Medial GonarthrosisNCT06655558
Validating the Clinical Effect of a Knee Orthosis
A study testing custom knee orthosis in people with Medial Gonarthrosis, run by TOPMED at 1 site in Canada.
Trial summary
The aging population is steadily increasing, partly due to increasing life expectancy. At the same time, chronic diseases, including those affecting the musculoskeletal system (e.g., osteoarthritis), whose prevalence increases with age, limit the daily activities of those affected and thus affect more and more people. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Medial Gonarthrosis
- What is being tested?
- custom knee orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- 31 Jul 2024to 6 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suffering from medial gonarthrosis
- Receiving a regular model of the O3D orthosis
Who cannot join
- Suffering from tricompartmental gonarthosis
- Having completed the delivery appointment for a O3D orthosis
Trial locations and contacts
1 site in 1 country.
About this study
The aging population is steadily increasing, partly due to increasing life expectancy. At the same time, chronic diseases, including those affecting the musculoskeletal system (e.g., osteoarthritis), whose prevalence increases with age, limit the daily activities of those affected and thus affect more and more people. Arthrosis is the most common form of these diseases worldwide. According to the l'Institut de la statistique du Québec, nearly one in two Quebecers aged 15 and over is affected by a chronic health problem.
Knee orthosis is one form of treatment that helps patients suffering from knee gonarthrosis. This treatment aims to compensate for certain biomechanical deficits in patients. A variety of joint configurations exists to target specific biomechanical deficits. A constant challenge for companies manufacturing orthoses is transmitting the orthosis's biomechanical effect to the patient. The desired effect requires a change in the forces applied inside the knee, but the orthosis cannot directly transmit forces to the patient's bones due to its external nature to the body. Customization of orthoses is crucial to improve the transmission of the biomechanical effect as well as tolerance to it. O3D Inc. aims to validate the effectiveness of its new custom orthosis for treating knee gonarthrosis symptoms.
Participants answered a Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire before receiving their custom knee brace(Baseline) and after 8 weeks (56 days) of treatment.
- Conditions
- Medial Gonarthrosis
- Being tested
- custom knee orthosis
- Keywords
- knee orthosis, knee brace, validation, WOMAC, knee pain, knee stiffness, daily activities, knee function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
custom knee orthosisDevice
The custom knee orthosis will be worn for 8 weeks (56 days).
| Study group | Role | What they receive |
|---|---|---|
| medial gonarthrosis | Experimental | Patients with medial gonarthrosis Receives: Device: custom knee orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in WOMAC Total Score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) 24 item questionnaire about knee pain, stiffness and function. Each item uses a 5 point scale ranging from 0 (no pain, stiffness or difficulty) to 4 (extreme pain, stiffness or difficulty). Total score is the sum of all items and ranges from 0 to 96. Therefore low scores represent better knee health whereas high scores represent worse knee health. Change is calculated as :
Change= Score after 8 weeks of treatment - Baseline Score
Measured: At baseline and after 8 weeks of intervention(Day 56)
Change in WOMAC Pain Score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subcore of 5 items about knee pain. Each item uses a 5 point scale ranging from 0 (no pain) to 4 (extreme pain). Pain score is the sum of all 5 items, ranges from 0 to 20. Therefore low scores represent better knee pain whereas high scores represent worse knee pain. Change is calculated as :
Change= Score after 8 weeks of treatment - Baseline Score
Measured: At baseline and after 8 weeks of intervention(Day 56)
Change in WOMAC Stiffness Score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscore of 2 items about knee stiffness. Each item uses a 5 point scale ranging from 0 (no stiffness) to 4 (extreme stiffness). Stiffness score is the sum of 2 items, ranges from 0 to 8. Therefore low scores represent better knee stiffness whereas high scores represent worse knee stiffness. Change is calculated as :
Change= Score after 8 weeks of treatment - Baseline Score
Measured: At baseline and after 8 weeks of intervention(Day 56)
Change in WOMAC Physical Function Score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscore of 17 items about knee function. Each item uses a 5 point scale ranging from 0 (no dificulty) to 4 (extreme dificulty). Functionnal limitation score is the sum of all 17 items, ranges from 0 to 68. Therefore low scores represent better knee function whereas high scores represent worse knee function. Change is calculated as :
Change= Score after 8 weeks of treatment - Baseline Score
Measured: At baseline and after 8 weeks of intervention(Day 56)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start31 Jul 2024
- Primary completion22 Dec 2024
- Study completion6 Jun 2025
Why it stopped: Budget for the research project ran out.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Medial GonarthrosisStudies 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
- Model description
- Longitudal treatment validation
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- TOPMED
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada, O3D inc.
- Responsible party
- Sponsor
- Investigators
- Edith Martin, Phd., Principal investigator, TOPMED
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655558
- Sponsor's protocol ID
- 241_O3D_Quest
- Status last verified
- Aug 2025
- First submitted
- 21 Oct 2024
- Last updated
- 4 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating the Clinical Effect of a Knee Orthosis
- ClinicalTrials.gov ID
- NCT06655558
- Acronym / sponsor ID
- 241_O3D_Quest
- Conditions
- Medial Gonarthrosis
- Keywords
- knee orthosis, knee brace, validation, WOMAC, knee pain, knee stiffness, daily activities, knee function
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Budget for the research project ran out.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- TOPMEDUniversity, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada, O3D inc.
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 22 Dec 2024 (actual)
- Study completion
- 6 Jun 2025 (actual)
- First posted
- 23 Oct 2024 (actual)
- Results
- Posted 4 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aging population is steadily increasing, partly due to increasing life expectancy. At the same time, chronic diseases, including those affecting the musculoskeletal system (e.g., osteoarthritis), whose prevalence increases with age, limit the daily activities of those affected and thus affect more and more people. Arthrosis is the most common form of these diseases worldwide. According to the l'Institut de la statistique du Québec, nearly one in two Quebecers aged 15 and over is affected by a chronic health problem.
Knee orthosis is one form of treatment that helps patients suffering from knee gonarthrosis. This treatment aims to compensate for certain biomechanical deficits in patients. A variety of joint configurations exists to target specific biomechanical deficits. A constant challenge for companies manufacturing orthoses is transmitting the orthosis's biomechanical effect to the patient. The desired effect requires a change in the forces applied inside the knee, but the orthosis cannot directly transmit forces to the patient's bones due to its external nature to the body. Customization of orthoses is crucial to improve the transmission of the biomechanical effect as well as tolerance to it. O3D Inc. aims to validate the effectiveness of its new custom orthosis for treating knee gonarthrosis symptoms.
Participants answered a Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire before receiving their custom knee brace(Baseline) and after 8 weeks (56 days) of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Longitudal treatment validation
| Arm | Type | Receives |
|---|---|---|
| medial gonarthrosis | Experimental | Device: custom knee orthosisPatients with medial gonarthrosis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Suffering from medial gonarthrosis
- Receiving a regular model of the O3D orthosis
Key exclusion criteria (2 listed)
- Suffering from tricompartmental gonarthosis
- Having completed the delivery appointment for a O3D orthosis
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 |
|---|---|---|
| custom knee orthosisThe custom knee orthosis will be worn for 8 weeks (56 days). | Device | medial gonarthrosis |
Primary outcome
Change in WOMAC Total Score
Time frame: At baseline and after 8 weeks of intervention(Day 56)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) 24 item questionnaire about knee pain, stiffness and function. Each item uses a 5 point scale ranging from 0 (no pain, stiffness or difficulty) to 4 (extreme pain, stiffness or difficulty). Total score is the sum of all items and ranges from 0 to 96. Therefore low scores represent better knee health whereas high scores represent worse knee health. Change is calculated as : Change= Score after 8 weeks of treatment - Baseline Score
Change in WOMAC Pain Score
Time frame: At baseline and after 8 weeks of intervention(Day 56)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subcore of 5 items about knee pain. Each item uses a 5 point scale ranging from 0 (no pain) to 4 (extreme pain). Pain score is the sum of all 5 items, ranges from 0 to 20. Therefore low scores represent better knee pain whereas high scores represent worse knee pain. Change is calculated as : Change= Score after 8 weeks of treatment - Baseline Score
Change in WOMAC Stiffness Score
Time frame: At baseline and after 8 weeks of intervention(Day 56)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscore of 2 items about knee stiffness. Each item uses a 5 point scale ranging from 0 (no stiffness) to 4 (extreme stiffness). Stiffness score is the sum of 2 items, ranges from 0 to 8. Therefore low scores represent better knee stiffness whereas high scores represent worse knee stiffness. Change is calculated as : Change= Score after 8 weeks of treatment - Baseline Score
Change in WOMAC Physical Function Score
Time frame: At baseline and after 8 weeks of intervention(Day 56)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscore of 17 items about knee function. Each item uses a 5 point scale ranging from 0 (no dificulty) to 4 (extreme dificulty). Functionnal limitation score is the sum of all 17 items, ranges from 0 to 68. Therefore low scores represent better knee function whereas high scores represent worse knee function. Change is calculated as : Change= Score after 8 weeks of treatment - Baseline Score
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Medial Gonarthrosis
RecruitingObservational study
Prospective Comparative Study of Clinical Outcomes and Complications in Medial Knee Prostheses: Fixed Bearing Versus Mobile Bearing Design
Medial Gonarthrosis
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 custom knee orthosis in people with Medial Gonarthrosis, 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 2 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: stopped early, as of the sponsor's last update on 4 Sep 2025. 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?
Yes. Results are posted in the registry (first posted 4 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 WOMAC Total Score (time frame: At baseline and after 8 weeks of intervention(Day 56)). The study lists 4 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 4 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.