Development of a flexible 3D-printed scoliosis brace
Rethinking Rigidity: Development of a 3D-Printed Scoliosis Brace With Varying Flexibility
This study is testing a new 3D-printed scoliosis brace for kids and teens to see if it’s more comfortable and helps them stick to their treatment better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 8 Years to 18 Years |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 2 sites (Houston, Texas and 1 other locations) |
| Trial ID | NCT06785207 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the comfort and adherence of scoliosis treatment by developing a 3D-printed brace with varying flexibility. Participants aged 8-18 with idiopathic scoliosis will receive a custom brace that mirrors their current one in shape but is made using 3D printing technology. The process involves scanning the patient's body, modifying the design, and fabricating the brace without additional imaging. Patient feedback will be collected to assess the comfort and effectiveness of the new brace design.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 8-18 diagnosed with juvenile or adolescent idiopathic scoliosis who currently wear a traditional brace.
Not a fit: Patients with scoliosis outside the specified Cobb angle range or those who do not currently wear a brace may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance brace comfort and improve adherence to treatment for adolescents with scoliosis.
How similar studies have performed: While traditional bracing methods have been established, the use of 3D printing for scoliosis braces is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 other than juvenile idiopathic scoliosis or adolescent idiopathic scoliosis 2. Have a Cobb angle outside the range of 20-40 degrees 3. Present as Risser 0 or 1 4. Do not currently wear a traditionally fabricated scoliosis brace 5. Have poor adherence in their current brace 6. Do not speak English 7. Are not willing participate in the study
Where this trial is running
Houston, Texas and 1 other locations
- University of Texas Health Science Center at Houston — Houston, Texas, United States (Completed)
- Align Clinic — The Woodlands, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Megan EG Castille, MS
- Email: megan.glahn@bcm.edu
- Phone: 713-798-3098
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.