NCT06785207 · Baylor College of Medicine
Rethinking Rigidity: Development of a 3D-Printed Scoliosis Brace With Varying Flexibility
(3DSCOLIBRACE)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
3D-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.
Primary outcome measures
Perceived brace comfort
Time frame: Comparing baseline comfort measures at enrollment (current brace) to comfort measures in 3D-printed brace at fitting (roughly 4 weeks after enrollment)
Participants will complete a series of tasks (sitting down, putting shoes on, stepping onto stool, etc.) in their current brace and in the 3D-printed scoliosis brace. Each task will be completed three times and researchers will be blinded to participant responses. A Wilcoxon signed-rank test will compare 3D printed brace comfort to baseline measures.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- Have poor adherence in their current brace
- Do not speak English
- Are not willing participate in the study
Where
- Houston, Texas
- The Woodlands, Texas
Collaborators
Scoliosis Research Society (SRS)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 2, 2026 · Source of record for eligibility and locations