Physical Therapy CEU

The Symptomatic SI Joint Clinical Examination, Diagnosis and Treatment

1 Genne’ DeHenau McDonald PT

• 28 years clinical experience (PT Degree Oakland University/Michigan State University)

• Former Adjunct Faculty and Clinical Lecturer • University of Florida DPT Program

• Former Faculty Herman and Wallace Pelvic Health Institute

• Publications • Musculoskeletal LBP During Pregnancy • Piriformis Syndrome • Co-Author and Editor Original Gynecological Manual SOWH

• APTA Member/SOWH Member since 1989

• Speaker for SOWH, SUNA

• Program/Project Manager Medical Affairs SI-BONE Continuing Education Credits

Website - http://www.questionpro.com/t/AKQvQZbCqQ

**Certificates will be e-mailed the first and third week of the month after completion of survey **Please check junk mail folder

Questions: Genné McDonald – Program/Project Manager - SI-BONE [email protected] 352-219-4286

Confidential & Proprietary 3 Course Objectives

1. Understand the prevalence of SI joint pain.

2. Review anatomy and biomechanics of the SI joint.

3. Review the integrated model of SI joint function.

4. Understand the relationship between the lumbar spine, SI joint and hip.

5. Review subjective history for patient with SI joint pain.

6. Correctly perform SI joint provocation testing

7. Review SI joint rehabilitation.

4 Prevalence of SI Joint Pain Is the SI Joint truly a problem? 15-30% 32-43% Component of chronic LBP Symptomatic Post-Lumbar Fusion

30.0% 27.0%

22.6%

18.5% DePalma – Pain Med 2011 14.5%

32% Katz 2003 35% Maigne 2005 43% DePalma 2011 Bernard Schwarzer Maigne Irwin Sembrano 40% Liliang 2011 1987 1995 1996 2007 2009

5 SIJ & Adjacent Segment Degeneration1,2

75% of post-lumbar fusion patients showed SI joint degenerative changes on CT scan 5 years after vs. only 38% age- and gender-matched controls without prior lumbar fusion

Ha et al. 2008

Lumbar fusion leads to increases in angular motion and joint stress at the SI joint Ivanov et al. 2009

1. Ha – Spine 2008 2. Ivanov – Spine 2009

6 Anatomy

Sacroiliac Joint

Articular Surface

7 Anatomy

Anterior Ligaments Posterior Ligaments

8 Biomechanics

Nutation Nutation Sacral base movement anteroinferior Counternutation Sacral base movement posterosuperior Translation Linear motion; motion in any one direction Counternutation

Forst 2006

9 SI Joint Motion

Multi-planar motion – Simultaneously rotate and translate through 3 axes of motion Motions (<4° in any plane) – Nutation / Counternutation • Primary motion Males: 1 - 2° Females: 2 - 4° Sacral Translation – (A-P motion) up to 1.6mm

Sturesson 1989

10 Integrated Model of SI Joint Function

• Describes effective transfer of force and load across the SI joint from the lower extremities to the spine. Snijders & Vleeming 1993

• Requires a stable core (lumbar spine, pelvis and soft tissues)

• 3 Components of Functional Stability Passive (form closure) Active (force closure) Neuromuscular Control (motor control)

Panjabi 1992

11 The Integrated Model of SIJ Function

Components

Form Closure/Structural Motor Control: Nervous system Integrity: The shape of the coordination / co-activation of sacrum and the integrity of deep stabilizing muscles the supporting ligaments (onset, duration, timing)

contribute to SI joint stability Snijders 1993, Hodges 1996, Richardson 2002

Lee 1998, Vleeming 1990a, Vleeming 1990b

Force Closure/Joint Compression: The external dynamic forces created by Core muscles should contract contraction of the stabilizing before load reaches the low muscles and their fascial and back and pelvis to prepare the ligamentous attachments system for impending load. Lee 1998, Vleeming 1990a, Vleeming 1990b

12 Form Closure

Osseous Structures – Macro, Micro Supporting Ligaments

13 The Integrated Model of SI Joint Function: Force Closure – Local Muscles

Local System: contracts prior to upper/lower limb movement regardless of direction Hodges 1997, 2003; Hodges & Richardson 1997; Hodges 1999; Moseley 2002,2003 Local Core Muscles

• Transversus Abdominus • Multifidus • Pelvic Floor Muscles • Diaphragm – More research being done on other contributing muscles

14 The Integrated Model of SI Joint Function: Force Closure – Global Muscles

Global System: Contracts later and is direction dependent Radebold 2000, 2001; Hodges 2003

Vleeming’s slings: Large Muscle Groups and their Fascial Connections – Posterior Oblique System – Anterior Oblique System – Deep Longitudinal System – Lateral System

Radebold 2000, 2001; Hodges 2003

15 Thoracolumbar Fascia & Paraspinal Muscles

Caudal part of the TLF, in combination with efficient paraspinal muscles, plays major role in force closure of SI joint

Macintosh & Bogduk – Spine 1993, Vleeming – Spine 1995

16 Motor Control

• Optimal force closure of the SI joint • Studies showing alteration of muscle activation patterns in low back, groin, and SI joint pain populations – TrA Delayed in LBP Hodges & Richardson 1996 – TrA Delayed in Groin Injuries Cowen 2004 – Altered Motor Control with SI joint Pain O’Sullivan 2002 • Timing, sequence and amplitude of muscle firing – Afferent input from receptors in joints, ligaments, fascia and muscles – Efferent response of central and peripheral nervous systems Hodges 2003

17 Evaluation of the Patient with Sacroiliac Joint Pain

18 Can we diagnose SI joint pain?

• Common pain patterns from multiple conditions – Spine (stenosis, facet, spondy, disc herniation, DDD, etc.) – SI Joint – Hip (OA, FAI, early AVN, etc.) – Pelvis (Glut tear, piriformis, pelvic floor) • Imaging not routinely helpful • History and Physical Examination

− Provocative maneuvers Laslett 2005, Szadek 2009

− SI joint ROM & Position testing not reliable Freburger 1999, Robinson 2007 • Diagnostic Injection

19 Lumbar Spine – SI Joint – Hip Pain Referral Patterns

Isolated Spinal Stenosis SI Joint Hip Pathology

Buttock common Buttock, PSIS (94%) Buttock pain (71%)

Groin uncommon (except L1, L2) Groin not uncommon (14%) Thigh and Groin (55%)

Lower extremity common Lower extremity common (28%) Knee or below (47%)

Lateral hip – common Lateral hip & thigh common Lateral hip – common

Lumbar region common Lower lumbar region (72%) Lumbar pain uncommon

Devin – JAAOS 2012 Vanelderen – Evid Based Med 2010 Devin – JAAOS 2012

20 Potential Causes of SIJ Pain: Traumatic

• MVA: Foot on Brake

• Slip and Fall

• Lifting and Twisting

• Traction Injuries

21

21 Potential Causes of SI Joint Pain: Gradual Onset

• Laxity of the SI joint / Pregnancy • Repetitive Forces on SI joint and Supporting Structures

• Biomechanical Abnormalities – Leg length inequality – Pelvic obliquity/scoliosis – Iliac crest bone graft

• Adjacent Segment Degeneration – After lumbar spinal fusion

• Post Infection Degeneration

22

22 Hip and Adjacent Segment (SI Joint)

Hip and SI Joint 42% Hip OA 76% (25/33) of patients 45% Subchondral cyst with symptomatic SI joint pathology had at least one 21% Retroversion abnormal finding on hip 12% Lateral CE* angle >40% radiograph 47% Coxa profunda A significant number met the strict 33% Cam impingement diagnostic criteria for FAI.

*Center Edge

Morgan 2013

23 Elements of the Diagnosis

Positive Positive SI Joint Subjective Provocative History Testing

Lumbar Spine Positive Response to and Intra-articular Hip Exam Injection

24 History and Complaints

HISTORY COMPLAINTS

• When did the pain start? • Lower back pain • Prior trauma • Sensation of numbness, tingling or weakness – A fall on the buttock • Pelvis / buttock pain – Car accident (T-bone, rear-end, head-on) • Hip / groin pain – Lift/Twist • Feeling of leg instability, buckling, or giving way – Other • Disturbed sleep patterns • Prior lumbar fusion • Disturbed sitting patterns (unable to sit – Prior iliac bone graft harvest for long periods, on one side) • Pregnancy • Pain going from sitting to standing

25

25 History: SI Joint Pain Presentation

Pain Diagram • Pain in buttock and posterior thigh – Usually not midline – Usually below L5 – At or lateral to PSIS – Occasionally groin • Secondary pain in lateral thigh, groin, and/or lateral calf

Fortin 1999

26

26 Exacerbating Activities

Pain with Transitional Motions - Supine to painful side - Sit to stand - Rolling over in bed - Getting in /out of bed Pain while Stationary - Sitting on affected side Unilateral Weight Bearing - Prolonged standing/sitting - Putting on Socks/Shoes - Ascending/Descending Stairs - Getting in and out of Car - Prolonged Walking (85% of gait cycle is single leg stance) Janda 1983 Sexual Intercourse

27

27 Relieving Activities

• Bearing weight on unaffected side

• Lying on unaffected side

• Manual or belt stabilization

28

28 Lumbar Spine – Hip – SI Joint Physical Examination

29 Assess Lumbar Spine: Facet Joint Pain

• Incidence 10-15% in patients with chronic LBP Saravanakumar 2008 • Low back pain from the facet joints: radiates down into the buttocks and posterior thigh.

• Clinical Findings – Point tenderness overlying the inflamed facet joints – Loss in spinal muscle flexibility (guarding) – More discomfort leaning backward than forward.

• No history findings or examination maneuver has been found to be unique or specific to this entity Kayser 2008, Cohen 2007, Jackson 1998

30 Assess Lumbar Spine: Disc-Related Pain

The McKenzie Procedure • More accurate than MRI in: – Differentiating discogenic from non-discogenic LBP – Differentiating contained from non-contained discs (Donelson 1997, 1990) • Measures patient's symptomatic response to repeated end-range movements

• Discogenic pain is associated with centralization with repeated end range movements (Young 2003, Hancock 2007)

• Most common direction of testing that centralizes pain is extension

31 Assess Lumbar Spine: Physical Exam

Standard tests to rule out lumbar radiculopathy • DTRs • Neuro Exam

Passive Straight Leg Raise To rule out lumbar radicular pain + at 35-70° • Sensitivity 91% • Specificity 26% Deville 2000 These can all be Slump Test performed quickly To rule out lumbar disc herniation's in supine before • Sensitivity 84% performing • Specificity 83% provocative testing Majlesi 2008 for the SI joint.

