Trial record 1 of 1 for:    NCT00448448
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Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST)

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Shriners Hospitals for Children
Children's Mercy Hospital Kansas City
University of Rochester
Information provided by (Responsible Party):
Stuart Weinstein, University of Iowa
ClinicalTrials.gov Identifier:
NCT00448448
First received: March 14, 2007
Last updated: June 23, 2014
Last verified: June 2014

March 14, 2007
June 23, 2014
February 2007
September 2013   (final data collection date for primary outcome measure)
Skeletal Maturity With a Cobb Angle of <50 Degrees (Successful Outcome) [ Time Frame: Skeletal maturity and the Cobb angle were measured at baseline and at each 6-month follow-up. Subjects were followed until they reached criteria for either success or failure. The average duration of follow-up was 23.67 months. ] [ Designated as safety issue: No ]
  • Cessation of skeletal growth
  • Progression of Cobb angle to greater than 50 degrees (proxy for surgical indication)
Complete list of historical versions of study NCT00448448 on ClinicalTrials.gov Archive Site
  • Clinical Measures [ Time Frame: Measured every 6 months ] [ Designated as safety issue: No ]
  • Radiographic Measures [ Time Frame: Measured every 6 months ] [ Designated as safety issue: No ]
  • Psychosocial Measures [ Time Frame: Measured every 6 months ] [ Designated as safety issue: Yes ]
  • Clinical
  • Radiographic
  • Psychosocial
Not Provided
Not Provided
 
Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST)
Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST)

Adolescent idiopathic scoliosis (AIS) is a structural curve of the spine with no clear underlying cause. Bracing is currently the standard of care for preventing curve progression and treating AIS. However, the effectiveness of bracing remains unclear. The purpose of this study is to compare the risk of curve progression in adolescents with AIS who wear a brace versus those who do not and to determine whether there are reliable factors that can predict the usefulness of bracing for a particular individual with AIS.

AIS is characterized by a lateral curvature of the spine greater than 10 degrees plus rotation of the spinal vertebrae. AIS is found in adolescents between the age of 10 and time of skeletal maturity. Progression of a spinal curve to 50 degrees suggests a high risk for continued curve progression throughout adulthood and usually indicates the need for spinal fusion surgery. Only about 10 percent of adolescents with AIS end up having curves that progress and require surgical intervention. While certain risk factors for curve progression have been identified, there is no reliable way of estimating the likelihood of needing surgery. Bracing is currently the standard of care for treating AIS. However, the effectiveness of bracing remains unclear, and it is unknown which adolescents in particular may benefit from bracing. Therefore, adolescents undergo bracing without knowing their likelihood of avoiding surgery. The purpose of this study is to compare the risk of curve progression in adolescents with AIS who wear a brace versus those who do not and to determine whether there are reliable factors that can predict the usefulness of bracing for a particular individual with AIS. The study will also evaluate the best dosing and duration schedule and how bracing affects quality of life, functioning, and psychosocial adjustment among participants.

Participation in this study will last until a participant reaches skeletal maturity or their spinal curve progresses to 50 degrees, after which usual care will continue. Participants will either be 1)randomly assigned to a treatment or 2) may decline randomization and choose their own treatment arm. Study visits will occur every 6 months at an orthopaedic surgeon's office and will include x-rays, a clinical exam, and questionnaires. Participants assigned to braces will be instructed to wear the brace at least 18 hours per day. Temperature monitors placed in the brace will be used to determine the actual wear time by each participant.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Adolescent Idiopathic Scoliosis
  • Device: Brace
    Brace (TLSO) applied for at least 18 hours per day. Wear time measured using a temperature monitor. Clinical, radiographic, and self-report follow-up every 6 months.
  • Other: Observation
    Clinical, radiographic, and self-report follow-up every 6 months.
  • Active Comparator: Brace
    This study involves full-time, rigid TLSO's only. Braced subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning. Orthotic evaluations are conducted every 6 months as as necessary to maintain brace fit and function.
    Intervention: Device: Brace
  • Active Comparator: Observation
    Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.
    Intervention: Other: Observation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
383
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of AIS
  • Skeletally immature (Risser grade 0, 1, or 2)
  • Pre-menarchal or post-menarchal by no more than 1 year
  • Primary Cobb angle between 20 and 40 degrees
  • Curve apex caudal to T7 vertebrae
  • Physical and mental ability to adhere to bracing protocol
  • Ability to read and understand English, Spanish, or French
  • Documented insurance coverage and/or personal willingness to pay for treatment

Exclusion Criteria:

  • Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
  • History of previous surgical or orthotic treatment for AIS
Both
10 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00448448
R01 AR052113, R01AR052113
Yes
Stuart Weinstein, University of Iowa
University of Iowa
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • Canadian Institutes of Health Research (CIHR)
  • Shriners Hospitals for Children
  • Children's Mercy Hospital Kansas City
  • University of Rochester
Principal Investigator: Stuart L. Weinstein, MD University of Iowa
Study Director: Lori A. Dolan, PhD University of Iowa
University of Iowa
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP