When to operate on Adult Scoliosis patients and when to say ‘No’ Frank Schwab, MD Jean-Pierre Farcy, MD New York University School of Medicine NYU-Hospital for Joint Diseases Department of Orthopaedic Surgery What is Adult Scoliosis? What is Adult Scoliosis? • Coronal plane deformity • Sagittal plane deformity • Imbalance/malalignment – Focal – Regional – Global Adolescent deformity in an adult AISA De-novo deformity…of aging DDS Scoliosis Prevalence – AIS 2-4% of screened pediatric population – Adult >60% of screened elderly population# Demographics : Life expectancy, birth rates…. Significant growth of aging population segment # Schwab et al. SPINE 2005 May 1;30(9):1082-5 Adolescent Idiopathic Scoliosis: surgical treatment Curve severity • Cobb angle • progression Classification • Lenke • King Skeletal maturity • Risser sign Curve pattern • apex • distribution • sagittal • overhang Surgical strategy Adult Scoliosis Scoliosis: treatment approach Curve severity • Cobb angle • progression Skeletal maturity • Risser sign Classification ? Cosmesis Pain Disability PT Pain Mgmt Bracing Surgery The aging spine Spine skeletal maturity 30’s disc degen. MRI changes 50’s facet DJD disc collapse Stable spine ankylosis Unfavorable degeneration stenosis spondylo deformity Adult Scoliosis Progressive collapse Stable ankylosis Adult Scoliosis / Deformity What are the disability / pain generators ? 98 patients (Schwab,Farcy. SPINE 2004) • adult scoliosis, all levels • SF-36 • radiographic-clinical analysis 325 patients (Schwab, Farcy. SDSG. SRS 2004) • thoracolumbar/lumbar scoliosis • SRS instrument, ODI • radiographic-clinical correlation Adult Scoliosis : Clinical impact • Significant – – – – Spondylolisthesis Lateral Subluxation Lumbar lordosis Thoracolumbar alignment – Apical level – Sagittal Balance (SVA) • Not significant – Coronal Cobb – Age – Adolescent vs. de-novo degenerative scoliosis Statistically significant: SRS-22, ODI, SF-12/36 Adult Scoliosis: the disability / pain generators plain radiographs • • • • Apical level of deformity (lumbar dominant) Lumbar lordosis T12-S1 Maximal intervertebral subluxation (frontal/sagittal) Sagittal balance (PlC7-S1 offset) Selected for high clinical impact: SRS, ODI, SF-36 (excluding fractures or other pathologies…) Classification of Adult Deformity Schwab et al. SPINE 2006 Type I II III IV V Type K thoracic-only curve (no other curves) upper thoracic major, apex T4-8 lower thoracic major, apex T9-T10 thoracolumbar major curve, apex T11-L1 lumbar major curve, apex L2-L4 no scoli (<100), principal sagittal plane deformity Lumbar Lordosis Modifier A B C marked lordosis >400 moderate lordosis 0-400 no lordosis present Cobb >00 Subluxation Modifier 0 + ++ no intervertebral subluxation any level maximal measured subluxation 1-6mm maximal subluxation >7mm Sagittal Balance Modifier N P VP normal, <4cm positive SVA positive, 4-9.5cm very positive, >9.5cm Adult Scoliosis 947 patients: (86% female, 14% male) Average age 48 years (SD 18) Coronal Cobb mean 460 (SD 19) ODI Lordosis Lordosis modifier A (< -40) Lordosis modifier C ( >= 0) Subluxation Subluxation Modifier 0 Subluxation Modifier ++ Global Balance Oswestry Mean SD p = 0.002 27 19 37 16 Oswestry Mean SD p < 0.001 27 20 34 18 SRS SRS Function Mean SD p < 0.001 69 17 57 15 SRS Function Mean SD p < 0.001 68 18 63 16 SRS Pain Mean SD p = 0.007 65 20 56 17 SRS Pain Mean SD p < 0.001 64 20 58 19 Adult Scoliosis / Deformity Thus….deformity = disability ? Yes, certain aspects … Focal: subluxation Regional: loss of lordosis Global: sagittal imbalance … Not coronal Cobb angle Coronal/Sagittal Sagittal plane Adult Scoliosis / Deformity: Why surgery ? Young adult: AISA >500 thoracic >300 lumbar (progressive) Curve progression likely – Disability later (potential) – More difficult to treat later • Depending upon age – Surgical risks greater later Progression with disability Cosmetic concerns Weinstein S,. Spine 24(24), 1999 Adult Scoliosis / Deformity: Why surgery ? Older Adult: AISA = DDS Pain unacceptable Disability unacceptable Pain/disability failed conservative care Risk/Benefit ratio - favorable Adult Scoliosis / Deformity If the justification for surgery is acceptable…. …..when is it really reasonable to operate ? Don’t do it Sure success Adult Scoliosis / Deformity Not a candidate for surgery: – – – – young AISA…no disability, mild/mod curve, happy patient who does not want surgery patient is unlikely to survive surgery patient does not understand risk/benefit • unrealistic expectations – planned operation is not reasonable • experience, team, environment Adult Scoliosis / Deformity Possibly Excellent candidate for surgery: – young AISA…progressive, severe curve (>700) DDS or AISA older adult: Perfectly isolated pain generator, failed extensive non-operative care • Well informed, wishes to pursue operative care • Excellent health • Realistic expectations, highly motivated – team has abundant experience only excellent results with planned intervention Adult Scoliosis / Deformity The common cases: • • • • • • Patient might consider surgery with certain assurances Health is acceptable (not ideal), Pain generators present (there are several), Non-operative care tried (variable participation and response), Expectations are overall rather realistic. The surgeon comfortable with intervention ? When to operate on Adult Scoliosis patients and when to say No How can we select the best patients for surgery ? (and how to optimize the chances of a successful outcome) • non-operative care vs. surgery • If surgery…which strategy/approach – Specific treatment algorithms lacking – few studies to guide us….where is the data ? Adult Scoliosis: Thoracolumbar / Lumbar Deformity Who gets surgery…and what type ? (n=809) Operative rates – Lordosis • Lost lordosis vs. good lordosis (B vs. A) 51% vs 37%, p<0.05 – Subluxation modifier • Marked subluxation vs. none (++ vs. 0) 52% vs. 36 %, p<0.05 – Sagittal Balance • Well balanced versus marked imbalance (N vs. VP) 39% vs.59%, p<0.05 Adult Scoliosis: Thoracolumbar / Lumbar Deformity Who gets surgery…and what type ? Use of osteotomies Lordosis >400 lordo vs. no lordo : 25% vs. 50% p=0.01 Sagittal balance no imbalance vs. >9.5cm : 25% vs. 53% p=0.01 Surgical Approach Anterior only: no lost lordosis, no subluxation Circumferential: some lost lordosis, marked subluxation Posterior only: marked loss of lordosis, marked sagittal imbalance Fusion to sacrum Lordosis Sagittal Balance Loss of lordosis more likely fusion to sacrum (p = .041) increasing positive balance: more fixation to sacrum. (<4cm: 59%, 4-9.5cm: 80%, >9.5cm: 88%) (all p<0.05) Adult Scoliosis: Thoracolumbar / Lumbar Deformity How about surgical outcomes ? • • • • 111patients 1-year follow up 45 patients 2-year follow up Adult Thoracolumbar / Lumbar major curves Surgical treatment, complete data – Full-length standing x-rays (0,12,24 months) – SRS, ODI, SF-12 2-year Surgical outcome: Lordosis modifier Lumbar Lordosis Modifier A B C marked lordosis >400 moderate lordosis 0-400 no lordosis present Cobb >00 Mean SRS Total Score at Baseline and Two Years by Lordosis Modifier 80 70 60 Mean Score 50 Marked Lordosis Moderate Lordosis No Lordosis 40 30 20 10 0 Baseline Two Year Measurement Period Lordosis modifier ‘C’…most improved 2-year Surgical outcome: sagittal balance (surgical approach) Sagittal Balance Modifier N P VP normal, <4cm positive SVA positive, 4-9.5cm very positive, >9.5cm Mean Oswestry Disability Index at Baseline and Two Years by Sagittal Balance Modifier and Surgical Approach 60 50 Mean Score 40 <40 Anterior <40 Circum <40 Posterior 40 to 95 Circum 40 to 95 Circum 96+ Circum posterior 96+ Circum 30 20 10 0 Baseline Two Year Measurement Period N with anterior approach did worst (VP posterior-only also not so good) P, VP did best with circumferential fusion 2-year Surgical outcome: sagittal balance (fixation to sacrum) Mean SRS Total Score at Baseline and Two Years by Sagittal Balance Modifier and Fixation to the Sacrum 90 80 70 Mean Score 60 <40 Without <40 With 40 to 95 Without 40 to 95 With 96+ Without 96+ With 50 40 30 20 10 0 Baseline Two Year Measurement Period VP without fixation to sacrum got worse P and VP did best with fixation to sacrum (no difference for N) 2-year Surgical outcome: osteotomy or not ? Mean SF-12v2 PCS at Baseline and Two Years by Osteotomy 50 45 40 35 Mean Score 30 No Osteotomy Osteotomy 25 20 15 10 5 0 Baseline Two Year Measurement Period Patients who had osteotomy did better ! Baseline to Two-Year Changes: Significant Interaction ODI / SRS