Cost Effectiveness of Nonoperative Management for Adult Spinal Deformity (HEO)

April 4, 2017 updated by: Shay Bess

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

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • University of California - Davis
      • San Francisco, California, United States, 94143
        • University of California - San Francisco Medical Center
    • Colorado
      • Denver, Colorado, United States, 80205
        • Rocky Mountain Scoliosis and Spine
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Leatherman Spine Center
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University at St. Louis
    • New York
      • New York, New York, United States, 10021
        • Hospital For Special Surgery
      • New York, New York, United States, 10010
        • NYU Hospital for Joint Diseases
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health Sciences University
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult spinal deformity patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Nonoperative
Adult spinal deformity (degenerative or idiopathic) with an ODI of 30 or greater

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Initial visit and six months post enrollment

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
SRS22r
Time Frame: Initial (Day1) and six months post enrollment
Assess pain, function, self image, and mental health.
Initial (Day1) and six months post enrollment
EQ5D-3L
Time Frame: Initial (Day1) and six months post enrollment
Assess health state (best imaginable vs worst imaginable).
Initial (Day1) and six months post enrollment
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.
Initial (Day1) and six months post enrollment
NRS
Time Frame: Initial (Day1) and six months post enrollment
Assess back and leg pain.
Initial (Day1) and six months post enrollment
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.
Initial clinic visit (Day1) , Phone interviews at 1, 2, 3, 4, and 5 months, and 6 months clinic visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shay Bess

Collaborators

Medtronic
DePuy Spine

Investigators

  • Principal Investigator: Shay Bess, MD, Rocky Mountain Scoliosis and Spine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (ACTUAL)

January 1, 2017

Study Completion (ACTUAL)

April 1, 2017

Study Registration Dates

First Submitted

June 14, 2013

First Submitted That Met QC Criteria

June 17, 2013

First Posted (ESTIMATE)

June 18, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 6, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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