32 Assess Hip: Physical Examination

FABER: For Intra-articular hip pathology (if pain anterior) • Hip flexion, abduction and ER with overpressure • 88% sensitive (Martin 2005) Scour: For Hip OA and other pathologies • Sensitivity 62% - 91% • Specificity 43% - 75% (Konin 2006, Magee 2008) FADIR: For FAI and labral tears: • Hip flexion, adduction, IR • Sensitivity = 75%, • Specificity = 43% (Austin 2008) FAIR: For Piriformis Syndrome (assure pain is posterior) • Sensitivity 88% • Specificity 83% (Fishman, 2002)

33 Assess Hip: Physical Examination

Range of Motion Testing of the Hip (Birrell 2001) • The most predictive finding for osteoarthritis is decreased range of motion with restriction in internal rotation • For those patients with one plane of restricted movement, the sensitivity for severe osteoarthritis is 100% and specificity is 42% • Used to rule in/out osteoarthritis

Femoral Neck Anteversion (FNA) Assessment Compare bilaterally • If IR is 30 degrees > then external rotation, predictor of FNA (Swanson 1963) • Trochanteric Prominence Angle Test (TPAT) or Craig test TPAT predicted the FNA measured intraoperatively, more accurately than either the CT or Magilligan method (Ruwe 1992)

34 Assess Hip: OA & FAI

• There is a strong association between early hip OA (osteoarthritis) and FAI (femoral acetabular impingement) • Altman Criteria for Hip OA: – Hip IR ≥ 15 degrees, Pain with Hip IR – Morning stiffness for ≤ 60 min and Age > 50 years or – Hip IR < 15 degrees, and Hip Flexion ≤ 115 degrees (Sensitivity 86 % Specificity 75 %) Altman 1991

• Patients with hip OA often develop osteophytic changes and bony over-growth of the acetabular rim and femoral head • This would create FAI in and of itself Chibulka 2009, Phillippon 2007

Clinical Presentation • Both may present with positive tests for FABER and FADIR • Both may present with a decrease in hip flexion and internal rotation (ROM)

35 Assess Hip: FAI (Femoral-Acetabular Impingement)

Contact between the femoral head- neck junction and the acetabular rim Confirmation • Arthroscopy: Gold Standard • Insidious onset 50% of cases Samora 2011 • MRI • Symptoms – Persistent insidious deep groin, lateral hip or buttock pain – Pain increased with prolonged sitting or standing and hip flexion-type movements – Decreased hip ROM Two Types • CAM (More common in young males) – Anterior-superior aspect • Pincer (More common in females) – Anterior acetabular labrum and chondral injury in posterior-inferior acetabular rim Ganz 2003

36 Assess Hip: Labral Tear Clinical Findings

• Morphological changes in proximal femur or acetabulum lead to abnormal contact during hip flexion Samora 2011

• Clinical Symptoms: anterior groin pain (96-100%), clicking, locking (58%), catching, instability, giving way and/or stiffness Martin 2006, Lewis 2006 – Predisposing factor: Coxa Valga = 87% of cases

• Clinical Sign: FADIR TEST

Method of Injury – Hip external rotation + extension, direct trauma, abnormal loading patterns MRI – May demonstrate labral tear, but often the bony articular pathology are missed

MRA – Gold standard is magnetic resonance arthrogram Samora 2011

37 Assess Hip: Piriformis Syndrome

Piriformis compresses or irritates the sciatic nerve Magnetic Resonance Neurography: • Incidence: 17.2% among low back pain patient Type of MRI that highlights Chen 2013 inflammation and compression of Clinical symptoms the nerves. • A dull ache in the buttock. Filler 2005 • Pain down the back of the thigh, calf and foot (sciatica) • Pain when walking up stairs or inclines. • Increased pain after prolonged sitting. Clinical Sign • FAIR Test: Reproduction of symptoms when piriformis muscle is put on stretch. (hip flexion, adduction and internal rotation) Fishman 2002, Loren 2010

38 Assess Hip: Gluteus Medius & Minimus Tears

Incidence • Common finding on MR imaging in patients with buttock, lateral hip, or groin pain. Kingzett-Taylor 1999 Clinical Symptoms • Dull lateral hip pain, buttock or groin pain

Clinical Signs • Focal tenderness at the gluteal insertion • Weak hip abduction • Pain with passive and then resisted hip internal rotation with the hip flexed to 90° Sen 88%, Spec 97.3% • Pain on one-legged stance for 30 sec or more Sen 100 % Spec 97.3% Lequesne 2008

39 SI Joint: Physical Exam Fortin Finger Test

Point to pain while standing • Able to localize pain with one finger • Within 1 cm of PSIS (inferomedial) • Consistent over at least 2 trials Ask patient to point to location of primary pain

• Below L5: Consider SI joint • Above L5: Consider lumbar spine etiologies

Fortin & Falco 1997

40 SI Joint: Physical Exam

Active Straight Leg Raise To assess functional pelvic stability

• Sensitivity: 87% • Specificity: 94%

Mens 2001

41 SI Joint: Provocative Tests

The following five provocative tests, when performed in combination are proven to have a high degree of sensitivity and specificity: Laslett Szadek 1. Distraction* (Highest PPV**) 3 or more positive tests 2. Thigh Thrust* Sensitivity 91% 85% 3. FABER 4. Compression* Specificity 78% 76% 5. Gaenslen’s Maneuver

* Most sensitive tests ** PPV = positive predictive value

Laslett 2005, 2008 Szadek 2009

42

42 SI Joint: Specificity of Provocative Tests

How to Interpret Your Results

1 Positive Test = Suspicion 2 Positive Tests = Fair Confidence 3+ Positive Tests = High Confidence

• Specificity increases when symptoms don’t centralize or peripheralize with thorough, multidirectional repeated movement assessment (McKenzie Assessment) • In some cases a patient may not tolerate having five (5) tests performed. Therefore, it’s recommended that the three (3) most sensitive, specific and reliable tests be performed first.

Laslett 2005, Laslett 2008, Szadek 2009

43 SI Joint Provocative Tests

Distraction Compression

 

Thigh Thrust Gaenslen’s

 

FABER 3 of 5 positive tests provides discriminative power for diagnosing SI joint pain

Szadek – J Pain 2009  Laslett – J Man Manip Ther 2008

44 SI Joint: Provocative Test Tips

 Assure the tester position is above the patient by lowering table or standing on a sturdy stool in order to provide adequate force.

 Start with light pressure and gradually increase, keeping hands cupped to minimize local contact pressure (30 second max).

 Keep arms straight and lean forward with your upper body to create gentle steady force.

 Stabilize patient on the table to prevent muscle guarding.

 Stabilize contralateral ASIS during Thigh Thrust and FABER tests.

 If pain is provoked with test, ask patient to identify pain location to confirm it is their typical pain.

45 SIJ Region Pain – Myofascial Causes

• Quadratus Lumborum

• Gluteus Maximus

• Piriformis

• Levator Ani

Travell and Simons 1992

46 Justification for SI Joint Injection

Positive Positive Positive Fortin Finger Test Provocation History and Testing Physical Exam (Lumbar Spine, SI Joint, and Hip)

47

47 SI Joint Injections

Injection Under Fluoroscopy

Diagnostic Injection • Confirm with contrast and imaging • Low volume, local anesthetic

Therapeutic Injection • Local anesthetic + corticosteroid • May provide intermediate or long-term relief • Results of can be unpredictable

48

48 Assessment: Post Diagnostic Injection

• Positive clinical response ≥ 50% VAS reduction during anesthetic phase indicates positive diagnosis of SI joint as pain generator. Relief during previously painful functional / provocative movements. • Minimal or no relief < 50% May have SI joint pain, but consider other pain sources.

ISASS and ASIPP utilize ≥ 50% reduction in pain as a threshold NASS utilizes ≥ 75% reduction in pain as a threshold

Maugars – Br J Rheumatol 1996; Maigne - Spine 1996; Pauza – AAPM&R 2001; Fritz – AJR Am J Roentgenol 2008; Rupert – Pain Physician 2009; Liliang – Pain Med 2011; Manchikanti – Pain Physician 2013;

49 Conservative Treatment Options for Sacroiliac Joint Pain

50 Conservative Treatment Options

Symptom Management • Medications (non-steroidal anti-inflammatories, oral steroids, pain medications) • External SI joint stabilization with belting • Therapeutic SI joint injections (1-4 per year) • Physical Therapy

Sembrano 2011 Cohen 2005

51 Conservative Treatment Options: Physical Therapy Treat the joint by returning it to its normal relationships

Fife 2008 • Optimal SI joint function occurs with the SI Joint in neutral (mid-range) position. DonTigney 1990, 1994, 1999, 2005; Fujiwara 1999; Pool-Goudzwaard 2001, 2003; Snijders 1993, 2004; Vleeming 1996

• Treatment goals should include restoration of : – Optimal alignment of the lumbar spine, sacroiliac and hip joints – Functional stability of the lumbopelvic region

52 Conservative Treatment Options: Physical Therapy

• Modification of Activities of Daily Living (ADLs) – specific focus on activities that may create or exacerbate symptoms.

• Patient education regarding maintaining optimal alignment with positioning, posture and body mechanics

• Stabilization Exercise/ Neuromuscular Re-education – Specific focus on timing and engagement of local and global core muscles Snijders 1993a, 1993b, Hodges 1996, Richardson 2002

53 Conservative Treatment Options: Physical Therapy

• Achieve normal muscle strength balance where existing deficits (include gluteus medius assessment) Lee 1998, Vleeming 1990, Vleeming 1989 • Achieve normal muscle length balance where existing imbalances exist – Consideration of muscles that attach to the ilium and sacrum directly and indirectly, especially limiters of hip internal rotation. Cibulka 1998, Lee 1998, Vleeming 1990, Vleeming 1989 • Adjacent segment joint and soft tissue restriction mobilization and manipulation as needed* – Consider the hip structures, lumbar and thoracic regions, knee and ankle joints.

