Study of Various Insoles in Patients With Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02530684
• Other study ID #: 271/14
• Status: Recruiting
• Start date: October 2014
• Est. completion date: March 2021

Study information

• Verified date: January 2020
• Source: University of Lausanne Hospitals
• Contact: Brigitte Jolles, Pr
• Email: brigitte.jolles-haeberli[@]chuv.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• insole
Insoles available on the market without prescription

Locations

Country	Name	City	State
Switzerland	Lausanne University Hospital	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	knee function questionnaire		Week 2 following enrollment
Primary	knee function questionnaire		week 6 following enrollment
Primary	knee function questionnaire		week 8 following enrollment
Primary	knee function questionnaire		week 12 following enrollment
Primary	knee function questionnaire		week 14 following enrollment
Primary	knee function questionnaire		week 18 following enrollment
Secondary	quality of life questionnaire (EQ-5D)	EQ-5D	Week 2, 6, 8, 12, 14 and 18 following enrollment