Total Score by lordosis • patients with no lordosis (C) greatest improvement, • Patients with marked lordosis (A) little or no improvement ODI / SRS Total Score by sagittal balance by surgical approach • well balanced least disabled, fused short of sacrum did best • very imbalance (VP) most disabled and worse off if not fused to sacrum SF-12v2 / SRS Total Score by Subluxation • significant subluxation (++,+) more improvement than no subluxation SF-12v2 PCS / SRS Total score by Osteotomy Status • patients with osteotomy had lower baseline scores •At 2 years f/u, patients with an osteotomy had higher scores Adult Scoliosis: Thoracolumbar / Lumbar Deformity Follow-up data • When is improvement clinically significant ? – Set a bar of 10-point increase in SRS score • From 100pt. Scale – Assumption of patient perceived improvement • Minimal Clinically Important Difference – Berven et al. Minimum 10 point SRS instrument improvement Met Ten-Point SRS Improvement Criterion by Year and Gender 100% 100% 100% 90% Percent Meeting Criterion 80% 69% 70% 62% 60% One Year Two Year 50% 40% 30% 20% 10% 0% Female Male Gender Minimum 10 point SRS instrument improvement Met Ten-Point SRS Improvement Criterion by Year and Lordosis Modifier 100% 100% 100% 90% 78% Percent Meeting Criterion 80% 70% 67% 61% 60% 57% One Year Two Year 50% 40% 30% 20% 10% 0% A - marked lordosis B - moderate lordosis C - No lordosis present Lordosis Modifier Loss of lumbar lordosis…greater likelihood of clinical success Minimum 10 point SRS instrument improvement Met Ten-Point SRS Improvement Criterion by Year and Sagittal Balance Modifier 100% 88% 90% 80% Percent Meeting Criterion 73% 73% 70% 64% 63% 60% 60% One Year Two Year 50% 40% 30% 20% 10% 0% Under 40 40 to 95 96 and Greater Sagittal Balance Modifier At 2-yr follow up: greater imbalance patients more likely to have successful outcome Minimum 10 point SRS instrument improvement Met Ten-Point SRS Improvement Criterion by Year and Osteotomy 100% 90% 80% 80% Percent Meeting Criterion 73% 70% 60% 66% 59% One Year Two Year 50% 40% 30% 20% 10% 0% No Osteotomy Performed Osteotomy Performed Osteotomy Patients having osteotomies more likely to have successful outcome Minimum 10 point SRS instrument improvement Met Ten-Point SRS Improvement Criterion by Year and Baseline SF-12 PCS 100% 92% 90% 83% 78% Percent Meeting Criterion 80% 70% 67% 58% 60% 58% 50% 44% 44% One Year Two Year 40% 30% 20% 10% 0% Under 25 25 to Under 35 35 to Under 45 45 and Higher Baseline SF-12 PCS Patients with lower baseline scores more likely to achieve significant improvement When to operate on Adult Scoliosis patients and when to say No How can we select the best patients for surgery ? (and how to optimize the chances of a successful outcome) Can we predict who will have successful surgery ? Predictive Models – – – – – – Gender Age Apical Modifier Lordosis Modifier Subluxation Modifier Sagittal Balance – – – – – – – Surgical Approach Osteotomy Fixation to Sacrum SF-12v2 Physical Component Summary SF-12v2 Mental Component Summary SRS Total Score Oswestry Disability Index Outcome ? Models to predict Clinical Improvement with Surgery Strength of Predictive Models Outcome Score (meeting the MCID threshold) % Correct Classification by Model Area Under ROC Curve (.80 and above is considered good discrimination) % of Surgical Cases Failing to Meet Criterion SRS Pain 81.1% .864 39.5% SRS Appearance 75.4% .838 33.3% SRS Pain and Appearance 78.1% .845 53.5% SF-12v2 PCS 77.9% .862 47.6% Follow-up data: Conclusions The winners – – – – – Greater disability at start (SRS, ODI, SF-12) Male Subluxation >6mm Lost lumbar lordosis <400 Osteotomy Who benefits least • minimal baseline disability (SRS, ODI, SF-12) • No subluxation, no marked sagittal imbalance • Good lordosis, >400 • Lack of osteotomy When to operate on Adult Scoliosis patients and when to say No How can we select the best patients for surgery ? (and how to optimize the chances of a successful outcome) Regional deformity apex Global sagittal balance SRS, ODI, SF-12 Surgical approach osteotomy gender Focal deformity Adult Scoliosis / Deformity: next steps Refine Classification + SRS ODI SF-12/36 Predictive outcomes model Treatment Algorithm Thank you….
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