Clinical trial NCT05597930: New 3D Printed Wrist Orthosis
Official title: Development and Validation of a New Wrist Orthosis by 3D Printing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carpal Tunnel Syndrome
Ulnar Nerve Injury
Rhizarthrosis
Tendinopathy, Thumb
Tenosynovitis de Quervain
Hand Disease
Lead sponsor: TOPMED
Sponsor class: OTHER
Collaborators: name: Medicus
name: Natural Sciences and Engineering Research Council, Canada
First posted: 2022-10-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in pain during treatment from baseline at day 14
timeFrame: Baseline and day 14
Secondary outcomes:
measure: Difficulty in donning the orthosis
timeFrame: Each day during 2 weeks of intervention
measure: Comfort
timeFrame: Each day during 2 weeks of intervention
measure: Weight satisfaction rating at baseline
timeFrame: Baseline
measure: Satisfaction on ease of donning
timeFrame: Baseline
measure: Satisfaction on ease of donning
timeFrame: Day 14 of intervention
measure: Satisfaction on ease of doffing
timeFrame: Baseline
measure: Satisfaction on ease of doffing
timeFrame: Day 14 of intervention
measure: Functional disability evaluation of the upper member
timeFrame: Baseline
measure: Functional disability evaluation of the upper member
timeFrame: Day 14 of intervention
measure: Weight satisfaction rating at day 14 of intervention
timeFrame: Day 14 of intervention
measure: aesthetic satisfaction rating at day 14 of intervention
timeFrame: Day 14 of intervention
measure: aesthetic satisfaction rating at baseline
timeFrame: Baseline
measure: material quality satisfaction rating at baseline
timeFrame: Baseline
measure: material quality satisfaction rating at day 14 of intervention
timeFrame: Day 14 of intervention
Other outcomes:
Locations:
city: Québec
country: Canada
facility: TOPMED
state: Quebec
Study officials:
References: