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Complex Adult Deformity Surgery (CADS)

Multi-Center Prospective Evaluation of Complex Adult Spinal Deformity Surgery

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04194138
Acronym
CADS
Enrollment
1500
Registered
2019-12-11
Start date
2018-07-30
Completion date
2032-07-31
Last updated
2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult Spinal Deformity, Kyphosis, Sagittal Imbalance, Scoliosis

Keywords

Scoliosis, Kyphosis, Sagittal Imbalance, Spinal deformity

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.

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. 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 1. Validation of the PROMIS tool for ASD 2. Establish a core set of PROMs for best practice guidelines for ASD 3. 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 4. 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

Interventions

Surgical interventions will be patient specified by treating surgeon.

Sponsors

International Spine Study Group Foundation
Lead SponsorOTHER
Medtronic
CollaboratorINDUSTRY
Globus Medical Inc
CollaboratorINDUSTRY
SI-BONE, Inc.
CollaboratorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Criteria: Inclusion Criteria: 1. Diagnosis of adult congenital, degenerative, idiopathic or iatrogenic spinal deformity 2. Full body EOS radiographic assessment (sagittal and coronal visualization from skull to foot) 3. Complex patients are defined as and meeting any one of the subsequent criteria: 1. Radiographic criteria: * PI-LL ≥ 25 degrees * TPA ≥ 30 degrees * SVA\>15cm * Thoracic scoliosis ≥ 70 degrees * Thoracolumbar/lumbar scoliosis ≥ 50 degrees * Global coronal malalignment \>7cm 2. Procedural criteria: * Posterior spinal fusion \> 12 levels * 3 column osteotomy or ACR 3. Geriatric criteria: * Age \>65 years and minimum 7 levels of spinal instrumentation during surgery

Exclusion criteria

1. Age \<18 years of age 2. Active spine tumor or infection 3. Deformity due to acute trauma 4. Neuromuscular conditions/diseases (Parkinson's, Multiple Sclerosis, Post-polio syndrome) 5. Syndromic scoliosis 6. Inflammatory arthritis/auto immune diseases (Rheumatoid arthritis, Lupus, Ankylosing Spondylitis) 7. Prisoners 8. Women who are pregnant 9. Non English speaking patients

Design outcomes

Primary

MeasureTime frameDescription
Scoliosis Research Society (SRS) 22rChange from Preop to 3 months and 1, 2, 5 & 10 year follow-upScoliosis specific patient reported outcome
Oswestry Disability Index (ODI)Change from Preop to 3 months and 1, 2, 5 & 10 year follow-upSpine 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-upPatient reported outcome
Radiographic EvaluationChange from Preop to 3 months and 1, 2, 5 & 10 year follow-upCobb angles, Coronal \& Sagittal balance, spinopelvic measures
Patient-Reported Outcome Measurement Information System (PROMIS) - AnxietyChange from Preop to 3 months and 1, 2, 5 & 10 year follow-upComputer adaptive PROs
Patient-Reported Outcome Measurement Information System (PROMIS) - DepressionChange from Preop to 3 months and 1, 2, 5 & 10 year follow-upComputer adaptive PRO
Patient-Reported Outcome Measurement Information System (PROMIS) - Pain InterferenceChange from Preop to 3 months and 1, 2, 5 & 10 year follow-upComputer adaptive PRO
Patient-Reported Outcome Measurement Information System (PROMIS) - Physical FunctionChange from Preop to 3 months and 1, 2, 5 & 10 year follow-upComputer adaptive PRO
Patient-Reported Outcome Measurement Information System (PROMIS) - Social Role SatisfactionChange from Preop to 3 months and 1, 2, 5 & 10 year follow-upComputer 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-upComputer adaptive PRO
Visual Analog Scale - Back PainChange from Preop to 3 months and 1, 2, 5 & 10 year follow-upSelf-reported back pain on scale of 0 (No pain) to 10 (severe pain)
Visual Analog Scale - Leg PainChange from Preop to 3 months and 1, 2, 5 & 10 year follow-upSelf-reported leg pain on scale of 0 (No pain) to 10 (severe pain)

Secondary

MeasureTime frameDescription
Edmonton Frail ScaleChange from Preop to 3months and 1, 2, 5 & 10 year follow-upEvaluate 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-upFrailty scale of 1 to 8; higher scores mean more frail
Adverse Events3 months and 1, 2, 5 & 10 year post treatmentOccurrence of Adverse events meeting reporting criteria and their relationship to intervention throughout the study

Countries

Canada, United States

Contacts

CONTACTChristine Baldus, MS
baldusc@wustl.edu618-444-4130
CONTACTRay Pinteric
ray.pinteric@outlook.com
PRINCIPAL_INVESTIGATORShay Bess, MD
PRINCIPAL_INVESTIGATORLawrence Lenke, MD

Columbia University, Department of Orthopedic Surgery

PRINCIPAL_INVESTIGATORChristopher Shaffrey, MD

Duke University, Departments of Neurosurgery and Orthopaedic Surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026