Casting vs Bracing for Idiopathic Early-Onset Scoliosis
CVBT
1 other identifier
interventional
71
3 countries
26
Brief Summary
Comparison of casting and bracing for the treatment of idiopathic early onset scoliosis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2021
Longer than P75 for not_applicable
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2020
CompletedFirst Posted
Study publicly available on registry
August 5, 2020
CompletedStudy Start
First participant enrolled
February 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
March 13, 2026
January 1, 2026
5.6 years
July 31, 2020
March 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Curve Response
Resolution - curve improvement to \<15 degrees (as measured on 2 consecutive radiographs) Failure 1. Initial Cobb 20-50° (inclusive): curve progression of ≥20° resulting in a curve ≥50° 2. Initial Cobb \>50°: curve progression of ≥20° Palliation - 2 years of treatment without resolution or failure
on or before 24 months of treatment
Secondary Outcomes (1)
Patient Health-related Quality of Life (HRQOL)
on or before 24 months of treatment
Other Outcomes (1)
Parent and Family Functioning
on or before 24 months of treatment
Study Arms (2)
Casting
ACTIVE COMPARATORSubjects will be treated with serial casting
Bracing
ACTIVE COMPARATORSubjects will be treated with full-time orthotics (braces)
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of idiopathic early-onset scoliosis
- Child standing independently but not older than 3 years of age
- ≤ Cobb angle ≤70° (largest structural curvature)
- Rib-vertebral angle difference (RVAD) greater than 20 degrees or Rib Phase II
- Parental consent to participate
- Parent or guardian of the minor subject
- Consent to participate
- Able to complete surveys
You may not qualify if:
- Previous operative or non-operative treatment for idiopathic early-onset scoliosis
- Not independently walking by 18 months of age or other signs/symptoms indicative of developmental delay
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Iowalead
- Orthopedic Research and Education Foundationcollaborator
- Pediatric Spine Study Groupcollaborator
Study Sites (26)
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342, United States
Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Shriners Hospitals for Children - Chicago
Chicago, Illinois, 60707, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Johns Hopkins
Baltimore, Maryland, 21287, United States
Children's Hospital of Boston
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, 55101, United States
Children's Mercy Kansas City
Kansas City, Missouri, 64108, United States
St. Louis Children's Hospital/Washington University
St Louis, Missouri, 63110, United States
Golisano Children's Hospital/University of Rochester
Rochester, New York, 14642, United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27514, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Doernbecher Children's Hospital / OHSU
Portland, Oregon, 97239, United States
Shriners Hospitals for Children - Portland
Portland, Oregon, 97239, United States
Children's Hospital of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Shriners Hospitals for Children - Philadelphia
Philadelphia, Pennsylvania, 19140, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Italian Scientific Spine Institute (ISICO)
Milan, Italy
Starship Child Health
Auckland, New Zealand
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stuart L Weinstein, MD
University of Iowa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Study outcome is determined from serial radiographs. Radiographic readers will be blinded to the treatment assigned or received.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 31, 2020
First Posted
August 5, 2020
Study Start
February 9, 2021
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
September 30, 2026
Last Updated
March 13, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- after our planned analyses and publications are completed
- Access Criteria
- Study data will be available to all CVBT investigators and Pediatric Spine Registry participants. Interested parties will prepare a proposal for consideration by the PI and the Pediatric Spine Study Group. If approved, the Pediatric Spine Registry staff will query the database and provide the required data for secondary analysis.
All study data (assessments and images) will reside in the Pediatric Spine Registry.