Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-27 @ 2:41 PM
Study NCT ID:
NCT05042492
Status:
UNKNOWN
Last Update Posted:
2022-04-27
First Post:
2021-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Post-operative Effect on Formation of Oedema After Total Knee Arthroplasty With or Without the Use of a Nerve Stimulator (the gekoTM Device)
Sponsor:
moveUP bv
Organization:
Study Overview
Official Title:
Postoperative Oedema Management Following Neuromuscular Electro- Stimulation of the Peroneal Nerve Using the gekoTM Device After Total Knee Arthroplasty
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: