Osteoarthritis, KneeNCT04967339
Comparison of Different Insoles as Conservative Treatment for Medial Knee Osteoarthritis
A study testing Foot deformity correcting insoles and Lateral wedge insoles in people with Osteoarthritis, Knee, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
In patients with early to mid-stage knee osteoarthritis (OA), a conservative treatment is indicated. In medial knee OA (when mainly the medial compartment of the knee is affected by OA), lateral wedge insoles have been promoted as cost effective and simple solution. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Foot deformity correcting insoles and Lateral wedge insoles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2021to 1 Aug 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent signed by the subject
- Aged between 40 to 80 years
- Early to mid-stage (KL 1 - 3) OA of the medial compartment of the knee based on X-ray and MRI images
- Plano-valgus foot deformity based on clinical assessment
- Availability of conventional radiographs, long-leg films, and a knee-MRI no older than 1 year at time of inclusion
- Ability to walk without walking aid for more than 15min
Who cannot join
- Contraindications and limitations of the MD as described in the instructions for use.
- Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject,
- Enrolment of the PI, his/her family members, employees and other dependent persons
- Relevant OA (Kellgren-Lawrence-Score >2) of the lateral compartment of the knee based on X-ray and MRI images
- BMI higher than 40 kg/m
- Fix varus deformities over 20 degrees
Show all 10Show fewer
- Neurological or rheumatoid diseases of any kind
- History of high tibial osteotomy, other realignment surgery of the knee or foot
- Foot or ankle problems that contraindicated the use of footwear load-modifying interventions
- Relevant ligamentous instability
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Universitätsklinik für Orthopädische Chirurgie und Traumatologie Inselspital
Bern, 3010
Andreas Andreas, 004131 632 21 11
About this study
Official title: A Randomized Control Trial in Patients With Medial Knee Osteoarthritis Comparing the Clinical and Biomechanical Effect of Foot Deformity Correcting Insoles and Lateral Wedge Insoles
In patients with early to mid-stage knee osteoarthritis (OA), a conservative treatment is indicated. In medial knee OA (when mainly the medial compartment of the knee is affected by OA), lateral wedge insoles have been promoted as cost effective and simple solution. However, clinical trials report conflicting results, with some reporting no benefit while others reported a small decrease in knee pain. Recent studies reported medial OA patients to have a tendency to a plano-valgus foot deformity, which is associated with a varus lower limb alignment and an internal rotation of the tibia. Some authors thus proposed the correction of plano-valgus deformity with foot deformity correcting insoles instead of lateral wedge insoles. Until today, only one study investigated the effect of foot deformity correcting insoles (e.g. with medial arch support) as alternative to lateral wedge insoles and reported encouraging results. However, they used lateral wedge insoles with custom arch support instead of foot deformity correcting customized insoles along (without lateral wedge). Furthermore, they did not perform any biomechanical analyses. The primary object of this study is to compare the effect of foot deformity correcting insoles for plano-valgus foot deformities and lateral wedge insoles on knee load distribution, knee pain and patient reported outcome measures in early to mid-stage medial knee OA patients after 6 and 12 months.
Read the detailed description
Osteoarthritis (OA) of the knee is defined as an inflammatory process leading to loss of protective cartilage which results in pain, disability and loss of function. Around 25% of the population between 55 and 84 years is affected by OA of the knee. It can be graded using various classification, one of the most used being the Kellgren-Lawrence-Score (KL) ranging from 1 (early) to 4 (end stage). The treatment of choice for end-stage three compartmental knee OA (KL 4) is a total knee arthroplasty (TKA), whereby the damaged/degenerated parts of the knee are removed and replaced by a prosthesis. However, in patients with early to mid-stage OA (KL 1-3), which are usually younger patients, a conservative treatment is indicated. The goal of this conservative treatment is to relieve symptoms and at best slow progression of the diseases.
In medial knee OA (when mainly the medial compartment of the knee is affected by OA), one approach is to reduce the medial compartment contact force (MCF) by shifting load from the medial (disease affected) to lateral (disease free) compartment. Thereby lateral wedge insoles have been promoted as cost effective and simple solution. The biomechanical idea of these insoles is a shift in load distribution through a change in lower limb alignment. The lateral wedge of the insoles leads to a change in foot alignment (varus hindfoot) and consequently to a change in knee alignment (valgus knee = "knock-knees") and load distribution. Biomechanical studies confirmed a reduction in external knee adduction moment (EKAM) and knee adduction angular impulse (KAAI), which are surrogate measures to estimate knee joint load distribution (e.g. MCF). However, clinical trials report conflicting results, with some reporting no benefit while others reported a small decrease in knee pain in at least some patients.
In the light of this, the connection between knee OA and foot deformities has been reassessed. One study found patients with medial knee OA to have a more pronated foot type (i.e. tendency to plano-valgus deformity) compared to an age-matched control group without OA. Other investigations found more rigid foot types in patients with medial knee OA and a more internally rotated tibia during gait as well as an inversion of the forefoot. This seems important because the hindfoot axis has a significant influence on the mechanical axis of the lower limb and thereby on the load distribution in the knee. Half a degree valgisation of the hindfoot axis leads to one-degree varisation of the mechanical axis. Furthermore, a plano-valgus foot morphology was found to lead to internal rotation of the tibia which increases shear forces in the medial knee compartment.
In summary, patients with medial knee OA tend to have a plano-valgus foot deformity which is associated with a varus lower limb alignment and an internal rotation of the tibia. Both have been associated to an increased loading of the medial compartment. Consequently, some authors proposed the correction of plano-valgus deformity with customized foot deformity correcting insoles instead of lateral wedge insoles as conservative treatment option for early to mid-stage medial knee OA. Until today, only one study investigated the effect of foot deformity correcting insoles (e.g. insoles with customized medial arch support) as alternative to lateral wedge insoles and reported encouraging results. However, they used lateral wedge insoles with and without medial arch support and did not explicitly only correct the foot deformity. Furthermore, they did not perform any biomechanical analysis, which seems important since some previous studies found significant differences in KAAI and EKAM among patients.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Foot deformity correcting insoles, Lateral wedge insoles
- Keywords
- Mediale Knee Osteoarthritis, Conservative Treatment, Insoles
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot deformity correcting insolesDevice
Foot deformity correcting insoles (e.g. insoles with medial arch support for plano-valgus deformity)
Lateral wedge insolesDevice
Lateral wedge insoles
| Study group | Role | What they receive |
|---|---|---|
| Foot deformity correcting insole arm | Experimental | Patients allocated to the "foot deformity correcting insole" arm will receive insoles to correct their foot deformities (plano-valgus foot deformity). Receives: Device: Foot deformity correcting insoles |
| Lateral wedge insole arm | Active comparator | Patient allocated to the "Lateral wedge insole" arm will receive conventional lateral wedge insole. Receives: Device: Lateral wedge insoles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain scale (NRS)
Measured: pre-treatment
Numeric pain scale (NRS)
Measured: 3 months
Numeric pain scale (NRS)
Measured: 6 months
Numeric pain scale (NRS)
Measured: 12 months
External knee adduction moment (EKAM)
Measured: pre-treatment
External knee adduction moment (EKAM)
Measured: 3 months
External knee adduction moment (EKAM)
Measured: 6 months
External knee adduction moment (EKAM)
Measured: 12 months
Knee adduction angular impulse (KAAI)
Measured: pre-treatment
Knee adduction angular impulse (KAAI)
Measured: 3 months
Knee adduction angular impulse (KAAI)
Measured: 6 months
Knee adduction angular impulse (KAAI)
Measured: 12 months
Western Ontario and McMaster OA Index (WOMAC)
Measured: pre-treatment
Western Ontario and McMaster OA Index (WOMAC)
Measured: 3 months
Western Ontario and McMaster OA Index (WOMAC)
Measured: 6 months
Western Ontario and McMaster OA Index (WOMAC)
Measured: 9 months
Western Ontario and McMaster OA Index (WOMAC)
Measured: 12 months
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Measured: pre-treatment
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Measured: 3 months
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Measured: 6 months
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Measured: 12 months
Oxford-12 Knee Score (OKS)
Measured: pre-treatment
Oxford-12 Knee Score (OKS)
Measured: 3 months
Oxford-12 Knee Score (OKS)
Measured: 6 months
Oxford-12 Knee Score (OKS)
Measured: 12 months
Knee Society Score (KSS)
Measured: pre-treatment
Knee Society Score (KSS)
Measured: 3 months
Knee Society Score (KSS)
Measured: 6 months
Knee Society Score (KSS)
Measured: 12 months
EQ-5D
Measured: pre-treatment
EQ-5D
Measured: 3 months
EQ-5D
Measured: 6 months
EQ-5D
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start1 Dec 2021
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
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 Insel Gruppe AG, University Hospital BernThe 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
- Randomized control trial
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank Klenke, Prof, Principal investigator, Universitätsklinik für Orthopädische Chirurgie und Traumatologie Inselspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967339
- Sponsor's protocol ID
- 2021-InsoleStudy
- Status last verified
- Feb 2023
- First submitted
- 13 Jul 2021
- Last updated
- 10 Feb 2023
- Results posted
- No
- 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 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial in Patients With Medial Knee Osteoarthritis Comparing the Clinical and Biomechanical Effect of Foot Deformity Correcting Insoles and Lateral Wedge Insoles
- ClinicalTrials.gov ID
- NCT04967339
- Acronym / sponsor ID
- 2021-InsoleStudy
- Conditions
- Osteoarthritis, Knee
- Keywords
- Mediale Knee Osteoarthritis, Conservative Treatment, Insoles
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 19 Jul 2021 (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.
In patients with early to mid-stage knee osteoarthritis (OA), a conservative treatment is indicated. In medial knee OA (when mainly the medial compartment of the knee is affected by OA), lateral wedge insoles have been promoted as cost effective and simple solution. However, clinical trials report conflicting results, with some reporting no benefit while others reported a small decrease in knee pain. Recent studies reported medial OA patients to have a tendency to a plano-valgus foot deformity, which is associated with a varus lower limb alignment and an internal rotation of the tibia. Some authors thus proposed the correction of plano-valgus deformity with foot deformity correcting insoles instead of lateral wedge insoles. Until today, only one study investigated the effect of foot deformity correcting insoles (e.g. with medial arch support) as alternative to lateral wedge insoles and reported encouraging results. However, they used lateral wedge insoles with custom arch support instead of foot deformity correcting customized insoles along (without lateral wedge). Furthermore, they did not perform any biomechanical analyses. The primary object of this study is to compare the effect of foot deformity correcting insoles for plano-valgus foot deformities and lateral wedge insoles on knee load distribution, knee pain and patient reported outcome measures in early to mid-stage medial knee OA patients after 6 and 12 months.
Detailed description
Osteoarthritis (OA) of the knee is defined as an inflammatory process leading to loss of protective cartilage which results in pain, disability and loss of function. Around 25% of the population between 55 and 84 years is affected by OA of the knee. It can be graded using various classification, one of the most used being the Kellgren-Lawrence-Score (KL) ranging from 1 (early) to 4 (end stage). The treatment of choice for end-stage three compartmental knee OA (KL 4) is a total knee arthroplasty (TKA), whereby the damaged/degenerated parts of the knee are removed and replaced by a prosthesis. However, in patients with early to mid-stage OA (KL 1-3), which are usually younger patients, a conservative treatment is indicated. The goal of this conservative treatment is to relieve symptoms and at best slow progression of the diseases.
In medial knee OA (when mainly the medial compartment of the knee is affected by OA), one approach is to reduce the medial compartment contact force (MCF) by shifting load from the medial (disease affected) to lateral (disease free) compartment. Thereby lateral wedge insoles have been promoted as cost effective and simple solution. The biomechanical idea of these insoles is a shift in load distribution through a change in lower limb alignment. The lateral wedge of the insoles leads to a change in foot alignment (varus hindfoot) and consequently to a change in knee alignment (valgus knee = "knock-knees") and load distribution. Biomechanical studies confirmed a reduction in external knee adduction moment (EKAM) and knee adduction angular impulse (KAAI), which are surrogate measures to estimate knee joint load distribution (e.g. MCF). However, clinical trials report conflicting results, with some reporting no benefit while others reported a small decrease in knee pain in at least some patients.
In the light of this, the connection between knee OA and foot deformities has been reassessed. One study found patients with medial knee OA to have a more pronated foot type (i.e. tendency to plano-valgus deformity) compared to an age-matched control group without OA. Other investigations found more rigid foot types in patients with medial knee OA and a more internally rotated tibia during gait as well as an inversion of the forefoot. This seems important because the hindfoot axis has a significant influence on the mechanical axis of the lower limb and thereby on the load distribution in the knee. Half a degree valgisation of the hindfoot axis leads to one-degree varisation of the mechanical axis. Furthermore, a plano-valgus foot morphology was found to lead to internal rotation of the tibia which increases shear forces in the medial knee compartment.
