Evaluation and Treatment of Sacroiliac Joint Pain. Steven Garfin, M.D. Distinguished Professor and Chair Department of Orthopaedic Surgery, UCSD

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1 Evaluation and Treatment of Sacroiliac Joint Pain Steven Garfin, M.D. Distinguished Professor and Chair Department of Orthopaedic Surgery, UCSD

2 Disclosures AO Spine Benvenue Medical EBI Globus Medical Intrinsic Therapy Johnson & Johnson, DePuy Spine Magnifi Group Medtronic NuVasive, Inc. Samumed SI Bone, Inc. Spinal Kinetics Stryker Symmetry Vertiflex

Spine Magnifi Group Medtronic NuVasive, Inc.

3 SI Joint Large surface area 1/4 1/3 synovial (anterior) Cartilaginous surfaces Strong ligaments + Motion (many directions) -- < 4⁰ Can be arthritic

4 Innervation Synovium and capsule contain unmyelinated nerve endings for pain and temperature Anteriorly from L2-S2 ventral rami and sacral plexus Posteriorly from L4-S4 dorsal rami Could sense pain

5 SI: Pain/Changes Low Back Pain From SI Joint (Adjacent Segment Disease) Post-Lumbar/Lumbosacral Fusion 14.5% Sembrano % Bernard 1987 (1293 patients) 30% Schwarzer % Maigne % Ivanov % DePalma % Ha 2008 (5 yr x-ray f-u)

5% Sembrano 2009 23% Bernard 1987 (1293 patients) 30% Schwarzer

6 Distribution of Pain Generators 200 patients complaining of LBP Spine 65% No cause identified = 10% 7.5% 8% SI Joint 5% 1.5% 0.5% Hip 2.5% Sembrano JN, Polly DW. How Often Is Low Back Pain Not Coming from the Back? Spine;34: 2009.

7 Patient Evaluation Clinical History is Subtle 60 % Pain usually inferior to L-5 40% At or caudal to PSIS Specific trauma or positional pain is rare Pain with prolonged sitting (also with DDD)

8 Exam DISTRACTION PATRICK S THIGH THRUST COMPRESSION GAENSLEN S SACRAL THRUST At least 3 +

9 Radiologic Testing X-rays, CT, MRI for abnormalities/asymmetry (often not helpful) Fluoroscopic or CT guided SI Joint injection (pain relief)

10 SIJ Dx Injection One injection that s at least 75% of pain 2 injections where both at least 50% of pain

11 Non-Op RX Physical therapy, manipulations/modalities NSAIDs Muscle relaxants Pelvic belt SI steroid injection

12 Fusion Candidate SI Joint pain = chronic SI Joint = primary pain generator (other primary causes ruled out) + response to diagnostic injection(s)

13 Recent Evidence Mixed for Open Fusion All Level IV Published Clinical Evidence 12 Articles Describe a wide variety of procedures Fibular allograft dowels Screws, rods, plates Anterior/posterior exposure Article Pts Results McGuire Good pain relief; Fusion = 89.5% + Kibsgard Schutz Buchowski yr = 48% good, 28% poor, 24% fair; No sig diff in ODI, VAS, SF-36 between surgery and non-surgery. LOS 25.2 days; Satisfaction = 18%; Fusion = 35% LOS 5.2 days; SF-36 sig improve; 60% would do surgery again. Giannikas Pain relief in 4 out of 5 + Belanger All fused, returned to work, satisfied All retrospective case series Berthelot All returned to work, pain relief, satisfied + Total of 261 patients Mixed results Guner LOS 10 days, fused, pain free + Moore % success. + Keating Pain decreased, improved work status. + Waisbrod % (11/21) satisfactory results. - Rand Pain relief, normal activity, fused. +

5% + Kibsgard 2012 50 Schutz 2006 17 Buchowski 2005 20 1yr = 48% good, 28% poor, 24% fair; No sig diff in ODI, VAS, SF-36 between surgery and non-surgery. LOS 25.

14 Key MIS SI Joint Fusion Articles Article N Design Results Product Level IIb Duhon Med Device Evid Res (safe & eff) 32 (outcomes) (SIFI), Prospective, multi-center, 6-mo interim results Improvement in pain, back function (ODI) and QOL (SF-36, EQ-5D) ifuse Post Long Fusion Schroeder Hosp Spec Surg J Retrospective, single-center, spine deformity adults w/prior longfusion; post-op MIS SIJ fusion results, 4-15 mo (10-avg) Improvement in back & leg pain, ODI, & scoliosis questionnaire ifuse Gaetani - J Neurosurg Sci Retrospective, single-center, 8-18 mo f/u. Improvement in pain, back function (ODI) and QOL (SF-36) ifuse Open vs. MIS Graham Smith Ann Surg Innov Res Open 114 MIS Retrospective, Open vs. MIS, 24- mo f/u MIS significantly better than open Open vs. ifuse Mason Eur Spine J Prospective, single-center, 36-mo avg f/u Improvement in pain, QOL, and pelvic specific questionnaire Bone substitute filled screws Endres Indian J Orthop Prospective analysis, single center, 13.2 mo f/u (6-24) Improvement pain and ODI DIANA cage into SIJ Cummings - Ann Surg Innov Res Retrospective, single-center, 12- mo f/u. Improvement in pain and back function ifuse Sachs - Adv Orthop Retrospective, single-center, 12- mo f/u. Improvement in pain ifuse

post-op MIS SIJ fusion results, 4-15 mo (10-avg) Improvement in back & leg pain, ODI, & scoliosis questionnaire ifuse Gaetani - J Neurosurg Sci 2013 12 Retrospective, single-center, 8-18 mo f/u.

15 Key MIS SI Joint Fusion Articles (cont.) Article N Design Results Product Safety Miller - Med Dev Evid Res Retrospective analysis, complaint database 4/2009 1/2013 Low overall complaint and revision rate ifuse Rudolf - Open Orthop J Retrospective, single-center, compares outcomes of patients with and without prior lumbar fusion, 24-mo f/u. Significant pain reduction in all groups, but no prior fusion better ifuse Sachs - Ann Surg Innov Res Retrospective, single-center, 12-mo f/u. Improved pain, high patient satisfaction ifuse McGuire Evid Based Spine Care J Retrospective, single-center, 40-mo mean f/u. Improvement in pain, most achieved fusion Allograft dowels longitudinally in SIJ Rudolf - Open Orthop J 2012 Khurana JBJS Br 2009 Wise J Spinal Disord Tech 2008 Al-khayer J Spinal Disord Tech Retrospective, single-center, 24-mo f/u. Prospective, single-center, 17-mo mean f/u. 13 Prospective, single-center, 24-mo f/u. 9 Retrospective, single center, 12-mo f/u. Rapid & sustained (mean 40mo f/u) improvement in pain, high patient satisfaction Improved QOL and pelvic scores Improvement in pain, fusion at 6mo shown by CT Improvement in pain and ODI ifuse Hollow screws across SIJ Threaded cages packed with BMP Hollow modular screws

Orthop J 2013 40 Retrospective, single-center, compares outcomes of patients with and without prior lumbar fusion, 24-mo f/u.

16 Pain Relief: Rapid & Sustained

17 Duhon Med Devices Evid Res 2013 Level IIB Safety and Midterm Effectiveness of Minimally Invasive Sacroiliac Joint Fusion: A Prospective Study Multi-center, prospective, single-arm study (SIFI NCT ) 23 sites 94 patients (32 in Effectiveness cohort, 94 in Safety cohort) Measure Baseline (n=32) Mo 6 (n=24) Change P-value* VAS SIJ pain <.0001 ODI <.0001 EQ5D SF-36 Satisfaction PCS MCS % somewhat or very % might or definitely have again (85%) 22 (85%) * Repeated measures analysis of variance (VAS, ODI, SF-36) or t test (EQ5D). A dash indicates not required in protocol

pain 76.2 29.3-48.6 <.0001 ODI 55.3 38.9-15.8 <.0001 EQ5D 43.0 65.3 +21.4 0.0006 SF-36 Satisfaction PCS MCS % somewhat or very % might or definitely have again 30.7 41.

Open versus Minimally Invasive Sacroiliac Joint Fusion: A Multi-Center Comparison of Perioperative Process Measure and Clinical Outcomes Multi-center comparative retrospective cohort study 7 sites (4

18 Open versus Minimally Invasive Sacroiliac Joint Fusion: A Multi-Center Comparison of Perioperative Process Measure and Clinical Outcomes Multi-center comparative retrospective cohort study 7 sites (4 MIS, 3 Open) 263 patients (114 MIS, 149 Open) N Open Mea n Δ N MIS Mea n Baseline month* 24- month* *p< for difference Open vs. MIS Graham Smith Ann Surg Innov Res 2013 VAS Pain Outcomes Δ

(114 MIS, 149 Open) N Open Mea n Δ N MIS Mea n Baseline 139 7.1 113 8.3 12- month* 24- month* *p<0.

19 Economics Article N Design Results Ackerman # Clinicoecon Outcomes Res ,452 Medicare Cost comparison: non-op vs. MIS SIJ fusion MIS fusion provided patient savings over nonop tx ($660 million over patients lifetime) Ackerman # Clinicoecon Outcomes Res 2014 Ackerman # J Neurosurg Spine ,533 14,552 Medicare Cost of non-op care for SIJ pathology Commercial Cost of non-op care for SIJ pathology SI joint non-op Tx = high economic burden for Medicare population SI joint non-op Tx = high economic burden for Commercial population

Res 2014 Ackerman # J Neurosurg Spine 2014 78,533 14,552 Medicare Cost of non-op care for SIJ pathology Commercial Cost of non-op care

20 MIS SI Joint Fusion is Safe and Effective Criteria ifuse Data Sources Safety Low complication rate Low complaint rate Low revision rate Low re-treatment rate Miller 2013 Graham-Smith 2013 Duhon 2013 Cummings 2014 Efficacy Pain improvement ODI improvement QOL improvement SF-12 SF-36 EQ-5D Long-Term Outcomes Graham-Smith 2013 Duhon 2013 Cummings 2014 Rudolf 2012 Rudulf 2013 Sachs 2013 Gaetani 2013

Cummings 2014 Efficacy Pain improvement ODI improvement QOL improvement SF-12 SF-36 EQ-5D Long-Term

21 Sero-Negative Spondylo-Arthropathy (Severe L buttock/groin pain)

24 SI Joint Fusion: Summary SI joint is pain generator with relatively high prevalence Correct diagnosis key (thorough SI joint exam, provocative tests, injections) Treatment options Conservative care little evidence MIS SIJ Fusion option when conservative care fails SI Joint pathology is an economic burden, cost effective options needed MIS SI joint fusion: extensive published clinical evidence for safety and efficacy AMA CPT Cat I Code

25 Thank You

Minimally Invasive Spine Surgery For Your Patients

Minimally Invasive Spine Surgery For Your Patients Lukas P. Zebala, M.D. Assistant Professor Orthopaedic and Neurological Spine Surgery Department of Orthopaedic Surgery Washington University School of