Study of Various Insoles in Patients With Knee Osteoarthritis

NCT ID: NCT02530684

Last Updated: 2020-01-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2021-03-31

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.

Conditions

Osteoarthritis, Knee

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

Knee osteoarthritis

Patients with knee osteoarthritis

insole

Intervention Type: OTHER

Insoles available on the market without prescription

Control participants

Individuals without signs of knee osteoarthritis

insole

Intervention Type: OTHER

Insoles available on the market without prescription

Interventions

insole

Insoles available on the market without prescription

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Lausanne Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Brigitte Jolles, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brigitte Jolles, Pr

Role: PRINCIPAL_INVESTIGATOR

University of Lausanne Hospitals

Locations

Lausanne University Hospital

Lausanne, Canton of Vaud, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Brigitte Jolles, Pr

Role: CONTACT

brigitte.jolles-haeberli@chuv.ch

Facility Contacts

Brigitte Jolles, Pr

Role: primary

brigitte.jolles-haeberli@chuv.ch

Other Identifiers

271/14

Identifier Type: -

Identifier Source: org_study_id