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Search / Trial NCT00448448

Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST)

Launched by STUART WEINSTEIN · Mar 14, 2007

Trial Information

Current as of April 30, 2025

Terminated

Keywords

Adolescent Idiopathic Scoliosis Orthotics Bracing Partially Randomized Preference Design

ClinConnect Summary

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 estim...

Gender

ALL

Eligibility criteria

  • 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

About Stuart Weinstein

Stuart Weinstein is a distinguished clinical trial sponsor known for his commitment to advancing medical research and improving patient outcomes. With a robust background in clinical medicine and a focus on innovative therapeutic approaches, he leads initiatives that seek to explore and validate new treatment modalities across various health conditions. His dedication to ethical research practices and stringent regulatory compliance ensures that all trials are conducted with the highest standards of integrity and scientific rigor. Through collaborative partnerships with healthcare professionals and research institutions, Weinstein aims to contribute valuable insights to the medical community and enhance the quality of care for patients worldwide.

Locations

New York, New York, United States

Philadelphia, Pennsylvania, United States

Rochester, New York, United States

Pittsburgh, Pennsylvania, United States

Toronto, Ontario, Canada

Saint Louis, Missouri, United States

Madera, California, United States

Cincinnati, Ohio, United States

Boston, Massachusetts, United States

Seattle, Washington, United States

Atlanta, Georgia, United States

Iowa City, Iowa, United States

Vancouver, British Columbia, Canada

Sacramento, California, United States

San Diego, California, United States

Wilmington, Delaware, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Lexington, Kentucky, United States

Minneapolis, Minnesota, United States

Kansas City, Missouri, United States

Saint Louis, Missouri, United States

Albuquerque, New Mexico, United States

Salt Lake City, Utah, United States

Charlottesville, Virginia, United States

Montreal, Quebec, Canada

Patients applied

0 patients applied

Trial Officials

Stuart L. Weinstein, MD

Principal Investigator

University of Iowa

Lori A. Dolan, PhD

Study Director

University of Iowa

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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