Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST)
NCT ID: NCT00448448
Last Updated: 2025-11-04
Study Results
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View full resultsBasic Information
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TERMINATED
NA
383 participants
INTERVENTIONAL
2007-02-28
2013-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Interventions
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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
Clinical, radiographic, and self-report follow-up every 6 months.
Eligibility Criteria
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Inclusion Criteria
* 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
* History of previous surgical or orthotic treatment for AIS
10 Years
15 Years
ALL
No
Sponsors
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Shriners Hospitals for Children
OTHER
Children's Mercy Hospital Kansas City
OTHER
University of Rochester
OTHER
Stuart L. Weinstein, MD
OTHER
Responsible Party
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Stuart L. Weinstein, MD
Professor of Orthopaedics and Rehabilitation
Principal Investigators
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Stuart L. Weinstein, MD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Lori A. Dolan, PhD
Role: STUDY_DIRECTOR
University of Iowa
Locations
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Children's Hospital Central California
Madera, California, United States
Shriners Hospital of Northern California
Sacramento, California, United States
Rady Childrens Hospital
San Diego, California, United States
Alfred I. duPont Hospital for Children and Nemours Children's Clinic
Wilmington, Delaware, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Shriner's Hospital for Children
Chicago, Illinois, United States
University of Iowa Children's Hospital
Iowa City, Iowa, United States
Shriners Hospitals for Children - Lexington
Lexington, Kentucky, United States
Children's Hospital Boston
Boston, Massachusetts, United States
Shriners Hospitals for Children - Minneapolis
Minneapolis, Minnesota, United States
Children's Mercy Hospitals and Clinics.
Kansas City, Missouri, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
Shriners Hospitals for Children - St. Louis
St Louis, Missouri, United States
Carrie Tingley Hospital
Albuquerque, New Mexico, United States
Hospital for Special Surgery
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Shriners Hospitals for Children - Salt Lake City
Salt Lake City, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Children's Hospital and Regional Medical Center
Seattle, Washington, United States
BC Children's Hospital
Vancouver, British Columbia, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Shriner's Hospital for Children
Montreal, Quebec, Canada
Countries
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References
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Dolan LA, Weinstein SL, Dobbs MB, Flynn JMJ, Green DW, Halsey MF, Hresko MT, Krengel WF 3rd, Mehlman CT, Milbrandt TA, Newton PO, Price N, Sanders JO, Schmitz ML, Schwend RM, Shah SA, Song K, Talwalkar V. BrAIST-Calc: Prediction of Individualized Benefit From Bracing for Adolescent Idiopathic Scoliosis. Spine (Phila Pa 1976). 2024 Feb 1;49(3):147-156. doi: 10.1097/BRS.0000000000004879. Epub 2023 Nov 23.
Weinstein SL, Dolan LA, Wright JG, Dobbs MB. Design of the Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST). Spine (Phila Pa 1976). 2013 Oct 1;38(21):1832-41. doi: 10.1097/01.brs.0000435048.23726.3e.
Dolan LA, Donzelli S, Zaina F, Weinstein SL, Negrini S. Adolescent Idiopathic Scoliosis Bracing Success Is Influenced by Time in Brace: Comparative Effectiveness Analysis of BrAIST and ISICO Cohorts. Spine (Phila Pa 1976). 2020 Sep 1;45(17):1193-1199. doi: 10.1097/BRS.0000000000003506.
Schwieger T, Campo S, Weinstein SL, Dolan LA, Ashida S, Steuber KR. Body Image and Quality-of-Life in Untreated Versus Brace-Treated Females With Adolescent Idiopathic Scoliosis. Spine (Phila Pa 1976). 2016 Feb;41(4):311-9. doi: 10.1097/BRS.0000000000001210.
Weinstein SL, Dolan LA, Wright JG, Dobbs MB. Effects of bracing in adolescents with idiopathic scoliosis. N Engl J Med. 2013 Oct 17;369(16):1512-21. doi: 10.1056/NEJMoa1307337. Epub 2013 Sep 19.
Schwieger T, Campo S, Weinstein SL, Dolan LA, Ashida S, Steuber KR. Body Image and Quality of Life and Brace Wear Adherence in Females With Adolescent Idiopathic Scoliosis. J Pediatr Orthop. 2017 Dec;37(8):e519-e523. doi: 10.1097/BPO.0000000000000734.
Related Links
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BrAIST-Calc is an online aid for patients with Adolescent Idiopathic Scoliosis who want to estimate their personal risk of scoliosis surgery with and without bracing treatment.
Other Identifiers
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200108052
Identifier Type: -
Identifier Source: org_study_id
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