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
  Purpose

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.


Condition Intervention Phase
Adolescent Idiopathic Scoliosis
Device: Brace
Other: Observation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST)

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 383
Study Start Date: February 2007
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Active Comparator: Observation
Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.
Other: Observation
Clinical, radiographic, and self-report follow-up every 6 months.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   10 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00448448

  Show 25 Study Locations
Sponsors and Collaborators
University of Iowa
Canadian Institutes of Health Research (CIHR)
Shriners Hospitals for Children
Children's Mercy Hospital Kansas City
University of Rochester
Investigators
Principal Investigator: Stuart L. Weinstein, MD University of Iowa
Study Director: Lori A. Dolan, PhD University of Iowa
  More Information

Publications:
Responsible Party: Stuart Weinstein, Professor of Orthopaedics and Rehabilitation, University of Iowa
ClinicalTrials.gov Identifier: NCT00448448     History of Changes
Other Study ID Numbers: R01 AR052113, R01AR052113
Study First Received: March 14, 2007
Results First Received: May 19, 2014
Last Updated: June 23, 2014
Health Authority: United States: Federal Government
Canada: Canadian Institutes of Health Research

Keywords provided by University of Iowa:
adolescent idiopathic scoliosis
orthotics
bracing
partially randomized preference design

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 24, 2014