Trial record 15 of 16 for:    Open Studies | "Kyphosis"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by International Spine Study Group Foundation
Sponsor:
Collaborator:
DePuy Spine
Information provided by (Responsible Party):
Shay Bess, International Spine Study Group Foundation
ClinicalTrials.gov Identifier:
NCT01880164
First received: June 14, 2013
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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


Condition
Spinal Deformity

Study Type: Observational
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.


Estimated Enrollment: 55
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)
Groups/Cohorts
Nonoperative
Adult spinal deformity (degenerative or idiopathic) with an ODI of 30 or greater

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.
  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult spinal deformity patients

Criteria

Inclusion Criteria:

  • ODI ≥30 And a minimum of one of the following radiographic criteria
  • adult degenerative or idiopathic scoliosis with curvature of the spine measuring ≥25 degrees
  • sagittal vertical axis (SVA) >5cm
  • pelvic tilt >25 degrees

Exclusion Criteria:

  • diagnosis other than degenerative or idiopathic
  • cardiopulmonary disease or comorbidities that preclude surgical intervention
  • patient not deemed surgical candidate by treating surgeon
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01880164

Contacts
Contact: Raymarla Pinteric 303-637-9914 raypinteric@q.com

Locations
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    fnaef1@jhmi.edu   
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    rosst@hss.edu   
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
Shay Bess
DePuy Spine
Investigators
Principal Investigator: Shay Bess, MD Rocky Mountain Scoliosis and Spine
  More Information

Publications:

Responsible Party: Shay Bess, President, ISSGF, International Spine Study Group Foundation
ClinicalTrials.gov Identifier: NCT01880164     History of Changes
Other Study ID Numbers: 2108
Study First Received: June 14, 2013
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by International Spine Study Group Foundation:
Scoliosis
Kyphosis
Sagittal plane deformity

Additional relevant MeSH terms:
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 28, 2014