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Study of Various Insoles in Patients With Knee Osteoarthritis

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02530684
Enrollment
30
Registered
2015-08-21
Start date
2014-10-31
Completion date
2021-03-31
Last updated
2020-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

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.

Interventions

OTHERinsole

Insoles available on the market without prescription

Sponsors

University of Lausanne Hospitals
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frame
knee function questionnaireWeek 2 following enrollment

Secondary

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

Countries

Switzerland

Contacts

Primary ContactBrigitte Jolles, Pr
brigitte.jolles-haeberli@chuv.ch

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026