This trial is active, not recruiting.

Condition spinal deformity
Sponsor Shay Bess
Collaborator DePuy Spine
Start date June 2015
End date January 2017
Trial size 21 participants
Trial identifier NCT01880164, 2108


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Adult spinal deformity (degenerative or idiopathic) with an ODI of 30 or greater

Primary Outcomes

Oswestry Disability Index (ODI)
time frame: Initial visit and six months post enrollment

Secondary Outcomes

time frame: Initial visit (Day 1)

Eligibility Criteria

Male or female participants from 40 years up to 75 years old.

Inclusion Criteria: 1. Age 40-75 years of age at the time of enrollment. 2. ODI ≥30 3. Adult degenerative or idiopathic lumbar scoliosis 10-40° as measured by the Cobb angle technique 4. 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 Criteria: 1. Adult degenerative or idiopathic scoliosis with a curvature of the spine measuring <10 degrees or >40 degrees 2. Diagnosis of scoliosis other than degenerative or idiopathic (i.e. neuromuscular, congenital, etc.) 3. Cardiopulmonary disease or comorbidities that preclude surgical intervention 4. Patient not deemed surgical candidate by treating surgeon 5. 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.

Additional Information

Official title Cost Effectiveness of Nonoperative Management for Adult Spinal Deformity Associated With Low Grade Scoliosis: A Prospective Pilot Study to Evaluate Disease Burden and Longitudinal Study Feasibility
Principal investigator Shay Bess, MD
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 associated with ASD. 3. Compare disease burden of ASD to other musculoskeletal and non-musculoskeletal diseases. 4. Identify efficacy of specific nonoperative treatment modalities to treat ASD and identify specific clinical and radiographic features of ASD responsive to nonoperative treatment modalities. 5. Compare QALY and ICER values for different ASD nonoperative treatment modalities to previously established QALY and ICER for values for operative and nonoperative treatment modalities for degenerative hip and knee disease, coronary artery disease, insulin dependent diabetes, and hypertension. 6. Evaluate the cost and work hours associated with data collection and minimum 85% patient follow up. 7. Evaluate patient characteristics associated with poor patient compliance for study follow up including demographic, radiographic and HRQOL values and for reasons for cross-over to operative treatment for ASD. 8. Establish standardized data collection methodology for economic based outcome studies based upon patient demographics and HRQOL values.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by International Spine Study Group Foundation.