54 Conservative Treatment Options: Physical Therapy

• Manual techniques to address myofascial pain

• Balance assessment and training

• Gait training

• Regain or maintain cardiovascular health

• Modalities for pain and muscle spasm

55 Surgical Treatment Options for Sacroiliac Joint Pain

56 Treatment Options: Surgical

Smith-Petersen 1926 Campbell 1927 Gaenslen 1927

Bloom 1937 iFuse 2008

57

57 MIS SI Joint Fusion Technologies

Examples of existing and/or SI-BONE: developing technologies. iFuse Implant System®

Globus: iFuse Implant is the ONLY SI-LOK Joint Fixation System SI joint fusion technology supported by multiple Medtronic: prospective clinical Rialto Sacroiliac Joint Fusion System publications, including 2 Randomized Controlled VG Innovations: SiJoin Posterior Sacroiliac Joint Fusion System Trials. (May 2017) X-spine Systems: Silex Sacroiliac Joint Fusion System

Zyga Technology: SImmetry Sacroiliac Joint Fusion System

58 iFuse Implant System®

• Unique Patented Design – Triangular shape (minimizes rotation) – Interference press fit (immediate stabilization) – Porous titanium surface (promotes bony ongrowth/ingrowth for long-term fusion)*

• Strength of Experience 25,000+ procedures worldwide (March 2017)

• Clinical Evidence – iFuse Implant is the ONLY device for treatment of SI joint dysfunction supported by multiple prospective clinical studies including 2 RCTs – More than 50 peer-reviewed publications

* MacBarb G, et al. Int J Spine Surg. 2017:11;116-28.

59 iFuse Procedure Overview

Incision Pin Soft Tissue Protector Measure

Drill Broach Insert Implant Repeat (optional with sharp-tip broach)

60 iFuse Implant System® Publications

…...…………………. 7 RCT (INSITE, iMIA)

…………………... 6 Prospective, Multicenter

…………….…. 5 Comparison

….………. 17 Retrospective Case Series …………. 3 Systematic Review, Meta-analysis ………. 5 Cost-effectiveness, Productivity, etc. Complications, Survivorship, …... 7 etc. Stability, Implant Placement, … 3 etc.

* Includes accepted articles that are pending publication (see iFuse bibliography)

61 Complete References in Bibliography

62 Complete References in Bibliography

63 Complete References in Bibliography

64 Post-Operative Considerations

Individual Treatment Plans Post Surgical Decisions Considerations: • Age • Plan for protected weight bearing • Weight Activity limitations • Bone quality • Post op rehab plans • Associated health factors • • Plan for return to activity

6565 Post-Operative Guidelines

To assist HCPs with Patient Education

66 Post-Operative Guidelines and Precautions

Weight-bearing Status

Post-Operative Swelling Prevention

Precautions and Activity Guidelines

67 Circulation and Stabilization Exercises

Description of Core Strengthening

Exercises for DVT Prevention combined with basic core strengthening

68 Bed Mobility, Transfers and Stairs

Patient is instructed in maintenance of neutral lumbopelvic mechanics with movement and utilization of TrA muscle to assist with stabilization

69 Post-Operative PT Considerations

Review of common musculoskeletal problems affecting the SI joint or affected by chronic SI disorders

Suggested areas to address post- operatively based on best practice and current evidence

70 Post-Operative Considerations

Patient Education: Positioning, Posture and Body Mechanics

Gait Training

Balance Assessment and Training

Timing and Engagement of Core Local/Global Stabilizers

Achieve Normal Muscle Strength and Length Balance

71 Post-Operative Considerations

Eliminate Restrictions in Adjacent Structures • Hip Capsule • Lumbar and Thoracic Spine / Knee and Ankle Joints

Retraining of Functional Movement Patterns/Motor Control • With Activities of Daily Living • With Recreational Activities in Patient Population

Regain / Maintain Cardiovascular Health

72 Conclusion

• SI joint can be painful: pathology is prevalent and underdiagnosed

• SI joint stability depends on a complex integrated system: Form and Force Closure, Motor Control

• Must understand the lumbar spine-SI joint-hip complex and how they interact

73 Conclusion

• Diagnosis of SI joint pain – History – Physical Examination of spine, hip and SI joint – Correct Performance of SI joint provocative tests – Diagnostic injection

• Treatment options for SI joint pathology – Non-surgical management – Surgical option – MIS SI joint fusion – Pre and post-operative considerations

74 The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit: www.si-bone.com/risks

One or more of the individuals named herein may be past or present SI-BONE employees, consultants, investors, clinical trial investigators, or grant recipients. Research described herein may have been supported in whole or in part by SI-BONE.

SI-BONE, SI University and iFuse Implant System are registered trademarks of SI-BONE, Inc. © 2017 SI-BONE, Inc. All rights reserved. Patents www.si-bone.com

