Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST)

Study acronym: BrAIST
StatusTerminated
PhaseNot applicable
Started

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Record History

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  1. Publications: 6 to 11v28
  2. Lead sponsor: Stuart Weinstein to Stuart L. Weinstein, MD
    • Publications: 5 to 6
    v27
  3. Publications: 4 to 5v26
  4. Phase: Phase 3 to Not applicablev25 Show 5 more changesShow less
    • Lead sponsor: University of Iowa to Stuart Weinstein
    • Trial status: Completed to Terminated
    • Sponsor's reason: Stopped for efficacy
    • Secondary endpoints shortened, about 6 words
    • Publications: 2 to 4
  5. Results first posted: Jul 23, 2014v24 Show 6 more changesShow less
    • Primary endpoints: 2 to 1
    • Trial status: Active, Not Recruiting to Completed
    • Enrollment target: estimated 500 to confirmed 383
    • Primary and study completion dates changed from estimate of Aug 2014 to Sep 2013
    • Secondary endpoints revised (3)
    • Publications: 1 to 2
Show 22 earlier versionsHide 22 earlier versions
  1. Primary and study completion dates: Aug 2012 to Aug 2014
    • Interventions: Brace (Device), Watchful waiting (Other) to Brace (Device), Observation (Other)
    v23
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 25 of 25 sites
    v22
  3. Lead sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) to University of Iowav21 Show 4 more changesShow less
    • Primary and study completion dates: Aug 2010 to Aug 2012
    • Study sites: 26 to 25
    • Collaborators revised (5)
    • Study description expanded, about 5 words
  4. Site contacts updated at 9 of 26 sitesv20
  5. 2 versions Re-verified since Mar 31, 2009, no change to tracked fieldsv18-v19
  6. Study sites: 25 to 26
    • Eligibility criteria revised
    v17
  7. Study sites: 24 to 25
    • Collaborators: 4 to 5
    v16
  8. Study sites: 23 to 24v15
  9. Study sites: 20 to 23v14
  10. Study sites: 21 to 20
    • Collaborators: 3 to 4
    v13
  11. Primary completion date: Aug 2010v12
  12. Site contacts updated at 6 of 21 sitesv11
  13. Study title shortened, about 4 wordsv10
  14. Interventions: Brace (Device) to Brace (Device), Watchful waiting (Other)v9 Show 6 more changesShow less
    • Eligibility criteria shortened, about 24 words
    • Secondary endpoints revised (3)
    • Study description shortened, about 11 words
    • Study sites revised (21)
    • Study arms: 0 to 2
    • Study title expanded, about 5 words
  15. Lead sponsor: University of Iowa to National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
    • Collaborators revised (3)
    v8
  16. Study sites: 16 to 21v7
  17. Site details revised at 5 of 16 sitesv6
  18. Site details revised at 1 of 16 sitesv5
  19. Site details revised at 1 of 16 sitesv4
  20. Site details revised at 1 of 16 sitesv3
  21. Site contacts updated at 1 of 16 sitesv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00448448
Lead Sponsor Stuart L. Weinstein, MD
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Canadian Institutes of Health Research (CIHR), Shriners Hospitals for Children, Children's Mercy Hospital Kansas City, University of Rochester
Conditions
(from sponsor)		 Adolescent Idiopathic Scoliosis
Enrollment 383 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov