Medial Knee OsteoarthritisNCT01909596
Lateral Wedge Insoles With Arch Support in Knee Osteoarthritis
A study testing Neutral customized foot orthoses, 6° lateral customized foot orthoses and 10° lateral customized foot orthoses in people with Medial Knee Osteoarthritis, run by Laval University at 1 site in Canada.
Trial summary
The purpose of this is to test lateral foot orthoses with different amount of wedging to find a model that predicts the optimal lateral inclination of foot orthosis based on biomechanical or feelings measures. This study was a cross-sectional study with patients serving as their own control. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Medial Knee Osteoarthritis
- What is being tested?
- Neutral customized foot orthoses, 6° lateral customized foot orthoses and 10° lateral customized foot orthoses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- May 2011to May 2012
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic medial knee osteoarthritis (OA ; Kellgren-Lawrence grade I, II or III) according to clinical and radiological criteria of the American College of Rheumatology
- Knee pain > 31/100 (Western Ontario and McMaster Universities Arthritis Index - WOMAC)
- Moderately active
- Varus knee alignment equal or superior to 2°
Who cannot join
- Severe knee OA (K-L grade IV)
- Rheumatoid arthritis or other inflammatory arthritis
- Avascular necrosis
- History of periarticular fracture or septic arthritis
- Bone metabolic disease
- Pigmented villonodular synovitis
Show all 15Show fewer
- Cartilaginous disease
- Neuropathic arthropathy
- Synovial osteochondromatosis
- Total or partial knee arthroplasty
- Flexion contracture of ipsi- or contra-lateral knee greater than 15°
- Hip or ankle joint damage with mobility limitation
- Obesity (BMI ≥ 40)
- Intra-articular corticosteroids injection in the affected knee during the two previous months
- Reduced mobility (Charnley class C)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Pavillon de l'Éducation Physique et des Sports - Université Laval
Québec, Quebec, G1V 0A6
About this study
Official title: Does it Exist a Relationship Between Inclination Angle of Foot Orthoses and Varus Angle of the Knee in the Relief of the Knee Osteoarthritis Symptoms?
The purpose of this is to test lateral foot orthoses with different amount of wedging to find a model that predicts the optimal lateral inclination of foot orthosis based on biomechanical or feelings measures. This study was a cross-sectional study with patients serving as their own control. The investigators recruited 24 knee osteoarthritis. Knee radiography and clinical angles measures was carried out before making orthoses, then motion analysis with an optoelectronic system was performed with each pair of foot orthoses. During motion analysis, five gait trials were carried out in each condition.
- Conditions
- Medial Knee Osteoarthritis
- Being tested
- Neutral customized foot orthoses, 6° lateral customized foot orthoses, 10° lateral customized foot orthoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neutral customized foot orthosesDevice
Also called Orthoconcept Inc, Laval, Qc, Canada
Foot orthoses with arch support and without lateral inclination
6° lateral customized foot orthosesDevice
Also called Orthoconcept Inc, Laval, Qc, Canada
Foot orthoses with arch support above insoles with lateral inclination set at 6°
10° lateral customized foot orthosesDevice
Also called Orthoconcept Inc, Laval, Qc, Canada
Foot orthoses with arch support above insoles with lateral inclination set at 10°
| Study group | Role | What they receive |
|---|---|---|
| Knee osteoarthritis patients - No insoles | No intervention | Without orthoses |
| Knee osteoarthritis patients - Customised | Active comparator | Medial arch support without lateral wedge Receives: Device: Neutral customized foot orthoses |
| Knee osteoarthritis patients - Customised + 6° | Active comparator | 6° lateral wedge insoles + Medial arch support Receives: Device: 6° lateral customized foot orthoses |
| Knee osteoarthritis patients - Customised + 10° | Active comparator | 10° lateral wedge insoles + Medial arch support Receives: Device: 10° lateral customized foot orthoses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee pain
A 20-cm visual analog scale (0-100) is used to assess pain.
Measured: At time of device receipt
Knee adduction moment
Measure of the knee adduction moment is a non invasive technic to identify change in medial knee loading, major problem in medial knee osteoarthritis.
Measured: At time of device receipt
Secondary outcomes (1)
Foot orthoses comfort
A 20-cm visual analog scale (0-100) is used to assess comfort.
Measured: At time of device receipt
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startMay 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medial Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada, Fonds de la Recherche en Santé du Québec, Ergorecherche Inc.
- Responsible party
- Sponsor
- Investigators
- Philippe Corbeil, PhD, Study director, Laval UniversityYoann Dessery, MSc, Principal investigator, Laval UniversityÉtienne L Belzile, MD, Study director, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909596
- Sponsor's protocol ID
- OP-2012
- Status last verified
- May 2024
- First submitted
- 17 Jul 2013
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does it Exist a Relationship Between Inclination Angle of Foot Orthoses and Varus Angle of the Knee in the Relief of the Knee Osteoarthritis Symptoms?
- ClinicalTrials.gov ID
- NCT01909596
- Acronym / sponsor ID
- OP-2012
- Conditions
- Medial Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada, Fonds de la Recherche en Santé du Québec, Ergorecherche Inc.
- Study start
- May 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 26 Jul 2013 (estimated)
- 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 purpose of this is to test lateral foot orthoses with different amount of wedging to find a model that predicts the optimal lateral inclination of foot orthosis based on biomechanical or feelings measures. This study was a cross-sectional study with patients serving as their own control. The investigators recruited 24 knee osteoarthritis. Knee radiography and clinical angles measures was carried out before making orthoses, then motion analysis with an optoelectronic system was performed with each pair of foot orthoses. During motion analysis, five gait trials were carried out in each condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Knee osteoarthritis patients - No insoles | No intervention | –Without orthoses |
| Knee osteoarthritis patients - Customised | Active comparator | Device: Neutral customized foot orthosesMedial arch support without lateral wedge |
| Knee osteoarthritis patients - Customised + 6° | Active comparator | Device: 6° lateral customized foot orthoses6° lateral wedge insoles + Medial arch support |
| Knee osteoarthritis patients - Customised + 10° | Active comparator | Device: 10° lateral customized foot orthoses10° lateral wedge insoles + Medial arch support |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symptomatic medial knee osteoarthritis (OA ; Kellgren-Lawrence grade I, II or III) according to clinical and radiological criteria of the American College of Rheumatology
- Knee pain > 31/100 (Western Ontario and McMaster Universities Arthritis Index - WOMAC)
- Moderately active
- Varus knee alignment equal or superior to 2°
Key exclusion criteria (15 listed)
- Severe knee OA (K-L grade IV)
- Rheumatoid arthritis or other inflammatory arthritis
- Avascular necrosis
- History of periarticular fracture or septic arthritis
- Bone metabolic disease
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 |
|---|---|---|
| Neutral customized foot orthosesAlso: Orthoconcept Inc, Laval, Qc, CanadaFoot orthoses with arch support and without lateral inclination | Device | Knee osteoarthritis patients - Customised |
| 6° lateral customized foot orthosesAlso: Orthoconcept Inc, Laval, Qc, CanadaFoot orthoses with arch support above insoles with lateral inclination set at 6° | Device | Knee osteoarthritis patients - Customised + 6° |
| 10° lateral customized foot orthosesAlso: Orthoconcept Inc, Laval, Qc, CanadaFoot orthoses with arch support above insoles with lateral inclination set at 10° | Device | Knee osteoarthritis patients - Customised + 10° |
Primary outcome
Knee pain
Time frame: At time of device receipt
A 20-cm visual analog scale (0-100) is used to assess pain.
Knee adduction moment
Time frame: At time of device receipt
Measure of the knee adduction moment is a non invasive technic to identify change in medial knee loading, major problem in medial knee osteoarthritis.
1 secondary outcome
Foot orthoses comfort
Time frame: At time of device receipt
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 16 May 2024.
Related trials for Medial Knee Osteoarthritis
RecruitingObservational study
Clinical Performance and Safety of the Unicompartmental Univation® XF Pro Implant
Gonarthritis, Degenerative Disease
Active, not recruiting
Unicompartmental Versus Total Knee Replacement for Medial Compartment Knee Osteoarthritis
Osteoarthritis, Knee
Recruiting
Total Versus Robotic Assisted Unicompartmental Knee Replacement
Osteo Arthritis Knee, Arthritis Knee
Recruiting
Neurolysis for the Treatment of Medial Chronic Knee Pain Due to Osteoarthritis
Osteoarthritis (OA) of the Knee, Knee Pain Arthritis
Not yet recruitingPhase 3
HTO and Tranexamic Acid Study
Osteoarthritis, Knee
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.
Philippe Corbeil, PhD study director
Laval University
Yoann Dessery, MSc principal investigator
Laval University
Étienne L Belzile, MD study director
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neutral customized foot orthoses, 6° lateral customized foot orthoses and 10° lateral customized foot orthoses in people with Medial Knee Osteoarthritis, run by Laval University 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 4 inclusion and 15 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 16 May 2024. 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?
Knee pain (time frame: At time of device receipt). The study lists 2 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 16 May 2024.