Knee OsteoarthritisNCT02234895
Shoe Orthotics for Improvement of Biomechanics and Symptoms of Knee Osteoarthritis
A study testing Lateral wedge and Lateral wedge plus medial arch support in people with Knee Osteoarthritis, run by University of British Columbia at 1 site in Canada.
Trial summary
Knee osteoarthritis (OA) is a widespread problem in Canada, leading to decreased quality of life and increased economic burden. Current research has focused on expensive, invasive treatments, whereas inexpensive conservative treatments have received less attention. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Lateral wedge and Lateral wedge plus medial arch support
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2014to Mar 2016
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 50 - 80 years (to meet the American College of Rheumatology clinical definition of OA)
- medial tibiofemoral OA, defined as medial knee pain on most days of the past month and evidence on radiographs of a definite osteophyte in the medial tibiofemoral compartment
- pronated feet, defined as a foot posture index that is 0.5 standard deviations above the reported population mean.
Who cannot join
- low pain score on a numerical rating scale of pain (average knee pain on walking ≤3 out of 10 over previous week) to allow detection of treatment response
- knee surgery or intra-articular corticosteroid injection within the previous six months
- current or recent (within 4 weeks) oral corticosteroid use
- any muscular, joint or neurological condition affecting lower limb within the past 6 months
- ankle/foot pathology or pain that precludes the use of orthotics
- current use of foot orthotics
Show all 9Show fewer
- use of footwear unable to accommodate an orthotic
- unable to walk without a gait aid
- inability to speak English or have a family member present to translate (required for the validity of the questionnaires)
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia; University Hospital
Vancouver, British Columbia
About this study
Official title: Combined Medial and Lateral Orthotics for the Treatment of Knee Osteoarthritis
Knee osteoarthritis (OA) is a widespread problem in Canada, leading to decreased quality of life and increased economic burden. Current research has focused on expensive, invasive treatments, whereas inexpensive conservative treatments have received less attention. One such treatment is the use of orthotics to reduce pain and increase function in people with knee OA. Currently, clinical practice guidelines for the use of orthotics are vague and contradictory, and could benefit from more research taking into account foot posture. This study aims to compare the use of two orthotics designs in people with knee OA.
- Conditions
- Knee Osteoarthritis
- Being tested
- Lateral wedge, Lateral wedge plus medial arch support
- Keywords
- osteoarthritis, knee, biomechanics, treatment, symptoms
- 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.
Lateral wedgeDevice
This will be a randomized cross-over study where all participants will receive both orthoses over a six month period. Each intervention will last two months, separated by a two month washout period of no orthotics wear, and will be preceded and followed by a laboratory-based gait and pain assessment. Two months has been chosen as the ideal time frame to ensure maximum participant adherence, to observe clinically meaningful changes in symptoms, and to minimize degradation of the insoles.
Lateral wedge plus medial arch supportDevice
This will be a randomized cross-over study where all participants will receive both orthoses over a six month period. Each intervention will last two months, separated by a two month washout period of no orthotics wear, and will be preceded and followed by a laboratory-based gait and pain assessment. Two months has been chosen as the ideal time frame to ensure maximum participant adherence, to observe clinically meaningful changes in symptoms, and to minimize degradation of the insoles.
| Study group | Role | What they receive |
|---|---|---|
| Lateral wedge plus medial arch support | Experimental | The lateral wedge plus medial support orthotic will be custom-made and designed using a 3D volumetric cast of the foot with the participant's foot in a subtalar joint neutral position. The cast will be balanced so that it rests in a neutral position then smoothed to address any irregularities and to allow for soft tissue splay. Polypropylene sheets of 3mm or 4mm thickness will be vacuum formed or milled directly to produce a ¾ length shell. An ethyl-vinyl-acetone (EVA) lateral post in the heel and forefoot of 5 degrees will be incorporated into the orthotic. The orthotic will be finished with a neoprene cover for improved comfort and patient compliance. Receives: Device: Lateral wedge plus medial arch support |
| Lateral wedge | Experimental | The lateral wedge only orthotic will be constructed of EVA, made to full length of the subject's footwear and incorporate a 5 degree posting. The wedge will be finished with a neoprene cover for improved comfort and patient compliance. Receives: Device: Lateral wedge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knee joint load during walking: knee adduction moment
Participants will undergo three-dimensional gait analysis. This will be performed barefoot with and without the orthotics (conditions tested in a random order). Kinematic and kinetic data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. Participants will be instructed to walk at a self-selected walking speed measured using photoelectric timing gates and placed along the walkway two metres on either side of the force platforms (note that walking speed during follow-up assessments will be kept similar (+/- 5%) to that chosen by each participant at baseline). A total of five trials will be collected.