9228.062017

75 76 References

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LEVEL I – Randomized Clinical Trial [7] • Dengler J, Kools D, Pflugmacher R, Gasbarrini A, Prestamburgo D, Gaetani P, Cher D, Van Eeckhoven E, Sturesson B. Low back pain originating from the sacroiliac joint – 1 year results from a randomized controlled trial of conservative management vs. minimally invasive surgical treatment. Pain Physician. 2017 [Accepted, publication pending] • Dengler J, Sturesson B, Kools D, Prestamburgo D, Cher D, van Eeckhoven E, Erk E, Pflugmacher R, Vajkoczy P; and the iMIA study group. Referred leg pain originating from the sacroiliac joint: 6-month outcomes from the prospective randomized controlled iMIA trial. Acta Neurochir (Wien). 2016;158(11):2219-2224. Epub 2016 Sep 15. DOI: 10.1007/s00701-016-2953-7. • Polly DW, Swofford J, Whang PG, Frank CJ, Glaser JA, Limoni RP, Cher DJ, Wine KD, Sembrano JN, and the INSITE Study Group. Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction. Int J Spine Surg. 2016;10.Article 28. DOI: 10.14444/3028. • Sturesson B, Kools D, Pflugmacher R, Gasbarrini A, Prestamburgo D, Dengler J. Six-Month Outcomes from a Randomized Controlled Trial of Minimally Invasive SI Joint Fusion with Triangular Titanium Implants vs Conservative Management. Eur Spine J. 2016 May 14 [Epub]. DOI: 10.1007/s00586-016-4599-9. • Polly D, Cher D, Whang PG, Frank C, Sembrano J, for the INSITE Study Group. Does Level of Response to SI Joint Block Predict Response to SI Joint Fusion? Int J Spine Surg. 2016;10:Article 4. DOI: 10.14444/3004. • Polly DW, Cher DJ, Wine KD, Whang PG, Frank CJ, Harvey CF, Lockstadt H, Glaser JA, Limoni RP, Sembrano JN, and the INSITE Study Group. Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion Using Triangular Titanium Implants vs. Non-Surgical Management for Sacroiliac Joint Dysfunction: 12-Month Outcomes. Neurosurgery. 2015;77:674-91. [Epub 2015 Aug 19]. DOI: 10.1227/NEU.0000000000000988. • Whang P, Cher D, Polly D, Frank C, Lockstadt H, Glaser J, Limoni R, Sembrano J, on behalf of the INSITE Study Group. Sacroiliac Joint Fusion Using Triangular Titanium Implants vs. Non-Surgical Management: Six-Month Outcomes from a Prospective Randomized Controlled Trial. Int J Spine Surg. 2015;9:Article 6. DOI: 10.14444/2006.

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LEVEL II/IIb – Prospective, Multicenter [6] • Dengler J, Duhon B, Whang P, Frank C, Glaser J, Sturesson B, Garfin S, Cher D, Rendahl A, Polly D, on behalf of the INSITE, iMIA and SIFI study groups. Predictors of Outcome in Conservative and Minimally Invasive Surgical Management of Pain Originating from the Sacroiliac Joint – a Pooled Analysis. Spine. 2017 March 27 [Epub ahead-of-print]. DOI: 10.1097/BRS.0000000000002169. • Duhon B, Bitan F, Lockstadt H, Kovalsky D, Cher D, Hillen T, on behalf of the SIFI Study Group. Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: 2-Year Follow-Up from a Prospective Multicenter Trial. Int J Spine Surg. 2016;10:Article 13. DOI: 10.14444/3013. • Capobianco R, Cher D. Safety and Effectiveness of Minimally Invasive Sacroiliac Joint Fusion in Women with Persistent Post-partum Posterior Pelvic Girdle Pain: 12-month Outcomes from a Prospective, Multi-center Trial. SpringerPlus. 2015 Oct 5;4(1):570. DOI: 10.1186/s40064-015-1359-y • Duhon B, Cher D, Wine K, Kovalsky D, Lockstadt H. Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: A Prospective Study. Global Spine J. 2016;6(3):257-69. [Epub 2015 Aug 11]. DOI: 10.1055/s-0035-1562912. • Cher DJ, Polly DW. Improvement in Health State Utility after Sacroiliac Joint Fusion: Comparison to Normal Populations. Global Spine J. 2016;6(2):100-7. [Epub 2015 Jun 25]; DOI: 10.1055/s-0035-1556581. • Duhon B, Cher D, Wine K, Lockstadt H, Kovalsky D, Soo C-L. Safety and 6-month Effectiveness of Minimally Invasive Sacroiliac Joint Fusion: A Prospective Study. Med Devices (Auckl). 2013;6:219–29. DOI: 10.2147/MDER.S55197.

LEVEL III – Clinical Comparisons [5] • Vanaclocha-Vanaclocha V, Herrera JM, Sáiz-Sapena N, Rivera-Paz M, Verdú-López F. Minimally Invasive Sacroiliac Joint Fusion, Radiofrequency Denervation and Conservative Management for Sacroiliac Joint Pain: Six Year Comparative Study. Neurosurgery. 2017 Apr 20. [Epub ahead of print]. DOI: 10.1093/neuros/nyx185. • Spain K, Holt T. Surgical Revision after Sacroiliac Joint Fixation or Fusion. Int J Spine Surg. 2017;11(1):24-30. DOI: 10.14444/4005. • Graham Smith A, Capobianco R, Cher D, Rudolf L, Sachs D, Gundanna M, et al. Open Versus Minimally Invasive Sacroiliac Joint Fusion: A Multi- center Comparison of Perioperative Measures and Clinical Outcomes. Ann Surg Innov Res. 2013;7:14. DOI: 10.1186/1750-1164-7-14. • Ledonio CGT, Polly DW, Swiontkowski MF. Minimally Invasive Versus Open Sacroiliac Joint Fusion: Are They Similarly Safe and Effective? Clin Orthop Relat Res. 2014;472:1831–8. DOI: 10.1007/s11999-014-3499-8. • Ledonio C, Polly D, Swiontkowski MF, Cummings J. Comparative Effectiveness of Open Versus Minimally Invasive Sacroiliac Joint Fusion. Med Devices (Auckl). 2014;2014:187–93. DOI: 10.2147/MDER.S60370.

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LEVEL IV – Clinical [17] • Bornemann R, Roessler PP, Strauss A, Sander K, Rommelspacher Y, Wirtz DC, Pflugmacher R, Frey SP. 2-year clinical results of patients with sacroiliac joint syndrome treated by arthrodesis using a triangular implant system. Technol Health Care. 2016 Nov 4. [Epub ahead of print]. DOI: 10.3233/THC-161272 • Sachs D, Kovalsky D, Redmond A, Limoni R, Meyer SC, Harvey C, Kondrashov D. Durable intermediate- to long-term outcomes after minimally invasive transiliac sacroiliac joint fusion using triangular titanium implants. Med Devices (Auckl). 2016;9:213-22. DOI: 10.2147/MDER.S109276. • Bornemann R, Pflugmacher R, Webler M, Koch EM, Dengler J, Wirtz DC, Frey SP. [Clinical Trial to Test the iFuse Implant System® in Patients with Sacroiliac Joint Syndrome: One Year Results]. Z Orthop Unfall. 2016 Jul 7. [Epub ahead of print] [Article in German]. DOI: 10.1055/s-0042-110207. • Manfré L. Percutaneous Sacroiliac Joint Fixation in Sacroiliac Instability. The First Case Report Using a Fully CT-Guided Technique. Interv Neuroradiol. 2014;20:621–5. DOI: 10.15274/INR-2014-10049. • Rudolf L, Capobianco R. Five-Year Clinical and Radiographic Outcomes After Minimally Invasive Sacroiliac Joint Fusion Using Triangular Implants. Open Orthop J. 2014;8:375–83. DOI: 10.2174/1874325001408010375. • Vanaclocha-Vanaclocha V, Verdú-López F, Sánchez-Pardo M, Gozalbes-Esterelles L, Herrera JM, Rivera-Paz M, Martínez-Gómez D. Minimally Invasive Sacroiliac Joint Arthrodesis: Experience in a Prospective Series with 24 Patients. J Spine. 2014;03. DOI: 10.4172/2165-7939.1000185. • Sachs D, Capobianco R, Cher D, Holt T, Gundanna M, Graven T, Shamie AN, Cummings J Jr. One-year Outcomes After Minimally Invasive Sacroiliac Joint Fusion with A Series of Triangular Implants: A Multicenter, Patient-level Analysis. Med Devices (Auckl). 2014;2014:299–304. • Scheyerer MJ, Hüllner MS, Pietsch C, Veit-Haibach P, Werner CML. Implant-Bone Interface of Sacroiliac Joint Fusion Using iFuse Implant System. ISRN Minimally Invasive Surgery. 2014;2014:Article ID 571014. DOI: 10.1155/2014/571014. • Schroeder JE, Cunningham ME, Ross T, Boachie-Adjei O. Early Results of Sacro–Iliac Joint Fixation Following Long Fusion to the Sacrum in Adult Spine Deformity. Hosp Spec Surg J. 2014;10:30–5. ePub 2013 Dec 11. DOI: 10.1007/s11420-013-9374-4. • Gaetani P, Miotti D, Risso A, Bettaglio R, Bongetta D, Custodi V, Silvani V. Percutaneous Arthrodesis of Sacro-iliac Joint: A Pilot Study. J Neurosurg Sci. 2013;57:297–301.

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LEVEL IV – Clinical [17] (cont.) • Cummings J, Capobianco RA. Minimally Invasive Sacroiliac Joint Fusion: One-year Outcomes in 18 Patients. Ann Surg Innov Res. 2013;7:12. DOI: 10.1186/1750-1164-7-12. • Sachs D, Capobianco R. Minimally Invasive Sacroiliac Joint Fusion: One-year Outcomes in 40 patients. Adv Orthop. 2013;2013:536128. DOI: 10.1155/2013/536128. • Rudolf L. MIS Fusion of the SI Joint: Does Prior Lumbar Spinal Fusion Affect Patient Outcomes? Open Orthop J. 2013;7:163–8. • Kim JT, Rudolf LM, Glaser JA. Outcome of percutaneous sacroiliac joint fixation with porous plasma-coated triangular titanium implants: an independent review. Open Orthop J. 2013;7:51-6. DOI: 10.2174/1874325001307010051. • Sachs D, Capobianco R. One Year Successful Outcomes for Novel Sacroiliac Joint Arthrodesis System. Ann Surg Innov Res. 2012;6:13. DOI: 10.1186/1750-1164-6-13. • Lokietek J-C, Gaspar B-S. L’Articulation sacro-iliaque “adjacent level”: Un probleme frequent et frequemment neglige. Le Rachis. 2012;24:11–6. • Rudolf L. Sacroiliac Joint Arthrodesis-MIS Technique with Titanium Implants: Report of the First 50 Patients and Outcomes. Open Orthop J. 2012;6:495–502. DOI: 10.2174/1874325001206010495.