In summary, patients with medial knee OA tend to have a plano-valgus foot deformity which is associated with a varus lower limb alignment and an internal rotation of the tibia. Both have been associated to an increased loading of the medial compartment. Consequently, some authors proposed the correction of plano-valgus deformity with customized foot deformity correcting insoles instead of lateral wedge insoles as conservative treatment option for early to mid-stage medial knee OA. Until today, only one study investigated the effect of foot deformity correcting insoles (e.g. insoles with customized medial arch support) as alternative to lateral wedge insoles and reported encouraging results. However, they used lateral wedge insoles with and without medial arch support and did not explicitly only correct the foot deformity. Furthermore, they did not perform any biomechanical analysis, which seems important since some previous studies found significant differences in KAAI and EKAM among patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Foot deformity correcting insole arm | Experimental | Device: Foot deformity correcting insolesPatients allocated to the "foot deformity correcting insole" arm will receive insoles to correct their foot deformities (plano-valgus foot deformity). |
| Lateral wedge insole arm | Active comparator | Device: Lateral wedge insolesPatient allocated to the "Lateral wedge insole" arm will receive conventional lateral wedge insole. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed Consent signed by the subject
- Aged between 40 to 80 years
- Early to mid-stage (KL 1 - 3) OA of the medial compartment of the knee based on X-ray and MRI images
- Plano-valgus foot deformity based on clinical assessment
- Availability of conventional radiographs, long-leg films, and a knee-MRI no older than 1 year at time of inclusion
Key exclusion criteria (10 listed)
- Contraindications and limitations of the MD as described in the instructions for use.
- Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject,
- Enrolment of the PI, his/her family members, employees and other dependent persons
- Relevant OA (Kellgren-Lawrence-Score >2) of the lateral compartment of the knee based on X-ray and MRI images
- BMI higher than 40 kg/m
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 |
|---|---|---|
| Foot deformity correcting insolesFoot deformity correcting insoles (e.g. insoles with medial arch support for plano-valgus deformity) | Device | Foot deformity correcting insole arm |
| Lateral wedge insolesLateral wedge insoles | Device | Lateral wedge insole arm |
Primary outcome
Numeric pain scale (NRS)
Time frame: pre-treatment
Numeric pain scale (NRS)
Time frame: 3 months
Numeric pain scale (NRS)
Time frame: 6 months
Numeric pain scale (NRS)
Time frame: 12 months
External knee adduction moment (EKAM)
Time frame: pre-treatment
External knee adduction moment (EKAM)
Time frame: 3 months
External knee adduction moment (EKAM)
Time frame: 6 months
External knee adduction moment (EKAM)
Time frame: 12 months
Knee adduction angular impulse (KAAI)
Time frame: pre-treatment
Knee adduction angular impulse (KAAI)
Time frame: 3 months
Knee adduction angular impulse (KAAI)
Time frame: 6 months
Knee adduction angular impulse (KAAI)
Time frame: 12 months
Western Ontario and McMaster OA Index (WOMAC)
Time frame: pre-treatment
Western Ontario and McMaster OA Index (WOMAC)
Time frame: 3 months
Western Ontario and McMaster OA Index (WOMAC)
Time frame: 6 months
Western Ontario and McMaster OA Index (WOMAC)
Time frame: 9 months
Western Ontario and McMaster OA Index (WOMAC)
Time frame: 12 months
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: pre-treatment
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 3 months
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 6 months
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 12 months
Oxford-12 Knee Score (OKS)
Time frame: pre-treatment
Oxford-12 Knee Score (OKS)
Time frame: 3 months
Oxford-12 Knee Score (OKS)
Time frame: 6 months
Oxford-12 Knee Score (OKS)
Time frame: 12 months
Knee Society Score (KSS)
Time frame: pre-treatment
Knee Society Score (KSS)
Time frame: 3 months
Knee Society Score (KSS)
Time frame: 6 months
Knee Society Score (KSS)
Time frame: 12 months
EQ-5D
Time frame: pre-treatment
EQ-5D
Time frame: 3 months
EQ-5D
Time frame: 6 months
EQ-5D
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- 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.
Frank Klenke, Prof principal investigator
Universitätsklinik für Orthopädische Chirurgie und Traumatologie Inselspital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot deformity correcting insoles and Lateral wedge insoles in people with Osteoarthritis, Knee, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 10 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: status not confirmed, as of the sponsor's last update on 10 Feb 2023. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frank Klenke, Prof (0041 31 632 21 11, ortho@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain scale (NRS) (time frame: pre-treatment). The study lists 33 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 10 Feb 2023.