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CompletedNCT05163431Updated Mar 6, 2023

Dimensional Validation of the Hallux Valgus Orthosis

An interventional study of Hallux Valgus orthosis in Hallux Valgus, sponsored by TOPMED. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-03-06.

Sponsored by TOPMED · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jul 2021, registered Dec 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The goal of this project is to optimize the design of the orthosis by establishing the key volumetric characteristics of the custom iterations in order to subsequently transpose them to a standard model and establish the increment proportions of the different sizes. The final product should reduce the pain by repositioning the phalanges of the first toe with the first metatarsal in its axis.

02

Conditions studied

  • Hallux Valgus

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03

In context

Hallux Valgus

157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.

This study's enrollment of 4 is below the median of 58 across 119 interventional studies indexed under Hallux Valgus.

Browse Hallux Valgus studies →

Lead sponsor

TOPMED is the lead sponsor of 12 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 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

  • Painful hallux valgus
  • three people maximum per shoe size

Exclusion criteria

Exclusion Criteria:

  • People with diabetes ;
  • People with severe obesity ;
  • People with hallux rigidus;
  • People wearing full-time foot orthosis;
  • People wearing high heel shoes regularly ;
  • People with degenerative disease ;
  • People with neuromuscular pathology ;
  • People with a circulatory disorder ;
  • People who have had major lower body surgery;
  • People with epilepsy or with a history of epilepsy.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    Painful Hallux Valgus

    Device: Hallux Valgus orthosis

Interventions

  • DeviceHallux Valgus orthosis

    Custom designed orthosis and manufactured by 3D printing.

06

What researchers measure

Primary outcomes

  1. Change in big toe deviation angle during gait at 1 month

    The big toe deviation angle is the angle between the big toe and the gait axis and measured with a motion capture system.

    Time frame: At baseline and 1 month

  2. Change in pain at 1 month

    Pain is measured with a Likert scale from 1 (decrease of pain) to 5 (increase of pain).

    Time frame: At baseline and 1 month

  3. Change in comfort at 1 month

    Comfort is measured with a Likert scale from 1 (not comfortable) to 5 (very comfortable).

    Time frame: At baseline and 1 month

07

Study locations

1 site
  • TOPMED
    Québec, Quebec G1S1C1, Canada
08

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

Ran from Jul 2021 to primary completion in Sep 2022, 14 months.

Of 51 non-industry interventional studies with no phase under Hallux Valgus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 55. This study's 14 months is below that.

Counting every sponsor, half of 56 studies reached it within 26 months; a quarter within 11 and three quarters within 55.

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

Registered
Dec 15, 2021
First posted
Dec 20, 2021
StartActual
Jul 20, 2021
Primary completionActual
Sep 30, 2022
CompletionActual
Sep 30, 2022
Last update
Mar 6, 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 Mar 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05163431
Lead sponsor
TOPMED
Collaborators
Natural Sciences and Engineering Research Council, Canada, Orthèse Hallux Valgus Inc.
Responsible party
Sponsor
First posted
Dec 20, 2021
Start date
Jul 20, 2021
Primary completion
Sep 30, 2022
Completion
Sep 30, 2022
Last update
Mar 6, 2023

Study contacts

Edith Martin, PhD
principal investigator · TOPMED

Oversight

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

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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