Clinical trial NCT02530684: Study of Various Insoles in Patients With Knee Osteoarthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis, Knee
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2015-08-21
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with knee osteoarthritis and control subjects

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.


Eligibility 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

Primary outcomes:
measure: knee function questionnaire
timeFrame: Week 2 following enrollment
measure: knee function questionnaire
timeFrame: week 6 following enrollment
measure: knee function questionnaire
timeFrame: week 8 following enrollment
measure: knee function questionnaire
timeFrame: week 12 following enrollment
measure: knee function questionnaire
timeFrame: week 14 following enrollment
measure: knee function questionnaire
timeFrame: week 18 following enrollment
Secondary outcomes:
measure: quality of life questionnaire (EQ-5D)
timeFrame: Week 2, 6, 8, 12, 14 and 18 following enrollment
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital
state: Vaud
Study officials:
affiliation: University of Lausanne Hospitals
name: Brigitte Jolles, Pr
role: PRINCIPAL_INVESTIGATOR
References: