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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. Identifier: NCT01880164
Recruitment Status : Completed
First Posted : June 18, 2013
Last Update Posted : April 6, 2017
DePuy Spine
Information provided by (Responsible Party):
Shay Bess, International Spine Study Group Foundation

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

Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Adult spinal deformity (degenerative or idiopathic) with an ODI of 30 or greater

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Radiographs [ Time Frame: Initial visit (Day 1) ]
    Coronal and sagittal radiographic views of the spine obtained to assess coronal curvature and sagittal balance.

Other Outcome Measures:
  1. SRS22r [ Time Frame: Initial (Day1) and six months post enrollment ]
    Assess pain, function, self image, and mental health.

  2. EQ5D-3L [ Time Frame: Initial (Day1) and six months post enrollment ]
    Assess health state (best imaginable vs worst imaginable).

  3. 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.

  4. NRS [ Time Frame: Initial (Day1) and six months post enrollment ]
    Assess back and leg pain.

  5. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult spinal deformity patients

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

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
  5. 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01880164

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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
Sponsors and Collaborators
Shay Bess
DePuy Spine
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Principal Investigator: Shay Bess, MD Rocky Mountain Scoliosis and Spine

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Responsible Party: Shay Bess, President, ISSGF, International Spine Study Group Foundation Identifier: NCT01880164    
Other Study ID Numbers: 2108
First Posted: June 18, 2013    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Shay Bess, International Spine Study Group Foundation:
Sagittal plane deformity
Additional relevant MeSH terms:
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Congenital Abnormalities