Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST) (BrAIST)
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| ClinicalTrials.gov Identifier: NCT00448448 |
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Recruitment Status :
Terminated
(Stopped for efficacy)
First Posted : March 16, 2007
Results First Posted : July 23, 2014
Last Update Posted : November 22, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Adolescent Idiopathic Scoliosis | Device: Brace Other: Observation | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 383 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Masking Description: | The outcomes assessor(s) are blinded to the treatment assignment. |
| Primary Purpose: | Treatment |
| Official Title: | Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST) |
| Study Start Date : | February 2007 |
| Actual Primary Completion Date : | September 2013 |
| Actual Study Completion Date : | September 2013 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
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Active Comparator: Observation
Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.
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Other: Observation
Clinical, radiographic, and self-report follow-up every 6 months. |
- 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. ]
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| Ages Eligible for Study: | 10 Years to 15 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00448448
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| Principal Investigator: | Stuart L. Weinstein, MD | University of Iowa | |
| Study Director: | Lori A. Dolan, PhD | University of Iowa |
Other Publications:
| Responsible Party: | Stuart Weinstein, Professor of Orthopaedics and Rehabilitation, University of Iowa |
| ClinicalTrials.gov Identifier: | NCT00448448 |
| Other Study ID Numbers: |
200108052 R01AR052113 ( U.S. NIH Grant/Contract ) |
| First Posted: | March 16, 2007 Key Record Dates |
| Results First Posted: | July 23, 2014 |
| Last Update Posted: | November 22, 2019 |
| Last Verified: | November 2019 |
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adolescent idiopathic scoliosis orthotics bracing partially randomized preference design |
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Scoliosis Spinal Curvatures Spinal Diseases Bone Diseases Musculoskeletal Diseases |