Status:
COMPLETED
Cost Effectiveness of Nonoperative Management for Adult Spinal Deformity
Lead Sponsor:
Shay Bess
Collaborating Sponsors:
DePuy Spine
Medtronic
Conditions:
Spinal Deformity
Eligibility:
All Genders
40-75 years
Brief Summary
Quantify the efficacy and cost of nonoperative treatment modalities used for adult spinal deformity.
Detailed Description
1. Identify disease burden associated with adult spinal deformity (ASD) using quality adjusted life year (QALY) analysis. 2. Identify disease burden of specific demographic and radiographic features a...
Eligibility Criteria
Inclusion
- Age 40-75 years of age at the time of enrollment.
- ODI ≥30
- Adult degenerative or idiopathic lumbar scoliosis 10-40° as measured by the Cobb angle technique
- Sagittal plane deformity by SRS Schwab classification with at least one modifier ++ or two modifiers + and associated coronal cobb of at least 10 degrees
Exclusion
- Adult degenerative or idiopathic scoliosis with a curvature of the spine measuring \<10 degrees or \>40 degrees
- Diagnosis of scoliosis other than degenerative or idiopathic (i.e. neuromuscular, congenital, etc.)
- Cardiopulmonary disease or comorbidities that preclude surgical intervention
- Patient not deemed surgical candidate by treating surgeon
- Patient unwilling to commit to monthly phone interviews or completion of necessary questionnaires or inability to return for defined follow up time points. Patients unwilling to comply with study protocol will not be offered enrollment into the study, regardless of meeting inclusion criteria.
Key Trial Info
Start Date :
June 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01880164
Start Date
June 1 2015
End Date
April 1 2017
Last Update
April 6 2017
Active Locations (10)
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1
University of California - Davis
Sacramento, California, United States, 95817
2
University of California - San Francisco Medical Center
San Francisco, California, United States, 94143
3
Rocky Mountain Scoliosis and Spine
Denver, Colorado, United States, 80205
4
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160