Recruiting

Orthosis

Sponsor:

TOPMED

Code:

NCT05597930

Conditions

Carpal Tunnel Syndrome

Ulnar Nerve Injury

Rhizarthrosis

Tendinopathy, Thumb

Tenosynovitis de Quervain

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Wrist and Thumb orthosis

Study Details

Brief summary:

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.

Conditions

Carpal Tunnel Syndrome

Ulnar Nerve Injury

Rhizarthrosis

Tendinopathy, Thumb

Tenosynovitis de Quervain

Study ID

NCT05597930

Start date

May 2, 2022

Status verified date

Jul, 2023

Completion date

May 24, 2024

Anticipated

Primary completion date

May 24, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Thumb then wrist orthosis

experimental: Wrist then thumb orthosis

Interventions

Wrist and Thumb orthosis

Custom 3D printed thumb and wrist orthosis

Primary outcome measure

  • Change in pain during treatment from baseline at day 14 [ Time Frame: Baseline and day 14 ]

Central Contacts and Locations

Central contacts

Edith Martin, PhD

4187801301emartin@topmed.ca

Locations

TOPMED

Recruiting

Québec, Quebec, Canada, G1S1C1

Contacts

Edith Martin, PhD

4187801301emartin@topmed.ca

Marianne Lancelot

4187801301mlancelot@topmed.ca

More Information

Sponsor

TOPMED

Last update posted

Jul 12, 2023

Last verified

Jul, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by TOPMED on 2023-07-12.