Condition category
Musculoskeletal Diseases
Date applied
04/07/2008
Date assigned
04/07/2008
Last edited
24/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.goosetowngraphics.com/braist/index.htm

Contact information

Type

Scientific

Primary contact

Dr James Gardner Wright

ORCID ID

Contact details

Department of Surgery
The Hospital for Sick Children
555 University Avenue
Toronto
M5G 1X8
Canada
+1 (0)416 813 6433
james.wright@sickkids.ca

Type

Public

Additional contact

Ms Magdalena Lysenko

ORCID ID

Contact details

Clinical Research Coordinator
Hospital for Sick Children
555 University Avenue
Toronto
M5G 1X8
Canada
-
magdalena.lysenko@sickkids.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00448448

Protocol/serial number

MCT-81050

Study information

Scientific title

Bracing in Adolescent Idiopathic Scoliosis Trial

Acronym

BrAIST

Study hypothesis

Bracing is an effective, non-operative treatment for adolescent idiopathic scoliosis.

Ethics approval

Research Ethics Board of the Hospital for Sick Children (Toronto), 19/04/2004, ref: 1000010719

Study design

Blinded (outcome assessor), randomised parallel assignment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information material on http://www.goosetowngraphics.com/braist/index.htm

Condition

Adolescent idiopathic scoliosis

Intervention

Amended as of 06/03/2009:
Bracing arm: Thoracolumbar spinal orthosis, worn daily until skeletal maturity or curve progression to 50 degrees
Watchful waiting arm: Physician evaluation every 6 months until skeletal maturity or curve progression to 50 degrees

Initial information at the time of registration:
Bracing arm: Thoracolumbar spinal orthosis, worn daily until skeletal maturity or curve progression greater than 45 degrees
Watchful waiting arm: Physician evaluation every 6 months until skeletal maturity or curve progression greater than 45 degrees

Intervention type

Device

Phase

Drug names

Primary outcome measures

Amended as of 06/03/2009:
Progression to 50 degrees as measured every 6 months.

Initial information at the time of registration:
Progression to greater than 45 degrees as measured every 6 months.

Secondary outcome measures

1. Child Health Questionnaire measured every 6 months
2. Self-Image Questionnaire for Young Adolescents measured every 6 months
3. Peds Quality of Life measured every 6 months
4. Spinal Appearance Questionnaire measured every 6 months

Overall trial start date

01/04/2007

Overall trial end date

01/04/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Amended as of 06/03/2009:
5. Primary Cobb angle 20 - 39 degrees

Initial information at the time of registration:
1. Diagnosis of adolescent idiopathic scoliosis
2. Aged 10 - 15 years, either sex
3. Risser 0 - 2
4. Menarche within 1 year
5. Primary Cobb angle 25 - 39 degrees
6. Curve Apex caudal to T7

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

449

Participant exclusion criteria

1. Other musculoskeletal, neurological, or developmental illnesses possibly responsible for the curvature
2. Physical and mental disability precluding adherence to bracing protocol
3. History of previous surgical or orthotic treatment
4. Inability to read and understand English, Spanish, and/or French

Recruitment start date

01/04/2007

Recruitment end date

01/04/2012

Locations

Countries of recruitment

Canada, United States of America

Trial participating centre

The Hospital for Sick Children
Toronto
M5G 1X8
Canada

Sponsor information

Organisation

The Hospital for Sick Children (Canada)

Sponsor details

555 University Avenue
Toronto
M5G 1X8
Canada

Sponsor type

Hospital/treatment centre

Website

http://www.sickkids.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (ref: MCT-81050)

Alternative name(s)

Instituts de Recherche en Santé du Canada, CIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Canada

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

See https://clinicaltrials.gov/ct2/show/results/NCT00448448

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24026162

Publication citations

  1. Protocol

    Weinstein SL, Dolan LA, Wright JG, Dobbs MB, Design of the Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST)., Spine, 2013, 38, 21, 1832-1841, doi: 10.1097/01.brs.0000435048.23726.3e.

Additional files

Editorial Notes

24/03/2016: added link to results - basic reporting.