NCT01880164

Cost Effectiveness of Nonoperative Management for Adult Spinal Deformity

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 21 (actual)
• Sponsor: Shay Bess · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Spinal Deformity

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-01-01
• Completion: 2017-04-01
• First posted: 2013-06-18
• Last updated: 2017-04-06

Locations

10 sites across 1 country: United States