Casting Vs Bracing for Idiopathic Early-Onset Scoliosis
- Conditions
- Scoliosis IdiopathicEarly-Onset Scoliosis Deformity of Spine
- Interventions
- Device: BracingProcedure: Casting
- Registration Number
- NCT04500041
- Lead Sponsor
- University of Iowa
- Brief Summary
Comparison of casting and bracing for the treatment of idiopathic early onset scoliosis
- Detailed Description
This study uses a multicenter, prospective hybrid research design, which will combine two methods of treatment assignment (randomized and parent preference) and an embedded internal pilot study for sample size re-estimation. Patients will be treated either with serial casts or a full-time brace and followed until curve resolution, failure or palliation (neither resolution nor failure after 2 years of treatment). Results of this study will provide clinicians and families with evidence to support informed treatment decisions.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 71
Patient Inclusion
- 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
Patient Exclusion
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bracing Bracing Subjects will be treated with full-time orthotics (braces) Casting Casting Subjects will be treated with serial casting
- Primary Outcome Measures
Name Time Method Curve Response on or before 24 months of treatment 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
- Secondary Outcome Measures
Name Time Method Patient Health-related Quality of Life (HRQOL) on or before 24 months of treatment Evaluation of patients' HRQOL as estimated by serial administrations of the Early Onset Scoliosis Questionnaire (EOSQ-24, completed by the parent at baseline and every 6 months, total score range 0-100, higher scores indicate higher level of HRQOL). Within and between treatment arm comparisons will be made.
Trial Locations
- Locations (26)
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
Texas Children's Hospital
🇺🇸Houston, Texas, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Italian Scientific Spine Institute (ISICO)
🇮🇹Milano, Italy
Starship Child Health
🇳🇿Auckland, New Zealand