Casting Vs Bracing for Idiopathic Early-Onset Scoliosis (CVBT)

University of Iowa

Status: Active, not recruiting

Conditions: Early-Onset Scoliosis Deformity of Spine; Scoliosis Idiopathic

Treatments: Device: Bracing; Procedure: Casting

Study type: Interventional

Funder types: Other

Identifiers

NCT04500041

202003169

Details and patient eligibility

About

Comparison of casting and bracing for the treatment of idiopathic early onset scoliosis

Full 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.

Enrollment: 71 patients

Sex: All

Ages: 12 to 36 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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71 participants in 2 patient groups

Casting

Active Comparator group

Description:

Subjects will be treated with serial casting

Treatment:

Procedure: Casting

Bracing

Active Comparator group

Description:

Subjects will be treated with full-time orthotics (braces)

Treatment:

Device: Bracing