, Costandi S, Abraham B, Samuel SW. Functional and patient-reported outcomes in symptomatic lumbar spinal stenosis following percutaneous decompression. Pain Pract. 2012 Jul;12(6):417-25. doi: 10.1111/j.1533-2500.2012.00565.x. Epub 2012 Jun 1. 61) Wilkinson JS, Fourney DR. Failure of percutaneous remodeling of the ligamentum flavum and lamina for neurogenic claudication. Neurosurgery. 2012 Jul;71(1):86-92. doi: 10.1227/NEU.0b013e31825356f5. 62) Nerland US, Jakola AS, Solheim O, Weber C, Rao V, Lønne G, Solberg TK, Salvesen Ø, Carlsen SM, Nygaard ØP, Gulati S. Minimally invasive decompression versus open laminectomy for central stenosis of the lumbar spine: pragmatic comparative effectiveness study. BMJ. 2015 Apr 1;350:h1603. doi: 10.1136/bmj.h1603. 63) Machino M, Yukawa Y, Hida T, Ito K, Nakashima H, Kanbara S, Morita D, Kato F. Modified double-door laminoplasty in managing multilevel cervical spondylotic myelopathy: surgical outcome in 520 patients and technique description. J Spinal Disord Tech. 2013 May;26(3):135- 40. doi: 10.1097/BSD.0b013e31823d848b. 64) Basu S. Mild procedure: single-site prospective IRB study. Clin J Pain. 2012 Mar- Apr;28(3):254-8. doi: 10.1097/AJP.0b013e31822bb344. 65) Katsumi K, Yamazaki A, Watanabe K, Ohashi M, Shoji H. Can prophylactic bilateral C4/C5 foraminotomy prevent postoperative C5 palsy after open-door laminoplasty?: a prospective study. Spine (Phila Pa 1976). 2012 Apr 20;37(9):748-54. doi: 10.1097/BRS.0b013e3182326957.

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66) Mekhail N, Vallejo R, Coleman MH, Benyamin RM. Long-term results of percutaneous lumbar decompression mild(®) for spinal stenosis. Pain Pract. 2012 Mar;12(3):184-93. doi: 10.1111/j.1533-2500.2011.00481.x. Epub 2011 Jun 16. 67) Lauryssen C. Technical advances in minimally invasive surgery: direct decompression for lumbar spinal stenosis. Spine (Phila Pa 1976). 2010 Dec 15;35(26 Suppl):S287-93. doi: 10.1097/BRS.0b013e3182023268. 68) Takaso M, Nakazawa T, Imura T, Okada T, Fukushima K, Ueno M, Saito W, Shintani R, Sakagami H, Takahashi K, Yamazaki M, Ohtori S, Kotani T. Less invasive and less technically demanding decompressive procedure for lumbar spinal stenosis--appropriate for general orthopaedic surgeons? Int Orthop. 2011 Jan;35(1):67-73. doi: 10.1007/s00264-010-0986-8. Epub 2010 Mar 14. 69) Ito K, Ishizaka S, Sasaki T, Miyahara T, Horiuchi T, Sakai K, Shigeta H, Hongo K. Safe and minimally invasive laminoplastic laminotomy using an ultrasonic bone curette for spinal surgery: technical note. Surg Neurol. 2009 Nov;72(5):470-5; discussion 475. doi: 10.1016/j.surneu.2009.01.012. Epub 2009 Mar 27. 70) Frank EH, Martin J, Hsu FP. An endoscopic curved Kerrison rongeur for spinal stenosis surgery. Minim Invasive Neurosurg. 2002 Dec;45(4):254-6. 71) Yücesoy K, Ozer E. Inverse laminoplasty for the treatment of lumbar spinal stenosis. Spine (Phila Pa 1976). 2002 Jul 1;27(13):E316-20. 72) Al-Mahfoudh R, Qattan E, Ellenbogen JR, Wilby M, Barrett C, Pigott T. Applications of the ultrasonic bone cutter in spinal surgery--our preliminary experience. Br J Neurosurg. 2014 Jan;28(1):56-60. doi: 10.3109/02688697.2013.812182. Epub 2013 Jul 10. 73) Hirabayashi K, Watanabe K, Wakano K, Suzuki N, Satomi K, Ishii Y. Expansive open-door laminoplasty for cervical spinal stenotic myelopathy. Spine (Phila Pa 1976). 1983 Oct;8(7):693- 9. 74) Dickinson LD, Phelps J, Summa CD, Vanichkachorn JS, Jeshuran WR, Randall JB, Mimran RI, Mitchell M, Macenski MM, Lauryssen C. Facet-sparing decompression with a minimally invasive flexible microblade shaver: a prospective operative analysis. J Spinal Disord Tech. 2013 Dec;26(8):427-36. doi: 10.1097/BSD.0b013e318290fc62.

—Retrospective Trials— 18) Klessinger S. (2013) Zygapophysial joint pain in post lumbar surgery syndrome. The efficacy of medial branch blocks and radiofrequency neurotomy. Pain Med. 14(3):374-7. 19) Schofferman J, Kine G. (2004) Effectiveness of repeated radiofrequency neurotomy for lumbar facet pain. Spine (Phila Pa 1976). 29(21):2471-3. 20) Kornick C, Kramarich SS, Lamer TJ, Todd Sitzman B. (2004) Complications of lumbar facet radiofrequency denervation. Spine (Phila Pa 1976). 29(12):1352-4. 21) Haufe SM, Mork AR. (2010) Endoscopic facet debridement for the treatment of facet arthritic pain--a novel new technique. Int J Med Sci. 7(3):120-3. 22) Yilmaz C, Kabatas S, Cansever T, Gulsen S, Coven I, Caner H, Altinors N. (2010) Radiofrequency facet joint neurotomy in treatment of facet syndrome. J Spinal Disord Tech. 23(7):480-5.

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75) Kanchiku T, Imajo Y, Suzuki H, Yoshida Y, Nishida N, Taguchi T. Percutaneous radiofrequency facet joint denervation with monitoring of compound muscle action potential of the multifidus muscle group for treating chronic low back pain: a preliminary report. J Spinal Disord Tech. 2014 Oct;27(7):E262-7. doi: 10.1097/BSD.0000000000000107. 76) Barbieri M, Bellini M. Radiofrequency neurotomy for the treatment of chronic pain: interference with implantable medical devices. Anaesthesiol Intensive Ther. 2014 Jul-Aug;46(3):162-5. doi: 10.5603/AIT.2014.0029. 77) Jia LS, Chen XS, Zhou SY, Shao J, Zhu W. En bloc resection of lamina and ossified ligamentum flavum in the treatment of thoracic ossification of the ligamentum flavum. Neurosurgery. 2010 Jun;66(6):1181-6. doi: 10.1227/01.NEU.0000369516.17394.B0. 78) Deer TR, Kapural L. New image-guided ultra-minimally invasive lumbar decompression method: the mild procedure. Pain Physician. 2010 Jan-Feb;13(1):35-41. 79) Hardman J, Graf O, Kouloumberis PE, Gao WH, Chan M, Roitberg BZ. Clinical and functional outcomes of laminoplasty and laminectomy. Neurol Res. 2010 May;32(4):416-20. doi: 10.1179/174313209X459084. Epub 2009 Jul 8. 80) Zhang J, Hirabayashi S, Saiki K, Sakai H. Effectiveness of multiple-level decompression in laminoplasty and simultaneous C1 laminectomy for patients with cervical myelopathy. Eur Spine J. 2006 Sep;15(9):1367-74. Epub 2005 Dec 21. 81) Nakagawa H, Kim SD, Mizuno J, Ohara Y, Ito K. Technical advantages of an ultrasonic bone curette in spinal surgery. J Neurosurg Spine. 2005 Apr;2(4):431-5. 82) Komagata M, Nishiyama M, Endo K, Ikegami H, Tanaka S, Imakiire A. Prophylaxis of C5 palsy after cervical expansive laminoplasty by bilateral partial foraminotomy. Spine J. 2004 Nov- Dec;4(6):650-5. 83) Park YK, Lee DY, Hur JW, Moon HJ. Delayed hinge fracture after plate-augmented, cervical open-door laminoplasty and its clinical significance. Spine J. 2014 Jul 1;14(7):1205-13. doi: 10.1016/j.spinee.2013.08.012. Epub 2013 Oct 29. 84) Bydon M, Xu R, Papademetriou K, Sciubba DM, Wolinsky JP, Witham TF, Gokaslan ZL, Jallo G, Bydon A. Safety of spinal decompression using an ultrasonic bone curette compared with a high-speed drill: outcomes in 337 patients. J Neurosurg Spine. 2013 Jun;18(6):627-33. doi: 10.3171/2013.2.SPINE12879. Epub 2013 Apr 5. 85) Gao R, Yuan W, Yang L, Shi G, Jia L. Clinical features and surgical outcomes of patients with thoracic myelopathy caused by multilevel ossification of the ligamentum flavum. Spine J. 2013 Sep;13(9):1032-8. doi: 10.1016/j.spinee.2013.02.034. 86) Chopko BW. Long-term results of percutaneous lumbar decompression for LSS: two-year outcomes. Clin J Pain. 2013 Nov;29(11):939-43. doi: 10.1097/AJP.0b013e31827fb803. 87) Ebata S, Sato H, Orii H, Sasaki S, Ohba T, Haro H. Risk management in posterior spinal endoscopic surgery in lumbar diseases. J Orthop Sci. 2013 May;18(3):369-73. doi: 10.1007/s00776-013-0360-y. Epub 2013 Feb 19. 88) Lawton CD, Smith ZA, Lam SK, Habib A, Wong RH, Fessler RG. Clinical outcomes of microendoscopic foraminotomy and decompression in the cervical spine. World Neurosurg. 2014 Feb;81(2):422-7. doi: 10.1016/j.wneu.2012.12.008. Epub 2012 Dec 12. 89) Levy RM, Deer TR. Systematic safety review and meta-analysis of procedural experience using percutaneous access to treat symptomatic lumbar spinal stenosis. Pain Med. 2012 Dec;13(12):1554-61. doi: 10.1111/j.1526-4637.2012.01504.x. Epub 2012 Nov 8.

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90) Kaymaz M, Borcek AO, Emmez H, Durdag E, Pasaoglu A. Effectiveness of single posterior decompressive laminectomy in symptomatic lumbar spinal stenosis: a retrospective study. Turk Neurosurg. 2012;22(4):430-4. doi: 10.5137/1019-5149.JTN.5401-11.1. 91) Wen SF, Wong IO, Long MJ, Li JG, Li XF, Guo DM, Xu ZH, Yin QS. Effectiveness of 3 surgical decompression strategies for treatment of multilevel cervical myelopathy in 3 spinal centers in China: a retrospective study. Spine (Phila Pa 1976). 2012 Aug 1;37(17):1463-9. 92) Pisapia JM, Bhowmick DA, Farber RE, Zager EL. Salvage C2 ganglionectomy after C2 nerve root decompression provides similar pain relief as a single surgical procedure for intractable occipital neuralgia. World Neurosurg. 2012 Feb;77(2):362-9. doi: 10.1016/j.wneu.2011.06.062. Epub 2011 Nov 7. 93) Nurboja B, Kachramanoglou C, Choi D. Cervical laminectomy vs laminoplasty: is there a difference in outcome and postoperative pain? Neurosurgery. 2012 Apr;70(4):965-70; discussion 970. doi: 10.1227/NEU.0b013e31823cf16b. 94) Onen MR, Yuvruk E, Akay S, Naderi S. The Reliability of the Ultrasonic Bone Scalpel in Cervical Spondylotic Myelopathy: A Comparative Study of 46 Patients. World Neurosurg. 2015 Dec;84(6):1962-7. doi: 10.1016/j.wneu.2015.08.043. Epub 2015 Sep 3. 95) Lauryssen C. Technical advances in minimally invasive surgery: direct decompression for lumbar spinal stenosis. Spine (Phila Pa 1976). 2010 Dec 15;35(26 Suppl):S287-93. doi: 10.1097/BRS.0b013e3182023268. 96) Kim K, Isu T, Matsumoto R, Isobe M, Kogure K. Surgical pitfalls of an ultrasonic bone curette (SONOPET) in spinal surgery. Neurosurgery. 2006 Oct;59(4 Suppl 2):ONS390-3; discussion ONS393. 97) Nakase H, Matsuda R, Shin Y, Park YS, Sakaki T. The use of ultrasonic bone curettes in spinal surgery. Acta Neurochir (Wien). 2006 Feb;148(2):207-12; discussion 212-3. Epub 2005 Nov 28. 98) Satomi K, Ogawa J, Ishii Y, Hirabayashi K. Short-term complications and long-term results of expansive open-door laminoplasty for cervical stenotic myelopathy. Spine J. 2001 Jan- Feb;1(1):26-30. 99) Hu X, Ohnmeiss DD, Lieberman IH. Use of an ultrasonic osteotome device in spine surgery: experience from the first 128 patients. Eur Spine J. 2013 Dec;22(12):2845-9. doi: 10.1007/s00586-013-2780-y. Epub 2013 Apr 16.

—Case Reports— 23) Osborne MD. (2009) Radiofrequency neurotomy for a patient with deep brain stimulators: proposed safety guidelines. Pain Med. 10(6):1046-9. 24) Terao T, Ishii T, Tani S, Abe T. (2011) Combination therapy of radiofrequency lumbar facet joint denervation and epidural spinal cord stimulation for failed back surgery syndrome. Neurol Med Chir (Tokyo). 51(11):805-9. 25) Burnham R. (2010) Radiofrequency sensory ablation as a treatment for symptomatic unilateral lumbosacral junction pseudarticulation (Bertolotti's syndrome): a case report. Pain Med. 11(6):853-5. 26) Abbott Z, Smuck M, Haig A, Sagher O. Irreversible spinal nerve injury from dorsal ramus radiofrequency neurotomy: a case report. Arch Phys Med Rehabil. 2007 Oct;88(10):1350-2. 27) Smith M, Ferretti G, Mortazavi S. (2005) Radiographic changes induced after cervical facet radiofrequency denervation. Spine J. 5(6):668-71.

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100) Walega D, Roussis C. Third-degree burn from cooled radiofrequency ablation of medial branch nerves for treatment of thoracic facet syndrome. Pain Pract. 2014 Jul;14(6):e154-8. doi: 10.1111/papr.12222. Epub 2014 May 2. 101) Stegemöller EL, Roper J, Hass CJ, Kennedy DJ. Changes in gait kinematics and lower back muscle activity post-radiofrequency denervation of the zygapophysial joint: a case study. Spine J. 2015 Jun 1;15(6):e21-7. doi: 10.1016/j.spinee.2013.06.061. Epub 2013 Oct 10. 102) Miyoshi Y, Yasuhara T, Date I. Posterior decompression of far-out foraminal stenosis caused by a lumbosacral transitional vertebra--case report. Neurol Med Chir (Tokyo). 2011;51(2):153-6. 103) Lee KS, Shim JJ, Doh JW, Yoon SM, Bae HG, Yun IG. Transient paraparesis after laminectomy in a patient with multi-level ossification of the spinal ligament. J Korean Med Sci. 2004 Aug;19(4):624-6.

—Systematic Literature Reviews— 28) Falco FJ, Manchikanti L, Datta S, Sehgal N, Geffert S, Onyewu O, Zhu J, Coubarous S, Hameed M, Ward SP, Sharma M, Hameed H, Singh V, Boswell MV. (2012) An update of the effectiveness of therapeutic lumbar facet joint interventions. Pain Physician. 15(6):E909-53. 29) Falco FJ, Manchikanti L, Datta S, Wargo BW, Geffert S, Bryce DA, Atluri S, Singh V, Benyamin RM, Sehgal N, Ward SP, Helm S 2nd, Gupta S, Boswell MV. (2012) Systematic review of the therapeutic effectiveness of cervical facet joint interventions: an update. Pain Physician. 15(6):E839-68. 30) Falco FJ, Erhart S, Wargo BW, Bryce DA, Atluri S, Datta S, Hayek SM. (2009) Systematic review of diagnostic utility and therapeutic effectiveness of cervical facet joint interventions. Pain Physician. 12(2):323-44. 31) Atluri S, Datta S, Falco FJ, Lee M. (2008) Systematic review of diagnostic utility and therapeutic effectiveness of thoracic facet joint interventions. Pain Physician. 11(5):611-29. 32) Boswell MV, Colson JD, Sehgal N, Dunbar EE, Epter R. (2007) A systematic review of therapeutic facet joint interventions in chronic spinal pain. Pain Physician. 10(1):229-53. 33) Hooten WM, Martin DP, Huntoon MA. (2005) Radiofrequency neurotomy for low back pain: evidence-based procedural guidelines. Pain Med. 6(2):129-38. 34) Manchikanti L, Abdi S, Atluri S, Benyamin RM, Boswell MV, Buenaventura RM, Bryce DA, Burks PA, Caraway DL, Calodney AK, Cash KA, Christo PJ, Cohen SP, Colson J, Conn A, Cordner H, Coubarous S, Datta S, Deer TR, Diwan S, Falco FJ, Fellows B, Geffert S, Grider JS, Gupta S, Hameed H, Hameed M, Hansen H, Helm S 2nd, Janata JW, Justiz R, Kaye AD, Lee M, Manchikanti KN, McManus CD, Onyewu O, Parr AT, Patel VB, Racz GB, Sehgal N, Sharma ML, Simopoulos TT, Singh V, Smith HS, Snook LT, Swicegood JR, Vallejo R, Ward SP, Wargo BW, Zhu J, Hirsch JA. (2013) An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations. Pain Physician. 16(2 Suppl):S49-283. 35) Van Kleef M, Vanelderen P, Cohen SP, Lataster A, Van Zundert J, Mekhail N. (2010) 12. Pain originating from the lumbar facet joints. Pain Pract. 10(5):459-69. 36) Manchikanti L, Datta S, Gupta S, Munglani R, Bryce DA, Ward SP, Benyamin RM, Sharma ML, Helm S 2nd, Fellows B, Hirsch JA. (2010) A critical review of the American Pain Society clinical

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practice guidelines for interventional techniques: part 2. Therapeutic interventions. Pain Physician. 13(4):E215-64. 37) Chou R, Atlas SJ, Stanos SP, Rosenquist RW. (2009) Nonsurgical interventional therapies for low back pain: a review of the evidence for an American Pain Society clinical practice guideline. Spine (Phila Pa 1976). 34(10):1078-93. 38) Datta S, Lee M, Falco FJ, Bryce DA, Hayek SM. (2009) Systematic assessment of diagnostic accuracy and therapeutic utility of lumbar facet joint interventions. Pain Physician. 12(2):437-60. 39) Cetas JS, Saedi T, Burchiel KJ. (2008) Destructive procedures for the treatment of nonmalignant pain: a structured literature review. J Neurosurg. 109(3):389-404. 40) Carragee EJ, Hurwitz EL, Cheng I, Carroll LJ, Nordin M, Guzman J, Peloso P, Holm LW, Côté P, Hogg-Johnson S, van der Velde G, Cassidy JD, Haldeman S; (2008) Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Treatment of neck pain: injections and surgical interventions: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). 33(4 Suppl):S153-69. 41) Markman JD, Philip A. (2007) Interventional approaches to pain management. Anesthesiol Clin. 25(4):883-98, viii. 42) Cohen SP, Raja SN. (2007) Pathogenesis, diagnosis, and treatment of lumbar zygapophysial (facet) joint pain. Anesthesiology. 106(3):591-614. 43) Boswell MV, Trescot AM, Datta S, Schultz DM, Hansen HC, Abdi S, Sehgal N, Shah RV, Singh V, Benyamin RM, Patel VB, Buenaventura RM, Colson JD, Cordner HJ, Epter RS, Jasper JF, Dunbar EE, Atluri SL, Bowman RC, Deer TR, Swicegood JR, Staats PS, Smith HS, Burton AW, Kloth DS, Giordano J, Manchikanti L; (2007) American Society of Interventional Pain Physicians. Interventional techniques: evidence-based practice guidelines in the management of chronic spinal pain. Pain Physician. 10(1):7-111. 44) Murtagh J, Foerster V. (2006) Radiofrequency neurotomy for lumbar pain. Issues Emerg Health Technol. (83):1-4. 106) Lauryssen C. Technical advances in minimally invasive surgery: direct decompression for lumbar spinal stenosis. Spine (Phila Pa 1976). 2010 Dec 15;35(26 Suppl):S287-93. doi: 10.1097/BRS.0b013e3182023268.

—Technical Notes— 104) Maroon JC, El-Kadi M, Bost J. Pneumatic Kerrison rongeur: technical note. Surg Neurol. 2009 Apr;71(4):466-8. doi: 10.1016/j.surneu.2008.10.008. Epub 2009 Jan 14. 105) Mizuno J, Nakagawa H, Song J, Matsuo N. Surgery for dural ossification in association with cervical ossification of the posterior longitudinal ligament via an anterior approach. Neurol India. 2005 Sep;53(3):354-7.

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Appendix C: Pub Med Literature Search Result Search #1 Query: (facet joint radiofrequency AND safety) OR (facet joint radiofrequency AND effectiveness) OR (facet joint rhizotomy) PubMed converted these search terms into the following: ((("zygapophyseal joint"[MeSH Terms] OR ("zygapophyseal"[All Fields] AND "joint"[All Fields]) OR "zygapophyseal joint"[All Fields] OR ("facet"[All Fields] AND "joint"[All Fields]) OR "facet joint"[All Fields]) AND radiofrequency[All Fields]) AND ("safety"[MeSH Terms] OR "safety"[All Fields])) OR ((("zygapophyseal joint"[MeSH Terms] OR ("zygapophyseal"[All Fields] AND "joint"[All Fields]) OR "zygapophyseal joint"[All Fields] OR ("facet"[All Fields] AND "joint"[All Fields]) OR "facet joint"[All Fields]) AND radiofrequency[All Fields]) AND effectiveness[All Fields]) OR (("zygapophyseal joint"[MeSH Terms] OR ("zygapophyseal"[All Fields] AND "joint"[All Fields]) OR "zygapophyseal joint"[All Fields] OR ("facet"[All Fields] AND "joint"[All Fields]) OR "facet joint"[All Fields]) AND ("rhizotomy"[MeSH Terms] OR "rhizotomy"[All Fields])) AND Filters: (("2004/01/01"[PDAT] : "2014/12/31"[PDAT]) AND "humans"[MeSH Terms] AND English[lang]) Results: (n=37) Table 2: Search #1 Inclusion/Exclusion Summary Included or Excluded Reference Excluded Reason Lakemeier S, Lind M, Schultz W, Fuchs-Winkelmann S, Included randomized, Timmesfeld N, Foelsch C, Peterlein CD. A comparison of double-blind, intraarticular lumbar facet joint steroid injections and lumbar controlled study facet joint radiofrequency denervation in the treatment of low back pain: a randomized, controlled, double-blind trial. Anesth Analg. 2013 Jul;117(1):228-35. doi: 10.1213/ANE.0b013e3182910c4d. Epub 2013 Apr 30. PubMed PMID: 23632051. Klessinger S. Zygapophysial joint pain in post lumbar surgery Included Retrospective syndrome. The efficacy of medial branch blocks and practice audit radiofrequency neurotomy. Pain Med. 2013 Mar;14(3):374-7. doi: 10.1111/pme.12012. Epub 2012 Dec 13. PubMed PMID: 23241083. Falco FJ, Manchikanti L, Datta S, Sehgal N, Geffert S, Included systematic Onyewu O, Zhu J, Coubarous S, Hameed M, Ward SP, literature review Sharma M, Hameed H, Singh V, Boswell MV. An update of the effectiveness of therapeutic lumbar facet joint interventions. Pain Physician. 2012 Nov-Dec;15(6):E909-53. Review. PubMed PMID: 23159980. Falco FJ, Manchikanti L, Datta S, Wargo BW, Geffert S, Included systematic Bryce DA, Atluri S, Singh V, Benyamin RM, Sehgal N, Ward literature review SP, Helm S 2nd, Gupta S, Boswell MV. Systematic review of the therapeutic effectiveness of cervical facet joint

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Included or Excluded Reference Excluded Reason interventions: an update. Pain Physician. 2012 Nov- Dec;15(6):E839-68. Review. PubMed PMID: 23159978. MacVicar J, Borowczyk JM, MacVicar AM, Loughnan BM, Included prospective, Bogduk N. Cervical medial branch radiofrequency neurotomy outcome study of in New Zealand. Pain Med. 2012 May;13(5):647-54. doi: consecutive 10.1111/j.1526-4637.2012.01351.x. Epub 2012 Mar 28. patients PubMed PMID: 22458772. Civelek E, Cansever T, Kabatas S, Kircelli A, Yilmaz C, Included Comparative Musluman M, Ofluoglu D, Caner H. Comparison of clinical study effectiveness of facet joint injection and radiofrequency denervation in chronic low back pain. Turk Neurosurg. 2012;22(2):200-6. doi: 10.5137/1019-5149.JTN.5207-11.1. PubMed PMID: 22437295. Masala S, Nano G, Mammucari M, Marcia S, Simonetti G. Included Medial branch neurotomy in low back pain. Neuroradiology. 2012 Jul;54(7):737-44. doi: 10.1007/s00234-011-0968-6. Epub 2011 Oct 18. PubMed PMID: 22006423. Tomé-Bermejo F, Barriga-Martín A, Martín JL. Identifying Included Prospective patients with chronic low back pain likely to benefit from clinical study lumbar facet radiofrequency denervation: a prospective study. J Spinal Disord Tech. 2011 Apr;24(2):69-75. doi: 10.1097/BSD.0b013e3181dc9969. PubMed PMID: 21445021. Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V, Excluded Randomized, Fellows B. Comparative effectiveness of a one-year follow-up double-blind of thoracic medial branch blocks in management of chronic active controlled thoracic pain: a randomized, double-blind active controlled trial trial. Pain Physician. 2010 Nov-Dec;13(6):535-48. PubMed Did not include PMID: 21102966. facet joint denervation, nerve blocks with and with steroids were compared. Manchikanti L, Singh V, Falco FJ, Cash KA, Fellows B. Excluded Randomized, Comparative outcomes of a 2-year follow-up of cervical double-blind medial branch blocks in management of chronic neck pain: a active controlled randomized, double-blind controlled trial. Pain Physician. trial 2010 Sep-Oct;13(5):437-50. PubMed PMID: 20859313. Did not include facet joint denervation, nerve blocks with and with steroids were compared.

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Included or Excluded Reference Excluded Reason Andres RH, Graupner T, Bärlocher CB, Augsburger A, Excluded Therapy was Fandino J. Laser-guided lumbar medial branch kryorhizotomy. kryorhizotomy J Neurosurg Spine. 2010 Sep;13(3):341-5. doi: not 10.3171/2010.3.SPINE09609. PubMed PMID: 20809727. radiofrequency. Also, study focused on modified technique as opposed to the therapy in general. Rambaransingh B, Stanford G, Burnham R. The effect of Included Prospective study repeated zygapophysial joint radiofrequency neurotomy on pain, disability, and improvement duration. Pain Med. 2010 Sep;11(9):1343-7. doi: 10.1111/j.1526-4637.2010.00923.x. Epub 2010 Jul 27. PubMed PMID: 20667024. Cohen SP, Williams KA, Kurihara C, Nguyen C, Shields C, Included Randomized, Kim P, Griffith SR, Larkin TM, Crooks M, Williams N, multicenter study Morlando B, Strassels SA. Multicenter, randomized, comparative cost-effectiveness study comparing 0, 1, and 2 diagnostic medial branch (facet joint nerve) block treatment paradigms before lumbar facet radiofrequency denervation. Anesthesiology. 2010 Aug;113(2):395-405. doi: 10.1097/ALN.0b013e3181e33ae5. PubMed PMID: 20613471. Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V. Excluded Did not include Evaluation of lumbar facet joint nerve blocks in managing facet joint chronic low back pain: a randomized, double-blind, controlled denervation, trial with a 2-year follow-up. Int J Med Sci. 2010 May nerve blocks with 28;7(3):124-35. PubMed PMID: 20567613; PubMed Central and with steroids PMCID: PMC2880841. were compared. Lang JK, Buchfelder M. Radiofrequency neurotomy for Included Prospective trial. headache stemming from the zygapophysial joints C2/3 and C3/4. Cent Eur Neurosurg. 2010 May;71(2):75-9. doi: 10.1055/s-0029-1224159. Epub 2009 Nov 27. PubMed PMID: 20358509. Lee CH, Derby R, Choi HS, Lee SH, Kim SH, Kang YK. The Excluded Cadaver study efficacy of two electrodes radiofrequency technique: focusing on comparison study using a cadaveric interspinous ligament and technique temperature measurement using egg white. Pain Physician. 2010 Jan-Feb;13(1):43-9. PubMed PMID: 20119462. Proschek D, Kafchitsas K, Rauschmann M, Kurth A, Vogl T, Excluded Study focused on Geiger F. Reduction of radiation dose during radiofrequency reducing denervation of the lumbar facet joints using the new targeting fluoroscopic system SabreSource: a prospective study in 20 patients. Arch exposure during Orthop Trauma Surg. 2010 Sep;130(9):1103-10. doi:

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Included or Excluded Reference Excluded Reason 10.1007/s00402-009-0983-9. Epub 2009 Oct 24. PubMed procedure. PMID: 19855988. Osborne MD. Radiofrequency neurotomy for a patient with Included Case study deep brain stimulators: proposed safety guidelines. Pain Med. focusing on use 2009 Sep;10(6):1046-9. doi: 10.1111/j.1526- of radiofrequency 4637.2009.00686.x. Epub 2009 Sep 9. PubMed PMID: medial branch 19744216. neurotomy on patient with deep brain stimulators. Included for labeling consideration. Bogduk N, Dreyfuss P, Govind J. A narrative review of Excluded Opinion piece lumbar medial branch neurotomy for the treatment of back pain. Pain Med. 2009 Sep;10(6):1035-45. doi: 10.1111/j.1526- 4637.2009.00692.x. Epub 2009 Aug 18. Review. PubMed PMID: 19694977. Falco FJ, Erhart S, Wargo BW, Bryce DA, Atluri S, Datta S, Included Systematic Hayek SM. Systematic review of diagnostic utility and literature review therapeutic effectiveness of cervical facet joint interventions. Pain Physician. 2009 Mar-Apr;12(2):323-44. Review. PubMed PMID: 19305483. Atluri S, Datta S, Falco FJ, Lee M. Systematic review of Included Systematic diagnostic utility and therapeutic effectiveness of thoracic literature review facet joint interventions. Pain Physician. 2008 Sep- Oct;11(5):611-29. Review. PubMed PMID: 18850026. Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V. Excluded Did not include Effectiveness of thoracic medial branch blocks in managing facet joint chronic pain: a preliminary report of a randomized, double- denervation, blind controlled trial. Pain Physician. 2008 Jul-Aug;11(4):491- nerve blocks with 504. PubMed PMID: 18690278. and with steroids were compared. Husted DS, Orton D, Schofferman J, Kine G. Effectiveness of Excluded Annual meeting repeated radiofrequency neurotomy for cervical facet joint proceedings pain. J Spinal Disord Tech. 2008 Aug;21(6):406-8. doi: 10.1097/BSD.0b013e318158971f. PubMed PMID: 18679094. Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V. Excluded Randomized, Lumbar facet joint nerve blocks in managing chronic facet double-blind joint pain: one-year follow-up of a randomized, double-blind controlled trial controlled trial: Clinical Trial NCT00355914. Pain Physician. Did not include 2008 Mar-Apr;11(2):121-32. PubMed PMID: 18354721. facet joint denervation, nerve blocks with

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Included or Excluded Reference Excluded Reason and with steroids were compared. Novak S, Nemeth WC. RE: cost-effectiveness of diagnostic Excluded Letter to the medial branch blocks before radiofrequency denervation. editor Spine J. 2008 Mar-Apr;8(2):412-3. doi: 10.1016/j.spinee.2007.11.002. Epub 2008 Jan 7. PubMed PMID: 18182330. Li G, Patil C, Adler JR, Lad SP, Soltys SG, Gibbs IC, Tupper Excluded Study evaluated L, Boakye M. CyberKnife rhizotomy for facetogenic back cyberknife pain: a pilot study. Neurosurg Focus. 2007;23(6):E2. PubMed technology, PMID: 18081475. different technology than radiofrequency McDonald M, Cooper R, Wang MY. Use of computed Excluded Study focused on tomography-single-photon emission computed tomography imaging fusion for diagnosing painful facet arthropathy. Technical technique, not note. Neurosurg Focus. 2007 Jan 15;22(1):E2. PubMed PMID: safety and 17608336. efficacy of therapy. Levin KH. Nonsurgical interventions for spine pain. Neurol Excluded Study focused on Clin. 2007 May;25(2):495-505. Review. PubMed PMID: nonsurgical 17445740. interventions. Iwatsuki K, Yoshimine T, Awazu K. Alternative denervation Included Study included, using laser irradiation in lumbar facet syndrome. Lasers Surg as it focused on Med. 2007 Mar;39(3):225-9. PubMed PMID: 17345622. dorsal surface of the facet capsule. Boswell MV, Colson JD, Sehgal N, Dunbar EE, Epter R. A Included Systematic systematic review of therapeutic facet joint interventions in literature review chronic spinal pain. Pain Physician. 2007 Jan;10(1):229-53. Review. PubMed PMID: 17256032. Birkenmaier C, Veihelmann A, Trouillier HH, Hausdorf J, von Excluded Nerve blocks, in Schulze Pellengahr C. Medial branch blocks versus combination with pericapsular blocks in selecting patients for percutaneous cryodenervation cryodenervation of lumbar facet joints. Reg Anesth Pain Med. were studied. 2007 Jan-Feb;32(1):27-33. PubMed PMID: 17196489. Different technology than radiofrequency denervation. Manchikanti L, Manchikanti KN, Manchukonda R, Pampati Excluded Evaluated medial V, Cash KA. Evaluation of therapeutic thoracic medial branch branch nerve block effectiveness in chronic thoracic pain: a prospective blocks. Did not outcome study with minimum 1-year follow up. Pain include Physician. 2006 Apr;9(2):97-105. PubMed PMID: 16703969. evaluation of radiofrequency

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Included or Excluded Reference Excluded Reason denervation. Staender M, Maerz U, Tonn JC, Steude U. Computerized Excluded Study evaluated tomography-guided kryorhizotomy in 76 patients with lumbar technique of CT- facet joint syndrome. J Neurosurg Spine. 2005 Dec;3(6):444- guided 9. PubMed PMID: 16381206. kryorhizotomy, a different technology than radiofrequency denervation. Dobrogowski J, Wrzosek A, Wordliczek J. Radiofrequency Included Randomized denervation with or without addition of pentoxifylline or controlled trial methylprednisolone for chronic lumbar zygapophysial joint pain. Pharmacol Rep. 2005 Jul-Aug;57(4):475-80. PubMed PMID: 16129914. Hooten WM, Martin DP, Huntoon MA. Radiofrequency Included Literature review neurotomy for low back pain: evidence-based procedural that focused on guidelines. Pain Med. 2005 Mar-Apr;6(2):129-38. Review. procedural PubMed PMID: 15773877. guidelines. Schofferman J, Kine G. Effectiveness of repeated Included Retrospective radiofrequency neurotomy for lumbar facet pain. Spine (Phila chart review. Pa 1976). 2004 Nov 1;29(21):2471-3. Review. PubMed PMID: 15507813. Kornick C, Kramarich SS, Lamer TJ, Todd Sitzman B. Included Retrospective Complications of lumbar facet radiofrequency denervation. chart review. Spine (Phila Pa 1976). 2004 Jun 15;29(12):1352-4. PubMed PMID: 15187637.

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Search #2

Query: (facet syndrome AND radiofrequency) OR (facet joint radiofrequency AND adverse events) OR (facet joint radiofrequency AND adverse effects) OR (facet joint rhizotomy AND adverse events) OR (facet joint rhizotomy AND adverse effects) NOT (facet joint radiofrequency AND effectiveness) NOT (facet joint radiofrequency AND safety)

PubMed converted to: ((facet[All Fields] AND ("syndrome"[MeSH Terms] OR "syndrome"[All Fields])) AND radiofrequency[All Fields]) OR ((("zygapophyseal joint"[MeSH Terms] OR ("zygapophyseal"[All Fields] AND "joint"[All Fields]) OR "zygapophyseal joint"[All Fields] OR ("facet"[All Fields] AND "joint"[All Fields]) OR "facet joint"[All Fields]) AND radiofrequency[All Fields]) AND (adverse[All Fields] AND events[All Fields])) OR ((("zygapophyseal joint"[MeSH Terms] OR ("zygapophyseal"[All Fields] AND "joint"[All Fields]) OR "zygapophyseal joint"[All Fields] OR ("facet"[All Fields] AND "joint"[All Fields]) OR "facet joint"[All Fields]) AND radiofrequency[All Fields]) AND ("adverse effects"[Subheading] OR ("adverse"[All Fields] AND "effects"[All Fields]) OR "adverse effects"[All Fields])) OR ((("zygapophyseal joint"[MeSH Terms] OR ("zygapophyseal"[All Fields] AND "joint"[All Fields]) OR "zygapophyseal joint"[All Fields] OR ("facet"[All Fields] AND "joint"[All Fields]) OR "facet joint"[All Fields]) AND ("rhizotomy"[MeSH Terms] OR "rhizotomy"[All Fields])) AND (adverse[All Fields] AND events[All Fields])) OR ((("zygapophyseal joint"[MeSH Terms] OR ("zygapophyseal"[All Fields] AND "joint"[All Fields]) OR "zygapophyseal joint"[All Fields] OR ("facet"[All Fields] AND "joint"[All Fields]) OR "facet joint"[All Fields]) AND ("rhizotomy"[MeSH Terms] OR "rhizotomy"[All Fields])) AND ("adverse effects"[Subheading] OR ("adverse"[All Fields] AND "effects"[All Fields]) OR "adverse effects"[All Fields])) NOT ((("zygapophyseal joint"[MeSH Terms] OR ("zygapophyseal"[All Fields] AND "joint"[All Fields]) OR "zygapophyseal joint"[All Fields] OR ("facet"[All Fields] AND "joint"[All Fields]) OR "facet joint"[All Fields]) AND radiofrequency[All Fields]) AND effectiveness[All Fields]) NOT ((("zygapophyseal joint"[MeSH Terms] OR ("zygapophyseal"[All Fields] AND "joint"[All Fields]) OR "zygapophyseal joint"[All Fields] OR ("facet"[All Fields] AND "joint"[All Fields]) OR "facet joint"[All Fields]) AND radiofrequency[All Fields]) AND ("safety"[MeSH Terms] OR "safety"[All Fields]))

Limits: (("2004/01/01"[PDAT] : "2014/12/31"[PDAT]) AND "humans"[MeSH Terms] AND English[lang])

Results: (n=30)

Table 3: Search #2 Inclusion/Exclusion Summary Included Excluded Reference Excluded Reason Shabat S, Leitner Y, Bartal G, Folman Y. Radiofrequency Included Prospective trial treatment has a beneficial role in reducing low back pain due to facet syndrome in octogenarians or older. Clin Interv Aging. 2013;8:737-40. doi: 10.2147/CIA.S44999. Epub 2013 Jun 17. PubMed PMID: 23818771; PubMed Central PMCID:

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Included Excluded Reference Excluded Reason PMC3693728. Manchikanti L, Abdi S, Atluri S, Benyamin RM, Boswell MV, Included Systematic Buenaventura RM, Bryce DA, Burks PA, Caraway DL, literature review Calodney AK, Cash KA, Christo PJ, Cohen SP, Colson J, Conn A, Cordner H, Coubarous S, Datta S, Deer TR, Diwan S, Falco FJ, Fellows B, Geffert S, Grider JS, Gupta S, Hameed H, Hameed M, Hansen H, Helm S 2nd, Janata JW, Justiz R, Kaye AD, Lee M, Manchikanti KN, McManus CD, Onyewu O, Parr AT, Patel VB, Racz GB, Sehgal N, Sharma ML, Simopoulos TT, Singh V, Smith HS, Snook LT, Swicegood JR, Vallejo R, Ward SP, Wargo BW, Zhu J, Hirsch JA. An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations. Pain Physician. 2013 Apr;16(2 Suppl):S49- 283. PubMed PMID: 23615883. Joo YC, Park JY, Kim KH. Comparison of alcohol ablation Included Comparative trial with repeated thermal radiofrequency ablation in medial branch neurotomy for the treatment of recurrent thoracolumbar facet joint pain. J Anesth. 2013 Jun;27(3):390-5. doi: 10.1007/s00540-012-1525-0. Epub 2012 Nov 29. PubMed PMID: 23192698. Marcia S, Masala S, Marini S, Piras E, Marras M, Mallarini G, Excluded Letter to the Mathieu A, Cauli A. Osteoarthritis of the zygapophysial joints: editor efficacy of percutaneous radiofrequency neurotomy in the treatment of lumbar facet joint syndrome. Clin Exp Rheumatol. 2012 Mar-Apr;30(2):314. Epub 2012 Apr 15. PubMed PMID: 22409995. Terao T, Ishii T, Tani S, Abe T. Combination therapy of Included Case study, radiofrequency lumbar facet joint denervation and epidural procedure spinal cord stimulation for failed back surgery syndrome. includes spinal Neurol Med Chir (Tokyo). 2011;51(11):805-9. PubMed PMID: cord stimulation. 22123488. Included for labeling consideration. Speldewinde GC. Outcomes of percutaneous zygapophysial Included Prospective and sacroiliac joint neurotomy in a community setting. Pain evaluation, single Med. 2011 Feb;12(2):209-18. doi: 10.1111/j.1526- center 4637.2010.01022.x. Epub 2010 Dec 10. PubMed PMID: 21143762. Ma K, Yiqun M, Wu T, Wang W, Liu X, Huang X, Wang Y. Included Randomized Efficacy of diclofenac sodium in pain relief after conventional controlled trial. radiofrequency denervation for chronic facet joint pain: a Evaluated use of double-blind randomized controlled trial. Pain Med. 2011 diclofenac Jan;12(1):27-35. doi: 10.1111/j.1526-4637.2010.00978.x. Epub sodium along

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Included Excluded Reference Excluded Reason 2010 Oct 28. PubMed PMID: 21040436. with RF denervation therapy van Kleef M, Vanelderen P, Cohen SP, Lataster A, Van Included Literature review Zundert J, Mekhail N. 12. Pain originating from the lumbar facet joints. Pain Pract. 2010 Sep-Oct;10(5):459-69. doi: 10.1111/j.1533-2500.2010.00393.x. Review. PubMed PMID: 20667027. Manchikanti L, Datta S, Gupta S, Munglani R, Bryce DA, Included Systematic Ward SP, Benyamin RM, Sharma ML, Helm S 2nd, Fellows B, literature review Hirsch JA. A critical review of the American Pain Society clinical practice guidelines for interventional techniques: part 2. Therapeutic interventions. Pain Physician. 2010 Jul- Aug;13(4):E215-64. Review. PubMed PMID: 20648212. 2.10: Burnham R. Radiofrequency sensory ablation as a Included Case study. treatment for symptomatic unilateral lumbosacral junction Included for pseudarticulation (Bertolotti's syndrome): a case report. Pain labeling Med. 2010 Jun;11(6):853-5. doi: 10.1111/j.1526- consideration. 4637.2010.00869.x. PubMed PMID: 20624239. Haufe SM, Mork AR. Endoscopic facet debridement for the Included Retrospective, treatment of facet arthritic pain--a novel new technique. Int J observational, Med Sci. 2010 May 25;7(3):120-3. PubMed PMID: 20567612; open label PubMed Central PMCID: PMC2880840. Gekht G, Nottmeier EW, Lamer TJ. Painful medial branch Excluded Case study, does neuroma treated with minimally invasive medial branch not need to be neurectomy. Pain Med. 2010 Aug;11(8):1179-82. doi: considered for 10.1111/j.1526-4637.2010.00851.x. Epub 2010 Apr 29. labeling. PubMed PMID: 20456081. Neurectomy procedure does not apply. Yilmaz C, Kabatas S, Cansever T, Gulsen S, Coven I, Caner H, Included Retrospective Altinors N. Radiofrequency facet joint neurotomy in treatment analysis of facet syndrome. J Spinal Disord Tech. 2010 Oct;23(7):480- 5. doi: 10.1097/BSD.0b013e3181bf1c76. PubMed PMID: 20124916. Lee CH, Derby R, Choi HS, Lee SH, Kim SH, Kang YK. The Excluded Cadaver study efficacy of two electrodes radiofrequency technique: focusing on comparison study using a cadaveric interspinous ligament and technique temperature measurement using egg white. Pain Physician. Also, repeat of 2010 Jan-Feb;13(1):43-9. PubMed PMID: 20119462. citation #16 in search #1.

