New 3D Printed Wrist Orthosis

NCT05597930 | Unknown

• 1 other identifier: RD-21-0376
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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; Hand Disease

Outcome Measures

Primary Outcomes (1)

• Change in pain during treatment from baseline at day 14

  Pain measure via 1-5 rating, possible scores range from1 (no pain) to 5 (worst possible pain). Change = (Day 14 score - baseline score)

  Baseline and day 14

Secondary Outcomes (14)

• Difficulty in donning the orthosis

  Each day during 2 weeks of intervention

• Comfort

  Each day during 2 weeks of intervention

• Weight satisfaction rating at baseline

  Baseline

• Satisfaction on ease of donning

  Baseline

• Satisfaction on ease of donning

  Day 14 of intervention

Study Arms (2)

Thumb then wrist orthosis

EXPERIMENTAL

Device: Wrist and Thumb orthosis

Wrist then thumb orthosis

EXPERIMENTAL

Device: Wrist and Thumb orthosis

Interventions

Wrist and Thumb orthosis DEVICE

Custom 3D printed thumb and wrist orthosis

Thumb then wrist orthosis; Wrist then thumb orthosis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• TOPMED: lead
• Medicus: collaborator
• Natural Sciences and Engineering Research Council, Canada: collaborator

Study Sites (1)

TOPMED

Québec, Quebec, G1S1C1, Canada

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Tendinopathy; De Quervain Disease

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Tendon Entrapment

Central Study Contacts

Edith Martin, PhD

CONTACT

4187801301; emartin@topmed.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 28, 2022
• Study Start: May 2, 2022
• Primary Completion: May 24, 2024
• Study Completion: May 24, 2024
• Last Updated: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)