Complex Adult Deformity Surgery (CADS)

Study Overview
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Brief Summary
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Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients, including radiographic and clinical outcomes, surgical and postoperative complications, risk factors for and revision surgery rates, and the role of standard work to improve patient outcomes and reduce surgical and postoperative complications.

Detailed Description
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Specific Aims: • Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients, including radiographic and clinical outcomes, surgical and postoperative complications, risk factors for and revision surgery rates, and the role of standard work to improve patient outcomes and reduce surgical and postoperative complications. a. Complex ASD patients will be defined based upon clinical, radiographic and/or procedural criteria identified in an analysis of the existing ISSG ASD database: i. Magnitude of coronal and/or sagittal spinal deformity ≥75th percentile of patients in the ISSG database. ii. Clinical or Radiographic parameters that corresponded to patients in the ISSG database that had complications requiring revision spine surgery and/or patients that had hospital length of stay >9 days. iii. Procedures involving 3 column osteotomies and/or anterior column reconstruction (ACR) of the spine Develop and validate a standardized, universal complications classification system for spine surgery Evaluate perioperative blood management approaches, transfusion requirements, including variance in thresholds for blood transfusion and associated complications for adult spinal deformity surgery Assess impact of opioid use and pain management on patient cost, complications and outcomes Evaluate optimal opioid and analgesic usage and protocols for standard work development Evaluate clinical outcomes utilizing legacy patient reported outcome measures (PROMs) including modified Oswestry Disability Index (mODI), Scoliosis Research Society Questionnaire 22r (SRS-22r), Veterans RAND-12 (VR-12), and numeric pain rating scale (NRS) and compare the results of these legacy PROMs to outcomes scores as measured by the NIH Patient Reported Outcomes Measurement Information System (PROMIS) - PROMIS Anxiety, Depression, Pain Interference, Physical Function, and Social Satisfaction. Secondary aims for PROM research for this study include Validation of the PROMIS tool for ASD Establish a core set of PROMs for best practice guidelines for ASD Evaluate patient reported outcome variance for ASD according to SRS-Schwab spine deformity type including variance in baseline PROM domains impacted and variance in improvement in PROM domains Evaluate ASD outcomes compared to population norms and investigate/develop appropriate measures of clinically significant improvement Evaluate clinical outcomes stratifying by patient chronological and physiological age Evaluate measures to quantify patient physiological age including patient frailty for ASD and validate a frailty measurement system for ASD Evaluate the role of functional tests in patient's baseline frailty assessment including hand manometer and Edmonton Frail Scale. See appendix, pages 17 & 18 for details. Evaluate the contribution of patient frailty to patient outcomes, cost of care, disability, and complications Evaluate if patient frailty is a static measure or if frailty is a dynamic measure that can be improved through pre-habilitation and if the according associations with reductions in frailty correlate with reductions of cost, complications, and improvement in outcomes Evaluate cost variance for ASD surgery according to patient, institution, and geographical region and evaluate the cost effectiveness of surgical intervention for ASD Evaluate incidence of and risk factors for mental health (MH) compromise among ASD patients and establish best practice guidelines for assessing MH for ASD patients Evaluate the association of MH with surgical complications, outcomes, hospital length of stay and cost for ASD surgery Evaluate the association of social health surgical complications, outcomes, hospital length of stay and cost for ASD surgery and risk factors for routine (home) discharge vs. skilled nursing facility (SNF)/rehabilitation facility Broaden the evaluation of the surgically treated ASD patient to maximize evaluation of the entirety of the episode of care to include steps that can be taken prior to surgery including prehabilitation, pain management, and MH care to improve treatment outcomes, reduce cost, reduce hospital length of stay, reduce non-routing discharge and reduce early and late complications Establish a core set of standard work guidelines to clinically and radiographically evaluate and treat ASD patients and evaluate the utility of standard work to improve outcomes for ASD and formulate best practice guidelines for surgical treatment of ASD Develop predictive analytic algorithms to risk stratify for best/worst outcomes, complications, sentinel events, and economic loss for ASD surgery

Official Title
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Multi-Center Prospective Evaluation of Complex Adult Spinal Deformity Surgery

