Knee OsteoarthritisMULTIWEDGENCT06251167
A Multi-centre Study of Shoe-worn Insoles and Knee Osteoarthritis
A study testing Lateral wedge insoles (LWIs) and Lateral wedge plus custom arch support (LWAS) in people with Knee Osteoarthritis, run by University of British Columbia at 1 site in Canada.
Trial summary
Shoe-worn insoles (also known as orthotics) can provide symptomatic relief for people with knee osteoarthritis. However, given they act at the feet, and given that many people with knee osteoarthritis also report foot pain, it is important to assess the effects of these devices at both joints. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Lateral wedge insoles (LWIs) and Lateral wedge plus custom arch support (LWAS)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- 4 Mar 2024to 10 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- medial tibiofemoral OA defined as definitive osteophytes and joint space narrowing in the medial compartment, as confirmed with radiographs
- history of knee pain longer than 6 months
- average self-reported knee pain of at least 3 out of 10 (using an 11-point numerical rating scale with terminal descriptors of 0 = "no pain" and 10 = "worst pain imaginable") over the 6 months prior to baseline testing
- pain in the same foot/feet as the painful knee(s)
- ability to communicate in English
- show an immediate biomechanical response to the insoles. This final eligibility criterion will be determined from an in-person biomechanical assessment after participants have passed all previous eligibility screening.
Who cannot join
- radiographic evidence of more lateral tibiofemoral OA than medial
- knee surgery or intra-articular injection within the previous 6 months
- current or recent (within 6 months) corticosteroid use for any reason
- presence of a systemic arthritic condition
- history of knee joint replacement or tibial osteotomy
- any other condition affecting lower limb function
- current usage of shoe-worn insoles, or planning to acquire footwear modifications in the next 6 months
- any previous experience with insoles that resulted in increased lower limb pain or a self- or clinician-initiated termination of use.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Motion Analysis and Biofeedback Laboratory
Vancouver, British Columbia, V5R 3N9
Natasha Krowchuk, 6048227948
About this study
Official title: A Multi-centre Feasibility Study Assessing Shoe-worn Insoles to Improve Clinical and Biomechanical Features of Knee Osteoarthritis
Shoe-worn insoles (also known as orthotics) can provide symptomatic relief for people with knee osteoarthritis. However, given they act at the feet, and given that many people with knee osteoarthritis also report foot pain, it is important to assess the effects of these devices at both joints. We will conduct a multi-centre randomized pilot trial to determine feasibility and preliminary efficacy.
- Conditions
- Knee Osteoarthritis
- Being tested
- Lateral wedge insoles (LWIs), Lateral wedge plus custom arch support (LWAS)
- Keywords
- Knee Osteoarthritis, Orthotics, Foot pain, Biomechanics
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral wedge insoles (LWIs)Device
Participants will be asked to wear these insoles in their own shoes for at least 5 hours per day for a period of 3 months. The LWIs will be constructed via 3D printing using a material of uniform density made to the length of the participant's feet, and will incorporate a 6 degree wedge along the lateral edge.
Lateral wedge plus custom arch support (LWAS)Device
Participants will be asked to wear these insoles in their own shoes for at least 5 hours per day for a period of 3 months. These insoles will be designed based on an innovative tablet-based app designed by industry partner Kintec Footlabs, who will be the provider of the insoles for this project. Using the high-fidelity 3D scanning tool available (Apple's True Depth sensor), the Epitek Self-Scanner app captures tens of thousands of 3D data points within a single 1-second capture, and then uploads this foot data to a secure patient record system that is used for insole fabrication. The LWAS insoles will be comprised of variable density material (more dense laterally than medially) and milled directly to produce a full-length shell. The 6 degree wedge will be incorporated along the full lateral length of the insoles.
| Study group | Role | What they receive |
|---|---|---|
| Lateral wedge insoles (LWIs) | Experimental | The LWIs will incorporate a 6 degree wedge along the lateral edge of the insole. Receives: Device: Lateral wedge insoles (LWIs) |
| Lateral wedge plus custom arch support (LWAS) | Experimental | The LWAS insoles will incorporate custom arch support along the medial edge as well as a 6 degree wedge along the lateral edge of the insole. Receives: Device: Lateral wedge plus custom arch support (LWAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment - number of screened patients who are eligible
The number of screened patients determined eligible to be enrolled in the study.
Measured: from onset of recruitment through study completion
Retention - proportion of assessments with complete outcome measures data
Proportion of assessments with complete outcome measures data out of total number of assessments in the study protocol.
Measured: immediately after the intervention
Insoles Delivery
Time between foot scan assessment and delivery of insoles. Given that insoles will be manufactured centrally and distributed to the sites, we are interested in assessing the expected timeframe for enrollment in the study.
Measured: from date of insoles ordering until date of delivery to the laboratory, assessed up to 3 months
Self-reported knee pain
Knee pain will be measured by the Pain subscale (9 items) of the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline and at 3-months. Each item is rated on a 5 points Likert scale where 0 = "No problems" and 4 = "Extreme Problems". Higher scores indicate better function. The scores are normalized to 0-100%.
Measured: Baseline, 3 Months
Self-reported foot pain
Foot pain will be measured at baseline and at 3-months by the Pain subscale (7 items) of the Foot Function Index revised short form (FFI-RS). This is a self-report questionnaire consisting of 34 items that provides the ability to quantify aspects of foot pain, disability and activity limitation.
Measured: Baseline, 3 Months
External knee adduction moment impulse
The external knee adduction moment impulse will be calculated. Participants will walk on an instrumented walkway (embedded force platform(s)) while high speed cameras track the trajectories of markers placed on bony landmarks. Moments will be calculated using an inverse dynamics approach.
Measured: Baseline, 3 Months
Secondary outcomes (5)
Self-reported overall physical function
Physical function will be measured by the Function, Daily Living subscale (17 items) of the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline and at 3-months. Each item is rated on a 5 points Likert scale where 0 = "No problems" and 4 = "Extreme Problems". Higher scores indicate better function. The scores are normalized to 0-100%.
Measured: Baseline, 3 Months
Self-reported foot function
Foot function will be measured at baseline and at 3-months by the Activity Limitations subscale (3 items) of the Foot Function Index revised short form (FFI-RS). This is a self-report questionnaire consisting of 34 items that provides the ability to quantify aspects of foot pain, disability and activity limitation.
Measured: Baseline, 3 Months
External knee flexion moment impulse
The external knee flexion moment impulse will be calculated using the same methods as described for the external knee adduction moment impulse.
Measured: Baseline, 3 Months
Self-selected gait speed
Self-selected gait speed will be calculated during the biomechanical gait analyses.
Measured: Baseline, 3 Months
Rearfoot eversion peak
Participants will walk on an instrumented walkway while high speed cameras track the trajectories of markers placed on bony landmarks.
Measured: Baseline, 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start4 Mar 2024
- Primary completion10 Apr 2027 (estimated)
- Study completion10 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Model description
- We will conduct a two-arm, parallel group, multi-centre randomized controlled pilot study to assess the feasibility of our unique clinical biomechanics study, as well as the preliminary efficacy of the interventions on clinical and biomechanical outcomes at the feet and knees.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Western University, Dalhousie University
- Responsible party
- Principal investigator, Michael Hunt, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251167
- Sponsor's protocol ID
- H22-03584
- Acronym
- MULTIWEDGE
- Status last verified
- May 2026
- First submitted
- 23 Jan 2024
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre Feasibility Study Assessing Shoe-worn Insoles to Improve Clinical and Biomechanical Features of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06251167
- Acronym / sponsor ID
- MULTIWEDGE / H22-03584
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Orthotics, Foot pain, Biomechanics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Western University, Dalhousie University
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 10 Apr 2027 (estimated)
- Study completion
- 10 Apr 2027 (estimated)
- First posted
- 9 Feb 2024 (actual)
- 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.
Shoe-worn insoles (also known as orthotics) can provide symptomatic relief for people with knee osteoarthritis. However, given they act at the feet, and given that many people with knee osteoarthritis also report foot pain, it is important to assess the effects of these devices at both joints. We will conduct a multi-centre randomized pilot trial to determine feasibility and preliminary efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- We will conduct a two-arm, parallel group, multi-centre randomized controlled pilot study to assess the feasibility of our unique clinical biomechanics study, as well as the preliminary efficacy of the interventions on clinical and biomechanical outcomes at the feet and knees.
