Trial Outcomes & Findings for Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST) (NCT NCT00448448)
NCT ID: NCT00448448
Last Updated: 2026-03-02
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
383 participants
Primary outcome timeframe
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.
Results posted on
2026-03-02
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
246
|
137
|
|
Overall Study
COMPLETED
|
146
|
96
|
|
Overall Study
NOT COMPLETED
|
100
|
41
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
13
|
2
|
|
Overall Study
On protocol when study ended
|
83
|
36
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Wrong diagnosis (n=3) or other
|
2
|
1
|
|
Overall Study
Signed consent lost
|
0
|
1
|
Baseline Characteristics
Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST)
Baseline characteristics by cohort
| Measure |
Brace
n=146 Participants
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
n=96 Participants
Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.
|
Total
n=242 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.7 years
STANDARD_DEVIATION 1.0 • n=41 Participants
|
12.7 years
STANDARD_DEVIATION 1.2 • n=35 Participants
|
12.7 years
STANDARD_DEVIATION 1.1 • n=76 Participants
|
|
Sex: Female, Male
Female
|
135 Participants
n=41 Participants
|
86 Participants
n=35 Participants
|
221 Participants
n=76 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
21 Participants
n=76 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
3 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
12 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
22 Participants
n=76 Participants
|
|
Race (NIH/OMB)
White
|
116 Participants
n=41 Participants
|
73 Participants
n=35 Participants
|
189 Participants
n=76 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
14 Participants
n=76 Participants
|
|
Risser grade
0
|
82 participants
n=41 Participants
|
60 participants
n=35 Participants
|
142 participants
n=76 Participants
|
|
Risser grade
1
|
45 participants
n=41 Participants
|
19 participants
n=35 Participants
|
64 participants
n=76 Participants
|
|
Risser grade
2
|
15 participants
n=41 Participants
|
12 participants
n=35 Participants
|
27 participants
n=76 Participants
|
|
Risser grade
3
|
2 participants
n=41 Participants
|
3 participants
n=35 Participants
|
5 participants
n=76 Participants
|
|
Risser grade
4
|
1 participants
n=41 Participants
|
0 participants
n=35 Participants
|
1 participants
n=76 Participants
|
|
Risser grade
5
|
1 participants
n=41 Participants
|
0 participants
n=35 Participants
|
1 participants
n=76 Participants
|
|
Risser grade
MISSING
|
0 participants
n=41 Participants
|
2 participants
n=35 Participants
|
2 participants
n=76 Participants
|
|
Cobb angle
|
30.5 angle in degrees
STANDARD_DEVIATION 5.8 • n=41 Participants
|
30.3 angle in degrees
STANDARD_DEVIATION 6.5 • n=35 Participants
|
30.4 angle in degrees
STANDARD_DEVIATION 6.0 • n=76 Participants
|
|
Curve type using SRS classification
Thoracic
|
38 participants
n=41 Participants
|
21 participants
n=35 Participants
|
59 participants
n=76 Participants
|
|
Curve type using SRS classification
Thoracolumbar
|
19 participants
n=41 Participants
|
13 participants
n=35 Participants
|
32 participants
n=76 Participants
|
|
Curve type using SRS classification
Lumbar
|
5 participants
n=41 Participants
|
4 participants
n=35 Participants
|
9 participants
n=76 Participants
|
|
Curve type using SRS classification
Double Major
|
37 participants
n=41 Participants
|
32 participants
n=35 Participants
|
69 participants
n=76 Participants
|
|
Curve type using SRS classification
Double Thoracic
|
15 participants
n=41 Participants
|
7 participants
n=35 Participants
|
22 participants
n=76 Participants
|
|
Curve type using SRS classification
Thoracic/Thoracolumbar
|
20 participants
n=41 Participants
|
13 participants
n=35 Participants
|
33 participants
n=76 Participants
|
|
Curve type using SRS classification
Triple
|
12 participants
n=41 Participants
|
6 participants
n=35 Participants
|
18 participants
n=76 Participants
|
PRIMARY outcome
Timeframe: 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.Population: 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.
