Splint Users' Satisfaction and Functional Status With Custom Finger Splints

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-09

Study Completion Date

2025-02-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Novel Splinting Technique Using 3D Models

NCT05351060

Arthritis Osteoarthritis Hand Scleroderma, Systemic +2 more

UNKNOWN NA

Three-dimensional Printed Hand Orthoses

NCT05320211

Hand Injuries and Disorders

COMPLETED NA

3D Printed Made to Measure Splints for Hand Patients

NCT04306796

Splints

COMPLETED NA

Deploying Digital Prosthetic Interface Technology and Exercise in Dysvascular Amputees

NCT05656924

Diabete Type 2 Amputation

RECRUITING PHASE2

Application of 3D Printing Technology in Subtalar Arthrodesis

NCT03152916

Ankle Injuries

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypermobility of Interphalangeal Joints Swan-Neck Deformity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

3D-Printed Finger Splints

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

Group Type EXPERIMENTAL

3D-Printed Finger Splints

Intervention Type DEVICE

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

Conventional Finger Splints

Participants who wear the control, conventionally made finger splints

Group Type ACTIVE_COMPARATOR

Conventional Finger Splints

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

3D-Printed Finger Splints

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

Intervention Type DEVICE

Conventional Finger Splints

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No