GonarthrosisNCT05814471
Validation of a Knee Brace for Gonarthrosis
A study testing Cable fastening system and 3d printed straps(14 days), Velcro straps system(14 days) and Adjustment period(Velcro-14 days) in people with Gonarthrosis, run by TOPMED at 1 site in Canada.
Trial summary
A study about the effects of different fastening systems for knee braces on comfort, ease of installation and treatment efficacy both physical and psychological. Two different systems will be tested, velcro straps and a cable-fastening system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gonarthrosis
- What is being tested?
- Cable fastening system and 3d printed straps(14 days), Velcro straps system(14 days) and Adjustment period(Velcro-14 days)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- 30 Mar 2023to 30 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has worn an ODRA knee brace multiple hours a day during the last 6 months
Who cannot join
- Wounds on the lower body
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protocol for the Clinical Validation of a Valgus Knee Brace for Gonarthrosis
A study about the effects of different fastening systems for knee braces on comfort, ease of installation and treatment efficacy both physical and psychological. Two different systems will be tested, velcro straps and a cable-fastening system.
Read the detailed description
There are 2 main types of knee braces for gonarthrosis: soft knee braces and rigid knee braces. Soft knee braces use malleable materials such as cloth or rubber to apply forces on the leg whereas rigid braces use plastic or metal shells. Three main types of fastening systems are used on these types of orthoses: velcro systems, hybrid systems and cable fastening systems. Therefore, different configurations exist to reduce biomechanical deficits caused by the pathology.
Each fastening system has its advantages and disadvantages. Velcro straps are fast and intuitive to use, altough multiple difficulties are mentionned: adjusment, cleaning, the number of straps needed to maintain the knee brace in position as well as the noise while detaching the straps. Hybrid systems regularly use velcro straps to which are added quick-release fasteners to simplify the installation and uninstallation process. Cable fastening systems also use quick-release fasteners. The adjusment process is simple and precise with minimal noise with these systems.
Comfort, efficacy and ease of use are essential qualities of a knee brace. Confort is primordial as it is directly linked to treatment adherence by the patients. Efficacy of a knee brace treatment may be measured by symptom or medication use evolution but also with daily practice of problematic movement by the patient. Ease of use must be optimized as it presents an opportunity to increase treatment adherence. The goal of the fastening system developped in partnership with Laboratoires Victhom is to increase ease of use of the knee brace while maintaining comfort and treatment efficacy.
- Conditions
- Gonarthrosis
- Being tested
- Cable fastening system and 3d printed straps(14 days), Velcro straps system(14 days), Adjustment period(Velcro-14 days)
- Keywords
- knee brace, orthosis, treatment efficacy, arthrosis, comfort, ease of use
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cable fastening system and 3d printed straps(14 days)Device
The participants will wear a Odra knee brace held in place with by a cable fastening system and 3d printed straps for 2 weeks.
Velcro straps system(14 days)Device
The participants will wear a Odra knee brace held in place with by a velcro straps system for 2 weeks.
Adjustment period(Velcro-14 days)Device
The participants will wear a new Odra knee brace held in place with by a velcro straps system for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Adjustement period(velcro)first, then Cable fastening system then Velcro Straps | Experimental | A new knee brace is worn for a 14 days adjustement period with velcro straps. Then the brace is worn with a cable fastening system for a first 14 days intervention period, therefore the knee brace is held in place by a cable fastening system and 3d printed straps. The second 14 days intervention period is done with velcro straps keeping the brace in position. Receives: Device: Cable fastening system and 3d printed straps(14 days); Device: Velcro straps system(14 days); Device: Adjustment period(Velcro-14 days) |
| Adjustement period(velcro)first, then Velcro Straps then Cable fastening system | Active comparator | A new knee brace is worn for a 14 days adjustement period with velcro straps. The first 14 days intervention period is done with velcro straps keeping the brace in position. Then the brace is worn with a cable fastening system for a second 14 days intervention period, therefore the knee brace is held in place by a cable fastening system and 3d printed straps. Receives: Device: Cable fastening system and 3d printed straps(14 days); Device: Velcro straps system(14 days); Device: Adjustment period(Velcro-14 days) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of Use Measurement Scale
The scale was developped for this study. The mesure is an average of 5 items with 5 point scale rating system(1 harder to use; 5 easier to use). Mean score ranges from (1 harder to use; 5 easier to use)
Measured: Before the 2 weeks of intervention with each brace, assessed after a brace fitting protocol and a few minutes of wearing the intervention brace.
Ease of Use Measurement Scale
The scale was developped for this study. The mesure is an average of 5 items with 5 point scale rating system(1 harder to use; 5 easier to use). Mean score ranges from (1 harder to use; 5 easier to use)
Measured: Directly after the 2 weeks of intervention with each brace, assessed after a brace fitting protocol and a few minutes of wearing the intervention brace.
