Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST) |
- Progression of Cobb angle to greater than 50 degrees (proxy for surgical indication) [ Time Frame: Measured throughout study ] [ Designated as safety issue: No ]
- Cessation of skeletal growth [ Time Frame: Measured throughout study ] [ Designated as safety issue: No ]
- 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 ]
| Estimated Enrollment: | 500 |
| Study Start Date: | February 2007 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2014 (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 |
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
Show 25 Study Locations| Principal Investigator: | Stuart L. Weinstein, MD | University of Iowa |
| Study Director: | Lori A. Dolan, PhD | University of Iowa |
More Information
Additional Information:
No publications provided
| 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 |
| Last Updated: | April 25, 2013 |
| 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 May 16, 2013