Recruiting

Scoliosis Brace

Sponsor:

Baylor College of Medicine

Code:

NCT06785207

Conditions

Scoliosis Idiopathic Adolescent Treatment

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

Interventions

3D-printed scoliosis brace

Study Details

Brief summary:

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.

Conditions

Scoliosis Idiopathic Adolescent Treatment

Study ID

NCT06785207

Start date

Apr 1, 2025

Status verified date

May, 2026

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Have a diagnosis of juvenile idiopathic scoliosis or adolescent idiopathic scoliosis
2. Have a Cobb angle between 20-40 degrees
3. Are between ages 8-18
4. Present as Risser 2+ on x-ray
5. Currently wear a traditionally fabricated scoliosis brace
6. Have good brace adherence in current brace (self-reported to be 75% of prescribed time)
7. Be an established patient of Align Clinic and Dr. Timothy Borden
8. Speak English (survey and semi-structured interview will only be available in English)
9. Assent and receive parental consent

Exclusion Criteria:

1. Have a diagnosis other than juvenile idiopathic scoliosis or adolescent idiopathic scoliosis
2. Have a Cobb angle outside the range of 20-40 degrees
3. Present as Risser 0 or 1
4. Do not currently wear a traditionally fabricated scoliosis brace
5. Have poor adherence in their current brace
6. Do not speak English
7. Are not willing participate in the study

Study Design

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: 3D-printed brace

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.

Interventions

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 measure

  • 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) ]

Central Contacts and Locations

Central contacts

Megan EG Castille, MS

713-798-3098megan.glahn@bcm.edu

Locations

Align Clinic

Recruiting

The Woodlands, Texas, United States, 77380

Contacts

Megan EG Castille, MS

713-798-3098megan.glahn@bcm.edu

More Information

Sponsor

Baylor College of Medicine

Last update posted

Jun 2, 2026

Last verified

May, 2026

Keywords

  • 3D-printed scoliosis brace
  • scoliosis brace
  • scoliosis bracing
  • 3D-printing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2026-06-02.