Casting vs Bracing for Idiopathic Early-Onset Scoliosis

Study Overview
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Brief Summary
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Comparison of casting and bracing for the treatment of idiopathic early onset scoliosis

Detailed Description
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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.

Official Title
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Casting vs Bracing for Idiopathic Early-Onset Scoliosis

Conditions
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Scoliosis Idiopathic, Early-Onset Scoliosis Deformity of Spine

Intervention / Treatment
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* Procedure: Casting
* Device: Bracing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Treatment (casting or bracing) via randomized assignment OR based on family preference
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Casting<br>Subjects will be treated with serial casting | Procedure: Casting<br>* Use of casts applied using corrective maneuvers<br>|
| Active Comparator: Bracing<br>Subjects will be treated with full-time orthotics (braces) | Device: Bracing<br>* Use of full-time spinal orthosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Curve Response | Resolution - curve improvement to <15 degrees (as measured on 2 consecutive radiographs) Failure Initial Cobb 20-50° (inclusive): curve progression of ≥20° resulting in a curve ≥50° Initial Cobb >50°: curve progression of ≥20° Palliation - 2 years of treatment without resolution or failure | on or before 24 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health-related Quality of Life (HRQOL) | 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. | on or before 24 months of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cast, Brace, Spinal Orthosis, Spinal Orthotic