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Study of Various Insoles in Patients With Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT02530684
Recruitment Status : Recruiting
First Posted : August 21, 2015
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Osteoarthritis, Knee Other: insole

Study Design

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Study Start Date : October 2014
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  1. quality of life questionnaire (EQ-5D) [ Time Frame: Week 2, 6, 8, 12, 14 and 18 following enrollment ]
    EQ-5D


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with knee osteoarthritis and control subjects
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02530684


Contacts
Contact: Brigitte Jolles, Pr brigitte.jolles-haeberli@chuv.ch

Locations
Switzerland
Lausanne University Hospital Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Brigitte Jolles, Pr       brigitte.jolles-haeberli@chuv.ch   
Principal Investigator: Julien Favre, PhD         
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
Principal Investigator: Brigitte Jolles, Pr Lausanne University Hospital
More Information

Responsible Party: Brigitte Jolles, MD, Professor, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT02530684     History of Changes
Other Study ID Numbers: 271/14
First Posted: August 21, 2015    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases