Casting vs Bracing for Idiopathic Early-Onset Scoliosis
Purpose
Comparison of casting and bracing for the treatment of idiopathic early onset scoliosis
Conditions
- Scoliosis Idiopathic
- Early-Onset Scoliosis Deformity of Spine
Eligibility
- Eligible Ages
- Between 12 Months and 36 Months
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Treatment (casting or bracing) via randomized assignment OR based on family preference
- 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Casting |
Subjects will be treated with serial casting |
|
|
Active Comparator Bracing |
Subjects will be treated with full-time orthotics (braces) |
|
Recruiting Locations
Nashville, Tennessee 37232
More Details
- Status
- Recruiting
- Sponsor
- University of Iowa
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.