Casting Vs Bracing for Idiopathic Early-Onset Scoliosis
NCT ID: NCT04500041
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
71 participants
INTERVENTIONAL
2021-02-09
2026-01-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Casting
Subjects will be treated with serial casting
Casting
Use of casts applied using corrective maneuvers
Bracing
Subjects will be treated with full-time orthotics (braces)
Bracing
Use of full-time spinal orthosis
Interventions
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Casting
Use of casts applied using corrective maneuvers
Bracing
Use of full-time spinal orthosis
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of idiopathic early-onset scoliosis
* Child standing independently but not older than 3 years of age
* 20≤ Cobb angle ≤70° (largest structural curvature)
* Rib-vertebral angle difference (RVAD) greater than 20 degrees or Rib Phase II
* Parental consent to participate
Parent Inclusion
* Parent or guardian of the minor subject
* Consent to participate
* Able to complete surveys
Exclusion Criteria
* 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
12 Months
36 Months
ALL
No
Sponsors
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Orthopedic Research and Education Foundation
OTHER
Pediatric Spine Study Group
UNKNOWN
University of Iowa
OTHER
Responsible Party
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Stuart L. Weinstein, MD
Professor
Principal Investigators
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Stuart L Weinstein, MD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Locations
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Arkansas Children's Hospital
Little Rock, Arkansas, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Shriners Hospitals for Children - Chicago
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Johns Hopkins
Baltimore, Maryland, United States
Children's Hospital of Boston
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, United States
Children's Mercy Kansas City
Kansas City, Missouri, United States
St. Louis Children's Hospital/Washington University
St Louis, Missouri, United States
Golisano Children's Hospital/University of Rochester
Rochester, New York, United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Doernbecher Children's Hospital / OHSU
Portland, Oregon, United States
Shriners Hospitals for Children - Portland
Portland, Oregon, United States
Children's Hospital of Pennsylvania
Philadelphia, Pennsylvania, United States
Shriners Hospitals for Children - Philadelphia
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Children's Hospital
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
Italian Scientific Spine Institute (ISICO)
Milan, , Italy
Starship Child Health
Auckland, , New Zealand
Countries
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Other Identifiers
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202003169
Identifier Type: -
Identifier Source: org_study_id