New 3D Printed Wrist Orthosis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Carpal Tunnel Syndrome; Rhizarthrosis; Ulnar Nerve Injury; Tendinopathy, Thumb; Tenosynovitis de Quervain; Hand Disease
• Intervention / Treatment: Device: Wrist and Thumb orthosis

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edith Martin, PhD; Phone Number: 4187801301; Email: emartin@topmed.ca

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1S1C1
      • Recruiting
      • TOPMED
      • Contact: Edith Martin, PhD; Phone Number: 4187801301; Email: emartin@topmed.ca
      • Contact: Marianne Lancelot; Phone Number: 4187801301; Email: mlancelot@topmed.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thumb then wrist orthosis	Device: Wrist and Thumb orthosis; Custom 3D printed thumb and wrist orthosis
Experimental: Wrist then thumb orthosis	Device: Wrist and Thumb orthosis; Custom 3D printed thumb and wrist orthosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difficulty in donning the orthosis	Yes/No question about having difficulty putting on the orthosis. No unit.	Each day during 2 weeks of intervention
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: TOPMED
• Collaborators: Natural Sciences and Engineering Research Council, Canada; Medicus

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2022
• Primary Completion (Estimated): May 24, 2024
• Study Completion (Estimated): May 24, 2024

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 28, 2022

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Tendon Injuries; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Tendon Entrapment; Carpal Tunnel Syndrome; Tendinopathy; Tenosynovitis; De Quervain Disease
• Other Study ID Numbers: RD-21-0376

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No