Completed

NCT Number: NCT05903391

Splint Users' Satisfaction and Functional Status With Custom Finger Splints

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.

Completed

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Key information

Conditions

Hypermobility of Interphalangeal Joints Swan-Neck Deformity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D-Printed Finger Splints

Device

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

Conventional Finger Splints

Device

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

Primary outcomes

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

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Jun 15, 2023
Registry last updated: Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.