| Arm | Type | Receives |
|---|---|---|
| Lateral wedge insoles (LWIs) | Experimental | Device: Lateral wedge insoles (LWIs)The LWIs will incorporate a 6 degree wedge along the lateral edge of the insole. |
| Lateral wedge plus custom arch support (LWAS) | Experimental | Device: Lateral wedge plus custom arch support (LWAS)The LWAS insoles will incorporate custom arch support along the medial edge as well as a 6 degree wedge along the lateral edge of the insole. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- medial tibiofemoral OA defined as definitive osteophytes and joint space narrowing in the medial compartment, as confirmed with radiographs
- history of knee pain longer than 6 months
- average self-reported knee pain of at least 3 out of 10 (using an 11-point numerical rating scale with terminal descriptors of 0 = "no pain" and 10 = "worst pain imaginable") over the 6 months prior to baseline testing
- pain in the same foot/feet as the painful knee(s)
- ability to communicate in English
Key exclusion criteria (8 listed)
- radiographic evidence of more lateral tibiofemoral OA than medial
- knee surgery or intra-articular injection within the previous 6 months
- current or recent (within 6 months) corticosteroid use for any reason
- presence of a systemic arthritic condition
- history of knee joint replacement or tibial osteotomy
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 wedge insoles (LWIs)Participants will be asked to wear these insoles in their own shoes for at least 5 hours per day for a period of 3 months. The LWIs will be constructed via 3D printing using a material of uniform density made to the length of the participant's feet, and will incorporate a 6 degree wedge along the lateral edge. | Device | Lateral wedge insoles (LWIs) |
| Lateral wedge plus custom arch support (LWAS)Participants will be asked to wear these insoles in their own shoes for at least 5 hours per day for a period of 3 months. These insoles will be designed based on an innovative tablet-based app designed by industry partner Kintec Footlabs, who will be the provider of the insoles for this project. Using the high-fidelity 3D scanning tool available (Apple's True Depth sensor), the Epitek Self-Scanner app captures tens of thousands of 3D data points within a single 1-second capture, and then uploads this foot data to a secure patient record system that is used for insole fabrication. The LWAS insoles will be comprised of variable density material (more dense laterally than medially) and milled directly to produce a full-length shell. The 6 degree wedge will be incorporated along the full lateral length of the insoles. | Device | Lateral wedge plus custom arch support (LWAS) |
Primary outcome
Recruitment - number of screened patients who are eligible
Time frame: from onset of recruitment through study completion
The number of screened patients determined eligible to be enrolled in the study.
Retention - proportion of assessments with complete outcome measures data
Time frame: immediately after the intervention
Proportion of assessments with complete outcome measures data out of total number of assessments in the study protocol.
Insoles Delivery
Time frame: from date of insoles ordering until date of delivery to the laboratory, assessed up to 3 months
Time between foot scan assessment and delivery of insoles. Given that insoles will be manufactured centrally and distributed to the sites, we are interested in assessing the expected timeframe for enrollment in the study.
Self-reported knee pain
Time frame: Baseline, 3 Months
Knee pain will be measured by the Pain subscale (9 items) of the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline and at 3-months. Each item is rated on a 5 points Likert scale where 0 = "No problems" and 4 = "Extreme Problems". Higher scores indicate better function. The scores are normalized to 0-100%.
Self-reported foot pain
Time frame: Baseline, 3 Months
Foot pain will be measured at baseline and at 3-months by the Pain subscale (7 items) of the Foot Function Index revised short form (FFI-RS). This is a self-report questionnaire consisting of 34 items that provides the ability to quantify aspects of foot pain, disability and activity limitation.
External knee adduction moment impulse
Time frame: Baseline, 3 Months
The external knee adduction moment impulse will be calculated. Participants will walk on an instrumented walkway (embedded force platform(s)) while high speed cameras track the trajectories of markers placed on bony landmarks. Moments will be calculated using an inverse dynamics approach.
5 secondary outcomes
Self-reported overall physical function
Time frame: Baseline, 3 Months
Self-reported foot function
Time frame: Baseline, 3 Months
External knee flexion moment impulse
Time frame: Baseline, 3 Months
Self-selected gait speed
Time frame: Baseline, 3 Months
Rearfoot eversion peak
Time frame: Baseline, 3 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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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.
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 insoles (LWIs) and Lateral wedge plus custom arch support (LWAS) 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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 1 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natasha Krowchuk (604-822-7948, natasha.krowchuk@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment - number of screened patients who are eligible (time frame: from onset of recruitment through study completion). The study lists 6 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 1 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.