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The Post-operative Effect on Formation of Oedema After Total Knee Arthroplasty With or Without the Use of a Nerve Stimulator (the gekoTM Device)

Osteoarthritis, Knee Clinical Trial

Official title:
Postoperative Oedema Management Following Neuromuscular Electro- Stimulation of the Peroneal Nerve Using the gekoTM Device After Total Knee Arthroplasty

Clinical Trial Summary

This study will investigate whether the recovery of muscle function of total knee arthroplasty is accelerated with the use of the gekoTM device along with its effect on reducing symptoms such as oedema and inhibition of the muscle function.

Clinical Trial Description

This study will investigate total knee arthroplasty patients: - One group gets standard of care (i.e. performing exercises & guidance by a physiotherapist via a CE-marked mobile application, called moveUP) - Second group gets standard of care + GekoTM device (i.e. non-invasive neuromuscular electrostimulation applied at the peroneal nerve for 10 days after the operation date.) The primary objective of the study is to assess the post-operative effect of gekoTM on formation of oedema (measured by perometer). The effect of the gekoTM device on the muscle function & the overall recovery will be also investigated. To collect parameters, the patient will be asked to complete questionnaires, including the following patient reported outcomes (PROMs): Knee Injury and Osteoarthritis Outcome Score (KOOS), Knee Society Score (KSS), Euroqol Health questionnaire EQ5D, Forgotten Joint Score (FJS), Oxford Knee Score (OKS). The collection of the PROMs will give an indication on outcome and overal recovery in the 2 groups. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05042492
Study type Interventional
Source moveUP bv
Contact Ward Servaes
Phone +32 800 88 008
Email support@moveup.care
Status Recruiting
Phase N/A
Start date January 14, 2021
Completion date November 2023
View Details
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