Osteoarthritis, KneeNCT05042492
The Post-operative Effect on Formation of Oedema After Total Knee Arthroplasty With or Without the Use of a Nerve Stimulator (the gekoTM Device)
A study testing gekoTM in people with Osteoarthritis, Knee and Edema Leg, run by moveUP bv at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Osteoarthritis, Knee, Edema Leg, Joint Diseases
- What is being tested?
- gekoTM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Jan 2021to Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
AZ maria middelares
Ghent, East-Flanders, 9000
Study- and scientific coordinator Hip & Knee Unit, +32 9 220 88 68, Wouter.VanLysebettens@azmmsj.be
secretariaat.heupknie@azmmsj.be
About this study
Official title: Postoperative Oedema Management Following Neuromuscular Electro- Stimulation of the Peroneal Nerve Using the gekoTM Device After Total Knee Arthroplasty
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.
Read the 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
- Being tested
- gekoTM
- Keywords
- Total Knee Arthroplasty, Osteoarthritis, Arthritis, Edema, Patient reported outcomes (PROMs), Telerehabilitation, Physiotherapy
- Medical subject headings
- Osteoarthritis, Knee, Joint Diseases, Osteoarthritis, Arthritis, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gekoTMDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1: SC (moveUP) | No intervention | 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 2: SC (moveUP) with 10 days of geko | Experimental | 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. Receives: Device: gekoTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study is to assess the post-operative effect of gekoTM on formation of oedema following Total Knee Arthroplasty (TKA)
This is measured by the use of a perometer. For each patient, change in limb volume shall be calculated as a percentage of original limb volume.
Shapiro-Wilk test shall be used to test whether there is a significant (p<0.05) departure from normal distribution in either group.
Measured: until end of rehabilitation (+- 3 months after TKA operation)
Secondary outcomes (21)
Incidence of Adverse Events
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.
(MDR Article 2(57)). The total number adverse events and the total number (%) of patients that had at least 1 adverse event will be stated.
Measured: until end of rehabilitation (+- 3 months after TKA operation)
Incidence of Device Deficiency
Any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in information supplied by the manufacturer.(MDR Article 2(59))
Measured: during 10 days after TKA operation
Oedema measurements - subjective slider
Temperature/swelling: Identical subjective slider as daily evaluated by the patient itself presenting the result as a Visual Analog Scale score, minimum 0 (no swelling) maximum 100 (Very swollen)
Measured: until end of rehabilitation (+- 3 months after TKA operation)
Oedema measurements - photographic evaluation
picture of both knees (moveUP): Patients need to make a picture of both knees, using the photo camera on their smartphone to see the swelling of the operated leg compared to the non-operated leg and to evaluate the swelling of the operated leg.
This blind assessment of pictures is performed by a physical therapist.
Measured: until end of rehabilitation (+- 3 months after TKA operation)
Patient Reported Outcome Measures (PROM's)
The PROMS's measured:
- KOOS: Knee injury and Osteoarthritis Outcome Score for Joint Replacement. 42 items on 5-point Likert scale (multiple choice), total score is on 100, lower scores being indicative of worse knee conditions and higher scores being indicative of better knee condition
Measured: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Patient Reported Outcome Measures (PROM's)
The PROMS's measured:
- KSS: Knee Satisfaction Score. Multiple choice scale. Total score on 100, lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.
Measured: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Patient Reported Outcome Measures (PROM's)
The PROMS's measured:
- EQ5-D: Euroqol Health questionnaire. 5 items on 5-point Likert scale (multiple choice). Total score on 100. Secondly there is also 1 visual analog scale (VAS). The VAS Score is scored separately with lower scores being indicative of worse health and higher scores being indicative of better health (generic questionnaire, not disease specific)
Measured: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Patient Reported Outcome Measures (PROM's)
The PROMS's measured:
- OKS: Oxford Knee Score. 12 items Multiple choice. a lower score can be indicative for bad function or pain after TKA
Measured: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Patient Reported Outcome Measures (PROM's)
The PROMS's measured:
- FJS: Forgotten Joint score. 12-item mutiple choice score. Total score on 100 (%), lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.
Measured: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Pain level
Visual analogue scale (VAS), a 0-100 scale with 100 score = the worst pain the patient can feel and 0 = the patient feels no pain
Measured: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Number of days of Painkiller intake
PK intake stop is defined as no PK consumption for 3 consecutive days with no new 3 day-period of PK intake.
Measured: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Dosage Painkiller intake
Measured: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Number of days of NSAID intake
NSAID intake stop is defined as no NSAID consumption for 3 consecutive days with no new 3 day-period of NSAID intake.
Measured: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Dosage NSAID intake
Measured: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Sleep duration
the wearable measures accelerations during 23h-8h and gives an assumption duration of sleep during the night. The assumption of amount of sleep is based on: very little registration (deep sleep), little movements (light sleep), a lot of movements (waking up).
Measured: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Sleep quality
the wearable measures accelerations during 23h-8h and gives an assumption quality of sleep during the night. The assumption of amount of sleep is based on: very little registration (deep sleep), little movements (light sleep), a lot of movements (waking up).
Measured: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Recovery of physical activity (PA)
number of weeks until post-operative PA level is similar to pre-operative PA level, meaning there is no significant difference between mean post-operative step count (calculated on each post-operative week) and mean pre-operative step count (calculated on 7 days before surgery).
Measured: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Number of days of crutches use
Measured: until end of rehabilitation (+- 3 months after TKA operation)
Resume driving a car
Number of days post-operative
Measured: until end of rehabilitation (+- 3 months after TKA operation)
Overall Net Promotor Score (NPS) of the rehabilitation in general
NPS = How likely would you recommend the rehabilitation to your friends or family?". Visual analogue scale (VAS), a 0-100 scale with 100 score = very likely and 0 = not likely
Measured: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Satisfaction and feedback on the geko device (only for patients using the geko)
Including:
- Ease of use
- Required level of stimulation (1 to 11)
- Adherence to the geko use: daily collection of number of hours worn during the 10 days the geko device is used
Measured: during 10 days after TKA operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start14 Jan 2021
- Primary completionJul 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- moveUP bv
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Firstkind Ltd
- Responsible party
- Sponsor
- Investigators
- Philippe Van Overschelde, Study director, Algemeen Ziekenhuis Maria Middelares
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042492
- Sponsor's protocol ID
- MMS.2020.058
- Status last verified
- Apr 2022
- First submitted
- 8 Jan 2021
- Last updated
- 27 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Oedema Management Following Neuromuscular Electro- Stimulation of the Peroneal Nerve Using the gekoTM Device After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05042492
- Acronym / sponsor ID
- MMS.2020.058
- Conditions
- Osteoarthritis, Knee, Edema Leg, Joint Diseases, Rehabilitation
- Keywords
- Total Knee Arthroplasty, Osteoarthritis, Arthritis, Edema, Patient reported outcomes (PROMs), Telerehabilitation, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- moveUP bvIndustry (pharma, biotech, devices)
- Collaborators
- Firstkind Ltd
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1: SC (moveUP) | No intervention | –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 2: SC (moveUP) with 10 days of geko | Experimental | Device: gekoTMIn 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gekoTMThe 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 | Device | Group 2: SC (moveUP) with 10 days of geko |
Primary outcome
The primary objective of the study is to assess the post-operative effect of gekoTM on formation of oedema following Total Knee Arthroplasty (TKA)
Time frame: until end of rehabilitation (+- 3 months after TKA operation)
This is measured by the use of a perometer. For each patient, change in limb volume shall be calculated as a percentage of original limb volume. Shapiro-Wilk test shall be used to test whether there is a significant (p<0.05) departure from normal distribution in either group.
21 secondary outcomes
Incidence of Adverse Events
Time frame: until end of rehabilitation (+- 3 months after TKA operation)
Incidence of Device Deficiency
Time frame: during 10 days after TKA operation
Oedema measurements - subjective slider
Time frame: until end of rehabilitation (+- 3 months after TKA operation)
Oedema measurements - photographic evaluation
Time frame: until end of rehabilitation (+- 3 months after TKA operation)
Patient Reported Outcome Measures (PROM's)
Time frame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Patient Reported Outcome Measures (PROM's)
Time frame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Patient Reported Outcome Measures (PROM's)
Time frame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Patient Reported Outcome Measures (PROM's)
Time frame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Patient Reported Outcome Measures (PROM's)
Time frame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Pain level
Time frame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Number of days of Painkiller intake
Time frame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Dosage Painkiller intake
Time frame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Number of days of NSAID intake
Time frame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Dosage NSAID intake
Time frame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Sleep duration
Time frame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Sleep quality
Time frame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Recovery of physical activity (PA)
Time frame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Number of days of crutches use
Time frame: until end of rehabilitation (+- 3 months after TKA operation)
Resume driving a car
Time frame: until end of rehabilitation (+- 3 months after TKA operation)
Overall Net Promotor Score (NPS) of the rehabilitation in general
Time frame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Satisfaction and feedback on the geko device (only for patients using the geko)
Time frame: during 10 days after TKA operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Van Overschelde study director
Algemeen Ziekenhuis Maria Middelares
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gekoTM in people with Osteoarthritis, Knee and Edema Leg, run by moveUP bv at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ward Servaes (+32 800 88 008, support@moveup.care), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: until end of rehabilitation (+- 3 months after TKA operation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.