Complex Adult Deformity Surgery (CADS)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
- 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.
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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.
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Procedures involving 3 column osteotomies and/or anterior column reconstruction (ACR) of the spine
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Develop and validate a standardized, universal complications classification system for spine surgery
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Evaluate perioperative blood management approaches, transfusion requirements, including variance in thresholds for blood transfusion and associated complications for adult spinal deformity surgery
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Assess impact of opioid use and pain management on patient cost, complications and outcomes
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Evaluate optimal opioid and analgesic usage and protocols for standard work development
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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
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Validation of the PROMIS tool for ASD
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Establish a core set of PROMs for best practice guidelines for ASD
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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
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Evaluate ASD outcomes compared to population norms and investigate/develop appropriate measures of clinically significant improvement
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Evaluate clinical outcomes stratifying by patient chronological and physiological age
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Evaluate measures to quantify patient physiological age including patient frailty for ASD and validate a frailty measurement system for ASD
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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.
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Evaluate the contribution of patient frailty to patient outcomes, cost of care, disability, and complications
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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
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Evaluate cost variance for ASD surgery according to patient, institution, and geographical region and evaluate the cost effectiveness of surgical intervention for ASD
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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
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Evaluate the association of MH with surgical complications, outcomes, hospital length of stay and cost for ASD surgery
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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
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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
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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
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Develop predictive analytic algorithms to risk stratify for best/worst outcomes, complications, sentinel events, and economic loss for ASD surgery
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Operative 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
Surgical interventions will be patient specified by treating surgeon.
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Outcome Measures
Primary Outcome Measures
- Scoliosis Research Society (SRS) 22r [Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up]
Scoliosis specific patient reported outcome
- Oswestry Disability Index (ODI) [Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up]
Spine specific patient reported outcome
- Veterans RAND 12 Item Health Survey (VR-12) [Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up]
Patient reported outcome
- Radiographic Evaluation [Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up]
Cobb angles, Coronal & Sagittal balance, spinopelvic measures
- Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety [Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up]
Computer adaptive PROs
- Patient-Reported Outcome Measurement Information System (PROMIS) - Depression [Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up]
Computer adaptive PRO
- Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference [Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up]
Computer adaptive PRO
- Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function [Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up]
Computer adaptive PRO
- Patient-Reported Outcome Measurement Information System (PROMIS) - Social Role Satisfaction [Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up]
Computer adaptive PRO
- Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction (DSA) [Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up]
Computer adaptive PRO
- Visual Analog Scale - Back Pain [Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up]
Self-reported back pain on scale of 0 (No pain) to 10 (severe pain)
- Visual Analog Scale - Leg Pain [Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up]
Self-reported leg pain on scale of 0 (No pain) to 10 (severe pain)
Secondary Outcome Measures
- Edmonton Frail Scale [Change from Preop to 3months and 1, 2, 5 & 10 year follow-up]
Evaluate frailty on scale of 0 to 17 where higher scores mean more frail
- Canadian Study of Health and Aging (CSHA) [Change from Preop to 3months and 1, 2, 5 & 10 year follow-up]
Frailty scale of 1 to 8; higher scores mean more frail
- Adverse Events [3 months and 1, 2, 5 & 10 year post treatment]
Occurrence of Adverse events meeting reporting criteria and their relationship to intervention throughout the study
Eligibility Criteria
Criteria
Criteria:
Inclusion Criteria:
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Diagnosis of adult congenital, degenerative, idiopathic or iatrogenic spinal deformity
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Full body EOS radiographic assessment (sagittal and coronal visualization from skull to foot)
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Complex patients are defined as and meeting any one of the subsequent criteria:
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Radiographic criteria:
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PI-LL ≥ 25 degrees
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TPA ≥ 30 degrees
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SVA>15cm
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Thoracic scoliosis ≥ 70 degrees
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Thoracolumbar/lumbar scoliosis ≥ 50 degrees
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Global coronal malalignment >7cm
- Procedural criteria:
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Posterior spinal fusion > 12 levels
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3 column osteotomy or ACR
- Geriatric criteria:
- Age >65 years and minimum 7 levels of spinal instrumentation during surgery
Exclusion Criteria:
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Age <18 years of age
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Active spine tumor or infection
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Deformity due to acute trauma
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Neuromuscular conditions/diseases (Parkinson's, Multiple Sclerosis, Post-polio syndrome)
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Syndromic scoliosis
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Inflammatory arthritis/auto immune diseases (Rheumatoid arthritis, Lupus, Ankylosing Spondylitis)
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Prisoners
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Women who are pregnant
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Non English speaking patients
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shiley Center for Orthopaedic Research and Education at Scripps Clinic | La Jolla | California | United States | 92037 |
| 2 | University of California, Davis, Department of Orthopedic Surgery | Sacramento | California | United States | 05616 |
| 3 | UCSF, Department of Neurosurgery | San Francisco | California | United States | 94143 |
| 4 | Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center | Denver | Colorado | United States | 80218 |
| 5 | University of Kansas, Department of Orthopedic Surgery | Kansas City | Kansas | United States | 66160 |
| 6 | John Hopkins University, Department of Orthopedic Surgery | Baltimore | Maryland | United States | 21224 |
| 7 | Washington University, Department of Orthopedic Surgery | Saint Louis | Missouri | United States | 63310 |
| 8 | NYU, Department of Orthopedics | New York | New York | United States | 10016 |
| 9 | Hospital for Special Surgery, Department of Orthopedic Surgery | New York | New York | United States | 10021 |
| 10 | Columbia University Medical Center | New York | New York | United States | 10032 |
| 11 | Duke University Health System | Durham | North Carolina | United States | 27710 |
| 12 | University Orthopedics | Providence | Rhode Island | United States | 02905 |
| 13 | Medical City Spine Hospital - Southwest Scoliosis Institute | Dallas | Texas | United States | 75243 |
| 14 | University of Virginia | Charlottesville | Virginia | United States | 22908 |
| 15 | Toronto Western | Toronto | Ontario | Canada |
Sponsors and Collaborators
- International Spine Study Group Foundation
- Medtronic
- Globus Medical Inc
- SI-BONE, Inc.
Investigators
- Principal Investigator: Shay Bess, MD, Denver International Spine Center
- Principal Investigator: Lawerence Lenke, MD, Columbia University, Department of Orthopedic Surgery
- Principal Investigator: Christopher Shaffrey, MD, Duke University, Departments of Neurosurgery and Orthopaedic Surgery
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2123