New 3D Printed Wrist Orthosis

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-02

Study Completion Date

2024-05-24

Brief Summary

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In order to offer a new product improving the healing and/or rehabilitation of injuries or injuries to the wrist and hand, Médicus is seeking to develop a new orthosis for the wrist and hand by 3D printing. This project will focus on the development of an orthosis related to carpal tunnel syndrome as well as droopy hand. Among the issues to be addressed in this development proposal, the investigators find: 1) Identification of the best methodology for taking digital impressions; design of an orthosis with the following characteristics: (i) no external attachment system, (ii) spiral design with a thumb ring, (iii) manufacturing by 3D printing and (iv) a cost of less than $150 ;3) Performing technical and clinical trials.

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Detailed Description

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Conditions

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Carpal Tunnel Syndrome Ulnar Nerve Injury Rhizarthrosis Tendinopathy, Thumb Tenosynovitis de Quervain Hand Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Thumb then wrist orthosis

Group Type EXPERIMENTAL

Wrist and Thumb orthosis

Intervention Type DEVICE

Custom 3D printed thumb and wrist orthosis

Wrist then thumb orthosis

Group Type EXPERIMENTAL

Wrist and Thumb orthosis

Intervention Type DEVICE

Custom 3D printed thumb and wrist orthosis

Interventions

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Wrist and Thumb orthosis

Custom 3D printed thumb and wrist orthosis

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Be between 18 and 70 years old
* Ability to accurately communicate comfort and discomfort,
* Carpal tunnel syndrome, or
* de Quervain's tenosynovitis, or
* Drop hand, or
* Ulnar nerve damage
* Rhizarthrosis, or
* Tendinopathy of the thumb
* And/or ulnar gale