Osteoarthritis, KneeNCT01870336
Combination of Lateral Foot Orthoses and Knee Brace for Treatment of the Knee Osteoarthritis
A study testing Combined treatment of medial knee osteoarthritis in people with Osteoarthritis, Knee, run by Laval University at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the immediate and short-term effects of the combination of lateral customized foot orthoses on the pain and medial knee loading during gait among medial knee osteoarthritis patients. The effects of the combination is compared to the single use of these devices. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Combined treatment of medial knee osteoarthritis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2012to May 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic medial knee 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: Combination of Lateral Foot Orthoses and Knee Brace for Treatment of the Medial Knee Osteoarthritis
The purpose of this study is to evaluate the immediate and short-term effects of the combination of lateral customized foot orthoses on the pain and medial knee loading during gait among medial knee osteoarthritis patients. The effects of the combination is compared to the single use of these devices. The investigators recruited 22 knee osteoarthritis. They have to wear each of treatments (foot orthoses, knee brace and combination) during three months. A fifteen days wash-out period is given after each three months. Biomechanical evaluation is carried out before and after each three months. This evaluation consisted of three questionnaires (Knee Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC) and Medical Outcome Study Short Form-36( MOS-SF36)), a motion analysis with an optoelectronic system, then a 6-min walk test. During motion analysis, ten gait trials are executed without treatment and ten with the treatment.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Combined treatment of medial knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined treatment of medial knee osteoarthritisDevice
| Study group | Role | What they receive |
|---|---|---|
| Lateral customized foot orthoses | Experimental | Foot orthoses with arch support and lateral inclination set at 7° (alone) Receives: Device: Combined treatment of medial knee osteoarthritis |
| Knee brace | Experimental | OdrA Knee brace (alone) Receives: Device: Combined treatment of medial knee osteoarthritis |
| Combination of the two treatments | Experimental | Combination of Lateral customized foot orthoses and knee brace Receives: Device: Combined treatment of medial knee osteoarthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knee adduction moment
Measured: Change from Baseline at 3 months
Change in Knee pain
A 20-cm visual analog scale (0-100) is used to assess pain.
Measured: Change from Baseline at 3 months
Secondary outcomes (3)
Change in Spatiotemporal gait parameters
Measured: Change from Baseline at 3 months
Change in Knee adduction angle
Measured: Change from Baseline at 3 months
Change in Comfort
A 20-cm visual analog scale (0-100) is used to assess comfort.
Measured: Change from Baseline at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startSep 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 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
- NCT01870336
- Sponsor's protocol ID
- OC-2013
- Status last verified
- Mar 2016
- First submitted
- 23 May 2013
- Last updated
- 4 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Lateral Foot Orthoses and Knee Brace for Treatment of the Medial Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01870336
- Acronym / sponsor ID
- OC-2013
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 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
- Sep 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 6 Jun 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 study is to evaluate the immediate and short-term effects of the combination of lateral customized foot orthoses on the pain and medial knee loading during gait among medial knee osteoarthritis patients. The effects of the combination is compared to the single use of these devices. The investigators recruited 22 knee osteoarthritis. They have to wear each of treatments (foot orthoses, knee brace and combination) during three months. A fifteen days wash-out period is given after each three months. Biomechanical evaluation is carried out before and after each three months. This evaluation consisted of three questionnaires (Knee Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC) and Medical Outcome Study Short Form-36( MOS-SF36)), a motion analysis with an optoelectronic system, then a 6-min walk test. During motion analysis, ten gait trials are executed without treatment and ten with the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lateral customized foot orthoses | Experimental | Device: Combined treatment of medial knee osteoarthritisFoot orthoses with arch support and lateral inclination set at 7° (alone) |
| Knee brace | Experimental | Device: Combined treatment of medial knee osteoarthritisOdrA Knee brace (alone) |
| Combination of the two treatments | Experimental | Device: Combined treatment of medial knee osteoarthritisCombination of Lateral customized foot orthoses and knee brace |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symptomatic medial knee 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 |
|---|---|---|
| Combined treatment of medial knee osteoarthritis | Device | Combination of the two treatments, Knee brace, Lateral customized foot orthoses |
Primary outcome
Change in Knee adduction moment
Time frame: Change from Baseline at 3 months
Change in Knee pain
Time frame: Change from Baseline at 3 months
A 20-cm visual analog scale (0-100) is used to assess pain.
3 secondary outcomes
Change in Spatiotemporal gait parameters
Time frame: Change from Baseline at 3 months
Change in Knee adduction angle
Time frame: Change from Baseline at 3 months
Change in Comfort
Time frame: Change from Baseline at 3 months
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 4 Mar 2016.
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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.
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 Combined treatment of medial knee osteoarthritis in people with Osteoarthritis, Knee, 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 4 Mar 2016. 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 Knee adduction moment (time frame: Change from Baseline at 3 months). 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 4 Mar 2016.