Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST) (BrAIST)

November 13, 2019 updated by: Stuart Weinstein
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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. 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 either be 1)randomly assigned to a treatment or 2) may decline randomization and choose their own treatment arm. 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. Temperature monitors placed in the brace will be used to determine the actual wear time by each participant.

Study Type

Interventional

Enrollment (Actual)

383

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • BC Children's Hospital
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Hospital for Sick Children
    • Quebec
      • Montreal, Quebec, Canada
        • Shriner's Hospital for Children
  • United States
    • California
      • Madera, California, United States, 93638
        • Children's Hospital Central California
      • Sacramento, California, United States, 95817
        • Shriners Hospital of Northern California
      • San Diego, California, United States, 92123
        • Rady Childrens Hospital
    • Delaware
      • Wilmington, Delaware, United States, 19899
        • Alfred I. duPont Hospital for Children and Nemours Children's Clinic
    • Georgia
      • Atlanta, Georgia, United States, 30342-4755
        • Children's Healthcare of Atlanta
    • Illinois
      • Chicago, Illinois, United States, 60707
        • Shriner's Hospital for Children
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Children's Hospital
    • Kentucky
      • Lexington, Kentucky, United States, 40502
        • Shriners Hospitals for Children - Lexington
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital Boston
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • Shriners Hospitals for Children - Minneapolis
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospitals and Clinics.
      • Saint Louis, Missouri, United States, 63110
        • St. Louis Children's Hospital
      • Saint Louis, Missouri, United States, 63131
        • Shriners Hospitals for Children - St. Louis
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102-1715
        • Carrie Tingley Hospital
    • New York
      • New York, New York, United States, 10021
        • Hospital For Special Surgery
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15213
        • Children's Hospital of Pittsburgh
    • Utah
      • Salt Lake City, Utah, United States, 84103
        • Shriners Hospitals for Children - Salt Lake City
    • Virginia
      • Charlottesville, Virginia, United States, 22908-0232
        • University of Virginia Health System
    • Washington
      • Seattle, Washington, United States, 98105
        • Children's Hospital and Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 15 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Brace
This study involves full-time, rigid TLSO's only. Braced subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning. Orthotic evaluations are conducted every 6 months as as necessary to maintain brace fit and function.
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.
ACTIVE_COMPARATOR: Observation
Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.
Other: Observation
Clinical, radiographic, and self-report follow-up every 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Skeletal Maturity With a Cobb Angle of <50 Degrees (Successful Outcome)
Time Frame: Skeletal maturity and the Cobb angle were measured at baseline and at each 6-month follow-up. Subjects were followed until they reached criteria for either success or failure. The average duration of follow-up was 23.67 months.
Skeletal maturity and the Cobb angle were measured at baseline and at each 6-month follow-up. Subjects were followed until they reached criteria for either success or failure. The average duration of follow-up was 23.67 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stuart Weinstein

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Canadian Institutes of Health Research (CIHR)
University of Rochester
Shriners Hospitals for Children
Children's Mercy Hospital Kansas City

Investigators

  • Principal Investigator: Stuart L. Weinstein, MD, University of Iowa
  • Study Director: Lori A. Dolan, PhD, University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

March 14, 2007

First Submitted That Met QC Criteria

March 14, 2007

First Posted (ESTIMATE)

March 16, 2007

Study Record Updates

Last Update Posted (ACTUAL)

November 22, 2019

Last Update Submitted That Met QC Criteria

November 13, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200108052
  • R01AR052113 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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