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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
3D-printed scoliosis brace
DeviceScoliosis 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.
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: 3D-printed braceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Perceived brace comfort
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.
Time frame
Comparing baseline comfort measures at enrollment (current brace) to comfort measures in 3D-printed brace at fitting (roughly 4 weeks after enrollment)Secondary outcomes
1
Semi-structured interview
A semi-structured interview will be performed to understand the differences between the two braces. Systematic coding procedures (e.g., open, axial, and selective coding) will be conducted by the research team.
Time frame
Conducted at one-week follow-up appointmentOther outcomes
1
Survey about perceived brace fit and comfort
Participants will answer a survey about their experience during the one-week trial with the 3D-printed brace. The survey will ask about comfort, preferences, design, etc.
Time frame
Completed at one-week follow-up appointmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Baylor College of Medicine
Lead sponsor
Scoliosis Research Society (SRS)
Collaborator
Source ClinicalTrials.gov