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Clinical Trials/NCT02530684
NCT02530684
Unknown
Not Applicable

Study of Various Insoles in Patients With Knee Osteoarthritis

University of Lausanne Hospitals1 site in 1 country30 target enrollmentOctober 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis, Knee
Sponsor
University of Lausanne Hospitals
Enrollment
30
Locations
1
Primary Endpoint
knee function questionnaire
Last Updated
6 years ago

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
March 2021
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Lausanne Hospitals
Responsible Party
Principal Investigator
Principal Investigator

Brigitte Jolles, MD

Professor

University of Lausanne Hospitals

Eligibility Criteria

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

Outcomes

Primary Outcomes

knee function questionnaire

Time Frame: week 18 following enrollment

Secondary Outcomes

  • quality of life questionnaire (EQ-5D)(Week 2, 6, 8, 12, 14 and 18 following enrollment)

Study Sites (1)

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