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, Edema Leg, Joint Diseases
About this trial
This is an interventional prevention trial for Osteoarthritis, Knee focused on measuring Total Knee Arthroplasty, Osteoarthritis, Arthritis, Edema, Patient reported outcomes (PROMs), Telerehabilitation, Physiotherapy
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
Sites / Locations
- AZ maria middelaresRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Group 1: SC (moveUP)
Group 2: SC (moveUP) with 10 days of geko
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
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.