Splint Users' Satisfaction and Functional Status With Custom Finger Splints

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypermobility of Interphalangeal Joints, Swan-Neck Deformity

Intervention / Treatment
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* Device: 3D-Printed Finger Splints
* Device: Conventional Finger Splints


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D-Printed Finger Splints<br>Participants who wear the experimental customizable 3D-printed finger splints | Device: 3D-Printed Finger Splints<br>* The intervention is wearing a novel finger splint produced by a 3D-printer<br>|
| Active Comparator: Conventional Finger Splints<br>Participants who wear the control, conventionally made finger splints | Device: Conventional Finger Splints<br>* This intervention is wearing a finger splint produced by a conventional method using thermoplastic material typically used in a clinical setting<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3d-printing, technology, finger splints, hypermobile joints