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

Trial Summary

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 data supports the effectiveness of the 3D-printed scoliosis brace treatment?

Research shows that 3D-printed scoliosis braces can provide immediate benefits, such as a 41% average correction in spine curvature for children with scoliosis. These braces are also thinner, lighter, and cheaper to produce than traditional braces, which may improve comfort and encourage more consistent use. ^{1 2 3 4 5}

Is the 3D-printed brace for scoliosis safe for humans?

The 3D-printed brace for scoliosis has been shown to be safe for children with adolescent idiopathic scoliosis, as it is lighter and more comfortable than traditional braces, which may improve patient satisfaction and compliance. ^{1 2 4 6 7}

How does the 3D-printed scoliosis brace treatment differ from other treatments for scoliosis?

The 3D-printed scoliosis brace is unique because it is custom-made using 3D scanning and printing technology, making it thinner, lighter, and more comfortable than traditional braces. This customization can lead to better patient satisfaction and compliance, potentially improving treatment outcomes. ^{1 2 3 7 8}

What is the purpose of 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 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

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

Assent and receive parental consent

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Immediate Outcomes and Benefits of 3D Printed Braces for the Treatment of Adolescent Idiopathic Scoliosis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

3D-printed brace in the treatment of adolescent idiopathic scoliosis: a study protocol of a prospective randomised controlled trial. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Methodology and application of three-dimensional technology for brace design and production for treatment in patients with adolescent idiopathic scoliosis: a scoping review protocol. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Personalized Three-Dimensional Printing Pedicle Screw Guide Innovation for the Surgical Management of Patients with Adolescent Idiopathic Scoliosis. [2021]

5. England pubmed.ncbi.nlm.nih.gov

3D printed templates improve the accuracy and safety of pedicle screw placement in the treatment of pediatric congenital scoliosis. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Radiographic classification of complications of instrumentation in adolescent idiopathic scoliosis. [2021]

7. France pubmed.ncbi.nlm.nih.gov

A review on different methods of scoliosis brace fabrication. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Does Three-dimensional Printing Plus Pedicle Guider Technology in Severe Congenital Scoliosis Facilitate Accurate and Efficient Pedicle Screw Placement? [2020]