Cost Effectiveness of Nonoperative Management for Adult Spinal Deformity (HEO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01880164|
Recruitment Status : Completed
First Posted : June 18, 2013
Last Update Posted : April 6, 2017
|Condition or disease|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||21 participants|
|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|
|Study Start Date :||June 2015|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||April 2017|
Adult spinal deformity (degenerative or idiopathic) with an ODI of 30 or greater
- Oswestry Disability Index (ODI) [ Time Frame: Initial visit and six months post enrollment ]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.
- Radiographs [ Time Frame: Initial visit (Day 1) ]Coronal and sagittal radiographic views of the spine obtained to assess coronal curvature and sagittal balance.
- SRS22r [ Time Frame: Initial (Day1) and six months post enrollment ]Assess pain, function, self image, and mental health.
- EQ5D-3L [ Time Frame: Initial (Day1) and six months post enrollment ]Assess health state (best imaginable vs worst imaginable).
- Work Productivity and Activity Impairment (WPAI:SHP) [ Time Frame: Initial (Day1) and six months post enrollment ]Assess ability to work and perform regular activities as relates to spinal deformity.
- NRS [ Time Frame: Initial (Day1) and six months post enrollment ]Assess back and leg pain.
- Resource Utilization (RRU) [ Time Frame: Initial clinic visit (Day1) , Phone interviews at 1, 2, 3, 4, and 5 months, and 6 months clinic visit ]Document nonoperative treatment modalities, such as observation only, pain medicine, physical therapy, chiropractic care, injections, diagnostic radiology, emergency visits, and other therapies. Analysis of this data will determine cost associated with nonoperative care for adult spinal disorders.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880164
|United States, California|
|University of California - Davis|
|Sacramento, California, United States, 95817|
|University of California - San Francisco Medical Center|
|San Francisco, California, United States, 94143|
|United States, Colorado|
|Rocky Mountain Scoliosis and Spine|
|Denver, Colorado, United States, 80205|
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|United States, Kentucky|
|Norton Leatherman Spine Center|
|Louisville, Kentucky, United States, 40202|
|United States, Missouri|
|Washington University at St. Louis|
|St. Louis, Missouri, United States, 63110|
|United States, New York|
|NYU Hospital for Joint Diseases|
|New York, New York, United States, 10010|
|Hospital for Special Surgery|
|New York, New York, United States, 10021|
|United States, Oregon|
|Oregon Health Sciences University|
|Portland, Oregon, United States, 97239|
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||Shay Bess, MD||Rocky Mountain Scoliosis and Spine|