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

NCT06785207 | Recruiting

• 1 other identifier: H-55196
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Perceived brace comfort

  Participants will complete a series of tasks (sitting down, putting shoes on, stepping onto stool, etc.) in their current brace and in the 3D-printed scoliosis brace. Each task will be completed three times and researchers will be blinded to participant responses. A Wilcoxon signed-rank test will compare 3D printed brace comfort to baseline measures.

  Comparing baseline comfort measures at enrollment (current brace) to comfort measures in 3D-printed brace at fitting (roughly 4 weeks after enrollment)

Secondary Outcomes (1)

• Semi-structured interview

  Conducted at one-week follow-up appointment

Other Outcomes (1)

• Survey about perceived brace fit and comfort

  Completed at one-week follow-up appointment

Study Arms (1)

3D-printed brace

EXPERIMENTAL

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.

Device: 3D-printed scoliosis brace

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.

3D-printed brace

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Scoliosis Research Society (SRS): collaborator

Study Sites (2)

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

COMPLETED

Align Clinic

The Woodlands, Texas, 77380, United States

RECRUITING

Related Publications (2)

• Nathan P, Chou SM, Liu G. A review on different methods of scoliosis brace fabrication. Prosthet Orthot Int. 2023 Aug 1;47(4):424-433. doi: 10.1097/PXR.0000000000000195. Epub 2023 Jan 31.

  PMID: 36723398 BACKGROUND

• Ronca A, Abbate V, Redaelli DF, Storm FA, Cesaro G, De Capitani C, Sorrentino A, Colombo G, Fraschini P, Ambrosio L. A Comparative Study for Material Selection in 3D Printing of Scoliosis Back Brace. Materials (Basel). 2022 Aug 19;15(16):5724. doi: 10.3390/ma15165724.

  PMID: 36013868 BACKGROUND

Central Study Contacts

Megan EG Castille, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 21, 2025
• Study Start: April 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

US (2)