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Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST)

NCT00448448 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 383

Last updated 2026-03-02

Study results available
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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. 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.

Conditions

  • Adolescent Idiopathic Scoliosis

Interventions

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.

OTHER

Observation

Clinical, radiographic, and self-report follow-up every 6 months.

Sponsors & Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Shriners Hospitals for Children

    collaborator OTHER

  • Children's Mercy Hospital Kansas City

    collaborator OTHER

  • University of Rochester

    collaborator OTHER

  • Stuart L. Weinstein, MD

    lead OTHER

Principal Investigators

  • Stuart L. Weinstein, MD · University of Iowa

  • Lori A. Dolan, PhD · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00448448 on ClinicalTrials.gov