Complex Adult Deformity Surgery (CADS)

Scoliosis Clinical Trial

— CADS  

Official title:

Multi-Center Prospective Evaluation of Complex Adult Spinal Deformity Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04194138
• Other study ID #: 2123
• Status: Recruiting
• Start date: July 30, 2018
• Est. completion date: July 31, 2032

Study information

• Verified date: March 2024
• Source: International Spine Study Group Foundation
• Contact: Christine Baldus, MS
• Phone: 6184444130
• Email: baldusc[@]wustl.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 31, 2032
• Est. primary completion date: December 31, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adult Spinal Deformity
• Congenital Abnormalities
• Kyphosis
• Sagittal Imbalance
• Scoliosis

Intervention

Procedure:
• Index or spine revision surgery for complex adult spinal deformity
Surgical interventions will be patient specified by treating surgeon.

Locations

Country	Name	City	State
Canada	Toronto Western	Toronto	Ontario
United States	John Hopkins University, Department of Orthopedic Surgery	Baltimore	Maryland
United States	University of Virginia	Charlottesville	Virginia
United States	Medical City Spine Hospital - Southwest Scoliosis Institute	Dallas	Texas
United States	Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center	Denver	Colorado
United States	Duke University Health System	Durham	North Carolina
United States	University of Texas - Houston	Houston	Texas
United States	University of Kansas, Department of Orthopedic Surgery	Kansas City	Kansas
United States	Shiley Center for Orthopaedic Research and Education at Scripps Clinic	La Jolla	California
United States	Norton Leatherman Spine Center	Louisville	Kentucky
United States	Columbia University Medical Center	New York	New York
United States	Hospital for Special Surgery, Department of Orthopedic Surgery	New York	New York
United States	Northwell Health	New York	New York
United States	NYU, Department of Orthopedics	New York	New York
United States	University Orthopedics	Providence	Rhode Island
United States	University of California, Davis, Department of Orthopedic Surgery	Sacramento	California
United States	Washington University, Department of Orthopedic Surgery	Saint Louis	Missouri
United States	UCSF, Department of Neurosurgery	San Francisco	California
United States	Spine Institute of Louisiana	Shreveport	Louisiana

Sponsors (4)

Lead Sponsor	Collaborator
International Spine Study Group Foundation	Globus Medical Inc, Medtronic, SI-BONE, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scoliosis Research Society (SRS) 22r	Scoliosis specific patient reported outcome	Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Primary	Oswestry Disability Index (ODI)	Spine specific patient reported outcome	Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Primary	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
Primary	Radiographic Evaluation	Cobb angles, Coronal & Sagittal balance, spinopelvic measures	Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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