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Included Excluded Reference Excluded Reason Chou R, Atlas SJ, Stanos SP, Rosenquist RW. Nonsurgical Included Systematic interventional therapies for low back pain: a review of the literature review evidence for an American Pain Society clinical practice guideline. Spine (Phila Pa 1976). 2009 May 1;34(10):1078-93. doi: 10.1097/BRS.0b013e3181a103b1. Review. PubMed PMID: 19363456. Datta S, Lee M, Falco FJ, Bryce DA, Hayek SM. Systematic Included Systematic assessment of diagnostic accuracy and therapeutic utility of literature review lumbar facet joint interventions. Pain Physician. 2009 Mar- Apr;12(2):437-60. Review. PubMed PMID: 19305489. Manchikanti L, Singh V. Diagnosis of facet joint pain and Excluded Letter to the prediction of success and failure for cervical facet editor radiofrequency denervation. Reg Anesth Pain Med. 2009 Jan- Feb;34(1):81-2; author reply 82-3. doi: 10.1097/AAP.0b013e3181926a7d. PubMed PMID: 19259006. Kroll HR, Kim D, Danic MJ, Sankey SS, Gariwala M, Brown Included Prospective, M. A randomized, double-blind, prospective study comparing randomized, the efficacy of continuous versus pulsed radiofrequency in the double-blinded treatment of lumbar facet syndrome. J Clin Anesth. 2008 study Nov;20(7):534-7. doi: 10.1016/j.jclinane.2008.05.021. PubMed PMID: 19041042. Manchikanti L, Singh V. Are the results of a multicenter Excluded Letter to the analysis of radiofrequency denervation success as a function of editor single diagnostic block reliable? Spine J. 2009 Aug;9(8):704-5; author reply 705-6. doi: 10.1016/j.spinee.2008.05.016. Epub 2008 Sep 14. PubMed PMID: 18790683. Cetas JS, Saedi T, Burchiel KJ. Destructive procedures for the Included Systematic treatment of nonmalignant pain: a structured literature review. J literature review Neurosurg. 2008 Sep;109(3):389-404. doi: 10.3171/JNS/2008/109/9/0389. Review. PubMed PMID: 18759567. Carragee EJ, Hurwitz EL, Cheng I, Carroll LJ, Nordin M, Included Systematic Guzman J, Peloso P, Holm LW, Côté P, Hogg-Johnson S, van literature review der Velde G, Cassidy JD, Haldeman S; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Treatment of neck pain: injections and surgical interventions: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S153-69. doi: 10.1097/BRS.0b013e31816445ea. Review. PubMed PMID: 18204388.

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Included Excluded Reference Excluded Reason Markman JD, Philip A. Interventional approaches to pain Included Literature review management. Anesthesiol Clin. 2007 Dec;25(4):883-98, viii. Review. PubMed PMID: 18054151. Abbott Z, Smuck M, Haig A, Sagher O. Irreversible spinal Included Case study. nerve injury from dorsal ramus radiofrequency neurotomy: a Included for case report. Arch Phys Med Rehabil. 2007 Oct;88(10):1350-2. labeling PubMed PMID: 17908581. consideration. Tekin I, Mirzai H, Ok G, Erbuyun K, Vatansever D. A Included Prospective, comparison of conventional and pulsed radiofrequency controlled study denervation in the treatment of chronic facet joint pain. Clin J Pain. 2007 Jul-Aug;23(6):524-9. PubMed PMID: 17575493. Cohen SP, Raja SN. Pathogenesis, diagnosis, and treatment of Included Systematic lumbar zygapophysial (facet) joint pain. Anesthesiology. 2007 analysis Mar;106(3):591-614. Review. PubMed PMID: 17325518. Boswell MV, Trescot AM, Datta S, Schultz DM, Hansen HC, Included Systematic Abdi S, Sehgal N, Shah RV, Singh V, Benyamin RM, Patel literature review VB, Buenaventura RM, Colson JD, Cordner HJ, Epter RS, Jasper JF, Dunbar EE, Atluri SL, Bowman RC, Deer TR, Swicegood JR, Staats PS, Smith HS, Burton AW, Kloth DS, Giordano J, Manchikanti L; American Society of Interventional Pain Physicians. Interventional techniques: evidence-based practice guidelines in the management of chronic spinal pain. Pain Physician. 2007 Jan;10(1):7-111. PubMed PMID: 17256025. Tominaga Y, Ndu AB, Coe MP, Valenson AJ, Ivancic PC, Ito Excluded Study included S, Rubin W, Panjabi MM. Neck ligament strength is decreased human ligament following whiplash trauma. BMC Musculoskelet Disord. 2006 specimens to Dec 21;7:103. PubMed PMID: 17184536; PubMed Central evaluate ligament PMCID: PMC1764743. strength after whiplash. Study does not apply. Murtagh J, Foerster V. Radiofrequency neurotomy for lumbar Included Systematic pain. Issues Emerg Health Technol. 2006 May;(83):1-4. literature review PubMed PMID: 16724429. Smith M, Ferretti G, Mortazavi S. Radiographic changes Included Case study. induced after cervical facet radiofrequency denervation. Spine Included for J. 2005 Nov-Dec;5(6):668-71. PubMed PMID: 16291110. labeling consideration.

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Included Excluded Reference Excluded Reason van Wijk RM, Geurts JW, Wynne HJ, Hammink E, Buskens E, Included Multicenter, Lousberg R, Knape JT, Groen GJ. Radiofrequency denervation randomized, of lumbar facet joints in the treatment of chronic low back pain: double-blind, a randomized, double-blind, sham lesion-controlled trial. Clin J sham treatment Pain. 2005 Jul-Aug;21(4):335-44. Erratum in: Clin J Pain. 2005 controlled trial Sep-Oct;21(5):462. PubMed PMID: 15951652.

Search #3

Query: (facet joint radiofrequency AND safety) OR (facet joint radiofrequency AND effectiveness) OR (facet joint rhizotomy)

Limits: English, Humans, Published since 15-JUN-2014

Results: (n=6)

Table 4: Search #1 Inclusion/Exclusion Summary REFERENCE INCLUDE EXCLUDED OR RATIONALE. IF EXCLUDE APPLICABLE Maas ET, Ostelo RW, Niemisto L, Jousimaa J, Hurri H, Exclude Systematic Literature Malmivaara A, van Tulder MW. Radiofrequency denervation Review for chronic low back pain. Cochrane Database Syst Rev. 2015 Oct 23;10:CD008572. doi: 10.1002/14651858.CD008572.pub2. Manchikanti L, Kaye AD, Boswell MV, Bakshi S, Gharibo Exclude Systematic Literature CG, Grami V, Grider JS, Gupta S, Jha SS, Mann DP, Review Nampiaparampil DE, Sharma ML, Shroyer LN, Singh V, Soin A, Vallejo R, Wargo BW, Hirsch JA. A Systematic Review and Best Evidence Synthesis of the Effectiveness of Therapeutic Facet Joint Interventions in Managing Chronic Spinal Pain. Pain Physician. 2015 Jul-Aug;18(4):E535-82.

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REFERENCE INCLUDE EXCLUDED OR RATIONALE. IF EXCLUDE APPLICABLE Veizi E, Hayek S. Interventional therapies for chronic low back Exclude Systematic Literature pain. Neuromodulation. 2014 Oct;17 Suppl 2:31-45. doi: Review 10.1111/ner.12250. Li ZZ, Hou SX, Shang WL, Song KR, Wu WW. Evaluation of Include endoscopic dorsal ramus rhizotomy in managing facetogenic chronic low back pain. Clin Neurol Neurosurg. 2014 Nov;126:11-7. doi: 10.1016/j.clineuro.2014.08.014. Epub 2014 Aug 18. Kanchiku T, Imajo Y, Suzuki H, Yoshida Y, Nishida N, Include Taguchi T. Percutaneous radiofrequency facet joint denervation with monitoring of compound muscle action potential of the multifidus muscle group for treating chronic low back pain: a preliminary report. J Spinal Disord Tech. 2014 Oct;27(7):E262-7. doi: 10.1097/BSD.0000000000000107. Poetscher AW, Gentil AF, Lenza M, Ferretti M. Exclude Systematic Literature Radiofrequency denervation for facet joint low back pain: a Review systematic review. Spine (Phila Pa 1976). 2014 Jun 15;39(14):E842-9. doi: 10.1097/BRS.0000000000000337.

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Search #4

Query: (facet joint radiofrequency AND adverse events) OR (facet joint radiofrequency AND adverse effects) OR (facet joint rhizotomy AND adverse events) OR (facet joint rhizotomy AND adverse effects) NOT (facet joint rhizotomy AND effectiveness) NOT (facet joint radiofrequency AND safety)

Limits: English, Humans, Published since 15-JUN-2014

PubMed converted these search terms into the following: ((("zygapophyseal joint"[MeSH Terms] OR ("zygapophyseal"[All Fields] AND "joint"[All Fields]) OR "zygapophyseal joint"[All Fields] OR ("facet"[All Fields] AND "joint"[All Fields]) OR "facet joint"[All Fields]) AND radiofrequency[All Fields]) AND (adverse[All Fields] AND events[All Fields])) OR ((("zygapophyseal joint"[MeSH Terms] OR ("zygapophyseal"[All Fields] AND "joint"[All Fields]) OR "zygapophyseal joint"[All Fields] OR ("facet"[All Fields] AND "joint"[All Fields]) OR "facet joint"[All Fields]) AND radiofrequency[All Fields]) AND ("adverse effects"[Subheading] OR ("adverse"[All Fields] AND "effects"[All Fields]) OR "adverse effects"[All Fields])) OR ((("zygapophyseal joint"[MeSH Terms] OR ("zygapophyseal"[All Fields] AND "joint"[All Fields]) OR "zygapophyseal joint"[All Fields] OR ("facet"[All Fields] AND "joint"[All Fields]) OR "facet joint"[All Fields]) AND ("rhizotomy"[MeSH Terms] OR "rhizotomy"[All Fields])) AND (adverse[All Fields] AND events[All Fields])) OR ((("zygapophyseal joint"[MeSH Terms] OR ("zygapophyseal"[All Fields] AND "joint"[All Fields]) OR "zygapophyseal joint"[All Fields] OR ("facet"[All Fields] AND "joint"[All Fields]) OR "facet joint"[All Fields]) AND ("rhizotomy"[MeSH Terms] OR "rhizotomy"[All Fields])) AND ("adverse effects"[Subheading] OR ("adverse"[All Fields] AND "effects"[All Fields]) OR "adverse effects"[All Fields])) NOT ((("zygapophyseal joint"[MeSH Terms] OR ("zygapophyseal"[All Fields] AND "joint"[All Fields]) OR "zygapophyseal joint"[All Fields] OR ("facet"[All Fields] AND "joint"[All Fields]) OR "facet joint"[All Fields]) AND ("rhizotomy"[MeSH Terms] OR "rhizotomy"[All Fields])) AND effectiveness[All Fields]) NOT ((("zygapophyseal joint"[MeSH Terms] OR ("zygapophyseal"[All Fields] AND "joint"[All Fields]) OR "zygapophyseal joint"[All Fields] OR ("facet"[All Fields] AND "joint"[All Fields]) OR "facet joint"[All Fields]) AND radiofrequency[All Fields]) AND ("safety"[MeSH Terms] OR "safety"[All Fields])) AND (("2014/06/15"[PDAT] : "2016/04/18"[PDAT]) AND "humans"[MeSH Terms] AND English[lang])

Results: (n=5)

Table 5: Search #2 Inclusion/Exclusion Summary REFERENCE INCLUDE EXCLUDED OR RATIONALE. IF EXCLUDE APPLICABLE Cohen SP, Moon JY, Brummett CM, White RL, Larkin TM. Exclude Outcomes not Medial Branch Blocks or Intra-Articular Injections as a applicable; diagnosis Prognostic Tool Before Lumbar Facet Radiofrequency prior to RF ablation Denervation: A Multicenter, Case-Control Study. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):376-83. doi: 10.1097/AAP.0000000000000229. Barbieri M, Bellini M. Radiofrequency neurotomy for the Include treatment of chronic pain: interference with implantable medical devices. Anaesthesiol Intensive Ther. 2014 Jul- Aug;46(3):162-5. doi: 10.5603/AIT.2014.0029.

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REFERENCE INCLUDE EXCLUDED OR RATIONALE. IF EXCLUDE APPLICABLE Walega D, Roussis C. Third-degree burn from cooled Include radiofrequency ablation of medial branch nerves for treatment of thoracic facet syndrome. Pain Pract. 2014 Jul;14(6):e154-8. doi: 10.1111/papr.12222. Epub 2014 May 2. Poetscher AW, Gentil AF, Lenza M, Ferretti M. Exclude Systematic Radiofrequency denervation for facet joint low back pain: a Literature Review systematic review. Spine (Phila Pa 1976). 2014 Jun 15;39(14):E842-9. doi: 10.1097/BRS.0000000000000337. Stegemöller EL, Roper J, Hass CJ, Kennedy DJ. Changes in Include gait kinematics and lower back muscle activity post- radiofrequency denervation of the zygapophysial joint: a case study. Spine J. 2015 Jun 1;15(6):e21-7. doi: 10.1016/j.spinee.2013.06.061. Epub 2013 Oct 10.

