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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 18
Healthy Volunteers: f
View:

• 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

• Currently wear a traditionally fabricated scoliosis brace

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

• Be an established patient of Align Clinic and Dr. Timothy Borden

• Speak English (survey and semi-structured interview will only be available in English)

• Assent and receive parental consent

Locations
United States
Texas
University of Texas Health Science Center at Houston
COMPLETED
Houston
Align Clinic
RECRUITING
The Woodlands
Contact Information
Primary
Megan EG Castille, MS
megan.glahn@bcm.edu
713-798-3098
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 5
Treatments
Experimental: 3D-printed brace
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.
Related Therapeutic Areas
Sponsors
Collaborators: Scoliosis Research Society (SRS)
Leads: Baylor College of Medicine

This content was sourced from clinicaltrials.gov