Splint Users' Satisfaction and Functional Status With Custom Finger Splints

Not Applicable

Completed

• Conditions: Hypermobility of Interphalangeal Joints; Swan-Neck Deformity
• Interventions: Device: Conventional Finger Splints; Device: 3D-Printed Finger Splints

• Registration Number: NCT05903391
• Lead Sponsor: Endeavor Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-05
• Study First Submitted QC: 2023-06-05
• Study First Posted: 2023-06-15
• Study Start: 2023-11-09
• Primary Completion: 2025-02-17
• Study Completion: 2025-02-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Fluent in English
• 18 years or older
• Finger proximal interphalangeal joint (PIP) joint hyperextension (with or without swan-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 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Finger Splints	Conventional Finger Splints	Participants who wear the control, conventionally made finger splints
3D-Printed Finger Splints	3D-Printed Finger Splints	Participants who wear the experimental customizable 3D-printed finger splints

Primary Outcome Measures

Name	Time	Method
Modified Version of Orthotics and Prosthetics User Survey - Satisfaction with Device	1 month	A modified version of a Self-report questionnaire which measures participants satisfaction with assigned splint device
Modified Version of Orthotics and Prosthetics User Survey - Functional Status	1 month	A modified version of a Self-report questionnaire which measures participants' functional status during the duration of time wearing assigned finger splint device

Trial Locations

Locations (2)

Swedish Hospital Part of NorthShore University HealthSystems; 🇺🇸 Chicago, Illinois, United States

NorthShore University HealthSystem; 🇺🇸 Evanston, Illinois, United States