NCT05903391

Splint Users' Satisfaction and Functional Status With Custom Finger Splints

Splint Users' Satisfaction and Functional Status With Custom Finger Splints: A Feasibility and Comparison Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Endeavor Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2023-11-09
• Primary completion: 2025-02-17
• Completion: 2025-02-17
• First posted: 2023-06-15
• Last updated: 2025-03-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study