ClinicalTrials.gg
RecruitingNCT05597930Updated Jul 12, 2023

New 3D Printed Wrist Orthosis

An interventional study of Wrist and Thumb orthosis in Carpal Tunnel Syndrome, Ulnar Nerve Injury and Rhizarthrosis, sponsored by TOPMED. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-07-12.

Sponsored by TOPMED · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 5 months ago, but the record still lists the study as recruiting.
  • Registered 5 months after the study started (first participant enrolled May 2022, registered Oct 2022).
  • Started May 2022; still recruiting 4 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 16 studies in Carpal Tunnel Syndrome with a site in Canada — 4 open to participants now, 4 under way, none of them phase 3. Carpal Tunnel Syndrome · Canada.

Planned enrollment
14th of 15
20 · median 60
Started
2022
with 1 other
No phase
8 of 16
2 open now
Registered
14th of 16
by date
Lead sponsor
1 of 16
TOPMED

Among the 16 studies in Carpal Tunnel Syndrome with a site in Canada, this one is the 14th largest by planned enrollment of the 15 interventional ones that give a count, is one of 2 that started in 2022, is one of 8 with no phase, and was the 14th registered.

Carpal Tunnel Syndrome

589 studies on the registry are indexed under Carpal Tunnel Syndrome; 134 are open to participants now.

Browse Carpal Tunnel Syndrome studies →

Open to participants now

4 of the 16 studies in Carpal Tunnel Syndrome with a site in Canada are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 73 Carpal Tunnel Syndrome studies recruiting now, 27 (37%) set no upper age limit and 37 (51%) stop at 75 or younger; 1 takes children under 18; 10 take healthy volunteers.

This study: 18 Years to 70 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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.

03

Conditions studied

  • Carpal Tunnel Syndrome
  • Ulnar Nerve Injury
  • Rhizarthrosis
  • Tendinopathy, Thumb
  • Tenosynovitis de Quervain
  • Hand Disease
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

    • Spasticity in the upper limbs
  • Paralysis, Insensitivity of the upper limbs
  • Neuromuscular pathology affecting the upper limbs
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Thumb then wrist orthosis

    Device: Wrist and Thumb orthosis

  • Experimental
    Wrist then thumb orthosis

    Device: Wrist and Thumb orthosis

Interventions

  • DeviceWrist and Thumb orthosis

    Custom 3D printed thumb and wrist orthosis

06

What researchers measure

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)

    Time frame: Baseline and day 14

Secondary outcomes

  1. Difficulty in donning the orthosis

    Yes/No question about having difficulty putting on the orthosis. No unit.

    Time frame: Each day during 2 weeks of intervention

  2. Comfort

    Comfort measure via 1-5 rating, possible scores range from1 (worst possible comfort) to 5 (best possible comfort). No unit.

    Time frame: Each day during 2 weeks of intervention

  3. 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.

    Time frame: Baseline

  4. 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.

    Time frame: Baseline

  5. 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.

    Time frame: Day 14 of intervention

  6. 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.

    Time frame: Baseline

  7. 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.

    Time frame: Day 14 of intervention

  8. 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.

    Time frame: Baseline

  9. 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.

    Time frame: Day 14 of intervention

  10. 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.

    Time frame: Day 14 of intervention

  11. 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.

    Time frame: Day 14 of intervention

  12. 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.

    Time frame: Baseline

  13. 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.

    Time frame: Baseline

  14. 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.

    Time frame: Day 14 of intervention

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2022 (actual). Primary completion is estimated for May 2024, 24 months after the start.

Of 251 non-industry interventional studies with no phase under Carpal Tunnel Syndrome, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 27. This study's planned 24 months is above that.

Counting every sponsor, half of 261 studies reached it within 12 months; a quarter within 7 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 20, 2022
First posted
Oct 28, 2022
StartActual
May 2, 2022
Primary completionEst.
May 24, 2024
CompletionEst.
May 24, 2024
Last update
Jul 12, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05597930
Lead sponsor
TOPMED
Collaborators
Medicus, Natural Sciences and Engineering Research Council, Canada
Responsible party
Sponsor
First posted
Oct 28, 2022
Start date
May 2, 2022
Primary completion
May 24, 2024 (estimated)
Completion
May 24, 2024 (estimated)
Last update
Jul 12, 2023

Study contacts

Edith Martin, PhD
Contact
emartin@topmed.ca
4187801301

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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