The Post-operative Effect on Formation of Oedema After Total Knee Arthroplasty With or Without the Use of a Nerve Stimulator (the gekoTM Device)
NCT05042492 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2022-04-27
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.
Conditions
- Osteoarthritis, Knee
- Edema Leg
- Joint Diseases
- Rehabilitation
Interventions
- 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
Sponsors & Collaborators
-
Firstkind Ltd
collaborator INDUSTRY -
moveUP bv
lead INDUSTRY
Principal Investigators
-
Philippe Van Overschelde · Algemeen Ziekenhuis Maria Middelares
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-01-14
- Primary Completion
- 2023-07-31
- Completion
- 2023-11-30
Countries
- Belgium
Study Locations
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