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

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.

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

All study data (assessments and images) will reside in the Pediatric Spine Registry.

after our planned analyses and publications are completed

Study data will be available to all CVBT investigators and Pediatric Spine Registry participants. Interested parties will prepare a proposal for consideration by the PI and the Pediatric Spine Study Group. If approved, the Pediatric Spine Registry staff will query the database and provide the required data for secondary analysis.

Study outcome is determined from serial radiographs. Radiographic readers will be blinded to the treatment assigned or received.