Status:
TERMINATED
Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST)
Lead Sponsor:
Stuart L. Weinstein, MD
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Canadian Institutes of Health Research (CIHR)
Conditions:
Adolescent Idiopathic Scoliosis
Eligibility:
All Genders
10-15 years
Phase:
NA
Brief Summary
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. Ho...
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....
Eligibility Criteria
Inclusion
- 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
- Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
- History of previous surgical or orthotic treatment for AIS
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
383 Patients enrolled
Trial Details
Trial ID
NCT00448448
Start Date
February 1 2007
End Date
September 1 2013
Last Update
November 4 2025
Active Locations (25)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital Central California
Madera, California, United States, 93638
2
Shriners Hospital of Northern California
Sacramento, California, United States, 95817
3
Rady Childrens Hospital
San Diego, California, United States, 92123
4
Alfred I. duPont Hospital for Children and Nemours Children's Clinic
Wilmington, Delaware, United States, 19899