New 3D Printed Wrist Orthosis

TOPMED

Status: Enrolling

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

Treatments: Device: Wrist and Thumb orthosis

Study type: Interventional

Funder types: Other

Identifiers

NCT05597930

RD-21-0376

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• • Spasticity in the upper limbs
• Paralysis, Insensitivity of the upper limbs
• Neuromuscular pathology affecting the upper limbs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Thumb then wrist orthosis

Experimental group

Treatment:

Device: Wrist and Thumb orthosis

Wrist then thumb orthosis

Experimental group

Treatment:

Device: Wrist and Thumb orthosis