RecruitingNot ApplicableNCT06785207

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

Sponsor

Baylor College of Medicine

Enrollment

5 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Scoliosis Idiopathic Adolescent Treatment

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.

Eligibility

Min Age: 8 YearsMax Age: 18 Years

Inclusion Criteria9

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

Exclusion Criteria7

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

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Interventions

DEVICE3D-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.