Cost Effectiveness of Nonoperative Management for Adult Spinal Deformity

Completed

Conditions studied: Spinal Deformity

In brief

Quantify the efficacy and cost of nonoperative treatment modalities used for adult spinal deformity.

Key facts

Study ID

NCT01880164

Run by

Shay Bess

People needed

21

Starts

2015-06-01

Expected to finish

2017-04-01

Last updated by the study team

2017-04-06

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of California - Davis — Sacramento, California, United States
• University of California - San Francisco Medical Center — San Francisco, California, United States
• Rocky Mountain Scoliosis and Spine — Denver, Colorado, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Norton Leatherman Spine Center — Louisville, Kentucky, United States
• Washington University at St. Louis — St Louis, Missouri, United States
• NYU Hospital for Joint Diseases — New York, New York, United States
• Hospital for Special Surgery — New York, New York, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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