- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04194138
Complex Adult Deformity Surgery (CADS) (CADS)
Multi-Center Prospective Evaluation of Complex Adult Spinal Deformity Surgery
Study Overview
Status
Intervention / Treatment
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
- 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
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Christine Baldus, MS
- Phone Number: 6184444130
- Email: baldusc@wustl.edu
Study Contact Backup
- Name: Ray Pinteric
- Phone Number: 7209348014
- Email: ray.pinteric@outlook.com
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada
- Recruiting
- Toronto Western
-
Contact:
- Sofia Magana
- Email: Sofia.Magana@uhn.on.ca
-
Principal Investigator:
- Stephen Lewis, MD
-
-
-
-
California
-
La Jolla, California, United States, 92037
- Recruiting
- Shiley Center for Orthopaedic Research and Education at Scripps Clinic
-
Contact:
- Tina Iannacone, MPH
- Phone Number: 858-554-7124
- Email: iannacone.tina@scrippshealth.org
-
Principal Investigator:
- Gregory Mundis, MD
-
Sub-Investigator:
- Robert Eastlack, MD
-
Sacramento, California, United States, 05616
- Active, not recruiting
- University of California, Davis, Department of Orthopedic Surgery
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San Francisco, California, United States, 94143
- Recruiting
- UCSF, Department of Neurosurgery
-
Principal Investigator:
- Christopher Ames, MD
-
Contact:
- Terry Nguyen
- Email: terry.nguyen@ucsf.edu
-
-
Colorado
-
Denver, Colorado, United States, 80218
- Recruiting
- Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center
-
Contact:
- Breton Line, BS
- Phone Number: 303-762-3472
- Email: breton.line@healthonecares.com
-
Principal Investigator:
- Shay Bess, MD
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- Recruiting
- University of Kansas, Department of Orthopedic Surgery
-
Contact:
- Stephanie Robinson
- Phone Number: 913-588-0581
- Email: srobinson6@kumc.edu
-
Principal Investigator:
- Douglas Burton, MD
-
-
Kentucky
-
Louisville, Kentucky, United States, 40207
- Recruiting
- Norton Leatherman Spine Center
-
Contact:
- Morgan Brown
- Email: morgan.brown2@nortonhealthcare.org
-
Principal Investigator:
- Jeff Gum, MD
-
-
Louisiana
-
Shreveport, Louisiana, United States, 71101
- Recruiting
- Spine Institute of Louisiana
-
Principal Investigator:
- Pierce Nunley, MD
-
Contact:
- Brandi Casey
- Email: bcasey@louisianaspine.org
-
-
Maryland
-
Baltimore, Maryland, United States, 21224
- Recruiting
- John Hopkins University, Department of Orthopedic Surgery
-
Principal Investigator:
- Khaled Kebaish, MD
-
Contact:
- Andrew Kim
- Email: akim172@jh.edu
-
-
Missouri
-
Saint Louis, Missouri, United States, 63310
- Recruiting
- Washington University, Department of Orthopedic Surgery
-
Sub-Investigator:
- Munish Gupta, MD
-
Contact:
- Alison Hageman
- Email: hageman@wustl.edu
-
-
New York
-
New York, New York, United States, 10032
- Recruiting
- Columbia University Medical Center
-
Contact:
- Fthimnir Hassan
- Phone Number: 212-932-4410
- Email: fh2444@cumc.columbia.edu
-
Principal Investigator:
- Lawrence G Lenke, MD
-
New York, New York, United States, 10075
- Recruiting
- Northwell Health
-
Principal Investigator:
- Frank Schwab
-
Contact:
- Jonathan Elysee
- Email: jelysee@northwell.edu
-
New York, New York, United States, 10021
- Recruiting
- Hospital for Special Surgery, Department of Orthopedic Surgery
-
Principal Investigator:
- Han Jo Kim, MD
-
Contact:
- Desmarie Sherwood
- Email: sherwoodd@hss.edu
-
New York, New York, United States, 10016
- Recruiting
- NYU, Department of Orthopedics
-
Contact:
- Connie Maglaras
- Email: constance.maglaras@nyulangone.org
-
Sub-Investigator:
- Themi Protopsaltis, MD
-
Principal Investigator:
- Peter Passias, MD
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Recruiting
- Duke University Health System
-
Contact:
- Ronald Pegues
- Email: ronald.pegues@duke.edu
-
Principal Investigator:
- Christopher Shaffrey, MD
-
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Rhode Island
-
Providence, Rhode Island, United States, 02905
- Recruiting
- University Orthopedics
-
Principal Investigator:
- Alan Daniels, MD
-
Contact:
- Krista Szatkowski
- Email: kszatkowski@universityorthopedics.com
-
-
Texas
-
Dallas, Texas, United States, 75243
- Recruiting
- Medical City Spine Hospital - Southwest Scoliosis Institute
-
Principal Investigator:
- Richard Hostin, MD
-
Contact:
- Brenda Olivares
- Email: brenda.olivares@hcahealthcare.com
-
Houston, Texas, United States, 77030
- Recruiting
- University of Texas - Houston
-
Principal Investigator:
- Eric Klineberg, MD
-
Contact:
- Olivia Nembhard
- Email: olivia.nembhard@uth.tmc.edu
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- Recruiting
- University of Virginia
-
Principal Investigator:
- Justin Smith, MD
-
Contact:
- Lorrie Sipe
- Phone Number: 434-924-8875
- Email: lag3k@virginia.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Operative
A. Multicenter, prospective, nonrandomized analysis of operatively treated complex ASD patients meeting the following Inclusion Criteria
|
Surgical interventions will be patient specified by treating surgeon.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Scoliosis Research Society (SRS) 22r
Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
|
Scoliosis 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)
Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
|
Patient reported outcome
|
Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
|
Visual Analog Scale - Back Pain
Time Frame: 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)
|
Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
|
Visual Analog Scale - Leg Pain
Time Frame: 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)
|
Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
|
Oswestry Disability Index (ODI)
Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
|
Spine specific patient reported outcome
|
Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
|
Radiographic Evaluation
Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
|
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
Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
|
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
Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
|
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
Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
|
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
Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
|
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
Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
|
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)
Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
|
Computer adaptive PRO
|
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
Time Frame: 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
|
Change from Preop to 3months and 1, 2, 5 & 10 year follow-up
|
Canadian Study of Health and Aging (CSHA)
Time Frame: Change from Preop to 3months and 1, 2, 5 & 10 year follow-up
|
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
Time Frame: 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
|
3 months and 1, 2, 5 & 10 year post treatment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Christopher Shaffrey, MD, Duke University, Departments of Neurosurgery and Orthopaedic Surgery
- Principal Investigator: Shay Bess, MD, Denver International Spine Center
- Principal Investigator: Lawrence Lenke, MD, Columbia University, Department of Orthopedic Surgery
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2123
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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