A review on different methods of scoliosis brace fabrication.
Parvathi Nathan, Siaw Meng Chou, Gabriel Liu
https://pubmed.ncbi.nlm.nih.gov/36723398/Actively Recruiting
Led by Baylor College of Medicine · Updated on 2026-06-02
5
Participants Needed
2
Research Sites
N/A
Total Duration
Researchers are studying adolescents with idiopathic scoliosis to evaluate a new 3D-printed scoliosis brace designed with varying flexibility. The goal is to improve how comfortable patients feel while wearing the brace, which may help them wear it more consistently. The study focuses on participants who currently use traditional scoliosis braces and aims to collect detailed feedback on the new 3D-printed design. Participants will receive a 3D-printed brace made to match the exact shape of their current brace. Unlike traditional methods that involve carving foam and molding plastic, this brace will be directly 3D printed using a specialized printer and material. Once fabricated, participants will be fitted with the new brace by a scoliosis bracing specialist, ensuring proper adjustment and comfort. They will then perform a series of daily activities while wearing the brace to test comfort and fit. The study involves several steps over 2 to 6 weeks. After enrollment, the 3D brace fabrication takes 1 to 4 weeks. Participants will visit the clinic for brace fitting and activity testing in one day, followed by a 1-week home wear period. At the end, they will provide feedback through surveys and interviews before returning the brace. Researchers will measure perceived comfort compared to their current brace and collect qualitative feedback to assess the new designs impact.
CONDITIONS
Rethinking Rigidity: Development of a 3D-Printed Scoliosis Brace With Varying Flexibility
M
Megan EG Castille, MS
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Baylor College of Medicine
Lead Sponsor
Scoliosis Research Society (SRS)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | 3D‑printed scoliosis brace | Standard rigid brace (e.g., TLSO) |
|---|---|---|
| What it is | A custom‑designed scoliosis brace made by 3D printing using the participant’s existing brace shape with strength‑enhancing corrugations in key areas | A conventional rigid thoracolumbosacral orthosis (TLSO) or similar brace fabricated by standard methods |
| Role in trial | Investigational single‑arm device being tested for feasibility | Not included in the trial but represents usual care against which the new brace would be compared in practice |
| Primary use | To assess feasibility and perceived comfort of a personalized 3D‑printed scoliosis brace | To stabilize spinal curvature during growth and reduce risk of progression |
| How it is given or performed | Printed using the participant’s brace shape via Filament Innovations Icarus printer with material CPX and corrugated reinforcement | Fabricated by conventional molding or thermoforming using rigid plastic such as polypropylene TLSO |
| Evidence status | Evidence limited to feasibility and comfort; effectiveness in curve control not yet established | Substantial evidence demonstrates brace efficacy in preventing curve progression in AIS |
| Important risks | Comfort and fit being assessed; specific safety risks not yet evaluated | Known risks include skin irritation, pressure sores, possible discomfort affecting adherence |
| Important limitations | Single‑arm feasibility design without direct comparison for curve control; small enrollment expected | Rigid design may be less comfortable and heavier than 3D‑printed alternative |
| Patient impact | Potential improvements in comfort and personalization; impact on curve progression unknown | May reduce curve progression and avoid surgery when adherence is good |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for enrollment, consent, and baseline testing
Duration - 1 to 4 weeks
Participants' braces are 3D printed using the exact same shape as their current braces. No additional scans or measurements are required from participants during this time.
No participant visits during fabrication
Duration - 1 day
Participants come to the clinic to be fit with the 3D printed brace. The fitting includes trimming, adding straps, and adjustments for comfort. On the same day, participants perform a series of activities to test brace comfort and fit.
1 visit (in-person) lasting 1 to 4 hours including fitting and activity testing
Duration - 1 week after fitting
One week after fitting, participants return the brace and provide feedback through a semi-structured interview and survey about their experience with the 3D printed brace.
1 visit (in-person) for follow-up interview and survey lasting 30 to 60 minutes
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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Parvathi Nathan, Siaw Meng Chou, Gabriel Liu
https://pubmed.ncbi.nlm.nih.gov/36723398/Alfredo Ronca, Valentina Abbate, Davide Felice Redaelli...
https://pubmed.ncbi.nlm.nih.gov/36013868/Baylor College of Medicine
Lead Sponsor
Scoliosis Research Society (SRS)
Collaborating Sponsor