REVIEWS [3] • Lingutla KK, Pollock R, Ahuja S. Sacroiliac joint fusion for low back pain: a systematic review and meta-analysis. Eur Spine J. 2016;25(6):1924-31. [Epub 2016 Mar 8]. DOI: 10.1007/s00586-016-4490-8. • Heiney J, Capobianco R, Cher D. A Systematic Review of Minimally Invasive Sacroiliac Joint Fusion Utilizing A Lateral Transarticular Technique. Int J Spine Surg. 2015;9:Article 40. DOI: 10.14444/2040. • Zaidi HA, Montoure AJ, Dickman CA. Surgical and clinical efficacy of sacroiliac joint fusion: a systematic review of the literature. J Neurosurg Spine. 2015;23:59-66. [Epub 2015 Apr 3]. DOI: 10.3171/2014.10.SPINE14516. Review.

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ECONOMICS [5] • Frank C, Kondrashov D, Meyer SC, Dix G, Lorio M, Kovalsky D, Cher D. Work Intensity in SI Joint Fusion and Lumbar Microdiscectomy. Clinicoecon Outcomes Res. 2016;8:367-76. DOI: 10.2147/CEOR.S112006. • Saavoss JD, Koenig L, Cher DJ. Productivity benefits of minimally invasive surgery in patients with chronic sacroiliac joint dysfunction. Clinicoecon Outcomes Res. 2016;8:77-85. DOI: 10.2147/CEOR.S101607. • Polly DW, Cher D. Ignoring the sacroiliac joint in chronic low back pain is costly. Clinicoecon Outcomes Res. 2016;8:23–31. DOI: 10.2147/CEOR.S97345. • Cher DJ, Frasco MA, Arnold RJG, Polly DW. Cost-effectiveness of minimally invasive sacroiliac joint fusion. Clinicoecon Outcomes Res. 2016;8:1-14. DOI:10.2147/CEOR.S94266. • Garber T, Ledonio CG, Polly DW Jr. How Much Work Effort is Involved in Minimally Invasive Sacroiliac Joint Fusion? Int J Spine Surg. 2015;9:Article 58. DOI: 10.14444/2058. eCollection 2015.

OTHER [7] • MacBarb RF, Lindsey DP, Woods SA, Lalor PA, Gundanna MI, Yerby SA. Fortifying the Bone-Implant Interface Part 2: An In Vivo Evaluation of 3D- Printed and TPS-Coated Triangular Implants. Int J Spine Surg. 2017;11:116-28. DOI: 10.14444/4016. • Vanaclocha-Vanaclocha V, Verdú-López F, Sáiz-Sapena N, Herrera JM, Rivera-Paz M. Biplanar x-ray fluoroscopy for sacroiliac joint fusion. Neurosurg Focus. 2016;41(Video Suppl 1):1. DOI: 10.3171/2016.2.FocusVid.1687. • Cher DJ, Reckling WC, Capobianco RA. Implant Survivorship Analysis after Minimally Invasive Sacroiliac Joint Fusion using the iFuse Implant System. Med Devices (Auckl). 2015;8:485-92. DOI: 10.2147/MDER.S94885. • Copay AG, Cher DJ. Is the Oswestry Disability Index a valid measure of response to sacroiliac joint treatment? Qual Life Res. 2015 Aug 6. • Woods M, Birkholz D, MacBarb R, Capobianco R, Woods A. Utility of Intraoperative Neuromonitoring During Minimally Invasive Fusion of the Sacroiliac Joint. Adv Orthop. 2014;2014:e154041. DOI: 10.1155/2014/154041. • Geisler F. Stabilization of the sacroiliac joint with the SI-bone surgical technique. Neurosurg Focus. 2013;35(2 Suppl):Video 8. DOI: 10.3171/2013.V2.FOCUS13195. • Miller L, Reckling WC, Block JE. Analysis of Postmarket Complaints Database for the iFuse SI Joint Fusion System: A Minimally Invasive Treatment for Degenerative Sacroiliitis and Sacroiliac Joint Disruption. Med Devices (Auckl). 2013;6:77–84. DOI: 10.2147/MDER.S44690.

86 iFuse Implant System – Bibliography

BIOMECHANICS [3] • Lindsey DP, Kiapour A, Yerby SA, Goel VK. Sacroiliac Joint Fusion Minimally Affects Adjacent Lumbar Segment Motion: A Finite Element Study. Int J Spine Surg. 2015;9:Article 64. DOI: 10.14444/2064. • Soriano-Baron H, Lindsey DP, Rodriguez-Martinez N, Reyes PM, Newcomb A, Yerby SA, Crawford NR. The Effect of Implant Placement on Sacroiliac Joint Range of Motion: Posterior vs Trans-articular. Spine. 2015;40:E525–30. DOI: 10.1097/BRS.0000000000000839. • Lindsey D, Perez-Orribo L, Rodriquez-Martinez N, Reyes PM, Newcomb A, Cable A, Hickam G, Yerby SA, Crawford NR. Evaluation of A Minimally Invasive Procedure for Sacroiliac Joint Fusion – An in vitro Biomechanical Analysis of Initial and Cycled Properties. Med Devices (Auckl). 2014;2014:131–7. DOI: 10.2147/MDER.S63499.

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