11/8/2013 Disclosures Shay Bess Pain, Disability and Adult Spinal Deformity; Old Myths, New • Consulting= Depuy/Synthes, Medtronic, Findings and Efforts from International Allosource, K2M, Alphatec Spine Study Group • Royalties= Pioneer Spine, K2M • Research support= Depuy/Synthes, Shay Bess, MD Medtronic, K2M • Scientific advisory board= Allosource 3rd Annual UCSF Techniques in Complex Spine Surgery Course Las Vegas, NV November 8-9, 2013 Adult Spinal Deformity and Disability Adult Spinal Deformity and Disability • Traditional teaching= scoliosis is • Problems Weinstein Studies not painful 1. No standardized HRQOL • “Supporting evidence” – Modified pain, depression, – Weinstein SL, et al. JAMA 2003 function and cosmesis scores – Weinstein SL. JBJS 2000 2. No sagittal analysis • Results – “It is essential that All patients= PA only – LIS =more pain and cosmetic vs community physicians and – Fundamental ASD controls the public recognize that LIS evaluation – LIS 68%= little or moderate pain is likely to cause little 3. Sagittal spinopelvic physical impairment other (similar to controls) malalignment than back pain and cosmetic – No effect on function, marital concerns.” – Foundation pain and disability status spinal deformity – Primary reason for not diagnosing pain ASD 1
11/8/2013 International Spine Study Group ISSG Structure • Site Members ASD research needs: • Independent private foundation (ISSGF 501 3c formed – Standardized clinical/radiographic OHSC Hart 2010) evaluation UC Davis Gupta, Klineberg • Online database (initiated 2009) – HRQOL correlations UCSF Ames, Deviren, – Best practice guidelines Mummaneni – Host site data entry; central data QA San Diego Akbarnia, • Clinical, economic, complications • Centralized radiographic measures (initiated 2009) Mundis, Eastlack • ISSG: Multi-center research group Colorado Bess. Line – Upload to FTP server (NYU site); measurements – 13 sites Hostin, O’Brien, Baylor SpineView software McCarthy – Evaluation & treatment ASD Kansas Burton • Personnel – Radiographic, psychological, HRQOL Johns Hopkins Kebaish – Central coordinator – Cost effectiveness Washington Univ Buchowski – Accountants and legal – Heath impact vs. disease states HSS Boachie, Kim – Preoperative planning – Health economists (JHU faculty and Baylor) NYU/HJD Lafage, Schwab – Complications Virginia Shaffrey, Smith ISSG Abstract Productivity SRS/IMAST Submissions ISSG Projects 52 1. Prospective Operative vs. NonOp for ASD 50 Submitted – Consecutive enrollment ASD (scoliosis ≥20° , SVA≥ 5cm, PT≥ 25 ° , AcceptedPodium or TK> 60 ° ) 45 40 Accepted Poster – Total =906; OP=415; NON=491 40 2. Three Column Osteotomy Database (3CO) 35 – Total =776 (data collection on going) 30 27 – Complete radiographic data=572 25 3. Proximal Junctional Failure (PJF); initiated 8/2012 19 – Retrospective analysis PJF in ASD 20 – Definition, incidence, risk factors, treatment 13 15 4. Prospective Cervical Deformity (PCD); initiated 1/1/2013 10 9 10 7 – Operative treatment adult PCD 6 6 6 6 5 5 3 5 5. Low grade adult spondylolisthesis; funding approved 2/2013 6. Cost effectiveness OP vs. NON for ASD; funding pending 0 2009 2010 2011 2012 2013 7. Root cause analysis for success and failure of ASD surgery; pending 2
11/8/2013 2012 ISSG Production and Topic Distribution; N= 27 2013 ISSG Production and Topic Distribution; N=52 SRS-Schwab ASD Pelvic Fixation 1; 4% 1; 4% 1; 2% 2; 7% Classification 6; 11% ASD Treatment/Outcomes ASD Treatment/Outcomes 10; 19% 2; 7% BMP Complications BMP Complications PJK/PJF 3; 6% PJK/PJF Health Impact ASD 7; 26% 2; 4% 2; 4% Health Impact ASD Cervical Deformity 3 Column Osteotomy Cervical Deformity 3; 6% 7; 26% Surgical Complications 5; 10% 3 Column Osteotomy Sagittal Alignment 4; 8% Surgical Complications Coronal Alignment 1; 2% 2; 7% 2; 4% Economics Coronal Alignment Psychology/Mental Health 1; 4% 6; 12% Economics 6; 12% 1; 4% 3; 11% MIS for ASD Background Information Health Impact Comparison of Different • SF-36 for ASD Disease States and Population Norms to – Little data comparing disease impact ASD vs. other disease states Adult Spinal Deformity (ASD): A Call for • Study Purpose Medical Attention – Use SF-36 baseline values Kai-Ming Fu MD, Shay Bess MD, Frank Schwab MD, Christopher – Consecutive cohort ASD patients Shaffrey MD, Virgine Lafage PhD, Justin Smith MD, Christopher Ames – No prior spine surgery MD, Oheneba Boachie-Adjei MD, Douglas Burton MD, Robert Hart MD, – Compare ASD SF-36 values Eric Klineberg MD, Richard Hostin MD, Gregory Mundis MD, Praveen Mummaneni MD, and the International Spine Study Group . • United States general population North American Spine Society 2012 (Best Paper Nominee) • United States generational norms Scoliosis Research Socitey 2012 • United States disease specific American Academy of Orthopaedic Surgeons 2013 norms American Academy of Neurosurgery 2012 – Compare disease impact using MCID AANS/CNS Joint Section 2013 values 3
11/8/2013 Results: Total Materials and Methods • ASD Demographic & • Data collection Radiographic – N=497 – Demographic, radiographic, ASD (n=497) Mean values (SD) Generational ASD US PCS ASD US MCS – Age 50.4 years Age; years 50.4 (16.9) HRQOL Age Groups PCS; Population Difference MCS; Population difference (n=total ASD NBS PCS; NBS (percentile NBS MCS; NBS – Scoliosis= 45.3 ° BMI 25.6 (6.4) patients) value value US general value value • ASD SF-36 (SD) population) (SD) SVA; mm 19.9 (58.1) – PT= 18.8 ° 18-24 years 51.3 53.5 -2.2 48.2 46.1 +2.2 (n=42) (8) PT; degrees (<50 th ) (10.5) 18.8 (10.2) – Physical component score (PCS) – SVA= 19.9mm 25-34 years 46.9 PT-LL mismatch; 53.6 -6.7 50.8 4.21 (17.6) 49.1 +1.7 – Mental component score (MCS) (<25 th ) (n=75) (9.2) degrees (9.6) • ASD vs. U.S. total 35-44 years 42.3 52.3 -10 49.7 49.1 +0.6 Maximal scoliosis; 45.3 (18.3) – Compared to United States (US) population (n=52) (9.5) (<25 th ) (9.0) degrees – PCS=-9 NBS (3 MCID) 45-54 years 41.9 49.7 -7.8 50.4 50.6 -0.2 • Total population norms SF-36 PCS 40.8 (11.2) (n=88) (10.5) (<25 th ) (10.9) – MCS= similar SF-36 MCS 49.4 (11.3) 55-64 years 38.7 47.4 -8.7 47.1 51.6 -4.5 • Age generational norms (n=138) (10.6) ODI (<25 th ) (13.1) 27.0 (18.6) • ASD vs. U.S. generational SRS-22; total score 3.39 (0.7) • Disease specific norms 65-74 years 33.6 44.7 -11.1 50.9 52.8 -1.9 norms: PCS (n=73) (10.3) (<25 th ) (11.7) SRS-22r; function 3.40 (0.8) – Minimum 2 MCID lower – Norm based scoring (NBS) ≥75 years 31.7 39.9 -8.2 52.8 50.2 +2.6 SRS-22r; pain 2.94 (0.7) (<25 th ) (n=29) (9.5) (8.5) – <25 th percentile SRS-22r; self-image 3.31 (0.8) – MCID values (cross-sectional) Total 40.9 50 -9.1 49.4 50 -0.6 – All generations except population (11.2) (<25 th ) (11.3) • PCS= 3 NBS points (n=497) SRS-22; mental health 3.86 (0.8) 18-24yrs; (-2.2 NBS) • MCS= 3 NBS points – More rapid decline than Leg Pain; NRS 2.63 (3.1) U.S. general Results: ASD No Other Comorbidities Results: ASD vs. U.S. Disease Norms • ASD vs. U.S Healthy and • ASD No Other Generational ASD PCS; US General PCS Difference ASD MCS: US General Disease State PCS; MCS; Age Groups NBS Population (percentile US NBS value Population Disease Norms mean mean (n=total ASD value (SD) PCS; NBS general (SD) MCS; NBS Comorbidities vs. U.S. patients) value population) value NBS NBS • PCS Total and Generational points points 18-24 years 52.7 53.5 -0.8 (<50 th ) 48.8 46.1 – Healthy US<14.5 NBS Norms (n=30) (7.3) (10.7) US Total Population 50 49.9 -6.5 (<25 th ) 25-34 years 46.8 53.6 51.2 (8.9) 49.1 • PCS (4 MCID ) (n=58) (9.6) US Healthy Population 55.4 52.9 – Back pain/Sciatica – Minimum one MCID 35-44 years 43.2 52.3 -9.1 (<25 th ) 50.2 (9.6) 49.1 ASD 40.9 49.4 (n=34) (10.3) <4.8 NBS (one MCID) lower U.S. norms 45-54 years 43.2 49.7 -6.5 (<25 th ) 49.9 (11.3) 50.6 Back Pain 45.7 47.6 (n=47) (10.8) – Hypertension<3.1 NBS – <25 th percentile 55-64 years 42.4 47.4 -5.0 (<25 th ) 48.9 (11.4) 51.6 Cancer 40.9 47.6 (one MCID) (n=57) (9.7) – ASD generations 65-74 years 35.8 44.7 -8.9 (<25 th ) 51.9 52.8 – Similar Depression 45.4 36.3 (except 18-24 yr) (n=14) (11.1) (12.2) • Cancer Diabetes 41.1 47.8 ≥75 years -3.1 (<25 th ) – More rapid decline 36.8 39.9 51.4 (9.3) 50.2 (n=6) (10.8) • Diabetes Heart Disease 38.9 48.3 than U.S. general Total 44.4 50 -5.6 (<25 th ) 50.2 50 population (10.5) (10.5) • MCS • Heart disease Hypertension 44.0 49.7 (n=246) – Similar • Limited use arms or Limited Use Arms 39.0 43.0 Legs legs Lung Disease 38.3 45.6 • Lung disease 4
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