Clinical trial 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)
Official title: Postoperative Oedema Management Following Neuromuscular Electro- Stimulation of the Peroneal Nerve Using the gekoTM Device After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Edema Leg
Joint Diseases
Rehabilitation
Keywords: Total Knee Arthroplasty
Osteoarthritis
Arthritis
Edema
Patient reported outcomes (PROMs)
Telerehabilitation
Physiotherapy
Lead sponsor: moveUP bv
Sponsor class: INDUSTRY
Collaborators: name: Firstkind Ltd
First posted: 2021-09-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was designed as a single centre, prospective, randomised (1:1), dual arm, single treatment, unblinded, interventional study that will be performed on patients undergoing unilateral TKA for primary OsteoArthritis.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: The primary objective of the study is to assess the post-operative effect of gekoTM on formation of oedema following Total Knee Arthroplasty (TKA)
timeFrame: until end of rehabilitation (+- 3 months after TKA operation)
Secondary outcomes:
measure: Incidence of Adverse Events
timeFrame: until end of rehabilitation (+- 3 months after TKA operation)
measure: Incidence of Device Deficiency
timeFrame: during 10 days after TKA operation
measure: Oedema measurements - subjective slider
timeFrame: until end of rehabilitation (+- 3 months after TKA operation)
measure: Oedema measurements - photographic evaluation
timeFrame: until end of rehabilitation (+- 3 months after TKA operation)
measure: Patient Reported Outcome Measures (PROM's)
timeFrame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
measure: Patient Reported Outcome Measures (PROM's)
timeFrame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
measure: Patient Reported Outcome Measures (PROM's)
timeFrame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
measure: Patient Reported Outcome Measures (PROM's)
timeFrame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
measure: Patient Reported Outcome Measures (PROM's)
timeFrame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
measure: Pain level
timeFrame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
measure: Number of days of Painkiller intake
timeFrame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
measure: Dosage Painkiller intake
timeFrame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
measure: Number of days of NSAID intake
timeFrame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
measure: Dosage NSAID intake
timeFrame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
measure: Sleep duration
timeFrame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
measure: Sleep quality
timeFrame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
measure: Recovery of physical activity (PA)
timeFrame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
measure: Number of days of crutches use
timeFrame: until end of rehabilitation (+- 3 months after TKA operation)
measure: Resume driving a car
timeFrame: until end of rehabilitation (+- 3 months after TKA operation)
measure: Overall Net Promotor Score (NPS) of the rehabilitation in general
timeFrame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
measure: Satisfaction and feedback on the geko device (only for patients using the geko)
timeFrame: during 10 days after TKA operation
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: AZ maria middelares
state: East-Flanders
Study officials:
affiliation: Algemeen Ziekenhuis Maria Middelares
name: Philippe Van Overschelde
role: STUDY_DIRECTOR
References: