NCT04500041

Casting vs Bracing for Idiopathic Early-Onset Scoliosis

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: University of Iowa · Academic / Other
• Sex: All
• Age: 12 Months – 36 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Scoliosis Idiopathic
• Early-Onset Scoliosis Deformity of Spine

Interventions

Type	Name	Description
PROCEDURE	Casting	Use of casts applied using corrective maneuvers
DEVICE	Bracing	Use of full-time spinal orthosis

Timeline

• Start date: 2021-02-09
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2020-08-05
• Last updated: 2026-03-13

Locations

26 sites across 3 countries: United States, Italy, New Zealand

Regulatory

• FDA-regulated device study