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OpenTrials
Completed

NCT Number: NCT02530684

Study of Various Insoles in Patients With Knee Osteoarthritis

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lausanne University Hospital

Lausanne, Canton of Vaud, 1011, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insole

Other

Insoles available on the market without prescription

Primary outcomes

  1. knee function questionnaire

    Time frame: Week 2 following enrollment

  2. knee function questionnaire

    Time frame: week 6 following enrollment

  3. knee function questionnaire

    Time frame: week 8 following enrollment

  4. knee function questionnaire

    Time frame: week 12 following enrollment

  5. knee function questionnaire

    Time frame: week 14 following enrollment

  6. knee function questionnaire

    Time frame: week 18 following enrollment

Secondary outcomes

  1. quality of life questionnaire (EQ-5D)

    Time frame: Week 2, 6, 8, 12, 14 and 18 following enrollment

    EQ-5D

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 21, 2015
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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