Conditions
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Adult Spinal Deformity, Scoliosis, Kyphosis, Sagittal Imbalance

Intervention / Treatment
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* Procedure: Index or spine revision surgery for complex adult spinal deformity


Participation Criteria
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Eligibility Criteria
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Criteria: Inclusion Criteria: Diagnosis of adult congenital, degenerative, idiopathic or iatrogenic spinal deformity Full body EOS radiographic assessment (sagittal and coronal visualization from skull to foot) Complex patients are defined as and meeting any one of the subsequent criteria: Radiographic criteria: PI-LL ≥ 25 degrees TPA ≥ 30 degrees SVA>15cm Thoracic scoliosis ≥ 70 degrees Thoracolumbar/lumbar scoliosis ≥ 50 degrees Global coronal malalignment >7cm Procedural criteria: Posterior spinal fusion > 12 levels 3 column osteotomy or ACR Geriatric criteria: Age >65 years and minimum 7 levels of spinal instrumentation during surgery Exclusion Criteria: Age <18 years of age Active spine tumor or infection Deformity due to acute trauma Neuromuscular conditions/diseases (Parkinson's, Multiple Sclerosis, Post-polio syndrome) Syndromic scoliosis Inflammatory arthritis/auto immune diseases (Rheumatoid arthritis, Lupus, Ankylosing Spondylitis) Prisoners Women who are pregnant Non English speaking patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Operative<br>A. Multicenter, prospective, nonrandomized analysis of operatively treated complex ASD patients meeting the following Inclusion Criteria 18 years of age or greater at the time of treatment Diagnosis of adult congenital, degenerative, idiopathic or iatrogenic spinal deformity Full body EOS radiographic assessment (sagittal and coronal visualization from skull to foot) Complex patients are defined as and meeting any one of the subsequent criteria: a. Radiographic criteria: i. PI-LL ≥ 25 degrees ii. TPA ≥ 30 degrees iii. SVA>15cm iv. Thoracic scoliosis ≥ 70 degrees v. Thoracolumbar/lumbar scoliosis ≥ 50 degrees vi. Global coronal malalignment >7cm b. Procedural criteria: i. Posterior spinal fusion > 12 levels ii. 3 column osteotomy or ACR c. Geriatric criteria: i. Age >65 years and minimum 7 levels of spinal instrumentation during surgery | Procedure: Index or spine revision surgery for complex adult spinal deformity<br>* Surgical interventions will be patient specified by treating surgeon.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scoliosis Research Society (SRS) 22r | Scoliosis specific patient reported outcome | Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up | 
| Oswestry Disability Index (ODI) | Spine specific patient reported outcome | Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up | 
| Veterans RAND 12 Item Health Survey (VR-12) | Patient reported outcome | Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up | 
| Radiographic Evaluation | Cobb angles, Coronal & Sagittal balance, spinopelvic measures | Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up | 
| Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety | Computer adaptive PROs | Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up | 
| Patient-Reported Outcome Measurement Information System (PROMIS) - Depression | Computer adaptive PRO | Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up | 
| Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference | Computer adaptive PRO | Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up | 
| Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function | Computer adaptive PRO | Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up | 
| Patient-Reported Outcome Measurement Information System (PROMIS) - Social Role Satisfaction | Computer adaptive PRO | Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up | 
| Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction (DSA) | Computer adaptive PRO | Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up | 
| Visual Analog Scale - Back Pain | Self-reported back pain on scale of 0 (No pain) to 10 (severe pain) | Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up | 
| Visual Analog Scale - Leg Pain | Self-reported leg pain on scale of 0 (No pain) to 10 (severe pain) | Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Edmonton Frail Scale | Evaluate frailty on scale of 0 to 17 where higher scores mean more frail | Change from Preop to 3months and 1, 2, 5 & 10 year follow-up | 
| Canadian Study of Health and Aging (CSHA) | Frailty scale of 1 to 8; higher scores mean more frail | Change from Preop to 3months and 1, 2, 5 & 10 year follow-up | 
| Adverse Events | Occurrence of Adverse events meeting reporting criteria and their relationship to intervention throughout the study | 3 months and 1, 2, 5 & 10 year post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scoliosis, Kyphosis, Sagittal Imbalance, Spinal deformity