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

ArmDescriptionAssigned Intervention
Active Comparator
Casting
Subjects will be treated with serial casting
  • Procedure: Casting
    Use of casts applied using corrective maneuvers
Active Comparator
Bracing
Subjects will be treated with full-time orthotics (braces)
  • Device: Bracing
    Use of full-time spinal orthosis

More Details

Status
Active, not recruiting
Sponsor
University of Iowa

Study Contact

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.