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

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ClinicalTrials.gov Identifier: NCT00448448
Recruitment Status : Terminated (Stopped for efficacy)
First Posted : March 16, 2007
Results First Posted : July 23, 2014
Last Update Posted : August 11, 2017
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Adolescent Idiopathic Scoliosis
Interventions Device: Brace
Other: Observation
Enrollment 383
Recruitment Details 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  
Arm/Group Title Brace Observation
Hide Arm/Group Description

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. 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.

Period Title: Overall Study
Started 246 137
Completed 146 96
Not Completed 100 41
Reason Not Completed
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             1
Signed consent lost             0             1
Arm/Group Title Brace Observation Total
Hide Arm/Group Description

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. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning. Total of all reporting groups
Overall Number of Baseline Participants 146 96 242
Hide Baseline Analysis Population Description
Age, gender, race, height, Scoliosis Research Society curve classification, Cobb angle, Risser grade
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 146 participants 96 participants 242 participants
12.7  (1.0) 12.7  (1.2) 12.7  (1.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 146 participants 96 participants 242 participants
Female
135
  92.5%
86
  89.6%
221
  91.3%
Male
11
   7.5%
10
  10.4%
21
   8.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 146 participants 96 participants 242 participants
American Indian or Alaska Native
2
   1.4%
1
   1.0%
3
   1.2%
Asian
5
   3.4%
7
   7.3%
12
   5.0%
Native Hawaiian or Other Pacific Islander
1
   0.7%
1
   1.0%
2
   0.8%
Black or African American
11
   7.5%
11
  11.5%
22
   9.1%
White
116
  79.5%
73
  76.0%
189
  78.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
11
   7.5%
3
   3.1%
14
   5.8%
Risser grade   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 146 participants 96 participants 242 participants
0 82 60 142
1 45 19 64
2 15 12 27
3 2 3 5
4 1 0 1
5 1 0 1
MISSING 0 2 2
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Angle in degrees
Number Analyzed 146 participants 96 participants 242 participants
30.5  (5.8) 30.3  (6.5) 30.4  (6.0)
[1]
Measure Description: 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 146 participants 96 participants 242 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]
Measure Description: The Scoliosis Research Society has classified scoliosis according to the apex of the curvature(s).
1.Primary Outcome
Title Skeletal Maturity With a Cobb Angle of <50 Degrees (Successful Outcome)
Hide Description [Not Specified]
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The primary analysis included all patients who had completed the trial by January 2013, including 116 patients from the randomized arm and 126 from the preference arm.
Arm/Group Title Brace Observation
Hide Arm/Group Description:

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. 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.

Overall Number of Participants Analyzed 146 96
Measure Type: Number
Unit of Measure: percentage of patient successes
72 48
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brace, Observation
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0267
Comments [Not Specified]
Method Regression, Logistic
Comments The success rate was adjusted for the propensity score (probability of receiving a brace) and the duration of follow-up.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.93
Confidence Interval (2-Sided) 95%
1.08 to 3.46
Estimation Comments [Not Specified]
Time Frame Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Adverse Event Reporting Description Multiple events per participant were recorded
 
Arm/Group Title Brace Observation
Hide Arm/Group Description

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. 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.

All-Cause Mortality
Brace Observation
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Brace Observation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/146 (0.68%)      0/96 (0.00%)    
Psychiatric disorders     
Anxiety and Depression  1 [1]  1/146 (0.68%)  1 0/96 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, SnoMed
[1]
Subject was hospitalized for anxiety and depression
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Brace Observation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   71/146 (48.63%)      36/96 (37.50%)    
Gastrointestinal disorders     
Abdominal pain  1  2/146 (1.37%)  2 0/96 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arm Pain  1  1/146 (0.68%)  1 0/96 (0.00%)  0
Backache  1  30/146 (20.55%)  37 25/96 (26.04%)  29
Dislocation of patellofemoral joint  1  1/146 (0.68%)  1 0/96 (0.00%)  0
Foot pain  1  1/146 (0.68%)  1 2/96 (2.08%)  2
Fracture of great toe  1  1/146 (0.68%)  1 1/96 (1.04%)  1
Hip pain  1  1/146 (0.68%)  1 2/96 (2.08%)  2
Knee pain  1  1/146 (0.68%)  1 0/96 (0.00%)  0
Neck pain  1  1/146 (0.68%)  1 0/96 (0.00%)  0
Nervous system disorders     
Headaches  1  1/146 (0.68%)  1 0/96 (0.00%)  0
Numbness of limb  1 [1]  4/146 (2.74%)  5 2/96 (2.08%)  2
Numbness of saddle area  1 [2]  1/146 (0.68%)  1 0/96 (0.00%)  0
Pain  1 [3]  1/146 (0.68%)  1 0/96 (0.00%)  0
Shoulder pain  1  5/146 (3.42%)  5 2/96 (2.08%)  2
Vaso vagal episode  1  1/146 (0.68%)  1 0/96 (0.00%)  0
Knee reflex abnormal  1 [4]  1/146 (0.68%)  1 0/96 (0.00%)  0
Psychiatric disorders     
Depression  1  2/146 (1.37%)  2 1/96 (1.04%)  1
Suicidal thoughts  1 [5]  1/146 (0.68%)  1 0/96 (0.00%)  0
Anxiety  1  2/146 (1.37%)  2 0/96 (0.00%)  0
Reproductive system and breast disorders     
SnoMed term not found  1 [6]  0/146 (0.00%)  0 1/96 (1.04%)  1
Respiratory, thoracic and mediastinal disorders     
Asthma  1 [7]  1/146 (0.68%)  1 0/96 (0.00%)  0
Skin and subcutaneous tissue disorders     
Eruption of skin  1 [8]  6/146 (4.11%)  6 0/96 (0.00%)  0
Superficial bruising  1  3/146 (2.05%)  4 0/96 (0.00%)  0
Superficial ulcer of skin  1  3/146 (2.05%)  3 0/96 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, SnoMed
[1]
Report of either or both arm and leg numbness and/or tingling
[2]
Report of numbness in hip area
[3]
Report of side pain
[4]
Report of asymmetrical patella reflexes
[5]
Subject with history of depression; event not related to protocol
[6]
non-specific report of abnormal breast development
[7]
Report of asthma exacerbation
[8]
Rash
Study was terminated early due to efficacy. 119 subjects were still on protocol.
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
Responsible Party: Stuart Weinstein, University of Iowa
ClinicalTrials.gov Identifier: NCT00448448     History of Changes
Other Study ID Numbers: 200108052
R01AR052113 ( U.S. NIH Grant/Contract )
First Submitted: March 14, 2007
First Posted: March 16, 2007
Results First Submitted: May 19, 2014
Results First Posted: July 23, 2014
Last Update Posted: August 11, 2017