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

NCT ID: NCT05042492

Last Updated: 2022-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-14
• Study Completion Date: 2023-11-30

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.

Conditions

Osteoarthritis, Knee; Edema Leg; Joint Diseases; Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group 1: SC (moveUP)

In group 1: moveUP (class 1, CE-marked, medical device) is being used as the rehabilitation solution after TKA. It has become a valid digital rehabilitation solution and is recognised by the Belgian government as mobile health application in rehabilitation of hip and knee arthroplasty surgeries. It's a full service with daily personalized and individualized follow up by certified physical therapists and certified health care providers. The use of tele-rehabilitation for TKA patients has been internationally recognized with the 2018 John N. Insall Award during the American Knee Society Meeting

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group 2: SC (moveUP) with 10 days of geko

In group 2: Next to SC (moveUP), the application of a single gekoTM device is used on the operated leg after surgery (day 0). This device will be worn for 24 hours and at least 8 hours from day 1 until day 10.

Group Type: EXPERIMENTAL

gekoTM

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Primary TKA planned for degenerative OA
• Subjects must be discharged to home environment and be able to independently perform the activities of daily life
• Obtain a written informed consent

Exclusion Criteria

• TED stockings, Dauerbinde, other compressive bandages
• Mechanical foot pump
• Cooling device type 'Game Ready'
• Posttraumatic OA of the knee
• History of DVT / Flebitis / Pulmonary embolism
• Surgical treatment of venous insufficiency <1y prior to TKA surgery
• Neurological deficit of lower limbs
• Current sciatic irradiating pain in lower limbs
• History of lumbar fusion
• Knee Arthroscopy of the involved limb <6m prior to TKA surgery
• Any per-operative complication related to the TKA procedure (bleeding, fracture, vascular injury, cardiac complication, pulmonary complication)
• In case of a release during the TKA procedure
• Any per-operative (e.g. epidural catheter, urethral catheter, intra articular catheter) or post-operative procedure that might interfere with the rehabilitation during and after hospitalization
• Any scheduled surgery in the 3 months following the reference surgery;
• Any significant medical condition (e.g. Parkinson's disease, multiple sclerosis, cerebral vascular accident) that might interfere with the rehabilitation
• Any significant psychiatric disorders, active alcohol/drug abuse
• Subject is either pregnant or interested in becoming pregnant during the duration of the study
• Subjects who are currently involved in any investigational drug or device study or have been enrolled in such study within the last 3 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Firstkind Ltd

INDUSTRY

Sponsor Role: collaborator

moveUP bv

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe Van Overschelde

Role: STUDY_DIRECTOR

Algemeen Ziekenhuis Maria Middelares

Locations

AZ maria middelares

Ghent, East-Flanders, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Ward Servaes

Role: CONTACT

support@moveup.care

+32 800 88 008

Facility Contacts

Study- and scientific coordinator Hip & Knee Unit

Role: primary

Wouter.VanLysebettens@azmmsj.be

+32 9 220 88 68

Role: backup

secretariaat.heupknie@azmmsj.be

Other Identifiers

MMS.2020.058

Identifier Type: -

Identifier Source: org_study_id