Cost Effectiveness of Nonoperative Management for Adult Spinal Deformity

Study Overview
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Brief Summary
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Quantify the efficacy and cost of nonoperative treatment modalities used for adult spinal deformity.

Detailed Description
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Identify disease burden associated with adult spinal deformity (ASD) using quality adjusted life year (QALY) analysis. Identify disease burden of specific demographic and radiographic features associated with ASD. Compare disease burden of ASD to other musculoskeletal and non-musculoskeletal diseases. Identify efficacy of specific nonoperative treatment modalities to treat ASD and identify specific clinical and radiographic features of ASD responsive to nonoperative treatment modalities. 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. Evaluate the cost and work hours associated with data collection and minimum 85% patient follow up. 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. Establish standardized data collection methodology for economic based outcome studies based upon patient demographics and HRQOL values.

Official Title
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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

Conditions
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Spinal Deformity

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nonoperative<br>Adult spinal deformity (degenerative or idiopathic) with an ODI of 30 or greater | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index (ODI) | This questionnaire has been designed to provide information as to how back pain affects ability to manage in everyday life. Score must be equal to or greater than 30 for eligibility to enroll. | Initial visit and six months post enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographs | Coronal and sagittal radiographic views of the spine obtained to assess coronal curvature and sagittal balance. | Initial visit (Day 1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scoliosis, Kyphosis, Sagittal plane deformity