Rethinking Rigidity: Development of a 3D-Printed Scoliosis Brace With Varying Flexibility
Baylor College of Medicine
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.
Description
After optimizing the brace design, the investigators will collect patient feedback about the design from currently braced participants. Once a participant enrolls in the study, the 3D printed brace will be made using the exact same shape as their current brace. The standard fabrication process includes the following: 1. Certified orthotist completes a full evaluation 2. Taking a scan of the patient's body 3. Modifying, or editing, the patient's body shape using Computer-Aided-Design and applying corrective pressures against the apex of the scoliotic curve 4. Carving a positive foam model of t…
Eligibility
- Age range
- 8–18 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Have a diagnosis of juvenile idiopathic scoliosis or adolescent idiopathic scoliosis 2. Have a Cobb angle between 20-40 degrees 3. Are between ages 8-18 4. Present as Risser 2+ on x-ray 5. Currently wear a traditionally fabricated scoliosis brace 6. Have good brace adherence in current brace (self-reported to be 75% of prescribed time) 7. Be an established patient of Align Clinic and Dr. Timothy Borden 8. Speak English (survey and semi-structured interview will only be available in English) 9. Assent and receive parental consent Exclusion Criteria: 1. Have a diagnosis…
Interventions
- Device3D-printed scoliosis brace
Scoliosis brace will be 3D printed using a Filament Innovations Icarus printer and the material CPX. There will be corrugations where extra strength is needed. The brace will be made using the same shape as the participant's current brace to minimize variables at play. According to Sec. 890.3490 of the Code of Federal Regulations Title 21, scoliosis braces are Class I devices, requiring only general controls. This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.
Locations (2)
- University of Texas Health Science Center at HoustonHouston, Texas
- Align ClinicThe Woodlands, Texas