3D-Printed Brace for Scoliosis
(3DSCOLIBRACE Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Baylor College of Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?

Scoliosis bracing is an effective treatment method for idiopathic scoliosis, but only if worn consistently for many hours a day. Unsurprisingly, brace discomfort is a significant deterrent against treatment adherence. For decades, custom braces for idiopathic scoliosis have been fabricated using one of three materials - copolymer, polypropylene, or polyethylene. The application of the biomechanical principles behind bracing have improved over the years, but the materials have not. The investigators' goal is to expand fabrication options by testing a 3D-printed scoliosis brace with variable flexibility. The aim is to improve patients' perceived brace comfort. After optimizing the brace design, the investigators will collect patient feedback about the design from currently braced participants. These participants understand what a standard brace feels like and will provide impactful feedback.

Eligibility Criteria

This trial is for individuals currently undergoing treatment for idiopathic scoliosis with standard braces. Participants should have firsthand experience with brace usage to provide valuable feedback on the new design.

Inclusion Criteria

Have good brace adherence in current brace (self-reported to be 75% of prescribed time)

Assent and receive parental consent

Have a Cobb angle between 20-40 degrees

See 6 more

Exclusion Criteria

Have poor adherence in their current brace

Present as Risser 0 or 1

I do not speak English.

See 4 more

Treatment Details

Interventions

3D-printed scoliosis brace (Brace)

Trial OverviewThe study is testing a novel 3D-printed scoliosis brace designed to be more comfortable by offering variable flexibility. The goal is to see if this improves comfort without compromising the brace's effectiveness.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: 3D-printed braceExperimental Treatment1 Intervention

Enrolled participants will be fit with a 3D printed brace. The brace will be made using the exact same shape as their current brace. The fitting procedures will also remain the same.