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Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST) (BrAIST)

This study has been completed.
Sponsor:
Collaborators:
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
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
Results First Received: May 19, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Adolescent Idiopathic Scoliosis
Interventions: Device: Brace
Other: Observation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from 25 centers in the US and Canada (see list of participating centers). The first subject was enrolled in April 2007 and the last in February 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

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.

Observation

Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.

Observation: Clinical, radiographic, and self-report follow-up every 6 months.


Participant Flow:   Overall Study
    Brace   Observation
STARTED   246   137 
COMPLETED   146   96 
NOT COMPLETED   100   41 
Withdrawal by Subject                13                2 
On protocol when study ended                83                36 
Lost to Follow-up                2                1 
Wrong diagnosis (n=3) or other                2                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Age, gender, race, height, Scoliosis Research Society curve classification, Cobb angle, Risser grade

Reporting Groups
  Description
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.

Brace: Brace (TLSO) prescribed for at least 18 hours per day. Wear time measured using a temperature monitor. Orthotic evaluations are conducted every 6 months and as necessary to maintain brace fit and function.

Observation Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.
Total Total of all reporting groups

Baseline Measures
   Brace   Observation   Total 
Overall Participants Analyzed 
[Units: Participants]
 146   96   242 
Age 
[Units: Years]
Mean (Standard Deviation)
 12.7  (1.0)   12.7  (1.2)   12.7  (1.1) 
Gender 
[Units: Participants]
     
Female   135   86   221 
Male   11   10   21 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   2   1   3 
Asian   5   7   12 
Native Hawaiian or Other Pacific Islander   1   1   2 
Black or African American   11   11   22 
White   116   73   189 
More than one race   0   0   0 
Unknown or Not Reported   11   3   14 
Risser grade [1] 
[Units: Participants]
     
 82   60   142 
 45   19   64 
 15   12   27 
 2   3   5 
 1   0   1 
 1   0   1 
MISSING   0   2   2 
[1] The Risser grade is a measure of the amount of ossification and eventual fusion of the iliac apophysis reflecting skeletal maturity. Grades range from 0 to 5, with higher grades indicating greater maturity. Patients who are classified as being Risser 0, 1 or 2 are regarded as having significant skeletal growth remaining and therefore as being at higher risk for scoliosis progression relative to those classified as Risser 3 or greater. Girls are generally considered skeletally mature at Risser 4 or greater; boys at Risser 5.
Cobb angle [1] 
[Units: Angle in degrees]
Mean (Standard Deviation)
 30.5  (5.8)   30.3  (6.5)   30.4  (6.0) 
[1] The Cobb angle is the most frequently used measurement of the magnitude of the curvature of the spine, and is a function of the tilt of the vertebrae at the top and bottom of the spinal curvature. A Cobb angle of 10 degrees or greater in association with rotation of the vertebrae indicates the presence of scoliosis.
Curve type using SRS classification [1] 
[Units: Participants]
     
Thoracic   38   21   59 
Thoracolumbar   19   13   32 
Lumbar   5   4   9 
Double Major   37   32   69 
Double Thoracic   15   7   22 
Thoracic/Thoracolumbar   20   13   33 
Triple   12   6   18 
[1] The Scoliosis Research Society has classified scoliosis according to the apex of the curvature(s).


  Outcome Measures

1.  Primary:   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. ]

2.  Secondary:   Clinical Measures   [ Time Frame: Measured every 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Radiographic Measures   [ Time Frame: Measured every 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Psychosocial Measures   [ Time Frame: Measured every 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study was terminated early due to efficacy. 119 subjects were still on protocol.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Lori A. Dolan
Organization: University of Iowa Dept of Orthopaedics and Rehabilitation
phone: 319-356-1075
e-mail: lori-dolan@uiowa.edu


Publications of Results:
Other Publications:

Responsible Party: Stuart Weinstein, University of Iowa
ClinicalTrials.gov Identifier: NCT00448448     History of Changes
Other Study ID Numbers: R01AR052113 ( US NIH Grant/Contract Award Number )
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