Splint Users' Satisfaction and Functional Status With Custom Finger Splints

Endeavor Health

Status: Completed

Conditions: Swan-Neck Deformity; Hypermobility of Interphalangeal Joints

Treatments: Device: Conventional Finger Splints; Device: 3D-Printed Finger Splints

Study type: Interventional

Funder types: Other

Identifiers

NCT05903391

EH23-047

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

3D-Printed Finger Splints

Experimental group

Description:

Participants who wear the experimental customizable 3D-printed finger splints

Treatment:

Device: 3D-Printed Finger Splints

Conventional Finger Splints

Active Comparator group

Description:

Participants who wear the control, conventionally made finger splints

Treatment:

Device: Conventional Finger Splints