NCT02530684

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 21, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

May 5, 2026

Status Verified

January 1, 2020

Enrollment Period

3 years

First QC Date

July 2, 2015

Last Update Submit

May 4, 2026

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (1)

  • quality of life questionnaire (EQ-5D)

    Week 2, 6, 8, 12, 14 and 18 following enrollment

Study Arms (2)

Knee osteoarthritis

Patients with knee osteoarthritis

Other: insole

Control participants

Individuals without signs of knee osteoarthritis

Other: insole

Interventions

insoleOTHER

Insoles available on the market without prescription

Control participantsKnee osteoarthritis

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with knee osteoarthritis and control subjects

You may qualify if:

  • Knee x-ray with less than a year
  • Medial compartment knee osteoarthritis
  • Varus knee between 0 and 10 degrees

You may not qualify if:

  • Neurological impairments
  • Prior lower-limbs surgery
  • Joint injection during the last six months
  • Convergent patella
  • CONTROL SUBJECTS
  • No lower-limbs or spine osteoarthritis
  • No pain during ambulation
  • Neurological impairments
  • Prior lower-limbs surgery or current treatments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lausanne University Hospital

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Foot Orthoses

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Orthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Officials

  • Brigitte Jolles, Pr

    University of Lausanne Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 2, 2015

First Posted

August 21, 2015

Study Start

January 1, 2014

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

May 5, 2026

Record last verified: 2020-01

Locations

CH(1)