CompletedNot Applicable

Splint Users' Satisfaction and Functional Status With Custom Finger Splints

United States22 participantsStarted 2023-11-09

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Modified Version of Orthotics and Prosthetics User Survey - Satisfaction with Device

Timeframe: 1 month

Modified Version of Orthotics and Prosthetics User Survey - Functional Status

Timeframe: 1 month

Trial details

NCT IDNCT05903391

SponsorEndeavor Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-17

View on ClinicalTrials.gov More Hypermobility of Interphalangeal Joints trials