NCT05042492

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: moveUP bv · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Osteoarthritis, Knee
• Edema Leg
• Joint Diseases
• Rehabilitation

Interventions

Type	Name	Description
DEVICE	gekoTM	The gekoTM device is a small, transcutaneous nerve stimulator that is placed non-invasively on the skin, whereby the surface electrodes will be attached close to the peroneal nerve. Activation of the peroneal nerve causes contraction of the calf muscle pump, which will increase blood circulation that corresponds to 60% of walking. The increased blood circulation reduces the pressure difference between capillaries and the surrounding tissue and transfers the tissue fluid back into the veins and lymph fibers

Timeline

• Start date: 2021-01-14
• Primary completion: 2023-07-01
• Completion: 2023-11-01
• First posted: 2021-09-13
• Last updated: 2022-04-27

Locations

1 site across 1 country: Belgium