Search #5

Query: (minimally invasive treatment spinal stenosis OR minimally invasive lumbar decompression OR flexible microblade shaving OR minimally invasive facet joint treatment OR spinal decompression) AND (effectiveness OR adverse event OR safety) NOT fusion

Limits: English, Humans, Published since 15-JUN-2014

PubMed converted these search terms into the following: ((minimally[All Fields] AND invasive[All Fields] AND ("therapy"[Subheading] OR "therapy"[All Fields] OR "treatment"[All Fields] OR "therapeutics"[MeSH Terms] OR "therapeutics"[All Fields]) AND ("spinal stenosis"[MeSH Terms] OR ("spinal"[All Fields] AND "stenosis"[All Fields]) OR "spinal stenosis"[All Fields])) OR (minimally[All Fields] AND invasive[All Fields] AND ("lumbosacral region"[MeSH Terms] OR ("lumbosacral"[All Fields] AND "region"[All Fields]) OR "lumbosacral region"[All Fields] OR "lumbar"[All Fields]) AND ("decompression"[MeSH Terms] OR "decompression"[All Fields])) OR (flexible[All Fields] AND microblade[All Fields] AND shaving[All Fields]) OR (minimally[All Fields] AND invasive[All Fields] AND ("zygapophyseal joint"[MeSH Terms] OR ("zygapophyseal"[All Fields] AND "joint"[All Fields]) OR "zygapophyseal joint"[All Fields] OR ("facet"[All Fields] AND "joint"[All Fields]) OR "facet joint"[All Fields]) AND ("therapy"[Subheading] OR "therapy"[All Fields] OR "treatment"[All Fields] OR "therapeutics"[MeSH Terms] OR "therapeutics"[All Fields])) OR (spinal[All Fields] AND ("decompression"[MeSH Terms] OR "decompression"[All Fields]))) AND (effectiveness[All Fields] OR (adverse[All Fields] AND event[All Fields]) OR ("safety"[MeSH Terms] OR "safety"[All Fields])) NOT ("Nucl Eng Des/Fusion"[Journal] OR "fusion"[All Fields] OR "FUSION"[Journal] OR "fusion"[All Fields]) AND (("2004/06/15"[PDAT] : "2016/04/18"[PDAT]) AND "humans"[MeSH Terms] AND English[lang])

Results: (n=197)

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Table 6: Search #3 Inclusion/Exclusion Summary REFERENCE INCLUDE EXCLUDED OR RATIONALE. IF EXCLUDE APPLICABLE George R, Jeba J, Ramkumar G, Chacko AG, Tharyan P. Exclude Systematic Interventions for the treatment of metastatic extradural spinal Literature Review cord compression in adults. Cochrane Database Syst Rev. 2015 Sep 4;9:CD006716. doi: 10.1002/14651858.CD006716.pub3. Benyamin RM, Staats PS. MiDAS ENCORE: Randomized Include Controlled Study Design and Protocol. Pain Physician. 2015 Jul-Aug;18(4):307-16. Tremolizzo L, Malpieri M, Ferrarese C, Appollonio I. Inner-ear Exclude Not applicable decompression sickness: 'hubble-bubble' without brain trouble? patient population; Diving Hyperb Med. 2015 Jun;45(2):135-6. inner-ear decompression sickness He M, Lovell J, Ng BL, Spillane J, Speakman D, Henderson Exclude Intervention and MA, Shackleton M, Gyorki DE. Post-operative survival patient population following metastasectomy for patients receiving BRAF not applicable; study inhibitor therapy is associated with duration of pre-operative reports BRAF treatment and elective indication. J Surg Oncol. 2015 inhibitor in Jun;111(8):980-4. doi: 10.1002/jso.23938. Epub 2015 Jun 17. mastastasectomy patients Wang H, Sribastav SS, Ye F, Yang C, Wang J, Liu H, Zheng Exclude Systematic Z. Comparison of Percutaneous Vertebroplasty and Balloon Literature Review Kyphoplasty for the Treatment of Single Level Vertebral Compression Fractures: A Meta-analysis of the Literature. Pain Physician. 2015 May-Jun;18(3):209-22. Yang Z, Yang Y, Zhang Y, Zhang Z, Chen Y, Shen Y, Han L, Exclude Systematic Xu D, Sun H. Minimal access versus open spinal surgery in Literature Review treating painful spine metastasis: a systematic review. World J Surg Oncol. 2015 Feb 21;13:68. doi: 10.1186/s12957-015- 0468-y. Ji GY, Oh CH, Moon B, Choi SH, Shin DA, Yoon YS, Kim Include KN. Efficacy of percutaneous epidural neuroplasty does not correlate with dural sac cross-sectional area in single level disc disease. Yonsei Med J. 2015 May;56(3):691-7. doi: 10.3349/ymj.2015.56.3.691. Nerland US, Jakola AS, Solheim O, Weber C, Rao V, Lønne Include G, Solberg TK, Salvesen Ø, Carlsen SM, Nygaard ØP, Gulati S. Minimally invasive decompression versus open laminectomy for central stenosis of the lumbar spine: pragmatic comparative effectiveness study. BMJ. 2015 Apr 1;350:h1603. doi: 10.1136/bmj.h1603.

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REFERENCE INCLUDE EXCLUDED OR RATIONALE. IF EXCLUDE APPLICABLE Evins AI, Banu MA, Njoku I Jr, Elowitz EH, Härtl R, Bernado Exclude Cadaveric study A, Hofstetter CP. Endoscopic lumbar foraminotomy. J Clin Neurosci. 2015 Apr;22(4):730-4. doi: 10.1016/j.jocn.2014.10.025. Epub 2015 Mar 2. Brouwer PA, Brand R, van den Akker-van Marle ME, Jacobs Exclude Intervention not WC, Schenk B, van den Berg-Huijsmans AA, Koes BW, van applicable; laser disc Buchem MA, Arts MP, Peul WC. Percutaneous laser disc decompression decompression versus conventional microdiscectomy in sciatica: a randomized controlled trial. Spine J. 2015 May 1;15(5):857-65. doi: 10.1016/j.spinee.2015.01.020. Epub 2015 Jan 20. Lønne G, Johnsen LG, Aas E, Lydersen S, Andresen H, Exclude Intervention not Rønning R, Nygaard ØP. Comparing cost-effectiveness of X- applicable; Stop with minimally invasive decompression in lumbar spinal implantable spacer stenosis: a randomized controlled trial. Spine (Phila Pa 1976). 2015 Apr 15;40(8):514-20. doi: 10.1097/BRS.0000000000000798. Urban-Baeza A, Zárate-Kalfópulos B, Romero-Vargas S, Obil- Exclude Outcomes measured Chavarría C, Brenes-Rojas L, Reyes-Sánchez A. Influence of were in regards to depression symptoms on patient expectations and clinical depression outcomes in the surgical management of spinal stenosis. J Neurosurg Spine. 2015 Jan;22(1):75-9. doi: 10.3171/2014.10.SPINE131106. Floeth FW, Herdmann J, Rhee S, Turowski B, Krajewski K, Exclude Intervention not Steiger HJ, Eicker SO. Open microsurgical tumor excavation applicable; cement and vertebroplasty for metastatic destruction of the second injection and cervical vertebra-outcome in seven cases. Spine J. 2014 Dec vertebroplasty 1;14(12):3030-7. doi: 10.1016/j.spinee.2014.09.018. Xu ZW, Lun DX. Surgical management of multilevel cervical Exclude Not applicable spinal stenosis and spinal cord injury complicated by cervical patient population; spine fracture. J Orthop Surg Res. 2014 Aug 22;9:77. doi: spinal cord injury 10.1186/s13018-014-0077-4. Martinez-del-Campo E, Rangel-Castilla L, Soriano-Baron H, Exclude No intervention and Theodore N. Magnetic resonance imaging in lumbar gunshot not applicable wounds: an absolute contraindication? Neurosurg Focus. patient population; 2014;37(1):E13. doi: 10.3171/2014.7.FOCUS1496. study reports the use of MRI in lumbar gunshot wounds Fehlings MG, Nater A, Holmer H. Cost-effectiveness of Exclude Systematic surgery in the management of metastatic epidural spinal cord Literature Review compression: a systematic review. Spine (Phila Pa 1976). 2014 Oct 15;39(22 Suppl 1):S99-S105. doi:

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REFERENCE INCLUDE EXCLUDED OR RATIONALE. IF EXCLUDE APPLICABLE 10.1097/BRS.0000000000000525. Puzzilli F, Gazzeri R, Galarza M, Neroni M, Panagiotopoulos Exclude Intervention not K, Bolognini A, Callovini G, Agrillo U, Alfieri A. Interspinous applicable; spacer decompression (X-STOP) for lumbar spinal stenosis and implantable spacer degenerative disk disease: a multicenter study with a minimum 3-year follow-up. Clin Neurol Neurosurg. 2014 Sep;124:166- 74. doi: 10.1016/j.clineuro.2014.07.004. Epub 2014 Jul 14. Hong P, Liu Y, Li H. Comparison of the efficacy and safety Exclude Systematic between interspinous process distraction device and open Literature Review decompression surgery in treating lumbar spinal stenosis: a meta analysis. J Invest Surg. 2015 Feb;28(1):40-9. doi: 10.3109/08941939.2014.932474. Epub 2014 Jul 15. Yang H, Lu X, Yuan W, Wang X, Chen D, Zhao D. Artificial Exclude Not applicable disk replacement in the treatment of degenerative cervical disk outcomes measured; disorder: a 30-year follow-up study. Spine (Phila Pa 1976). study reports range 2014 Sep 1;39(19):1564-71. doi: of motion, 10.1097/BRS.0000000000000484. radiographical outcomes of surgery, and adjacent segmental changes Gazzeri R, Galarza M, Alfieri A. Controversies about Exclude Intervention not interspinous process devices in the treatment of degenerative applicable; lumbar spine diseases: past, present, and future. Biomed Res implantable spacer Int. 2014;2014:975052. doi: 10.1155/2014/975052. Epub 2014 Apr 13. Alexandre A, Alexandre AM, De Pretto M, Corò L, Saggini R. Exclude Intervention not One-year follow-up of a series of 100 patients treated for applicable; lumbar spinal canal stenosis by means of HeliFix interspinous implantable spacer process decompression device. Biomed Res Int. 2014;2014:176936. doi: 10.1155/2014/176936. Epub 2014 Apr 15. McGregor AH, Probyn K, Cro S, Doré CJ, Burton AK, Exclude Systematic Balagué F, Pincus T, Fairbank J. Rehabilitation following Literature Review surgery for lumbar spinal stenosis. A Cochrane review. Spine (Phila Pa 1976). 2014 Jun 1;39(13):1044-54. doi: 10.1097/BRS.0000000000000355. van Geest S, Kuijper B, Oterdoom M, van den Hout W, Brand Exclude Outcomes not yet R, Stijnen T, Assendelft P, Koes B, Jacobs W, Peul W, reported Vleggeert-Lankamp C. CASINO: surgical or nonsurgical treatment for cervical radiculopathy, a randomised controlled trial. BMC Musculoskelet Disord. 2014 Apr 14;15:129. doi: 10.1186/1471-2474-15-129.

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REFERENCE INCLUDE EXCLUDED OR RATIONALE. IF EXCLUDE APPLICABLE Kelekis A, Filippiadis DK. Percutaneous treatment of cervical Article Unable to make I/E and lumbar herniated disc. Eur J Radiol. 2015 May;84(5):771- needed determination from 6. doi: 10.1016/j.ejrad.2014.02.023. Epub 2014 Mar 3. abstract alone Nerland US, Jakola AS, Solheim O, Weber C, Rao V, Lønne Exclude Outcomes not yet G, Solberg TK, Salvesen O, Carlsen SM, Nygaard OP, Gulati reported S. Comparative effectiveness of microdecompression and laminectomy for central lumbar spinal stenosis: study protocol for an observational study. BMJ Open. 2014 Mar 20;4(3):e004651. doi: 10.1136/bmjopen-2013-004651. Tibiletti M, Kregar Velikonja N, Urban JP, Fairbank JC. Disc Exclude Intervention not cell therapies: critical issues. Eur Spine J. 2014 Jun;23 Suppl applicable; cell- 3:S375-84. doi: 10.1007/s00586-014-3177-2. Epub 2014 Feb 8. based therapy Nakashima H, Kato F, Yukawa Y, Imagama S, Ito K, Machino Exclude M, Ishiguro N. Comparative effectiveness of open-door laminoplasty versus French-door laminoplasty in cervical compressive myelopathy. Spine (Phila Pa 1976). 2014 Apr 15;39(8):642-7. doi: 10.1097/BRS.0000000000000252. Patil CG, Sarmiento JM, Ugiliweneza B, Mukherjee D, Nuño Exclude Intervention not M, Liu JC, Walia S, Lad SP, Boakye M. Interspinous device applicable; versus laminectomy for lumbar spinal stenosis: a comparative implantable spacer effectiveness study. Spine J. 2014 Aug 1;14(8):1484-92. doi: 10.1016/j.spinee.2013.08.053. Epub 2013 Oct 4. Park YK, Lee DY, Hur JW, Moon HJ. Delayed hinge fracture Include after plate-augmented, cervical open-door laminoplasty and its clinical significance. Spine J. 2014 Jul 1;14(7):1205-13. doi: 10.1016/j.spinee.2013.08.012. Epub 2013 Oct 29. Jiang L, Liu XG, Yuan HS, Yang SM, Li J, Wei F, Liu C, Exclude Systematic Dang L, Liu ZJ. Diagnosis and treatment of vertebral Literature Review hemangiomas with neurologic deficit: a report of 29 cases and literature review. Spine J. 2014 Jun 1;14(6):944-54. doi: 10.1016/j.spinee.2013.07.450. Epub 2013 Oct 8. Lindsey RW. Surgery for cervical spondylotic myelopathy: Exclude Commentary right evidence or evidence right now?: commentary on an article by Michael G. Fehlings, MD, PhD, et al.: "Efficacy and safety of surgical decompression in patients with cervical spondylotic myelopathy. Results of the AOSpine North America prospective multi-center study". J Bone Joint Surg Am. 2013 Sep 18;95(18):e138. doi: 10.2106/JBJS.M.01030. Fehlings MG, Wilson JR, Kopjar B, Yoon ST, Arnold PM, Exclude Excluded; fusion Massicotte EM, Vaccaro AR, Brodke DS, Shaffrey CI, Smith with instrumentation JS, Woodard EJ, Banco RJ, Chapman JR, Janssen ME, Bono performed after CM, Sasso RC, Dekutoski MB, Gokaslan ZL. Efficacy and

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REFERENCE INCLUDE EXCLUDED OR RATIONALE. IF EXCLUDE APPLICABLE safety of surgical decompression in patients with cervical decompression spondylotic myelopathy: results of the AOSpine North America prospective multi-center study. J Bone Joint Surg Am. 2013 Sep 18;95(18):1651-8. doi: 10.2106/JBJS.L.00589. Lawrence BD, Jacobs WB, Norvell DC, Hermsmeyer JT, Exclude Systematic Chapman JR, Brodke DS. Anterior versus posterior approach Literature Review for treatment of cervical spondylotic myelopathy: a systematic review. Spine (Phila Pa 1976). 2013 Oct 15;38(22 Suppl 1):S173-82. doi: 10.1097/BRS.0b013e3182a7eaaf. Fehlings MG, Wilson JR, Karadimas SK, Arnold PM, Kopjar Exclude Outcomes not yet B. Clinical evaluation of a neuroprotective drug in patients with reported cervical spondylotic myelopathy undergoing surgical treatment: design and rationale for the CSM-Protect trial. Spine (Phila Pa 1976). 2013 Oct 15;38(22 Suppl 1):S68-75. doi: 10.1097/BRS.0b013e3182a7e9b0. Kato S, Hozumi T, Takaki Y, Yamakawa K, Goto T, Kondo T. Exclude Not applicable Optimal schedule of preoperative embolization for spinal outcomes measured; metastasis surgery. Spine (Phila Pa 1976). 2013 Oct timing of surgery 15;38(22):1964-9. doi: 10.1097/BRS.0b013e3182a46576. after presurgery embolization Lei W, Ehmsen RJ, Chiacchierini RP, Krelle JL, diZerega GS. Exclude Intervention not Reduction of Leg Pain by Oxiplex Gel After Lumbar applicable; adhesion Discectomy in Patients With Predominant Leg Pain and prevention gel Elevated Levels of Lower Back Pain: A Prospective, Randomized, Blinded, Multicenter Clinical Study. J Spinal Disord Tech. 2015 Oct;28(8):301-7. doi: 10.1097/BSD.0b013e3182a35590. Joaquim AF, Ghizoni E, Tedeschi H, Pereira EB, Giacomini Exclude Systematic LA. Stereotactic radiosurgery for spinal metastases: a literature Literature Review review. Einstein (Sao Paulo). 2013 Apr-Jun;11(2):247-55. Review. English, Portuguese. Lee JH, Lee SH. Clinical effectiveness of percutaneous Exclude Not applicable adhesiolysis and predictive factors of treatment efficacy in patient population; patients with lumbosacral spinal stenosis. Pain Med. 2013 adhesions in the Oct;14(10):1497-504. doi: 10.1111/pme.12180. Epub 2013 Jun sacral region 26. Parker SL, Godil SS, Zuckerman SL, Mendenhall SK, Wells Exclude Not applicable JA, Shau DN, McGirt MJ. Comprehensive assessment of 1- patient population; year outcomes and determination of minimum clinically suboccipital important difference in pain, disability, and quality of life after craniectomy suboccipital decompression for Chiari malformation I in adults. Neurosurgery. 2013 Oct;73(4):569-81; discussion 581. doi:

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REFERENCE INCLUDE EXCLUDED OR RATIONALE. IF EXCLUDE APPLICABLE 10.1227/NEU.0000000000000032. Huang AP, Chen CM, Lai HS, Chou CC, Lu DC, Kuo LT, Exclude Outcomes not yet Chuang HY, Tsai JC. Posterior transthecal approach for repair reported of cauda equina fibers and ventral dural laceration in lumbar burst fracture: a novel surgical technique. Spine (Phila Pa 1976). 2013 Aug 15;38(18):E1156-61. doi: 10.1097/BRS.0b013e31829e0d6c. Beynon R, Hawkins J, Laing R, Higgins N, Whiting P, Exclude Intervention not Jameson C, Sterne JA, Vergara P, Hollingworth W. The applicable; injectable diagnostic utility and cost-effectiveness of selective nerve root anaesthetics blocks in patients considered for lumbar decompression surgery: a systematic review and economic model. Health Technol Assess. 2013 May;17(19):1-88, v-vi. doi: 10.3310/hta17190. Mogilner AY. Quality and cost-effectiveness of interventional Exclude Commentary pain procedures: minimally invasive lumbar decompression (MILD) as a paradigm? Pain Med. 2013 May;14(5):613-4. doi: 10.1111/pme.12140. Epub 2013 May 10. Manchikanti L, Falco FJ, Benyamin RM, Caraway DL, Deer Exclude Systematic TR, Singh V, Hameed H, Hirsch JA. An update of the Literature Review systematic assessment of mechanical lumbar disc decompression with nucleoplasty. Pain Physician. 2013 Apr;16(2 Suppl):SE25-54. Manchikanti L, Singh V, Calodney AK, Helm S 2nd, Deer TR, Exclude Systematic Benyamin RM, Falco FJ, Hirsch JA. Percutaneous lumbar Literature Review mechanical disc decompression utilizing Dekompressor®: an update of current evidence. Pain Physician. 2013 Apr;16(2 Suppl):SE1-24. Beyer F, Yagdiran A, Neu P, Kaulhausen T, Eysel P, Sobottke Exclude Intervention not R. Percutaneous interspinous spacer versus open applicable; decompression: a 2-year follow-up of clinical outcome and implantable spacer quality of life. Eur Spine J. 2013 Sep;22(9):2015-21. doi: 10.1007/s00586-013-2790-9. Epub 2013 Apr 27. Papadopoulos EC, Boachie-Adjei O, Hess WF, Sanchez Perez- Exclude Not applicable Grueso FJ, Pellisé F, Gupta M, Lonner B, Paonessa K, Faloon outcomes measured; M, Cunningham ME, Kim HJ, Mendelow M, Sacramento C, radiological Yazici M; Foundation of Orthopedics and Complex Spine, assessment of New York, NY. Early outcomes and complications of posterior deformity correction vertebral column resection. Spine J. 2015 May 1;15(5):983-91. doi: 10.1016/j.spinee.2013.03.023. Bydon M, Xu R, Papademetriou K, Sciubba DM, Wolinsky JP, Include Witham TF, Gokaslan ZL, Jallo G, Bydon A. Safety of spinal

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REFERENCE INCLUDE EXCLUDED OR RATIONALE. IF EXCLUDE APPLICABLE decompression using an ultrasonic bone curette compared with a high-speed drill: outcomes in 337 patients. J Neurosurg Spine. 2013 Jun;18(6):627-33. doi: 10.3171/2013.2.SPINE12879. Epub 2013 Apr 5. Gao R, Yuan W, Yang L, Shi G, Jia L. Clinical features and Include surgical outcomes of patients with thoracic myelopathy caused by multilevel ossification of the ligamentum flavum. Spine J. 2013 Sep;13(9):1032-8. doi: 10.1016/j.spinee.2013.02.034. Racz GB, Heavner JE, Bosscher H, Helm S 2nd. The MILD Exclude Commentary procedure. Pain Pract. 2013 Sep;13(7):594-6. doi: 10.1111/papr.12051. Epub 2013 Mar 20. Babu R, Owens TR, Thomas S, Karikari IO, Grunch BH, Exclude Intervention not Moreno JR, Lad SP, Bagley CA. Timing of tracheostomy after applicable; spinal anterior cervical spine fixation. J Trauma Acute Care Surg. fixation 2013 Apr;74(4):961-6. doi: 10.1097/TA.0b013e3182826ea4. Chopko BW. Long-term results of percutaneous lumbar Include decompression for LSS: two-year outcomes. Clin J Pain. 2013 Nov;29(11):939-43. doi: 10.1097/AJP.0b013e31827fb803. Ebata S, Sato H, Orii H, Sasaki S, Ohba T, Haro H. Risk Include management in posterior spinal endoscopic surgery in lumbar diseases. J Orthop Sci. 2013 May;18(3):369-73. doi: 10.1007/s00776-013-0360-y. Epub 2013 Feb 19. Ha KY, Kim YH, Yoo TW. Intraoperative radiofrequency Include Case Review; will ablation for metastatic spine disease: report of 4 cases and only be used for review. Eur J Orthop Surg Traumatol. 2013 Nov;23 Suppl labelling 2:S129-34. doi: 10.1007/s00590-012-1048-2. Epub 2012 Jul considerations 12. Bartels RH, Hosman AJ, van de Meent H, Hofmeijer J, Vos Exclude Intervention not PE, Slooff WB, Öner FC, Coppes MH, Peul WC, Verbeek AL. applicable; spinal Design of COSMIC: a randomized, multi-centre controlled trial fixation comparing conservative or early surgical management of incomplete cervical cord syndrome without spinal instability. BMC Musculoskelet Disord. 2013 Jan 31;14:52. doi: 10.1186/1471-2474-14-52. Park CH, Lee SH. Effectiveness of percutaneous Exclude Intervention not transforaminal adhesiolysis in patients with lumbar applicable; injectable neuroforaminal spinal stenosis. Pain Physician. 2013 compound for Jan;16(1):E37-43. adhesion lysis Gilles R, Couvreur T, Dammous S. Ultrasonic orthognathic Exclude Not applicable surgery: enhancements to established osteotomies. Int J Oral patient population; Maxillofac Surg. 2013 Aug;42(8):981-7. doi: intervention used in

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REFERENCE INCLUDE EXCLUDED OR RATIONALE. IF EXCLUDE APPLICABLE Orthop Trauma Surg. 2010 Sep;130(9):1103-10. doi: ablation 10.1007/s00402-009-0983-9. Epub 2009 Oct 24. Lui TH, Chan KB, Chan LK. Portal safety and efficacy of Exclude Cadaveric study anterior subtalar arthroscopy: a cadaveric study. Knee Surg Sports Traumatol Arthrosc. 2010 Feb;18(2):233-7. doi: 10.1007/s00167-009-0917-7. Epub 2009 Sep 25. Kutlay M, Topuz K, Colak A, Simşek H, Cetinkal A, Demircan Include MN. Management of disc herniations with bi-radicular symptoms via combined lateral and interlaminar approach. Neurosurg Rev. 2010 Jan;33(1):97-105. doi: 10.1007/s10143- 009-0218-0. Gempp E, Blatteau JE. Risk factors and treatment outcome in Exclude Not applicable scuba divers with spinal cord decompression sickness. J Crit patient population; Care. 2010 Jun;25(2):236-42. doi: 10.1016/j.jcrc.2009.05.011. spinal cord Epub 2009 Aug 13. decompression sickness Hardman J, Graf O, Kouloumberis PE, Gao WH, Chan M, Include Roitberg BZ. Clinical and functional outcomes of laminoplasty and laminectomy. Neurol Res. 2010 May;32(4):416-20. doi: 10.1179/174313209X459084. Epub 2009 Jul 8. Tederko P, Krasuski M, Kiwerski J, Nyka I, Białoszewski D. Exclude Not applicable Strategies for neuroprotection following spinal cord injury. patient population; Ortop Traumatol Rehabil. 2009 Mar-Apr;11(2):103-10. spinal cord injury Singh V, Benyamin RM, Datta S, Falco FJ, Helm S 2nd, Exclude Systematic Manchikanti L. Systematic review of percutaneous lumbar Literature Review mechanical disc decompression utilizing Dekompressor. Pain Physician. 2009 May-Jun;12(3):589-99. Singh V, Manchikanti L, Benyamin RM, Helm S, Hirsch JA. Exclude Systematic Percutaneous lumbar laser disc decompression: a systematic Literature Review review of current evidence. Pain Physician. 2009 May- Jun;12(3):573-88. Jordan J, Konstantinou K, O'Dowd J. Herniated lumbar disc. Exclude Systematic BMJ Clin Evid. 2009 Mar 26;2009. pii: 1118. Literature Review Brouwer PA, Peul WC, Brand R, Arts MP, Koes BW, van den Exclude Intervention not Berg AA, van Buchem MA. Effectiveness of percutaneous applicable; laser laser disc decompression versus conventional open discectomy in the treatment of lumbar disc herniation; design of a prospective randomized controlled trial. BMC Musculoskelet Disord. 2009 May 13;10:49. doi: 10.1186/1471-2474-10-49. Weber P, Vogel T, Bitterling H, Utzschneider S, von Schulze Exclude Intervention not

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REFERENCE INCLUDE EXCLUDED OR RATIONALE. IF EXCLUDE APPLICABLE Pellengahr C, Birkenmaier C. Spinal cord infarction after applicable; spinal operative stabilisation of the thoracic spine in a patient with stabilization tuberculous spondylodiscitis and sickle cell trait. Spine (Phila Pa 1976). 2009 Apr 15;34(8):E294-7. doi: 10.1097/BRS.0b013e3181970c2f. Zhang JW, Xiao BP, Xu RM, Zhao LJ, Ma WH, Ruan YP. Include Analysis of safety and effect of reconstructing anterior and middle columns by single posterior approach in treating lumbar burst fractures. Chin J Traumatol. 2009 Apr;12(2):107-12. Kwon BK, Curt A, Belanger LM, Bernardo A, Chan D, Markez Exclude Not applicable JA, Gorelik S, Slobogean GP, Umedaly H, Giffin M, Nikolakis patient population; MA, Street J, Boyd MC, Paquette S, Fisher CG, Dvorak MF. spinal cord injury Intrathecal pressure monitoring and cerebrospinal fluid drainage in acute spinal cord injury: a prospective randomized trial. J Neurosurg Spine. 2009 Mar;10(3):181-93. doi: 10.3171/2008.10.SPINE08217. Pao JL, Chen WC, Chen PQ. Clinical outcomes of Include microendoscopic decompressive laminotomy for degenerative lumbar spinal stenosis. Eur Spine J. 2009 May;18(5):672-8. doi: 10.1007/s00586-009-0903-2. Epub 2009 Feb 24. Chen L, Yang H, Yang T, Xu Y, Bao Z, Tang T. Effectiveness Exclude Not applicable of surgical treatment for traumatic central cord syndrome. J patient population; Neurosurg Spine. 2009 Jan;10(1):3-8. doi: traumatic spinal cord 10.3171/2008.9.SPI0822. injury Gempp E, Blatteau JE, Stephant E, Pontier JM, Constantin P, Exclude Not applicable Pény C. MRI findings and clinical outcome in 45 divers with patient population; spinal cord decompression sickness. Aviat Space Environ Med. spinal cord 2008 Dec;79(12):1112-6. decompression sickness Heck CA, Brown CR, Richardson WJ. Venous Exclude Intervention not thromboembolism in spine surgery. J Am Acad Orthop Surg. applicable; 2008 Nov;16(11):656-64. thromboembolism prophylaxis George R, Jeba J, Ramkumar G, Chacko AG, Leng M, Tharyan Exclude Systematic P. Interventions for the treatment of metastatic extradural Literature Review spinal cord compression in adults. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD006716. doi: 10.1002/14651858.CD006716.pub2. Li J, Yan DL, Zhang ZH. Percutaneous cervical nucleoplasty in Include the treatment of cervical disc herniation. Eur Spine J. 2008 Dec;17(12):1664-9. doi: 10.1007/s00586-008-0786-7. Epub

