3D-Printed Brace for Scoliosis

(3DSCOLIBRACE Trial)

Overseen By Megan EG Castille, MS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Other scoliosis, Cobb angle, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of scoliosis brace made with 3D printing technology. The goal is to determine if these 3D-printed braces offer more comfort than traditional ones, potentially improving adherence to prescribed wear. The trial targets individuals with juvenile or adolescent idiopathic scoliosis who currently wear a traditional brace regularly. Participants will compare the comfort and fit of the new brace to their current one. As an unphased trial, this study provides a unique opportunity to contribute to the development of potentially more comfortable scoliosis braces.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this 3D-printed brace is safe for scoliosis patients?

Previous studies have examined the safety of 3D-printed braces for treating scoliosis. These braces are custom-made for each person using 3D printing technology. The studies have shown that these braces are generally safe and comfortable for patients. Users did not report any serious side effects or discomfort different from traditional braces. The main goal of these braces is to improve comfort, potentially encouraging more regular use. Overall, the research suggests that 3D-printed scoliosis braces are a promising and safe option for those needing treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The 3D-printed brace for scoliosis is unique because it offers a highly personalized fit by using 3D printing technology to replicate the exact shape of a patient's existing brace. This customization can potentially improve comfort and effectiveness compared to traditional braces, which are often mass-produced and adjusted manually for each patient. Researchers are excited about this treatment because it could lead to better patient adherence and outcomes, as a more comfortable brace is likely to be worn more consistently, crucial for managing scoliosis effectively.

What evidence suggests that this 3D-printed brace is effective for scoliosis?

Research has shown that 3D-printed braces for scoliosis can be more comfortable than traditional ones. One study found these braces to be lighter and thinner, making them easier to wear. This comfort can encourage patients to continue wearing them, which is crucial for successful treatment. They work well initially, but researchers are still studying their long-term performance. While more research is needed, early findings suggest that 3D-printed braces could effectively treat scoliosis. Participants in this trial will be fitted with a 3D-printed brace to further evaluate its effectiveness and comfort. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals currently undergoing treatment for idiopathic scoliosis with standard braces. Participants should have firsthand experience with brace usage to provide valuable feedback on the new design.

Inclusion Criteria

Assent and receive parental consent

Have good brace adherence in current brace (self-reported to be 75% of prescribed time)

Have a Cobb angle between 20-40 degrees

Exclusion Criteria

Have poor adherence in their current brace

Present as Risser 0 or 1

I am not willing to participate in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Brace Fabrication

3D printed brace is fabricated using the same shape as the participant's current brace

1-4 weeks

Brace Fitting and Activity Testing

Participants are fit with the 3D-printed brace and perform a series of tasks to test comfort

1 day

1 visit (in-person)

Home Trial

Participants take the brace home and wear it for 1 week

1 week

Follow-up

Participants return the brace and provide feedback through a semi-structured interview and survey

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• 3D-printed scoliosis brace

Trial Overview The study is testing a novel 3D-printed scoliosis brace designed to be more comfortable by offering variable flexibility. The goal is to see if this improves comfort without compromising the brace's effectiveness.

How Is the Trial Designed?

Group I: 3D-printed brace Experimental Treatment 1 Intervention

Enrolled participants will be fit with a 3D printed brace. The brace will be made using the exact same shape as their current brace. The fitting procedures will also remain the same.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Scoliosis Research Society (SRS)

Collaborator

Trials

1

Recruited

5+

Published Research Related to This Trial

In a study of 466 patients with adolescent idiopathic scoliosis, the reoperation rates after spinal deformity surgery varied by technique, ranging from 4.5% for open anterior spinal fusion to 8.8% for posterior spinal fusion with hooks, indicating that while reoperations are necessary, they occur at relatively low rates.

The study identified common serious radiographic adverse events, such as rod breakage and proximal screw pullout, but found no significant differences in the incidence of these events across different surgical techniques, suggesting that all methods have similar safety profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiographic classification of complications of instrumentation in adolescent idiopathic scoliosis. Flynn, JM., Betz, RR., O'Brien, MF., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9397992/

Immediate Outcomes and Benefits of 3D Printed Braces for ... As a conclusion, the 3D printed brace had good immediate treatment effectiveness, but the long-time effect is still required time to explore.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878875024009288

Patient-specific 3D-printed Brace for Adolescent Idiopathic ... Patient-tailored 3D-printed brace is lighter, thinner, and more comfortable than conventional braces in the treatment of AIS.

3. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-025-08311-w

On mobility and gait in scoliosis patients: a comparison of ... This pilot study aimed at determining whether 3D-printed braces could induce advantages or disadvantages compared to conventional braces in terms of mobility ...

4. bmjopen.bmj.com bmjopen.bmj.com/content/10/11/e038373

3D-printed brace in the treatment of adolescent idiopathic ... A prospective, controlled study based on data from the brace study of the scoliosis research Society. J Bone Joint Surg Am 1995;77:815–22.doi:10.2106 ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa1307337

Effects of Bracing in Adolescents with Idiopathic Scoliosis Bracing significantly decreased the progression of high-risk curves to the threshold for surgery in patients with adolescent idiopathic scoliosis.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7703428/

3D-printed brace in the treatment of adolescent idiopathic ... Adolescent idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine. Brace treatment is effective for eligible patients with AIS ...

7. link.springer.com link.springer.com/article/10.1007/s00170-020-06181-1

3D printing orthopedic scoliosis braces: a test comparing ... This work evaluates the feasibility of producing orthopedic scoliosis braces by 3D printing, comparing performance and costs with classical thermoforming ...

8. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-025-09070-4

The current state of 3D-printed orthoses clinical outcomes This review examines the clinical outcomes of 3D-printed orthoses, including insoles, AFOs, spinal orthoses, upper-limb orthoses, and helmets, ...

9. app.iass2024.org app.iass2024.org/files/IASS_2024_Paper_563.pdf

Numerical Investigation of 3D-printed Spinal Braces Abstract. Spinal braces are shell-type structures used by patients exhibiting deformities of the spine, relying on.