Cost Effectiveness of Nonoperative Management for Adult Spinal Deformity (HEO)
This study is not yet open for participant recruitment.
Verified June 2013 by International Spine Study Group Foundation
Information provided by (Responsible Party):
Shay Bess, International Spine Study Group Foundation
First received: June 14, 2013
Last updated: June 17, 2013
Last verified: June 2013
Quantify the efficacy and cost of nonoperative treatment modalities used for adult spinal deformity.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Cost Effectiveness of Nonoperative Management for Adult Spinal Deformity: A Prospective Pilot Study to Evaluate Disease Burden and Longitudinal Study Feasibility|
Resource links provided by NLM:
Further study details as provided by International Spine Study Group Foundation:
Primary Outcome Measures:
- Oswestry Disability Index (ODI) [ Time Frame: Initial visit and six months post enrollment ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Radiographs [ Time Frame: Initial visit (Day 1) ] [ Designated as safety issue: Yes ]Coronal and sagittal radiographic views of the spine obtained to assess coronal curvature and sagittal balance.
Other Outcome Measures:
- SRS22r [ Time Frame: Initial (Day1) and six months post enrollment ] [ Designated as safety issue: No ]Assess pain, function, self image, and mental health.
- EQ5D-3L [ Time Frame: Initial (Day1) and six months post enrollment ] [ Designated as safety issue: No ]Assess health state (best imaginable vs worst imaginable).
- Work Productivity and Activity Impairment (WPAI:SHP) [ Time Frame: Initial (Day1) and six months post enrollment ] [ Designated as safety issue: No ]Assess ability to work and perform regular activities as relates to spinal deformity.
- NRS [ Time Frame: Initial (Day1) and six months post enrollment ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Adult spinal deformity (degenerative or idiopathic) with an ODI of 30 or greater
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01880164
|Contact: Raymarla Pintericfirstname.lastname@example.org|
|United States, California|
|San Diego Center for Spinal Disorders|
|La Jolla, California, United States, 92037|
|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, Maryland|
|Johns Hopkins University||Not yet recruiting|
|Baltimore, Maryland, United States, 21287-0882|
|Contact: Floreana Naef 410-428-3388 email@example.com|
|Principal Investigator: Khaled Kebaish, MD|
|United States, New York|
|Hospital for Special Surgery||Not yet recruiting|
|New York, New York, United States, 10021|
|Contact: Tom Ross 212-606-1723 firstname.lastname@example.org|
|Principal Investigator: Oheneba Boachie-Adjei, MD|
|Sub-Investigator: Matthew Cunningham, MD|
|Sub-Investigator: Han Jo Kim, MD|
|NYU Hospital for Joint Diseases|
|New York, New York, United States, 10010|
|United States, Oregon|
|Oregon Health Sciences University|
|Portland, Oregon, United States, 97239|
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22908|
Sponsors and Collaborators
|Principal Investigator:||Shay Bess, MD||Rocky Mountain Scoliosis and Spine|