Hallux ValgusNCT05163431
Dimensional Validation of the Hallux Valgus Orthosis
A study testing Hallux Valgus orthosis in people with Hallux Valgus, run by TOPMED at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- Hallux Valgus orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jul 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Painful hallux valgus
- three people maximum per shoe size
Who cannot join
- 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 ;
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hallux Valgus
- Being tested
- Hallux Valgus orthosis
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hallux Valgus orthosisDevice
Custom designed orthosis and manufactured by 3D printing.
| Study group | Role | What they receive |
|---|---|---|
| Painful Hallux Valgus | Experimental | Not described Receives: Device: Hallux Valgus orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and 1 month
Change in pain at 1 month
Pain is measured with a Likert scale from 1 (decrease of pain) to 5 (increase of pain).
Measured: At baseline and 1 month
Change in comfort at 1 month
Comfort is measured with a Likert scale from 1 (not comfortable) to 5 (very comfortable).
Measured: At baseline and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start20 Jul 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- TOPMED
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada, Orthèse Hallux Valgus Inc.
- Responsible party
- Sponsor
- Investigators
- Edith Martin, PhD, Principal investigator, TOPMED
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163431
- Sponsor's protocol ID
- RD-19-0241_HV_HV
- Status last verified
- Mar 2023
- First submitted
- 15 Dec 2021
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dimensional Validation of the Hallux Valgus Orthosis
- ClinicalTrials.gov ID
- NCT05163431
- Acronym / sponsor ID
- RD-19-0241_HV_HV
- Conditions
- Hallux Valgus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- TOPMEDUniversity, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada, Orthèse Hallux Valgus Inc.
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 20 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Painful Hallux Valgus | Experimental | Device: Hallux Valgus orthosis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Painful hallux valgus
- three people maximum per shoe size
Key exclusion criteria (10 listed)
- People with diabetes ;
- People with severe obesity ;
- People with hallux rigidus;
- People wearing full-time foot orthosis;
- People wearing high heel shoes regularly ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hallux Valgus orthosisCustom designed orthosis and manufactured by 3D printing. | Device | Painful Hallux Valgus |
Primary outcome
Change in big toe deviation angle during gait at 1 month
Time frame: At baseline and 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.
Change in pain at 1 month
Time frame: At baseline and 1 month
Pain is measured with a Likert scale from 1 (decrease of pain) to 5 (increase of pain).
Change in comfort at 1 month
Time frame: At baseline and 1 month
Comfort is measured with a Likert scale from 1 (not comfortable) to 5 (very comfortable).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edith Martin, PhD principal investigator
TOPMED
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hallux Valgus orthosis in people with Hallux Valgus, run by TOPMED at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in big toe deviation angle during gait at 1 month (time frame: At baseline and 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.