New 3D Printed Wrist Orthosis

Not Applicable

Recruiting

• Conditions: Tendinopathy, Thumb; Hand Disease; Rhizarthrosis; Carpal Tunnel Syndrome; Ulnar Nerve Injury; Tenosynovitis de Quervain
• Interventions: Device: Wrist and Thumb orthosis

• Registration Number: NCT05597930
• Lead Sponsor: TOPMED

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-02
• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2022-10-25
• Study First Posted: 2022-10-28
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-10
• Last Update Posted: 2023-07-12
• Primary Completion: 2024-05-24
• Study Completion: 2024-05-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Wrist then thumb orthosis	Wrist and Thumb orthosis	-
Thumb then wrist orthosis	Wrist and Thumb orthosis	-

Primary Outcome Measures

Name	Time	Method
Change in pain during treatment from baseline at day 14	Baseline and 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)

Secondary Outcome Measures

Name	Time	Method
Difficulty in donning the orthosis	Each day during 2 weeks of intervention	Yes/No question about having difficulty putting on the orthosis. No unit.
Satisfaction on ease of donning	Day 14 of intervention	Satisfaction measure via 1-5 rating on ease of donning, possible scores range from 1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
Satisfaction on ease of doffing	Day 14 of intervention	Satisfaction measure via 1-5 rating on ease of doffing, possible scores range from 1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
aesthetic satisfaction rating at baseline	Baseline	Aesthetic satisfaction measure via 1-5 rating, possible scores range from1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
Comfort	Each day during 2 weeks of intervention	Comfort measure via 1-5 rating, possible scores range from1 (worst possible comfort) to 5 (best possible comfort). No unit.
Weight satisfaction rating at day 14 of intervention	Day 14 of intervention	Weight satisfaction measure via 1-5 rating, possible scores range from1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
material quality satisfaction rating at day 14 of intervention	Day 14 of intervention	Material quality satisfaction measure via 1-5 rating, possible scores range from1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
Weight satisfaction rating at baseline	Baseline	Weight satisfaction measure via 1-5 rating, possible scores range from1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
material quality satisfaction rating at baseline	Baseline	Material quality satisfaction measure via 1-5 rating, possible scores range from1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.
Functional disability evaluation of the upper member	Day 14 of intervention	Evaluation of disability of arm, shoulder and hand in activities of daily living via Quick Disability of arm, shoulder and hand (Quick DASH) (validated 11 elements 5-point rating). Possible scores range from 1 (No difficulty) to 5 (Incapacity to complete task). No unit.
aesthetic satisfaction rating at day 14 of intervention	Day 14 of intervention	Aesthetic satisfaction measure via 1-5 rating, possible scores range from1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.

Trial Locations

Locations (1)

TOPMED; 🇨🇦 Québec, Quebec, Canada