Casting vs Bracing for Idiopathic Early-Onset Scoliosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Iowa
- Enrollment
- 71
- Locations
- 26
- Primary Endpoint
- Curve Response
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Study outcome is determined from serial radiographs. Radiographic readers will be blinded to the treatment assigned or received.
Eligibility Criteria
- Ages
- 12 Months to 36 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Will enroll both patients with scoliosis and 1 of their parents/guardians
- •Inclusion Criteria:
- •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 Criteria
- •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
Arms & Interventions
Casting
Subjects will be treated with serial casting
Intervention: Casting (Procedure)
Bracing
Subjects will be treated with full-time orthotics (braces)
Intervention: Bracing (Device)
Outcomes
Primary Outcomes
Curve Response
Time Frame: 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 Outcomes
- Patient Health-related Quality of Life (HRQOL)(on or before 24 months of treatment)
Investigators
Stuart L. Weinstein, MD
Professor
University of Iowa