SI Joint Burden of Disease

Transcription

1 SI Joint Burden of Disease David W. Polly, Jr., MD James W. Ogilvie Professor and Chief of Spine Surgery Catherine Mills Davis endowed chair Department of Orthopaedic Surgery Professor of Neurosurgery (w) University of Minnesota Past President Scoliosis Research Society Board of Councilors and Board of Specialty Societies American Academy of Orthopaedic Surgeons Board of Directors Minnesota Orthopaedic Society Disclosures I have no industry conflicts I was an investigator in an industry sponsored clinical trial (INSITE SI Bone) Is It A Problem? Low back pain- a significant national burden of disease Greatest source of disability in the working age population SI joint accounts for 15-22% of LBP It is very debilitating 1

2 SI Joint Pain vs. Other Common Orthopedic Conditions 2

3 SI Joint Pain Has Comparatively Low Quality of Life Misdiagnosing LBP is Costly $ 13.3B* ~325,000 lumbar fusions (LF) annually in US (~$41K each) 1 $ 2.3B* ~17% of LF patients potentially misdiagnosed 2 $ 5.3B* 40% LFs do not relieve pain/disability 3 $ 5-30K Annual SI joint NSM costs 2 : Without prior LF: $5,258 / patient / year With LF: $30,573 / patient / year $50-80K 2-year cost of care for failed back surgery 4,5 Misdiagnosis is very common Cost of ignoring SIJ during LBP assessment: $3,100/pt/2 yrs Misdiagnosis is very expensive: wrong surgery, expensive side effects Costs of non-coverage = Misdiagnosis/Wrong Surgery + Ineffective NSM 1. idata Research Inc., US Market for Sacroiliac Joint Disorders and Fusion, Ackerman Clinicoecon Outcomes Res 2014;6: PMA Approval InFUSE Bone Graft/LT-CAGE Lumbar Tapered Fusion Devices - P000058; July 2, Hollingworth Spine Lad Spine 2014 * Calculations: 325,000 x $41,000 = $13,325,000; $13.3B x 0.17 = $2.3B; $13.3B x 0.40 = $5.3B 8 3

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6 Burden of Disease SI joint pain is fairly common SI joint pain is very debilitating Misdiagnosis resulting in wrong treatment is expensive 6

7 1/17/2018 SIJ Fusion Review of Clinical Outcomes Jonathan N. Sembrano MD Associate Professor in Orthopaedic Surgery University of Minnesota SIJ Fusion Webinar Lumbar Spine Research Society January 18, 2018 Disclosures Research support: SI-Bone: INSITE (Investigation of Sacroiliac Fusion Treatment) site PI (study now closed) Zyga: Biomechanical study on SIJ fixation PI (completed) NuVasive: IGA studies (Integrated Global Alignment) - site PI (ongoing) AO Spine: PEEDS (Prospective Evaluation of Elderly Spinal Deformity Study) site PI (ongoing) When does a procedure become MIS? Practically every paper describing a new technique or modification of a known technique claims to be less invasive. Even before the recent explosion of MIS SIJ fusion systems, there have been attempts at performing SIJ fusion less invasively. 1

8 1/17/2018 Earliest report (1995) Single case report. 42/m with intra-articular osteochondroma Removed lesion, packed with iliac crest autograft (harvested separately). LOS = 10 days Transient L5-S1 numbness x 2 wks At 1 yr pain-free CONCLUSION: Encouraging result, recommend technique. Percutaneous Fusion Cages (2008) PROSPECTIVE 13 patients, 19 joints Posterior perc cage insertion, with BMP (2.1mg/cage) x 2 VAS back and leg pain improved 10/13 (77%) would do it again 17/19 solid fusion at 6mo CT; 1 nonunion revised NO other complications Conclusion: safe and efficacious Percutaneous Hollow Modular Anchorage (HMA) Screws Al Khayer et al, Khurana et al,

9 1/17/2018 Percutaneous Hollow Modular Anchorage (HMA) Screws Al Khayer et al, Level IV N=9 pxs, 12 joints Single HMA screw packed with bone reaming and DBM 1 infxn I&D, abx VAS improved ODI improved 59 45; deteriorated in one. 100% would do it again May offer safe and effective treatment for intractable SIJ pain Khurana et al, Level IV N=15 pxs, 19 joints Two HMA screws packed with DBM No complications SF-36 improved (PF 37 80; GH 53 86) Majeed: 13/15 good-excellent Satisfactory method of achieving SI fusion Ingrowth Titanium Rods Ingrowth Titanium Rods Level I (MIS vs Nonop care) Polly D, in press [INSITE 1 yr] Whang P, 2015 [INSITE 6 mos] Level II Duhon B, 2013 [SIFI 6 mos] Level III (w/ vs w/o previous lumbar fusion) Rudolf L, 2013 Level III (Open vs MIS) Graham-Smith A, 2013 Ledonio C, 2014 Level IV Rudolf L, 2012 Sachs D, 2012 Cummings J,

10 1/17/2018 Level IV Studies Author Rudolf (2012) Sachs (2012) Cummings (2013) Patients (joints) Op time; EBL 50 (55) 65 min; <50cc in all 11 (12) 78 min; <50cc in all F/u Results Complications 40 mos (24-56) 12 mos 18 (18) NR 12 mos Pain 7.6 (preop), 3.9 (3mo), 4.3 (12mo), 5.6 (40mo) Satisfaction 82% (12mo) Pain 7.9 to 2.3 (12mo) Satisfaction 100% VAS improved by 6.6 ODI improved by 37.5 Satisfaction 95% 4 (8%) reop rate at 3 yrs 10 (20%) periop complications (3 cellulitis, 1 deep infxn, 2 hematomas, 1 implant penetration into foramen, 1 nondisplaced fracture, 1 late loosening 1piriformis synd (PT); 1 LBP (facet inj) 1 explant at 3mo for malposition; 1 fluid retention; 3 troch bursitis; 1 toe numbness; 1 hematoma; 1 new radicular sxs Level III N=40 Grp NF = 18 no previous spinal fusion Grp PF = 15 previous spinal fusion Grp LP = 7 with lumbar pathology treated nonop Op time similar F/u 24 mos Final pain score: NF 2.99; PF 3.50; LP 4.28 Satisfaction: NF 89%; PF 92%; LP 63% Conclusion: Presence of symptomatic lumbar pathology potentially confounds treatment effect, as patients may not be able to discriminate between symptoms arising from SI joint and spine. Level III Open vs MIS Graham-Smith, 2013 N=149 open vs 114 MIS Op time: 163 vs 70 min (MIS) EBL: 288 vs 33cc (MIS) LOS: 5.1 vs 1.3 days (MIS) ODI (preop 12mo 24mo): Open: MIS: No. reaching MCID and SCB higher in MIS at 12 and 24 mos Postop complications: open 21% vs MIS 18% Conclusion: MIS results in more favorable periop, measures, fewer reops, and significantly improved clinical outcomes. Ledonio C, 2014 N=22 open vs 22 MIS (propensitymatched) Op time: 128 vs 68 min (MIS) EBL: 681 vs 41cc (MIS) LOS: 3.3 vs 2.0 days (MIS) F/u 12 mos Final ODI similar: 47 (open) vs 54 (MIS) ODI improved by 19.8 (open) vs 12 (MIS) Conclusion: EBL, op time, LOS favored MIS. ODI similar. 4

11 1/17/2018 Level II SIFI (SI Fusion with ifuse Implant) Duhon BS et al, Med Devices, N=26/94 had 6 month f/u Op time = 48.2 min; EBL = 59 cc; LOS = 0.79 days VAS improved by 4.9 ODI improved by 15.8 (55.3 to 38.9) Only 90% of patient ambulatory at baseline regained full ambulation by 6 months. (myelopathy, back pain, cholecystitis) 23 AE s within 1 st month; 29 more after; 6 severe AE s but none device-related Mid-term follow-up after MIS SIJ fusion indicates high rate of improvement in pain and function with high rates of satisfaction Level I INSITE (Investigation of Sacroiliac Fusion Treatment) N=102 (128) Surg group vs 46 NSM group Op time = 45 mins; Fluoro time = 2.5 mins; EBL = 33cc; LOS median 1 day Success rate (>20mm VAS improvement, NO AE, NO revision): 81.4% (Surg) vs 23.9% (NSM) ODI MCID reached in 75% (Surg) vs 27.3% (NSM) VAS improved 82.3 to 29.8 (Surg) vs 82.2 to 70.4 (NSM) Total AE s 181; 27 severe (21 Surg vs 6 NSM). Events per subject: 1.3 (Surg) vs 1.0 (NSM) In patients with severe SIJ pain, MIS SIJ fusion using triangular titanium implants placed across the joint provides superior six month outcomes compared to non-surgical management INSITE 1 yr (in press) Polly DW et al. NSM patients allowed to cross over after 6 mos 35/44 (80%) of NSM patients crossed over and underwent surgery Good 6mo outcomes in Surg group was maintained at 12 mos SIJ Pain: ODI: Crossover patients also improved similar to Surg group SIJ Pain: (6mo) ODI: (6mo) Conclusion: In carefully selected patients with SIJ dysfunction, MIS SIJ fusion provides superior 6-month outcomes over NSM, that are maintained at 12 months. 5

12 1/17/2018 Summary Published MIS SIJ fusion outcomes appear very promising High-level studies are now being conducted and published Limitations: Publication bias? Industry sponsored studies, authors with conflicts of interest Future Directions Current lack of: High-level studies with LONG-TERM outcomes High-level non-industry sponsored studies Comparison of different MIS techniques Joint decortication and grafting vs ingrowth implants Prospective Open vs MIS techniques Thank You! 6

13 1/16/2018 Vikas V. Patel, MA. MD. BSME. Professor, University of Colorado Chief, Orthopaedic Spine Surgery Fellowship Director Significant Unmet Clinical Need 12 million office visits/year in the US for Lower Back Pain (LBP) 25% of LBP patients have significant pain coming from their hip and/or SI Joints Sembrano & Polly, million spinal fusion procedures annually Success rate of surgical treatment of LBP varies from 35% to 89% Sembrano and Polly, % Spine 65% 8% 7.5% 1.5% SI Joint Hip 0.5% 2.5% 2 3 Current SIJ Research: 15-30% of LBP comes from the SI Joint 22.5% of patients with reported LBP had SIJ pain Bernard & Kirkaldy-Willis, % of LBP SIJ in origin, but diagnosis of SIJ disease frequently overlooked Cohen SP. Anesth & Analgesia % incidence of SIJ pain in LBP patients Schwarzer AC. Spine % incidence of SIJ pain in LBP patients Maigne JY. Spine % incidence of SIJ pain in LBP patients Irwin RW. Am J Phys Med Rehabil % of LBP patients have significant pain coming from their hip and/or SI Joints Sembrano & Polly, % of LBP comes from the SI Joint 1

14 1/16/2018 SIJ often overlooked in Spectrum of LBP 4 LBP exam Typically no complete exam of SI Joint Provocative pain tests for SI Joint Not utilized regularly Spine surgeons approach to SI joint pain Rarely included in differential diagnosis Treatment too invasive If you can t treat it, you don t look for it. First you have to believe then you have to be aware 2

15 1/16/2018 Awareness When taking a history On Physical Exam When ordering tests Proprietary and Confidential. 8 SI Joint Diagnostic Challenges SI joint symptoms are similar to those of other lumbar spine and hip conditions Imaging studies often inconclusive Referral pain patterns from the three structures overlap (Lumbar Spine SI Hip) Proprietary and Confidential. 9 Overlapping Pain Referral Patterns Disc Facet SI Joint SIJ-related pain patterns can be similar to the L5 and S1 dermatome areas 1-5 1) Buijs 2007; 2) Bernard 1997; 3) Slipman 2001; 4) Fortin 2003; 5) Visser

16 1/16/2018 Algorithm for SI Joint Complaints 10 History Physical Exam Rule in and rule out pathologies Injection, injection, injection History 11 Low back pain (below L5) Buttock/Pelvis pain Hip/groin pain Lower extremity pain (numbness, tingling, weakness) Feeling of instability Poor sleep habits Sitting problems History - functional Painful Ascending/Descending Stairs Transitional movements (e.g., sit to stand, supine to sit) Getting out of car Getting in /out of bed Sitting on affected side Relieving Bearing weight on unaffected side Lying on unaffected side Manual or belt stabilization Walking Lying Down Prolonged standing/sitting 4

17 1/16/2018 Pain Localization 13 Fortin Finger Test 1 Point to pain while standing 1. Able to localize pain with one finger 2. Within 1 cm of PSIS (inferomedial) 3. Consistent over at least 2 trials Tenderness over SIJ sulcus Posterior SIJ tender to palpation Not sitting on affected side. From Forst SL et al. Pain Physician Fortin JD. Am J Orthop 1997;26(7): Proprietary and Confidential. SI Joint Provocative Tests 14 Distraction Compression Thigh Thrust Gaenslen FABER 3 of 5 positive tests provides discriminative power for diagnosing SI joint pain Szadek J Pain 2009 Laslett J Man Manip Ther 2008 Proprietary and Confidential. 15 SI Joint: Provocative Tests 1. Distraction* (Highest PPV**) 2. Thigh Thrust* 3. FABER 4. Compression* 5. Gaenslen s Maneuver Laslett 1,2 Szadek 3 3 or more positive tests Sensitivity 91% 85% Specificity 78% 76% * Most sensitive of tests ** PPV = positive predictive value 1. Laslett Man Ther Laslett J Man Manip Ther Szadek J Pain

18 1/16/2018 SI Joint Diagnostic Injection Proprietary and Confidential. 16 Proprietary and Confidential. 17 SI Joint Diagnosis Based on 4 components: 1. Positive subjective history 2. Lumbar, hip and SI joint exam 3. Positive SI joint provocative testing 4. Positive response to intra-articular injection Establishing a working relationship with your injectionist is the key to diagnosing these patients Proprietary and Confidential. 18 Injection Protocol Surgeon should be well-versed on the types of injections Work with injectionist to determine best protocol for the patients Discussion should include Types of injections: Therapeutic vs. Diagnostic Amount of anesthetic and contrast volume: < 2.5 ml Pre- and post-injection evaluation Documentation Patient messaging 6

19 1/16/2018 Diagnostic Injection Protocol Pre-injection evaluation and preparation Provocative maneuvers/functional movements Patients need to be aware of diagnostic nature of injection!!! Image guided SI joint injection (fluro/ct) Confirm contrast in joint Post-Injection Evaluation Repeat provocative maneuvers/functional movements Document % of SI joint pain relief Document duration of SI joint pain relief Critical if using a differential diagnostic block protocol 19 Diagnostic Injection Confirmation 20 Assessment: Post-Injection Positive clinical response 50% VAS reduction during anesthetic phase indicates positive diagnosis of SI joint as pain generator. Relief during previously painful functional activities Minimal or no relief < 50% May have SI joint pain, but consider other pain sources. 21 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; 7

20 1/16/2018 Beware of inadequate injections I prefer at least 1 CT guided injection 100% confidence of intra-articular 8

21 1/16/2018 SI Joint Pain Treatment Non Steroid Anti-Inflammatory Drugs (NSAIDS) Chiropractic Manipulation Physical Therapy Loosen/Stretch for hypomobility Strengthen for hypermobility Pelvic Belt Others: Prolotherapy, RF ablation, Rolfing, etc. Steroid injections Last Resort: Fusion 25 I do not feel comfortable with the dangers: Complex Pelvic Anatomy, Soft Tissue Dangers Makes more sense to use navigation 9

22 1/16/2018 Experience to date Over 100 Patients All treated with navigation Multiple modifications of insertion technique 2 guide pin breakages, none in the last 75 patients Developed Mini-Open Fusion and Grafting Technique 10

23 1/16/2018 Results (first 50 Patients) : VAS VAS SI joint pain mean (SD) improvement from baseline (SD) P-value pre-op baseline 6.2 (1.8) weeks 2.9 (2.0) 3.2 (2.0) < months 2.0 (2.2) 4.2 (2.4) < months 1.9 (2.5) 4.3 (3.1) < months 0.5 (0.6) 5.1 (2.4) < Results: ODI ODI for SI joint pain mean (SD) improvement from baseline (SD) P-value pre-op baseline 48.9 (16.1) weeks 42.5 (15.8) 4.0 (9.1) months 32.9 (10.6) 18.8 (12.8) months 28.3 (11.2) 16.5 (4.6) months 22.3 (14.2) 23.2 (15.1) Research Denver SI Joint Questionnaire: DSIJQ Validation Study Clinical Trials SIFI, INSITE 11

24 1/16/2018 Conclusions SI Joint pain is real Awareness and Diagnosis is key New MIS treatments options are very successful When it comes to the SI Joint, Don t do this! Thank You! 12

25 LSRS Sacroiliac Joint Fusion Webinar: SIJ and Trauma, The Dysmorphic Sacrum William W. Cross III, MD Division of Orthopedic Trauma Department of Orthopedic Surgery 2017 MFMER slide-1 Disclosures Independent Device Design contract with Mayo Clinic Ventures and CoorsTek Medical 2017 MFMER slide-2 Outline The sacrum and the trauma surgeon or how I got into treating SI joint mediated pain Acute injuries to the SI joint Post-traumatic sequellae 2017 MFMER slide-3 1

26 /15/2018 Sacroiliac Joint Trauma Studies MFMER slide Sacroiliac Joint Pain Studies MFMER slide-5 Trauma surgeon to SI disease Grand Rounds talk to Mayo Orthopedics MFMER slide-6 2

27 2017 MFMER slide-7 Trauma Correlates to SI joint pathology Pelvic Ring Injuries: Young and Burgess 2017 MFMER slide-8 Unique anatomy and stability of the SI joint: Posterior ligaments Surgical Atlas of the Musculoskeletal System, , MFMER AAOS slide-9 3

28 Unique anatomy and stability of the SI joint: Anterior ligaments Surgical Atlas of the Musculoskeletal System, , MFMER AAOS slide-10 Unique anatomy and stability of the SI joint: Interosseus ligaments 2017 MFMER slide-11 Unique anatomy and stability of the SI joint: Neurology AP 2017 MFMER slide-12 4

29 Unique anatomy and stability of the SI joint: Neurology Oblique (iliac oblique) 2017 MFMER slide-13 Treatment and Surgical Approaches Type 1: Nonop, ORIF anterior ring Type 2: ORIF anterior ring followed by posterior pelvic ring fixation SI screws 1 vs MFMER slide-14 Treatment and Surgical Approaches Type 3: Traction, ORIF of SI joint, fixation of anterior ring, SI screw (s) Vertical Shear: Traction, ORIF of SI joint, fixation of anterior ring, SI screw (s) 2017 MFMER slide-15 5

30 Surgical Approaches Anterior Approach Pfannenstiel incision approach Lateral window Ilioinguinal approach lateral window Lateral, Middle, Medial Lateral, Vascular, Stoppa 2017 MFMER slide-16 Lateral Window 2017 MFMER slide MFMER slide-18 6

31 2017 MFMER slide-19 Imaging for Treatment 2017 MFMER slide MFMER slide-21 7

32 SI joint visualization 3 primary imaging techniques Outlet imaging: Cranial Caudal Inlet imaging: Anterior Posterior Lateral imaging: iliac cortical density 2017 MFMER slide-22 Outlet imaging: Cranial-Caudal movements 2017 MFMER slide MFMER slide-24 8

33 Inlet imaging: Anterior-posterior movements 2017 MFMER slide MFMER slide-26 Inlet View Anterior- Posterior adjustment 2017 MFMER slide-27 9

34 Outlet View Cranial Caudal Adjustment 2017 MFMER slide-28 Lateral View Assurance that you are behind the Iliac cortical density (L5) Line up greater sciatic notches for true lateral 2017 MFMER slide-29 Goals of treatment Stable pelvic ring Type 3, VS: anatomic reduction 2017 MFMER slide-30 10

35 23 patients Pure vertical shear pelvic ring injuries Only factor that matters: ANATOMIC REDUCTION OPEN REDUCTION NECESSARY 2017 MFMER slide-31 Less than anatomic reduction, Natural History Post-traumatic arthritis 2017 MFMER slide MFMER slide-33 11

36 2017 MFMER slide total pts (746 SI joints) included Mean age: 57 years 181 females, 192 males Defined degeneration in SI Joints Type 0: None Type 1: Bilateral, minimal changes Type 2: Unilateral, significant, without ankylosis Type 3: SI joint ankylosis 2017 MFMER slide MFMER slide-36 12

37 Sacral dysmorphism Recognition and Implications 2017 MFMER slide-37 Key Imaging Recognition: Dysmorphism 2017 MFMER slide-38 Sacral Dysmorphism 30-40% of adult patients Upper Sacral Segment Lower Sacral Segment Radiographic signs: Outlet radiograph 1. Near co-linearity of the iliac crest at level of lumbosacral disc space 2. Obliquely oriented residual transverse process on sacral ala 3. Noncircular, misshapen first sacral anterior neural tunnel exits 4. A residual disc space between upper two sacral segments 5. Acute sacral alar slopes 2017 MFMER slide-39 13

38 Sacral Dysmorphism Radiographic signs on CT 1. Undulating tongue-in-groove sacroiliac articulations 2. Acutely sloped sacral ala Iliac Cortical Densities (ICDs) unreliable intraoperatively 2017 MFMER slide MFMER slide-41 Dysmorphic Sacrum CT axial 2017 MFMER slide-42 14

39 2017 MFMER slide MFMER slide MFMER slide-45 15

40 2017 MFMER slide MFMER slide MFMER slide-48 16

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45 2017 MFMER slide-61 Normal Standard Sacrum 2017 MFMER slide MFMER slide-63 21

46 2017 MFMER slide MFMER slide MFMER slide-66 22

47 2017 MFMER slide MFMER slide MFMER slide-69 23

48 2017 MFMER slide MFMER slide MFMER slide-72 24

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52 2017 MFMER slide MFMER slide MFMER slide-84 28

53 2017 MFMER slide MFMER slide MFMER slide-87 29

54 2017 MFMER slide MFMER slide-89 Implant ramifications Normal outlet implant Dysmorphic sacrum implant 2017 MFMER slide-90 30

55 Summary Acute Trauma Current standard is anatomic reduction with ORIF Post-traumatic sequellae High likelihood of arthritis on imaging QUESTION: Symptomatic or not Dysmorphic Sacra RECOGNITION Neurovascular risks greatly increase 2017 MFMER slide-91 31

56 Revision Strategies David W. Polly, Jr., MD James W. Ogilvie Professor and Chief of Spine Surgery Catherine Mills Davis endowed chair Department of Orthopaedic Surgery Professor of Neurosurgery (w) University of Minnesota Past President Scoliosis Research Society Board of Councilors and Board of Specialty Societies American Academy of Orthopaedic Surgeons Board of Directors Minnesota Orthopaedic Society Failure Is ALWAYS on the Sacral Side Halo + Reactive Sclerotic Rind at Sacral Tip 1

57 Is This the Symptom Generator? Not all patients with this finding are significantly symptomatic But if they are- Rule out other sources Same physical exam maneuvers CT guided SI injection Stop pain meds before Do activities that flare the symptoms Have injection Repeat activities that flare the symptoms Grade response Things I have Tried Plate anterior symphysis Remove transiliac implants bone graft and screw fixation Augment with smaller implants Remove implants bone graft screw fixation and anterior ilioinguinal approach and autograft What Level of Response to the Block is Positive????? Intl J Spine Surg

58 MW: 49 yo F Pre-operative XR 10/6/2011 3

59 MW: 49 yo F Post-operative XR 1/6/2012 MW: 49 yo F Post-operative XR 5/16/2013 MW: 49 yo F Post-operative XR 4/24/2014 4

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69 Revision Summary Confirm that the SI joint is the pain generator Find a way to stabilize the joint as well as possible Achieve adequate biology for healing Clinical results, as expected, are not as good as primaries but can be better than the severe disability of the untreated condition 14