Rethinking Rigidity: Development of a 3D-Printed Scoliosis Brace With Varying Flexibility

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-18
SponsorBaylor College of Medicine

About 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

Qualifiers

Have a diagnosis of juvenile idiopathic scoliosis or adolescent idiopathic scoliosis

Have a Cobb angle between 20-40 degrees

Are between ages 8-18

Present as Risser 2+ on x-ray

Disqualifiers

Have a diagnosis other than juvenile idiopathic scoliosis or adolescent idiopathic scoliosis

Have a Cobb angle outside the range of 20-40 degrees

Present as Risser 0 or 1

Do not currently wear a traditionally fabricated scoliosis brace

Trial design

Treatments tested in this trial

  • 3D-printed scoliosis brace

Treatment groups

5 Participants
are divided into 1 treatment group

Sponsors and collaborators

Baylor College of Medicine

Lead sponsor

Scoliosis Research Society (SRS)

Collaborator