Study of Various Insoles in Patients With Knee Osteoarthritis

May 4, 2026 updated by: Brigitte Jolles, MD, University of Lausanne Hospitals
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Canton of Vaud
      • Lausanne, Canton of Vaud, Switzerland, 1011
        • Lausanne University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with knee osteoarthritis and control subjects

Description

PATIENTS WITH KNEE OSTEOARTHRITIS

Inclusion Criteria:

  • Knee x-ray with less than a year
  • Medial compartment knee osteoarthritis
  • Varus knee between 0 and 10 degrees

Exclusion Criteria:

  • Neurological impairments
  • Prior lower-limbs surgery
  • Joint injection during the last six months
  • Convergent patella

CONTROL SUBJECTS

Inclusion Criteria:

  • No lower-limbs or spine osteoarthritis
  • No pain during ambulation

Exclusion Criteria:

  • Neurological impairments
  • Prior lower-limbs surgery or current treatments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Knee osteoarthritis
Patients with knee osteoarthritis
Other: insole
Insoles available on the market without prescription
Control participants
Individuals without signs of knee osteoarthritis
Other: insole
Insoles available on the market without prescription

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
knee function questionnaire
Time Frame: Week 2 following enrollment
Week 2 following enrollment
knee function questionnaire
Time Frame: week 6 following enrollment
week 6 following enrollment
knee function questionnaire
Time Frame: week 8 following enrollment
week 8 following enrollment
knee function questionnaire
Time Frame: week 12 following enrollment
week 12 following enrollment
knee function questionnaire
Time Frame: week 14 following enrollment
week 14 following enrollment
knee function questionnaire
Time Frame: week 18 following enrollment
week 18 following enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life questionnaire (EQ-5D)
Time Frame: Week 2, 6, 8, 12, 14 and 18 following enrollment
EQ-5D
Week 2, 6, 8, 12, 14 and 18 following enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lausanne Hospitals

Investigators

  • Principal Investigator: Brigitte Jolles, Pr, University of Lausanne Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

July 2, 2015

First Submitted That Met QC Criteria

August 19, 2015

First Posted (Estimated)

August 21, 2015

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 271/14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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