Splint Users' Satisfaction and Functional Status With Custom Finger Splints

Last updated: March 24, 2025
Sponsor: Endeavor Health
Overall Status: Completed

Phase

N/A

Condition

Holoprosencephaly

Birth Defects

Treatment

3D-Printed Finger Splints

Finger Splints

Conventional Finger Splints

Clinical Study ID

NCT05903391
EH23-047
  • Ages > 18
  • All Genders

Study Summary

This feasibility and non-randomized comparison study explores the possible benefits of splint design and production by 3D-printing in a clinical setting and looks at splint users' experiences with customizable 3D-printed finger splints compared to conventionally made splints. Fifty participants with a hyperextended finger condition are assigned by researcher to either an interventional group (customizable 3D-printed finger splint) or a control group (conventional thermoplastic finger splint). Participants will wear assigned splint for 1 month. Functional status and satisfaction with splint will be assessed at the end of the 1-month duration in the form of surveys on satisfaction and functional status participants will be asked to complete. The findings will contribute to evidence that customizable 3D-printed finger splints can serve as a feasible, cost-effective option to improve patient satisfaction and functional status. It will further justify the need for the application of 3D-printing in a clinical setting.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Fluent in English

  • 18 years or older

  • Finger proximal interphalangeal joint (PIP) joint hyperextension (with or withoutswan-neck deformity)

  • Pregnant or not pregnant women

  • Able to tolerate a finger orthosis over the course of 1 month

  • Not decisionally impaired

  • Have or have not previously worn a finger orthosis for symptoms

Exclusion

Exclusion Criteria:

  • Non-fluent in English

  • Decisionally impaired

  • Younger than 18 years old

  • No proximal interphalangeal joint (PIP) joint finger hyperextension

  • Unable to tolerate a finger orthosis over the course of 1 month

Study Design

Total Participants: 22
Treatment Group(s): 3
Primary Treatment: 3D-Printed Finger Splints
Phase:
Study Start date:
November 09, 2023
Estimated Completion Date:
February 17, 2025

Connect with a study center

  • NorthShore University HealthSystems

    Chicago, Illinois 60625
    United States

    Site Not Available

  • Swedish Hospital Part of NorthShore University HealthSystems

    Chicago, Illinois 60625
    United States

    Site Not Available

  • NorthShore University HealthSystem

    Evanston, Illinois 60201
    United States

    Site Not Available

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