Study Design. Descriptive.
Objective. To describe the design and development of Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST).
Summary of Background Data. Bracing has remained the standard of care for the nonoperative treatment of adolescent idiopathic scoliosis since the introduction of the Milwaukee brace in the late 1940s, but it has never been subjected to a rigorous evaluation of either its efficacy or its effectiveness. The BrAIST was designed to address the primary question: Do braces (specifically a thoracolumbosacral orthosis) lower the risk of curve progression to a surgical threshold (≥50°) in patients with adolescent idiopathic scoliosis relative to watchful waiting alone?
Methods. The authors describe the rationale for BrAIST, including the limitations of the current literature evaluating bracing for adolescent idiopathic scoliosis. Second, the authors describe the preliminary work, including the preparation of the National Institutes of Health clinical trials planning grant. Finally, the authors describe the trial design in detail.
Results. BrAIST was conducted in 25 sites in North America. Subjects were treated either with a thoracolumbosacral orthosis or watchful waiting and followed every 6 months until they reached skeletal maturity or the surgical threshold of 50° Cobb angle.
Conclusion. Clinical decision making will be improved by translation of the BrAIST results into evidence-based prognosis and estimates of how the prognosis, specifically the risk of progressing to surgery, may be altered by the use of bracing.
Level of Evidence: N/A
The Bracing in Adolescent Idiopathic Scoliosis Trial was designed to assess the relative effectiveness of bracing treatment and watchful waiting in preventing curve progression to surgical threshold. This article outlines the rationale, research design, and protocol.
*Department of Orthopaedics and Rehabilitation, University of Iowa, Iowa City, IA
†Department of Surgery, The Hospital for Sick Children, Toronto, Ontario, Canada, and the Division of Orthopedic Surgery, University of Toronto, Toronto, Ontario, Canada; and
‡Department of Orthopaedic Surgery, Washington University School of Medicine and St. Louis Shriners Hospital for Children, St. Louis, MO.
Address correspondence and reprint requests to Stuart L. Weinstein, MD, Department of Orthopaedics and Rehabilitation, University of Iowa, 200 Hawkins Dr., Iowa City, IA 52242; E-mail: email@example.com
Acknowledgment date: May 17, 2013. Revision date: July 22, 2013. Acceptance date: August 16, 2013.
The device(s)/drug(s) that is/are the subject of this manuscript is/are exempt from FDA or corresponding national regulations.
The project described was supported by Award Numbers R21AR049587 and R01AR052113 from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (Weinstein SL, PI); the Shriners Hospitals for Children (#79125, Dobbs, MB, PI); the Canadian Institutes of Health Research (FRN-81050, Wright JG, PI); the University of Rochester (Sanders JO, PI); the Children's Mercy Hospitals & Clinics (Price NJ, PI); and the Children's Miracle Network (Weinstein SL, PI).
Relevant financial activities outside the submitted work: grants, board membership, royalties, travel/accommodations/meeting expenses, patents, consultancy.