Osteoarthritis, KneeNCT02530684
Study of Various Insoles in Patients With Knee Osteoarthritis
An observational study of Osteoarthritis, Knee, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
It is critical to improve our understanding of knee osteoarthritis and to design better therapeutic options for this disease. The function of the knee during walking is an important factor in the development and progression of the disease. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- insole
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2014to 1 Jan 2017
- Phase
- Observational
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with knee osteoarthritis and control subjects
Who may be able to join
- Knee x-ray with less than a year
- Medial compartment knee osteoarthritis
- Varus knee between 0 and 10 degrees
- No lower-limbs or spine osteoarthritis
- No pain during ambulation
Who cannot join
- Neurological impairments
- Prior lower-limbs surgery
- Joint injection during the last six months
- Convergent patella
- CONTROL SUBJECTS
- Neurological impairments
- Prior lower-limbs surgery or current treatments
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Lausanne University Hospital
Lausanne, Canton of Vaud, 1011
About this study
It is critical to improve our understanding of knee osteoarthritis and to design better therapeutic options for this disease. The function of the knee during walking is an important factor in the development and progression of the disease. Many models of insoles that can be inserted in regular shoes with the objectives of improving the function of the knee are available on the market without prescription. Prior studies on these insoles failed to report clear benefits for the patients, mainly because the results varied strongly between persons. Walking is a complex tasks and it is well known that everybody develops his/her individual way of walking (ie., there are subtle but very important differences in the function of the knee). This observation and the fact that patient responses could vary between individuals suggest that using the same standard insoles with all patients might not be appropriated. This further suggests that care could be greatly improved if it was possible to identify patients that would respond positively to a model of insoles. Unfortunately, while several randomized controlled trials were conducted on these insoles for knee osteoarthritis, there is a paucity of data regarding their effects on the ambulatory function of the knee. Therefore, this study aims to improve the understanding regarding the effects of insoles freely available on the market in terms of knee mechanics during walking and its relation with quality of life. This study will test the hypotheses that (i) insoles have an effect on the static and dynamic lower-limb function and (ii) that benefits perceived by the patients are related to the mechanical effects produced by the insoles.
- Conditions
- Osteoarthritis, Knee
- Being tested
- insole
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insoleOther
Insoles available on the market without prescription
| Study group | Role | What they receive |
|---|---|---|
| Knee osteoarthritis | Patients with knee osteoarthritis Receives: Other: insole | |
| Control participants | Individuals without signs of knee osteoarthritis Receives: Other: insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
knee function questionnaire
Measured: Week 2 following enrollment
knee function questionnaire
Measured: week 6 following enrollment
knee function questionnaire
Measured: week 8 following enrollment
knee function questionnaire
Measured: week 12 following enrollment
knee function questionnaire
Measured: week 14 following enrollment
knee function questionnaire
Measured: week 18 following enrollment
Secondary outcomes (1)
quality of life questionnaire (EQ-5D)
EQ-5D
Measured: Week 2, 6, 8, 12, 14 and 18 following enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study start1 Jan 2014
- Primary completion1 Jan 2017
- Study completion1 Jan 2017
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.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brigitte Jolles, MD, University of Lausanne Hospitals
- Investigators
- Brigitte Jolles, Pr, Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530684
- Sponsor's protocol ID
- 271/14
- Status last verified
- Jan 2020
- First submitted
- 2 Jul 2015
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Various Insoles in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02530684
- Acronym / sponsor ID
- 271/14
- Conditions
- Osteoarthritis, Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 21 Aug 2015 (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.
It is critical to improve our understanding of knee osteoarthritis and to design better therapeutic options for this disease. The function of the knee during walking is an important factor in the development and progression of the disease. Many models of insoles that can be inserted in regular shoes with the objectives of improving the function of the knee are available on the market without prescription. Prior studies on these insoles failed to report clear benefits for the patients, mainly because the results varied strongly between persons. Walking is a complex tasks and it is well known that everybody develops his/her individual way of walking (ie., there are subtle but very important differences in the function of the knee). This observation and the fact that patient responses could vary between individuals suggest that using the same standard insoles with all patients might not be appropriated. This further suggests that care could be greatly improved if it was possible to identify patients that would respond positively to a model of insoles. Unfortunately, while several randomized controlled trials were conducted on these insoles for knee osteoarthritis, there is a paucity of data regarding their effects on the ambulatory function of the knee. Therefore, this study aims to improve the understanding regarding the effects of insoles freely available on the market in terms of knee mechanics during walking and its relation with quality of life. This study will test the hypotheses that (i) insoles have an effect on the static and dynamic lower-limb function and (ii) that benefits perceived by the patients are related to the mechanical effects produced by the insoles.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Knee osteoarthritis | – | Other: insolePatients with knee osteoarthritis |
| Control participants | – | Other: insoleIndividuals without signs of knee osteoarthritis |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with knee osteoarthritis and control subjects
Key inclusion criteria (5 listed)
- Knee x-ray with less than a year
- Medial compartment knee osteoarthritis
- Varus knee between 0 and 10 degrees
- No lower-limbs or spine osteoarthritis
- No pain during ambulation
Key exclusion criteria (7 listed)
- Neurological impairments
- Prior lower-limbs surgery
- Joint injection during the last six months
- Convergent patella
- CONTROL SUBJECTS
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 |
|---|---|---|
| insoleInsoles available on the market without prescription | Other | Control participants, Knee osteoarthritis |
Primary outcome
knee function questionnaire
Time frame: Week 2 following enrollment
knee function questionnaire
Time frame: week 6 following enrollment
knee function questionnaire
Time frame: week 8 following enrollment
knee function questionnaire
Time frame: week 12 following enrollment
knee function questionnaire
Time frame: week 14 following enrollment
knee function questionnaire
Time frame: week 18 following enrollment
1 secondary outcome
quality of life questionnaire (EQ-5D)
Time frame: Week 2, 6, 8, 12, 14 and 18 following enrollment
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 5 May 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. This study is not recruiting at the moment.
Brigitte Jolles, Pr principal investigator
University of Lausanne Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by University of Lausanne Hospitals 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 5 inclusion and 7 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 5 May 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 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?
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 function questionnaire (time frame: Week 2 following enrollment). 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 5 May 2026.