Status:
ACTIVE_NOT_RECRUITING
Casting Vs Bracing for Idiopathic Early-Onset Scoliosis
Lead Sponsor:
University of Iowa
Collaborating Sponsors:
Orthopedic Research and Education Foundation
Pediatric Spine Study Group
Conditions:
Scoliosis Idiopathic
Early-Onset Scoliosis Deformity of Spine
Eligibility:
All Genders
12-36 years
Phase:
NA
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 sa...
Eligibility Criteria
Inclusion
- Will enroll both patients with scoliosis and 1 of their parents/guardians
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2026
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT04500041
Start Date
February 9 2021
End Date
January 30 2026
Last Update
December 16 2024
Active Locations (26)
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1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
2
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
3
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States, 19803
4
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30342