Hypermobility of Interphalangeal Joints, Swan-Neck Deformity
Conditions
Keywords
3d-printing, technology, finger splints, hypermobile joints
Brief 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.
Interventions
DEVICE3D-Printed Finger Splints
The intervention is wearing a novel finger splint produced by a 3D-printer
DEVICEConventional Finger Splints
This intervention is wearing a finger splint produced by a conventional method using thermoplastic material typically used in a clinical setting
Sponsors
Endeavor Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Version of Orthotics and Prosthetics User Survey - Satisfaction with Device | 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 | 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 |
Countries
United States
Outcome results
None listed