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REFERENCE INCLUDE EXCLUDED OR RATIONALE. IF EXCLUDE APPLICABLE 2008 Oct 1. Allen TL, Tatli Y, Lutz GE. Fluoroscopic percutaneous lumbar Exclude Intervention not zygapophyseal joint cyst rupture: a clinical outcome study. applicable; cyst Spine J. 2009 May;9(5):387-95. doi: rupture 10.1016/j.spinee.2008.08.008. Epub 2008 Sep 21. Armin SS, Holly LT, Khoo LT. Minimally invasive Exclude Commentary decompression for lumbar stenosis and disc herniation. Neurosurg Focus. 2008;25(2):E11. doi: 10.3171/FOC/2008/25/8/E11. Idler C, Zucherman JF, Yerby S, Hsu KY, Hannibal M, Exclude Intervention not Kondrashov D. A novel technique of intra-spinous process applicable; injection of PMMA to augment the strength of an inter-spinous implantable spacer process device such as the X STOP. Spine (Phila Pa 1976). 2008 Feb 15;33(4):452-6. doi: 10.1097/BRS.0b013e318163e06d. Cavuşoğlu H, Türkmenoğlu O, Kaya RA, Tuncer C, Colak I, Include Sahin Y, Aydin Y. Efficacy of unilateral laminectomy for bilateral decompression in lumbar spinal stenosis. Turk Neurosurg. 2007 Apr;17(2):100-8. Frankel BM, Jones T, Wang C. Segmental Exclude Intervention not polymethylmethacrylate-augmented pedicle screw fixation in applicable; spinal patients with bone softening caused by osteoporosis and fixation metastatic tumor involvement: a clinical evaluation. Neurosurgery. 2007 Sep;61(3):531-7; discussion 537-8. Cavuşoğlu H, Kaya RA, Türkmenoglu ON, Tuncer C, Colak I, Include Aydin Y. Midterm outcome after unilateral approach for bilateral decompression of lumbar spinal stenosis: 5-year prospective study. Eur Spine J. 2007 Dec;16(12):2133-42. Epub 2007 Aug 22. White BD, Buxton N, Fitzgerald JJ. Anterior cervical Include foramenotomy for cervical radiculopathy. Br J Neurosurg. 2007 Aug;21(4):370-4. Messing-Jünger AM, Ibáñez J, Calbucci F, Choux M, Lena G, Exclude Intervention not Mohsenipour I, Van Calenbergh F. Effectiveness and handling applicable; artificial characteristics of a three-layer polymer dura substitute: a dura use prospective multicenter clinical study. J Neurosurg. 2006 Dec;105(6):853-8. Xu Y, Zhou X, Yu C, Cheng M, Dong Q, Qian Z. Exclude Intervention not Effectiveness of postural and instrumental reduction in the applicable; fracture treatment of thoracolumbar vertebra fracture. Int Orthop. 2008 reduction

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REFERENCE INCLUDE EXCLUDED OR RATIONALE. IF EXCLUDE APPLICABLE Jun;32(3):361-5. Epub 2007 Mar 1. Rosen DS, O'Toole JE, Eichholz KM, Hrubes M, Huo D, Include Sandhu FA, Fessler RG. Minimally invasive lumbar spinal decompression in the elderly: outcomes of 50 patients aged 75 years and older. Neurosurgery. 2007 Mar;60(3):503-9; discussion 509-10. Fessler RG, O'Toole JE, Eichholz KM, Perez-Cruet MJ. The Exclude Commentary development of minimally invasive spine surgery. Neurosurg Clin N Am. 2006 Oct;17(4):401-9. Darsaut TE, Ashforth R, Bhargava R, Broad R, Emery D, Exclude Intervention not Kortbeek F, Lambert R, Lavoie M, Mahood J, MacDowell I, applicable; MRI Fox RJ. A pilot study of magnetic resonance imaging-guided guided reduction of closed reduction of cervical spine fractures. Spine (Phila Pa fracture 1976). 2006 Aug 15;31(18):2085-90. Friess DM, Yoo JU. Intraoperative technique to define the safe Exclude Cadaveric study lateral limits of anterior cervical corpectomy: a cadaveric study. J Spinal Disord Tech. 2006 Aug;19(6):394-8. Schirmer CM, Malek AM, Kwan ES, Hoit DA, Weller SJ. Exclude Intervention not Preoperative embolization of hypervascular spinal metastases applicable; using percutaneous direct injection with n-butyl cyanoacrylate: thromboembolism technical case report. Neurosurgery. 2006 Aug;59(2):E431-2; prophylaxis author reply E431-2. Takeno K, Kobayashi S, Yonezawa T, Hayakawa K, Hachiya Exclude Intervention not Y, Uchida K, Negoro K, Timbihurira G, Baba H. Salvage applicable; laser operation for persistent low back pain and sciatica induced by percutaneous laser disc decompression performed at outside institution: correlation of magnetic resonance imaging and intraoperative and pathological findings. Photomed Laser Surg. 2006 Jun;24(3):414-23. Mangano FT, Menendez JA, Smyth MD, Leonard JR, Narayan Exclude Not applicable P, Park TS. Pediatric neurosurgical injuries associated with all- patient population; terrain vehicle accidents: a 10-year experience at St. Louis all-terrain vehicle Children's Hospital. J Neurosurg. 2006 Jul;105(1 Suppl):2-5. accidents Tafazal SI, Ng L, Sell P. Randomised placebo-controlled trial Exclude Intervention not on the effectiveness of nasal salmon calcitonin in the treatment applicable; nasal of lumbar spinal stenosis. Eur Spine J. 2007 Feb;16(2):207-12. salmon calcitonin Epub 2006 Jul 25. Oda I, Abumi K, Ito M, Kotani Y, Oya T, Hasegawa K, Exclude Intervention not Minami A. Palliative spinal reconstruction using cervical applicable; spinal pedicle screws for metastatic lesions of the spine: a fixation retrospective analysis of 32 cases. Spine (Phila Pa 1976). 2006

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REFERENCE INCLUDE EXCLUDED OR RATIONALE. IF EXCLUDE APPLICABLE Jun 1;31(13):1439-44. Lin SM, Tseng SH, Yang JC, Tu CC. Chimney sublaminar Include decompression for degenerative lumbar spinal stenosis. J Neurosurg Spine. 2006 May;4(5):359-64. Arts MP, Peul WC, Brand R, Koes BW, Thomeer RT. Cost- Exclude Outcomes not yet effectiveness of microendoscopic discectomy versus reported conventional open discectomy in the treatment of lumbar disc herniation: a prospective randomised controlled trial [ISRCTN51857546]. BMC Musculoskelet Disord. 2006 May 13;7:42. Lidar Z, Lifshutz J, Bhattacharjee S, Kurpad SN, Maiman DJ. Exclude Cadaveric study Minimally invasive, extracavitary approach for thoracic disc herniation: technical report and preliminary results. Spine J. 2006 Mar-Apr;6(2):157-63. Epub 2006 Feb 3. Tokuhashi Y, Matsuzaki H, Oda H, Uei H. Effectiveness of Exclude Not applicable posterior decompression for patients with ossification of the outcomes measured; posterior longitudinal ligament in the thoracic spine: usefulness radiological of the ossification-kyphosis angle on MRI. Spine (Phila Pa assessment of 1976). 2006 Jan 1;31(1):E26-30. decompression success Weiner BK. Interspinous process decompression system (X Exclude Intervention not STOP) device affords superior outcomes and equal safety to applicable; nonoperative therapy. Spine (Phila Pa 1976). 2005 Dec implantable spacer 15;30(24):2846-7. Thomé C, Zevgaridis D, Leheta O, Bäzner H, Pöckler- Include Schöniger C, Wöhrle J, Schmiedek P. Outcome after less- invasive decompression of lumbar spinal stenosis: a randomized comparison of unilateral laminotomy, bilateral laminotomy, and laminectomy. J Neurosurg Spine. 2005 Aug;3(2):129-41. Zhang J, Hirabayashi S, Saiki K, Sakai H. Effectiveness of Include multiple-level decompression in laminoplasty and simultaneous C1 laminectomy for patients with cervical myelopathy. Eur Spine J. 2006 Sep;15(9):1367-74. Epub 2005 Dec 21. Chi JH, Manley GT, Chou D. Pregnancy-related vertebral Exclude Not applicable hemangioma. Case report, review of the literature, and patient population; management algorithm. Neurosurg Focus. 2005 Sep pregnancy-related 15;19(3):E7. hemangioma Uribe J, Green BA, Vanni S, Moza K, Guest JD, Levi AD. Exclude Not applicable Acute traumatic central cord syndrome--experience using patient population; surgical decompression with open-door expansile cervical

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REFERENCE INCLUDE EXCLUDED OR RATIONALE. IF EXCLUDE APPLICABLE laminoplasty. Surg Neurol. 2005 Jun;63(6):505-10; discussion spinal cord injury 510. Nakagawa H, Kim SD, Mizuno J, Ohara Y, Ito K. Technical Include advantages of an ultrasonic bone curette in spinal surgery. J Neurosurg Spine. 2005 Apr;2(4):431-5. Gasbarrini A, Cappuccio M, Mirabile L, Bandiera S, Terzi S, Exclude Systematic Barbanti Bròdano G, Boriani S. Spinal metastases: treatment Literature Review evaluation algorithm. Eur Rev Med Pharmacol Sci. 2004 Nov- Dec;8(6):265-74. Galiano K, Obwegeser AA, Gabl MV, Bauer R, Twerdy K. Include Long-term outcome of laminectomy for spinal stenosis in octogenarians. Spine (Phila Pa 1976). 2005 Feb 1;30(3):332-5. Tassi GP. Preliminary Italian experience of lumbar spine Exclude Intervention not percutaneous laser disc decompression according to Choy's applicable; laser method. Photomed Laser Surg. 2004 Oct;22(5):439-41. McMillan MR, Patterson PA, Parker V. Percutaneous laser disc Exclude Intervention not decompression for the treatment of discogenic lumbar pain and applicable; laser sciatica: a preliminary report with 3-month follow-up in a general pain clinic population. Photomed Laser Surg. 2004 Oct;22(5):434-8. Choy DS. Percutaneous laser disc decompression: a 17-year Exclude Intervention not experience. Photomed Laser Surg. 2004 Oct;22(5):407-10. applicable; laser McLain RF, Kalfas I, Bell GR, Tetzlaff JE, Yoon HJ, Rana M. Exclude Not applicable Comparison of spinal and general anesthesia in lumbar outcomes measured; laminectomy surgery: a case-controlled analysis of 400 effect of different patients. J Neurosurg Spine. 2005 Jan;2(1):17-22. anesthesia in surgery Komagata M, Nishiyama M, Endo K, Ikegami H, Tanaka S, Include Imakiire A. Prophylaxis of C5 palsy after cervical expansive laminoplasty by bilateral partial foraminotomy. Spine J. 2004 Nov-Dec;4(6):650-5. Gaitanis IN, Hadjipavlou AG, Katonis PG, Tzermiadianos MN, Exclude Intervention not Pasku DS, Patwardhan AG. Balloon kyphoplasty for the applicable; balloon treatment of pathological vertebral compressive fractures. Eur kyphoplasty Spine J. 2005 Apr;14(3):250-60. Epub 2004 Oct 8. Locher S, Stadler KS, Boehlen T, Bouillon T, Leibundgut D, Exclude Not applicable Schumacher PM, Wymann R, Zbinden AM. A new closed-loop outcomes measured; control system for isoflurane using bispectral index different outperforms manual control. Anesthesiology. 2004 anesthesiology Sep;101(3):591-602. methods in spinal decompression

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REFERENCE INCLUDE EXCLUDED OR RATIONALE. IF EXCLUDE APPLICABLE Lee KS, Shim JJ, Doh JW, Yoon SM, Bae HG, Yun IG. Include Case Review; will Transient paraparesis after laminectomy in a patient with multi- only be used for level ossification of the spinal ligament. J Korean Med Sci. labelling 2004 Aug;19(4):624-6. considerations Hadjipavlou AG, Katonis PK, Gaitanis IN, Muffoletto AJ, Include Tzermiadianos MN, Crow W. Percutaneous transpedicular discectomy and drainage in pyogenic spondylodiscitis. Eur Spine J. 2004 Dec;13(8):707-13. Epub 2004 Jun 12.

Search #6 Query: (io-Flex OR rongeur OR spine shaver OR ultrasonic scalpel OR Sonopet) NOT fusion AND spine Limits: English, Humans PubMed converted these search terms into the following: (io-Flex[All Fields] OR rongeur[All Fields] OR (("spine"[MeSH Terms] OR "spine"[All Fields]) AND shaver[All Fields]) OR (("ultrasonography"[MeSH Terms] OR "ultrasonography"[All Fields] OR "ultrasonic"[All Fields] OR "ultrasonics"[MeSH Terms] OR "ultrasonics"[All Fields]) AND ("Scalpel"[Journal] OR "scalpel"[All Fields] OR "Scalpel (Brux)"[Journal] OR "scalpel"[All Fields])) OR Sonopet[All Fields]) NOT ("Nucl Eng Des/Fusion"[Journal] OR "fusion"[All Fields] OR "FUSION"[Journal] OR "fusion"[All Fields]) AND ("spine"[MeSH Terms] OR "spine"[All Fields]) AND ("humans"[MeSH Terms] AND English[lang]) Results: (n=53) Table 7: Search #4 Inclusion/Exclusion Summary REFERENCE INCLUDE EXCLUDED OR RATIONALE. IF EXCLUDE APPLICABLE Onen MR, Yuvruk E, Akay S, Naderi S. The Reliability of the Include Ultrasonic Bone Scalpel in Cervical Spondylotic Myelopathy: A Comparative Study of 46 Patients. World Neurosurg. 2015 Dec;84(6):1962-7. doi: 10.1016/j.wneu.2015.08.043. Epub 2015 Sep 3. Yamane K, Tanaka M, Sugimoto Y, Ichimura K, Ozaki T. Include Case Review; will Spinal metaplastic meningioma with osseous differentiation in only be used for the ventral thoracic spinal canal. Acta Med Okayama. labelling 2014;68(5):313-6. considerations Wu Q, Zhao YB, Sun ZH, Ni J, Wu YZ, Shao HH, Qu JW, Exclude Not applicable Huang XE. Clinical application of endoscopic inguinal lymph patient population; node resection after lipolysis and liposuction for vulvar cancer. vulvar cancer

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REFERENCE INCLUDE EXCLUDED OR RATIONALE. IF EXCLUDE APPLICABLE Asian Pac J Cancer Prev. 2013;14(12):7121-6. Uei H, Tokuhashi Y, Oshima M, Miyake Y. Vascular injury Include Case Review; will following microendoscopic lumbar discectomy treated with only be used for stent graft placement. J Neurosurg Spine. 2014 Jan;20(1):67-70. labelling doi: 10.3171/2013.9.SPINE13282. Epub 2013 Nov 1. considerations Al-Mahfoudh R, Qattan E, Ellenbogen JR, Wilby M, Barrett C, Include Pigott T. Applications of the ultrasonic bone cutter in spinal surgery--our preliminary experience. Br J Neurosurg. 2014 Jan;28(1):56-60. doi: 10.3109/02688697.2013.812182. Epub 2013 Jul 10. Hu X, Ohnmeiss DD, Lieberman IH. Use of an ultrasonic Include osteotome device in spine surgery: experience from the first 128 patients. Eur Spine J. 2013 Dec;22(12):2845-9. doi: 10.1007/s00586-013-2780-y. Epub 2013 Apr 16. Pribitkin E, Greywoode JD. Sonic rhinoplasty: innovative Exclude Not applicable applications. Facial Plast Surg. 2013 Apr;29(2):127-32. doi: patient population; 10.1055/s-0033-1341584. Epub 2013 Apr 5. rhinoplasty surgery Dickinson LD, Phelps J, Summa CD, Vanichkachorn JS, Include Jeshuran WR, Randall JB, Mimran RI, Mitchell M, Macenski MM, Lauryssen C. Facet-sparing decompression with a minimally invasive flexible microblade shaver: a prospective operative analysis. J Spinal Disord Tech. 2013 Dec;26(8):427- 36. doi: 10.1097/BSD.0b013e318290fc62. Vadalà G, Russo F, Pattappa G, Schiuma D, Peroglio M, Exclude Cadaveric Study Benneker LM, Grad S, Alini M, Denaro V. The transpedicular approach as an alternative route for intervertebral disc regeneration. Spine (Phila Pa 1976). 2013 Mar 15;38(6):E319- 24. doi: 10.1097/BRS.0b013e318285bc4a. Dezawa A, Mikami H, Sairyo K. Percutaneous endoscopic Include translaminar approach for herniated nucleus pulposus in the hidden zone of the lumbar spine. Asian J Endosc Surg. 2012 Nov;5(4):200-3. doi: 10.1111/j.1758-5910.2012.00142.x. Lauryssen C, Berven S, Mimran R, Summa C, Sheinberg M, Exclude Cadaveric Study Miller LE, Block JE. Facet-sparing lumbar decompression with a minimally invasive flexible MicroBlade Shaver® versus traditional decompression: quantitative radiographic assessment. Clin Interv Aging. 2012;7:257-66. doi: 10.2147/CIA.S32536. Epub 2012 Jul 20. Yip SL, Woo SB, Kwok TK, Mak KH. Nightmare of lumbar Include Case Review; will diskectomy: aorta laceration. Spine (Phila Pa 1976). 2011 Dec only be used for labelling

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REFERENCE INCLUDE EXCLUDED OR RATIONALE. IF EXCLUDE APPLICABLE 15;36(26):E1758-60. doi: 10.1097/BRS.0b013e3182194e1c. considerations Dezawa A, Sairyo K. New minimally invasive discectomy Include technique through the interlaminar space using a percutaneous endoscope. Asian J Endosc Surg. 2011 May;4(2):94-8. doi: 10.1111/j.1758-5910.2011.00072.x. Lauryssen C. Technical advances in minimally invasive Include surgery: direct decompression for lumbar spinal stenosis. Spine (Phila Pa 1976). 2010 Dec 15;35(26 Suppl):S287-93. doi: 10.1097/BRS.0b013e3182023268. Bydon A, Xu R, Conte JV, Gokaslan ZL, Brinker JA, Witham Include Case Review; will TF, Yassari R. Surgical mystery: where is the missing pituitary only be used for rongeur tip? Spine (Phila Pa 1976). 2010 Aug 1;35(17):E867- labelling 72. doi: 10.1097/BRS.0b013e3181d85bec. considerations Takaso M, Nakazawa T, Imura T, Okada T, Fukushima K, Include Ueno M, Saito W, Shintani R, Sakagami H, Takahashi K, Yamazaki M, Ohtori S, Kotani T. Less invasive and less technically demanding decompressive procedure for lumbar spinal stenosis--appropriate for general orthopaedic surgeons? Int Orthop. 2011 Jan;35(1):67-73. doi: 10.1007/s00264-010- 0986-8. Epub 2010 Mar 14. Podnar S. Cauda equina lesions as a complication of spinal Exclude Outcomes not surgery. Eur Spine J. 2010 Mar;19(3):451-7. doi: applicable; cauda 10.1007/s00586-009-1170-y. Epub 2009 Sep 21. equina lesions post spinal surgery Ponnusamy K, Chewning S, Mohr C. Robotic approaches to the Exclude Non-human study; posterior spine. Spine (Phila Pa 1976). 2009 Sep 1;34(19):2104- porcine 9. doi: 10.1097/BRS.0b013e3181b20212. Taylor JA, Maercks RA, Jones DC, Gordon CB. Endoscopically Exclude Cadaveric Study assisted Le Fort I osteotomy using an ultrasonic scalpel: a feasibility study in cadavers. J Oral Maxillofac Surg. 2009 Jul;67(7):1420-4. doi: 10.1016/j.joms.2008.12.058. Ghodadra N, Nho SJ, Verma NN, Reiff S, Piasecki DP, Exclude Not applicable Provencher MT, Romeo AA. Arthroscopic decompression of patient population; the suprascapular nerve at the spinoglenoid notch and suprascapular suprascapular notch through the subacromial space. Arthroscopy. 2009 Apr;25(4):439-45. doi: 10.1016/j.arthro.2008.10.024. Ito K, Ishizaka S, Sasaki T, Miyahara T, Horiuchi T, Sakai K, Include Shigeta H, Hongo K. Safe and minimally invasive laminoplastic laminotomy using an ultrasonic bone curette for spinal surgery: technical note. Surg Neurol. 2009 Nov;72(5):470-5; discussion

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REFERENCE INCLUDE EXCLUDED OR RATIONALE. IF EXCLUDE APPLICABLE 475. doi: 10.1016/j.surneu.2009.01.012. Epub 2009 Mar 27. Agrawal V. Arthroscopic decompression of a bony Exclude Not applicable suprascapular foramen. Arthroscopy. 2009 Mar;25(3):325-8. patient population; doi: 10.1016/j.arthro.2008.06.014. Epub 2008 Aug 28. suprascapular Maroon JC, El-Kadi M, Bost J. Pneumatic Kerrison rongeur: Include technical note. Surg Neurol. 2009 Apr;71(4):466-8. doi: 10.1016/j.surneu.2008.10.008. Epub 2009 Jan 14. Pflum FA, Selby RM, Vizzone JP. Arthroscopic anterior Include diskectomy of the cervical spine. Arthroscopy. 2008 May;24(5):612-4. doi: 10.1016/j.arthro.2007.08.002. Epub 2007 Nov 14. Cho KT, Im SH, Hong SK. Ureteral injury after inadvertent Include Case Review; will violation of the intertransverse space during posterior lumbar only be used for diskectomy: a case report. Surg Neurol. 2008 Feb;69(2):135-7. labelling doi: 10.1016/j.surneu.2007.01.072. considerations Kim K, Isu T, Morimoto D, Kominami S, Kobayashi S, Include Case Review; will Teramoto A. Anterior vertebral artery decompression with an only be used for ultrasonic bone curette to treat bow hunter's syndrome. Acta labelling Neurochir (Wien). 2008 Mar;150(3):301-3; discussion 303. doi: considerations 10.1007/s00701-008-1491-8. Epub 2008 Feb 4. Barber FA. Percutaneous arthroscopic release of the Exclude Not applicable suprascapular nerve. Arthroscopy. 2008 Feb;24(2):236.e1-4. patient population; doi: 10.1016/j.arthro.2007.05.004. suprascapular Forst L, Friedman L, Shapiro D. Carpal tunnel syndrome in Exclude Not applicable spine surgeons: a pilot study. Arch Environ Occup Health. 2006 patient population; Nov-Dec;61(6):259-62. carpal tunnel in surgeons Jeon SH, Lee SH, Choi WC. Iliac artery perforation following Include Case Review; will lumbar discectomy with microsurgical carbon dioxide laser: a only be used for report of a rare case and discussion on the treatment. Spine labelling (Phila Pa 1976). 2007 Feb 1;32(3):E124-5. considerations Kim K, Isu T, Matsumoto R, Isobe M, Kogure K. Surgical Include pitfalls of an ultrasonic bone curette (SONOPET) in spinal surgery. Neurosurgery. 2006 Oct;59(4 Suppl 2):ONS390-3; discussion ONS393. Ying C, Zhaoying Z, Ganghua Z. Effects of different tissue Exclude Non-human study loads on high power ultrasonic surgery scalpel. Ultrasound Med Biol. 2006 Mar;32(3):415-20. Nakase H, Matsuda R, Shin Y, Park YS, Sakaki T. The use of Include ultrasonic bone curettes in spinal surgery. Acta Neurochir

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REFERENCE INCLUDE EXCLUDED OR RATIONALE. IF EXCLUDE APPLICABLE (Wien). 2006 Feb;148(2):207-12; discussion 212-3. Epub 2005 Nov 28. Mizuno J, Nakagawa H, Song J, Matsuo N. Surgery for dural Include ossification in association with cervical ossification of the posterior longitudinal ligament via an anterior approach. Neurol India. 2005 Sep;53(3):354-7. Nakagawa H, Kim SD, Mizuno J, Ohara Y, Ito K. Technical Include advantages of an ultrasonic bone curette in spinal surgery. J Neurosurg Spine. 2005 Apr;2(4):431-5. Nord KD, Smith GB, Mauck BM. Arthroscopic biceps Exclude Not applicable tenodesis using suture anchors through the subclavian portal. patient population; Arthroscopy. 2005 Feb;21(2):248-52. rotator cuff surgery Humphreys SC, Eck JC, Hodges SD, Hagen J. Preliminary Exclude Technical Report experience with a new surgical treatment for dysphagia due to anterior cervical osteophytes. J Surg Orthop Adv. 2004 Summer;13(2):106-9. Satomi K, Ogawa J, Ishii Y, Hirabayashi K. Short-term Include complications and long-term results of expansive open-door laminoplasty for cervical stenotic myelopathy. Spine J. 2001 Jan-Feb;1(1):26-30. Frank EH, Martin J, Hsu FP. An endoscopic curved Kerrison Include rongeur for spinal stenosis surgery. Minim Invasive Neurosurg. 2002 Dec;45(4):254-6. Yücesoy K, Ozer E. Inverse laminoplasty for the treatment of Include lumbar spinal stenosis. Spine (Phila Pa 1976). 2002 Jul 1;27(13):E316-20. Sim E. A useful modification of the Kerrison rongeur. Spine Exclude Technical Report (Phila Pa 1976). 2002 Jan 1;27(1):E9-10. Ohmori K, Kawaguchi Y, Kanamori M, Ishihara H, Takagi H, Include Case Review; will Kimura T. Image-guided anterior thoracolumbar corpectomy: a only be used for report of three cases. Spine (Phila Pa 1976). 2001 May labelling 15;26(10):1197-201. considerations Harrington JF Jr. Far lateral disc excision at L5-S1 complicated Include Case Review; will by iliolumbar artery incursion: case report. Neurosurgery. 2001 only be used for Jun;48(6):1377-9; discussion 1379-80. labelling considerations Brown PG, Shaver EG. Myolipoma in a tethered cord. Case Exclude Different patient report and review of the literature. J Neurosurg. 2000 Apr;92(2 population; Suppl):214-6. intradural tumor

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REFERENCE INCLUDE EXCLUDED OR RATIONALE. IF EXCLUDE APPLICABLE Mayer HM, Brock M. Percutaneous endoscopic discectomy: Include surgical technique and preliminary results compared to microsurgical discectomy. J Neurosurg. 1993 Feb;78(2):216-25. Sakou T, Masuda A. Percutaneous diskectomy for lumbar disk Include herniation. A preliminary report. Clin Orthop Relat Res. 1993 Jan;(286):174-9. Mayer HM, Brock M. Percutaneous endoscopic lumbar Include discectomy (PELD). Neurosurg Rev. 1993;16(2):115-20. Beatty RA. Foraminotomy rongeur. Spine (Phila Pa 1976). Exclude Technical Note 1991 Dec;16(12):1388-9. Pfeiffer M, Schäfer T, Griss P, Mennel HD, Arndt D, Henkel K. Exclude Cadaveric Study Automated percutaneous lumbar discectomy with and without chymopapain pretreatment versus non-automated discoscopy- monitored percutaneous lumbar discectomy. An experimental study in human cadaver spines. Arch Orthop Trauma Surg. 1990;109(4):211-6. Collins JD, Graves WA, Shaver ML. The importance of the Exclude Not applicable "sloping rib" in interventional radiology procedures of the patient population; chest. J Natl Med Assoc. 1988 Dec;80(12):1293-6. radiological procedures of the chest Salander JM, Youkey JR, Rich NM, Olson DW, Clagett GP. Include Case Review; will Vascular injury related to lumbar disk surgery. J Trauma. 1984 only be used for Jul;24(7):628-31. labelling considerations Hirabayashi K, Watanabe K, Wakano K, Suzuki N, Satomi K, Include Ishii Y. Expansive open-door laminoplasty for cervical spinal stenotic myelopathy. Spine (Phila Pa 1976). 1983 Oct;8(7):693- 9. Bass J Jr, Lach J, Fegelman RH. Vascular injuries during Exclude Commentary lumbar laminectomy. Am Surg. 1980 Nov;46(11):649-51. Lake PA. Modified disc rongeur. Technical note. J Neurosurg. Exclude Technical Note 1975 Oct;43(4):504.

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Appendix D. Dr. Haufe’s CV

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Appendix E. Comparative Device Promotional Literature E-1 Cosman RRE Ray Electrode Brochure E-2 NeuroTherm Electrode Brochure E-3 Stryker Venom Cannula and Electrode Brochure E-4 Stryker Venom Electrode IFU E-5 Baylis RF Generator IFU E-6 NeuroTherm RF Generator Brochure E-7 Midas Rex Legend (electric) Brochure E-8 Integra Kerrison Rongeurs Brochure E-9 Mild Device Kit IFU E-10 Stryker Sonopet Brochure E-11 iO-Flex/iO-Tome Devive IFU

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Appendix F. DenerveX Instructions For Use (IFU) document

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Appendix G. Quality Assessment of Articles Included in Literature Review (MEDDEV 2.7.1 Rev 3) This Appendix provices a summary of the key quality-assessment characteristics of the 107 clinical publications that were included in the clinical literature review. Table 8: Appendix G1: Included Article Summary Quality Assessment Appropriate Appropriate Appropriate Acceptable Data Outcome Follow up Statistical Clinical Device device patient report/data source measures significance significance application population collation type D1 = Actual device A1=Same use P1 = R1=High T1=Yes O1=Yes F1=Yes S1=Yes C1=Yes Applicable quality D2 = Equivalent A2 = One P2 = Limited R2 = Minor T2 = No O2 = No F2 = No S2 = No C2 = No Device: 2a. intended use deficiencies Citation Equivalent for RF, 2b. Equivalent for mechanical tissue destruction