Study of Various Insoles in Patients With Knee Osteoarthritis

Study Overview
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Brief Summary
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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
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Osteoarthritis, Knee

Intervention / Treatment
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* Other: insole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Knee osteoarthritis<br>Patients with knee osteoarthritis | Other: insole<br>* Insoles available on the market without prescription<br>|
| Control participants<br>Individuals without signs of knee osteoarthritis | Other: insole<br>* Insoles available on the market without prescription<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| knee function questionnaire |  | Week 2 following enrollment | 
| knee function questionnaire |  | week 6 following enrollment | 
| knee function questionnaire |  | week 8 following enrollment | 
| knee function questionnaire |  | week 12 following enrollment | 
| knee function questionnaire |  | week 14 following enrollment | 
| knee function questionnaire |  | week 18 following enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life questionnaire (EQ-5D) | EQ-5D | Week 2, 6, 8, 12, 14 and 18 following enrollment |