Comfort Measurement Scale
The scale was developped for this study. The mesure is an average of 2 items with 5 point scale rating system(1 lowest comfort; 5 highest comfort). Total score is adjusted to 0 (lowest comfort) to 100 (highest comfort).
Measured: Before the 2 weeks of intervention with each brace, assessed after a brace fitting protocol and a few minutes of wearing the intervention brace.
Comfort Measurement Scale
The scale was developped for this study. The mesure is an average of 2 items with 5 point scale rating system(1 lowest comfort; 5 highest comfort). Total score is adjusted to 0 (lowest comfort) to 100 (highest comfort).
Measured: Directly after the 2 weeks of intervention with each brace, assessed after a brace fitting protocol and a few minutes of wearing the intervention brace.
Physical Symptoms
Knee injury and Osteoarthritis Outcome Total Score (KOOS), translated to French(Quebec). Minimum=0(worst symptoms); Maximum=100(no symptoms);
Measured: Change between baseline(directly before adjustment period) and directly after 2 weeks adjustment period.
Physical Symptoms
Knee injury and Osteoarthritis Outcome Total Score (KOOS), translated to French(Quebec). Minimum=0(worst symptoms); Maximum=100(no symptoms);
Measured: Change between directly after 2 weeks adjustment period and directly after 2 weeks of use for each arm
Psychological Symptoms
Psychological Symptoms Inventory Total Score(Ilfeld, F. W. (1976). Further validation of a psychiatric symptom index in a normal population. Psychological Reports, 39(3, Pt 2), 1215-1228.). Minimum=0; (No symptoms); Maximum=100(Worst Symptoms);
Measured: Change between baseline(directly before adjustment period) and directly after 2 weeks adjustment period.
Psychological Symptoms
Psychological Symptoms Inventory Total Score(Ilfeld, F. W. (1976). Further validation of a psychiatric symptom index in a normal population. Psychological Reports, 39(3, Pt 2), 1215-1228.). Minimum=0; (No symptoms); Maximum=100(Worst Symptoms);
Measured: Change between directly after 2 weeks adjustment period and directly after 2 weeks of use for each arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start30 Mar 2023
- Primary completion27 Sep 2023
- Study completion30 Jan 2025
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 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
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized trial with condition crossover
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- TOPMED
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada, Laboratoire Victhom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814471
- Sponsor's protocol ID
- RD-241-VicD_1
- Status last verified
- Jul 2025
- First submitted
- 16 Mar 2023
- Last updated
- 29 Jul 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 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for the Clinical Validation of a Valgus Knee Brace for Gonarthrosis
- ClinicalTrials.gov ID
- NCT05814471
- Acronym / sponsor ID
- RD-241-VicD_1
- Conditions
- Gonarthrosis
- Keywords
- knee brace, orthosis, treatment efficacy, arthrosis, comfort, ease of use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- TOPMEDUniversity, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada, Laboratoire Victhom
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 14 Apr 2023 (actual)
- Results
- Posted 29 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study about the effects of different fastening systems for knee braces on comfort, ease of installation and treatment efficacy both physical and psychological. Two different systems will be tested, velcro straps and a cable-fastening system.
Detailed description
There are 2 main types of knee braces for gonarthrosis: soft knee braces and rigid knee braces. Soft knee braces use malleable materials such as cloth or rubber to apply forces on the leg whereas rigid braces use plastic or metal shells. Three main types of fastening systems are used on these types of orthoses: velcro systems, hybrid systems and cable fastening systems. Therefore, different configurations exist to reduce biomechanical deficits caused by the pathology.
Each fastening system has its advantages and disadvantages. Velcro straps are fast and intuitive to use, altough multiple difficulties are mentionned: adjusment, cleaning, the number of straps needed to maintain the knee brace in position as well as the noise while detaching the straps. Hybrid systems regularly use velcro straps to which are added quick-release fasteners to simplify the installation and uninstallation process. Cable fastening systems also use quick-release fasteners. The adjusment process is simple and precise with minimal noise with these systems.
Comfort, efficacy and ease of use are essential qualities of a knee brace. Confort is primordial as it is directly linked to treatment adherence by the patients. Efficacy of a knee brace treatment may be measured by symptom or medication use evolution but also with daily practice of problematic movement by the patient. Ease of use must be optimized as it presents an opportunity to increase treatment adherence. The goal of the fastening system developped in partnership with Laboratoires Victhom is to increase ease of use of the knee brace while maintaining comfort and treatment efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized trial with condition crossover
| Arm | Type | Receives |
|---|---|---|
| Adjustement period(velcro)first, then Cable fastening system then Velcro Straps | Experimental | Device: Cable fastening system and 3d printed straps(14 days), Device: Velcro straps system(14 days), Device: Adjustment period(Velcro-14 days)A new knee brace is worn for a 14 days adjustement period with velcro straps. Then the brace is worn with a cable fastening system for a first 14 days intervention period, therefore the knee brace is held in place by a cable fastening system and 3d printed straps. The second 14 days intervention period is done with velcro straps keeping the brace in position. |
| Adjustement period(velcro)first, then Velcro Straps then Cable fastening system | Active comparator | Device: Cable fastening system and 3d printed straps(14 days), Device: Velcro straps system(14 days), Device: Adjustment period(Velcro-14 days)A new knee brace is worn for a 14 days adjustement period with velcro straps. The first 14 days intervention period is done with velcro straps keeping the brace in position. Then the brace is worn with a cable fastening system for a second 14 days intervention period, therefore the knee brace is held in place by a cable fastening system and 3d printed straps. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Has worn an ODRA knee brace multiple hours a day during the last 6 months
Key exclusion criteria (1 listed)
- Wounds on the lower body
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 |
|---|---|---|
| Cable fastening system and 3d printed straps(14 days)The participants will wear a Odra knee brace held in place with by a cable fastening system and 3d printed straps for 2 weeks. | Device | Adjustement period(velcro)first, then Cable fastening system then Velcro Straps, Adjustement period(velcro)first, then Velcro Straps then Cable fastening system |
| Velcro straps system(14 days)The participants will wear a Odra knee brace held in place with by a velcro straps system for 2 weeks. | Device | Adjustement period(velcro)first, then Cable fastening system then Velcro Straps, Adjustement period(velcro)first, then Velcro Straps then Cable fastening system |
| Adjustment period(Velcro-14 days)The participants will wear a new Odra knee brace held in place with by a velcro straps system for 2 weeks. | Device | Adjustement period(velcro)first, then Cable fastening system then Velcro Straps, Adjustement period(velcro)first, then Velcro Straps then Cable fastening system |
Primary outcome
Ease of Use Measurement Scale
Time frame: Before the 2 weeks of intervention with each brace, assessed after a brace fitting protocol and a few minutes of wearing the intervention brace.
The scale was developped for this study. The mesure is an average of 5 items with 5 point scale rating system(1 harder to use; 5 easier to use). Mean score ranges from (1 harder to use; 5 easier to use)
Ease of Use Measurement Scale
Time frame: Directly after the 2 weeks of intervention with each brace, assessed after a brace fitting protocol and a few minutes of wearing the intervention brace.
The scale was developped for this study. The mesure is an average of 5 items with 5 point scale rating system(1 harder to use; 5 easier to use). Mean score ranges from (1 harder to use; 5 easier to use)
Comfort Measurement Scale
Time frame: Before the 2 weeks of intervention with each brace, assessed after a brace fitting protocol and a few minutes of wearing the intervention brace.
The scale was developped for this study. The mesure is an average of 2 items with 5 point scale rating system(1 lowest comfort; 5 highest comfort). Total score is adjusted to 0 (lowest comfort) to 100 (highest comfort).
Comfort Measurement Scale
Time frame: Directly after the 2 weeks of intervention with each brace, assessed after a brace fitting protocol and a few minutes of wearing the intervention brace.
The scale was developped for this study. The mesure is an average of 2 items with 5 point scale rating system(1 lowest comfort; 5 highest comfort). Total score is adjusted to 0 (lowest comfort) to 100 (highest comfort).
Physical Symptoms
Time frame: Change between baseline(directly before adjustment period) and directly after 2 weeks adjustment period.
Knee injury and Osteoarthritis Outcome Total Score (KOOS), translated to French(Quebec). Minimum=0(worst symptoms); Maximum=100(no symptoms);
Physical Symptoms
Time frame: Change between directly after 2 weeks adjustment period and directly after 2 weeks of use for each arm
Knee injury and Osteoarthritis Outcome Total Score (KOOS), translated to French(Quebec). Minimum=0(worst symptoms); Maximum=100(no symptoms);
Psychological Symptoms
Time frame: Change between baseline(directly before adjustment period) and directly after 2 weeks adjustment period.
Psychological Symptoms Inventory Total Score(Ilfeld, F. W. (1976). Further validation of a psychiatric symptom index in a normal population. Psychological Reports, 39(3, Pt 2), 1215-1228.). Minimum=0; (No symptoms); Maximum=100(Worst Symptoms);
Psychological Symptoms
Time frame: Change between directly after 2 weeks adjustment period and directly after 2 weeks of use for each arm
Psychological Symptoms Inventory Total Score(Ilfeld, F. W. (1976). Further validation of a psychiatric symptom index in a normal population. Psychological Reports, 39(3, Pt 2), 1215-1228.). Minimum=0; (No symptoms); Maximum=100(Worst Symptoms);
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cable fastening system and 3d printed straps(14 days), Velcro straps system(14 days) and Adjustment period(Velcro-14 days) in people with 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 1 inclusion and 1 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 29 Jul 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 29 Jul 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?
Ease of Use Measurement Scale (time frame: Before the 2 weeks of intervention with each brace, assessed after a brace fitting protocol and a few minutes of wearing the intervention brace.). The study lists 8 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 29 Jul 2025.