Scoliosis Idiopathic, Early-Onset Scoliosis Deformity of Spine
Conditions
Keywords
Cast, Brace, Spinal Orthosis, Spinal Orthotic
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.
Interventions
Sponsors
University of Iowa
Orthopedic Research and Education Foundation
Pediatric Spine Study Group
Study design
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.
Intervention model description
Treatment (casting or bracing) via randomized assignment OR based on family preference
Eligibility
Sex/Gender
ALL
Age
12 Months to 36 Months
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy, New Zealand, United States
Contacts
PRINCIPAL_INVESTIGATORStuart L Weinstein, MD
University of Iowa
Outcome results
None listed