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Splint Users' Satisfaction and Functional Status With Custom Finger Splints

NCT05903391 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-03-27

No results posted yet for this 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.

Conditions

  • Hypermobility of Interphalangeal Joints
  • Swan-Neck Deformity

Interventions

DEVICE

3D-Printed Finger Splints

The intervention is wearing a novel finger splint produced by a 3D-printer

DEVICE

Conventional Finger Splints

This intervention is wearing a finger splint produced by a conventional method using thermoplastic material typically used in a clinical setting

Sponsors & Collaborators

  • Endeavor Health

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-09
Primary Completion
2025-02-17
Completion
2025-02-17
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05903391 on ClinicalTrials.gov