Rethinking Rigidity: Development of a 3D-Printed Scoliosis Brace With Varying Flexibility

Conditions

• Scoliosis Idiopathic Adolescent Treatment

Eligibility Criteria

Sex

ALL

Age

8 Years - 18 Years

Healthy Volunteers

Not accepted

Interventions

• 3D-printed scoliosis brace — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Apr 1, 2025

Status verified

May 2026

Primary completion

Oct 31, 2026

Completion

Oct 31, 2026

Study Design

Enrollment

5 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

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.

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

• Megan EG Castille, MS
  713-798-3098
  [email protected]

Locations (2)

Find similar trials in Houston, TX

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