New 3D Printed Wrist Orthosis

Carpal Tunnel Syndrome Clinical Trial

Official title:

Development and Validation of a New Wrist Orthosis by 3D Printing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05597930
• Other study ID #: RD-21-0376
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2022
• Est. completion date: May 24, 2024

Study information

• Verified date: July 2023
• Source: TOPMED
• Contact: Edith Martin, PhD
• Phone: 4187801301
• Email: emartin[@]topmed.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 24, 2024
• Est. primary completion date: May 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• De Quervain Disease
• Rhizarthrosis
• Tendinopathy
• Tenosynovitis

Intervention

Device:
• Wrist and Thumb orthosis
Custom 3D printed thumb and wrist orthosis

Locations

Country	Name	City	State
Canada	TOPMED	Québec	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
TOPMED	Medicus, Natural Sciences and Engineering Research Council, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difficulty in donning the orthosis	Yes/No question about having difficulty putting on the orthosis. No unit.	Each day during 2 weeks of intervention
Secondary	Comfort	Comfort measure via 1-5 rating, possible scores range from1 (worst possible comfort) to 5 (best possible comfort). No unit.	Each day during 2 weeks of intervention
Secondary	Weight satisfaction rating at baseline	Weight satisfaction measure via 1-5 rating, possible scores range from1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.	Baseline
Secondary	Satisfaction on ease of donning	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.	Baseline
Secondary	Satisfaction on ease of donning	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.	Day 14 of intervention
Secondary	Satisfaction on ease of doffing	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.	Baseline
Secondary	Satisfaction on ease of doffing	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.	Day 14 of intervention
Secondary	Functional disability evaluation of the upper member	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.	Baseline
Secondary	Functional disability evaluation of the upper member	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.	Day 14 of intervention
Secondary	Weight satisfaction rating at 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.	Day 14 of intervention
Secondary	aesthetic satisfaction rating at 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.	Day 14 of intervention
Secondary	aesthetic satisfaction rating at baseline	Aesthetic satisfaction measure via 1-5 rating, possible scores range from1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.	Baseline
Secondary	material quality satisfaction rating at baseline	Material quality satisfaction measure via 1-5 rating, possible scores range from1 (worst possible satisfaction) to 5 (best possible satisfaction). No unit.	Baseline
Secondary	material quality satisfaction rating at 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.	Day 14 of intervention