Cost Effectiveness of Nonoperative Management for Adult Spinal Deformity
NCT ID: NCT01880164
Last Updated: 2017-04-06
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
21 participants
Study Classification
OBSERVATIONAL
Study Start Date
2015-06-30
Study Completion Date
2017-04-30
Brief Summary
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Quantify the efficacy and cost of nonoperative treatment modalities used for adult spinal deformity.
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Detailed Description
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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.
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
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Spinal Deformity
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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Nonoperative
Adult spinal deformity (degenerative or idiopathic) with an ODI of 30 or greater
No interventions assigned to this group
Eligibility Criteria
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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
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
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
Minimum Eligible Age
40 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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DePuy Spine
INDUSTRY
Sponsor Role
collaborator
Medtronic
INDUSTRY
Sponsor Role
collaborator
Shay Bess
OTHER
Sponsor Role
lead
Responsible Party
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Shay Bess
President, ISSGF
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Shay Bess, MD
Role: PRINCIPAL_INVESTIGATOR
Rocky Mountain Scoliosis and Spine
Locations
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University of California - Davis
Sacramento, California, United States
Site Status
University of California - San Francisco Medical Center
San Francisco, California, United States
Site Status
Rocky Mountain Scoliosis and Spine
Denver, Colorado, United States
Site Status
University of Kansas Medical Center
Kansas City, Kansas, United States
Site Status
Norton Leatherman Spine Center
Louisville, Kentucky, United States
Site Status
Washington University at St. Louis
St Louis, Missouri, United States
Site Status
NYU Hospital for Joint Diseases
New York, New York, United States
Site Status
Hospital for Special Surgery
New York, New York, United States
Site Status
Oregon Health Sciences University
Portland, Oregon, United States
Site Status
University of Virginia
Charlottesville, Virginia, United States
Site Status
Countries
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United States
References
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Other Identifiers
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2108
Identifier Type: -
Identifier Source: org_study_id
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