The primary loading variable will be the KAM impulse - defined as the area under the KAM curve. Rather than a single peak value, the KAM impulse is more reflective of load experienced over the duration of stance and reflects the cumulative loading experienced at the knee during walking.
Measured: Baseline and 2 months
Change in Knee Pain
The WOMAC is a disease-specific questionnaire that quantifies self-reported joint pain, joint stiffness, and physical function. It is a valid, reliable, and responsive outcome measure that is recommended for use in osteoarthritis clinical trials.
Measured: Baseline and 2 Months
Secondary outcomes (2)
Change in Self-Reported Physical Function
The physical function subscale (17 questions) on the WOMAC will be used.
Measured: Baseline and 2 Months
Change in Foot Pain
Participants will rate their perceived foot function and pain using the Foot Function Index (revised - short form). This is a self-report questionnaire which consists of 34 items and provides the ability to quantify aspects of pain, disability and activity limitation. Such assessment of pain has been widely used and is a valid and reliable method in clinical research studies
Measured: Baseline and 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Pedorthic Research Foundation of Canada, Kintec Footlabs
- Responsible party
- Sponsor
- Investigators
- Michael A Hunt, PhD, PT, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234895
- Sponsor's protocol ID
- H14-01313
- Status last verified
- Jun 2016
- First submitted
- 4 Sep 2014
- Last updated
- 8 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hunt MA, Takacs J, Krowchuk NM, Hatfield GL, Hinman RS, Chang R. Lateral wedges with and without custom arch support for people with medial knee osteoarthritis and pronated feet: an exploratory randomized crossover study. J Foot Ankle Res. 2017 May 2;10:20. doi: 10.1186/s13047-017-0201-x. eCollection 2017.
PubMed 28473871
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Medial and Lateral Orthotics for the Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02234895
- Acronym / sponsor ID
- H14-01313
- Conditions
- Knee Osteoarthritis
- Keywords
- osteoarthritis, knee, biomechanics, treatment, symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Pedorthic Research Foundation of Canada, Kintec Footlabs
- Study start
- Aug 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 9 Sep 2014 (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.
Knee osteoarthritis (OA) is a widespread problem in Canada, leading to decreased quality of life and increased economic burden. Current research has focused on expensive, invasive treatments, whereas inexpensive conservative treatments have received less attention. One such treatment is the use of orthotics to reduce pain and increase function in people with knee OA. Currently, clinical practice guidelines for the use of orthotics are vague and contradictory, and could benefit from more research taking into account foot posture. This study aims to compare the use of two orthotics designs in people with knee OA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lateral wedge plus medial arch support | Experimental | Device: Lateral wedge plus medial arch supportThe lateral wedge plus medial support orthotic will be custom-made and designed using a 3D volumetric cast of the foot with the participant's foot in a subtalar joint neutral position. The cast will be balanced so that it rests in a neutral position then smoothed to address any irregularities and to allow for soft tissue splay. Polypropylene sheets of 3mm or 4mm thickness will be vacuum formed or milled directly to produce a ¾ length shell. An ethyl-vinyl-acetone (EVA) lateral post in the heel and forefoot of 5 degrees will be incorporated into the orthotic. The orthotic will be finished with a neoprene cover for improved comfort and patient compliance. |
| Lateral wedge | Experimental | Device: Lateral wedgeThe lateral wedge only orthotic will be constructed of EVA, made to full length of the subject's footwear and incorporate a 5 degree posting. The wedge will be finished with a neoprene cover for improved comfort and patient compliance. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 50 - 80 years (to meet the American College of Rheumatology clinical definition of OA)
- medial tibiofemoral OA, defined as medial knee pain on most days of the past month and evidence on radiographs of a definite osteophyte in the medial tibiofemoral compartment
- pronated feet, defined as a foot posture index that is 0.5 standard deviations above the reported population mean.
Key exclusion criteria (9 listed)
- low pain score on a numerical rating scale of pain (average knee pain on walking ≤3 out of 10 over previous week) to allow detection of treatment response
- knee surgery or intra-articular corticosteroid injection within the previous six months
- current or recent (within 4 weeks) oral corticosteroid use
- any muscular, joint or neurological condition affecting lower limb within the past 6 months
- ankle/foot pathology or pain that precludes the use of orthotics
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 |
|---|---|---|
| Lateral wedgeThis will be a randomized cross-over study where all participants will receive both orthoses over a six month period. Each intervention will last two months, separated by a two month washout period of no orthotics wear, and will be preceded and followed by a laboratory-based gait and pain assessment. Two months has been chosen as the ideal time frame to ensure maximum participant adherence, to observe clinically meaningful changes in symptoms, and to minimize degradation of the insoles. | Device | Lateral wedge |
| Lateral wedge plus medial arch supportThis will be a randomized cross-over study where all participants will receive both orthoses over a six month period. Each intervention will last two months, separated by a two month washout period of no orthotics wear, and will be preceded and followed by a laboratory-based gait and pain assessment. Two months has been chosen as the ideal time frame to ensure maximum participant adherence, to observe clinically meaningful changes in symptoms, and to minimize degradation of the insoles. | Device | Lateral wedge plus medial arch support |
Primary outcome
Change in knee joint load during walking: knee adduction moment
Time frame: Baseline and 2 months
Participants will undergo three-dimensional gait analysis. This will be performed barefoot with and without the orthotics (conditions tested in a random order). Kinematic and kinetic data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. Participants will be instructed to walk at a self-selected walking speed measured using photoelectric timing gates and placed along the walkway two metres on either side of the force platforms (note that walking speed during follow-up assessments will be kept similar (+/- 5%) to that chosen by each participant at baseline). A total of five trials will be collected. The primary loading variable will be the KAM impulse - defined as the area under the KAM curve. Rather than a single peak value, the KAM impulse is more reflective of load experienced over the duration of stance and reflects the cumulative loading experienced at the knee during walking.
Change in Knee Pain
Time frame: Baseline and 2 Months
The WOMAC is a disease-specific questionnaire that quantifies self-reported joint pain, joint stiffness, and physical function. It is a valid, reliable, and responsive outcome measure that is recommended for use in osteoarthritis clinical trials.
2 secondary outcomes
Change in Self-Reported Physical Function
Time frame: Baseline and 2 Months
Change in Foot Pain
Time frame: Baseline and 2 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 8 Jun 2016.
- Derived from this study: PubMed 28473871Hunt MA, Takacs J, Krowchuk NM, Hatfield GL, Hinman RS, Chang R. Lateral wedges with and without custom arch support for people with medial knee osteoarthritis and pronated feet: an exploratory randomized crossover study. J Foot Ankle Res. 2017 May 2;10:20. doi: 10.1186/s13047-017-0201-x. eCollection 2017.
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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.
Michael A Hunt, PhD, PT principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lateral wedge and Lateral wedge plus medial arch support in people with Knee Osteoarthritis, run by University of British Columbia 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 3 inclusion and 9 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 8 Jun 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 joint load during walking: knee adduction moment (time frame: Baseline and 2 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?
On the ClinicalTrials.gov record for NCT02234895, which also lists 1 linked publication.
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 8 Jun 2016.