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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, respec- tively, showed at least 50% improvement in pain. Mean operating time per joint was 17 mi- nutes (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.
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