Outcome measures
| Measure |
Brace
n=146 Participants
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
n=96 Participants
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.
|
|---|---|---|
|
Skeletal Maturity With a Cobb Angle of <50 Degrees (Successful Outcome)
|
72 percentage of patient successes
|
48 percentage of patient successes
|
Adverse Events
Brace
Serious events: 1 serious events
Other events: 71 other events
Deaths: 0 deaths
Observation
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Brace
n=146 participants at risk
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
n=96 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Anxiety and Depression
|
0.68%
1/146 • Number of events 1 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
0.00%
0/96 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
Other adverse events
| Measure |
Brace
n=146 participants at risk
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
n=96 participants at risk
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.
|
|---|---|---|
|
Reproductive system and breast disorders
SnoMed term not found
|
0.00%
0/146 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
1.0%
1/96 • Number of events 1 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
|
Musculoskeletal and connective tissue disorders
Arm Pain
|
0.68%
1/146 • Number of events 1 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
0.00%
0/96 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
|
Musculoskeletal and connective tissue disorders
Backache
|
20.5%
30/146 • Number of events 37 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
26.0%
25/96 • Number of events 29 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
|
Psychiatric disorders
Depression
|
1.4%
2/146 • Number of events 2 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
1.0%
1/96 • Number of events 1 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
|
Musculoskeletal and connective tissue disorders
Dislocation of patellofemoral joint
|
0.68%
1/146 • Number of events 1 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
0.00%
0/96 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
|
Skin and subcutaneous tissue disorders
Eruption of skin
|
4.1%
6/146 • Number of events 6 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
0.00%
0/96 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
|
Musculoskeletal and connective tissue disorders
Foot pain
|
0.68%
1/146 • Number of events 1 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
2.1%
2/96 • Number of events 2 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
|
Musculoskeletal and connective tissue disorders
Fracture of great toe
|
0.68%
1/146 • Number of events 1 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
1.0%
1/96 • Number of events 1 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
|
Nervous system disorders
Headaches
|
0.68%
1/146 • Number of events 1 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
0.00%
0/96 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
0.68%
1/146 • Number of events 1 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
2.1%
2/96 • Number of events 2 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
|
Nervous system disorders
Numbness of limb
|
2.7%
4/146 • Number of events 5 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
2.1%
2/96 • Number of events 2 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
|
Nervous system disorders
Numbness of saddle area
|
0.68%
1/146 • Number of events 1 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
0.00%
0/96 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
|
Nervous system disorders
Pain
|
0.68%
1/146 • Number of events 1 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
0.00%
0/96 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
|
Nervous system disorders
Shoulder pain
|
3.4%
5/146 • Number of events 5 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
2.1%
2/96 • Number of events 2 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
|
Psychiatric disorders
Suicidal thoughts
|
0.68%
1/146 • Number of events 1 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
0.00%
0/96 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
|
Skin and subcutaneous tissue disorders
Superficial bruising
|
2.1%
3/146 • Number of events 4 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
0.00%
0/96 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
|
Skin and subcutaneous tissue disorders
Superficial ulcer of skin
|
2.1%
3/146 • Number of events 3 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
0.00%
0/96 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
|
Nervous system disorders
Vaso vagal episode
|
0.68%
1/146 • Number of events 1 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
0.00%
0/96 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
2/146 • Number of events 2 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
0.00%
0/96 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
|
Psychiatric disorders
Anxiety
|
1.4%
2/146 • Number of events 2 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
0.00%
0/96 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.68%
1/146 • Number of events 1 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
0.00%
0/96 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
0.68%
1/146 • Number of events 1 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
0.00%
0/96 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
|
Nervous system disorders
Knee reflex abnormal
|
0.68%
1/146 • Number of events 1 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
0.00%
0/96 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.68%
1/146 • Number of events 1 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
0.00%
0/96 • Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
|
Additional Information
Dr. Lori A. Dolan
University of Iowa Dept of Orthopaedics and Rehabilitation
Phone: 319-356-1075
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place