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Sponsors and Collaborators: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) University of Iowa Canadian Institutes of Health Research (CIHR) Shriners Hospitals for Children Children's Mercy Hospital Kansas City University of Rochester |
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Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
ClinicalTrials.gov Identifier: | NCT00448448 |
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 |
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Adolescent Idiopathic Scoliosis |
Device: Brace Other: Watchful waiting |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment |
Official Title: | Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST) |
Estimated Enrollment: | 500 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Brace: Experimental |
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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Observation: Active Comparator
Watchful waiting
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Other: Watchful waiting
Clinical, radiographic and self-report follow-up every 6 months.
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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 be randomly assigned to wear a thoracolumbosacral orthoses brace or not wear a brace. 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. Monitors placed in the brace will be used to determine the actual wear time by each participant.
Ages Eligible for Study: | 10 Years to 15 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Stuart L. Weinstein, MD | 319-356-1872 | stuart-weinstein@uiowa.edu |
Contact: Lori Dolan, PhD | 319-356-1075 | lori-dolan@uiowa.edu |
Principal Investigator: | Stuart L. Weinstein, MD | University of Iowa |
Study Director: | Lori A. Dolan, PhD | University of Iowa |
Responsible Party: | University of Iowa ( Stuart L. Weinstein ) |
Study ID Numbers: | R01 AR052113 |
Study First Received: | March 14, 2007 |
Last Updated: | September 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00448448 |
Health Authority: | United States: Federal Government; Canada: Canadian Institutes of Health Research |
adolescent idiopathic scoliosis orthotics bracing randomized trial |
Spinal Diseases Scoliosis Musculoskeletal Diseases Bone Diseases |
Spinal Curvatures |