- ICH GCP
- US Clinical Trials Registry
- 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)
Postoperative Oedema Management Following Neuromuscular Electro- Stimulation of the Peroneal Nerve Using the gekoTM Device After Total Knee Arthroplasty
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ward Servaes
- Phone Number: +32 800 88 008
- Email: support@moveup.care
Study Locations
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-
East-Flanders
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Ghent, East-Flanders, Belgium, 9000
- Recruiting
- AZ Maria Middelares
-
Contact:
- Study- and scientific coordinator Hip & Knee Unit
- Phone Number: +32 9 220 88 68
- Email: Wouter.VanLysebettens@azmmsj.be
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Contact:
-
Principal Investigator:
- Pieter Vansintjan, dr.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 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
|
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Experimental: 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.
|
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
until end of rehabilitation (+- 3 months after TKA operation)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Adverse Events
Time Frame: until end of rehabilitation (+- 3 months after TKA operation)
|
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. |
until end of rehabilitation (+- 3 months after TKA operation)
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Incidence of Device Deficiency
Time Frame: during 10 days after TKA operation
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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))
|
during 10 days after TKA operation
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Oedema measurements - subjective slider
Time Frame: until end of rehabilitation (+- 3 months after TKA operation)
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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)
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until end of rehabilitation (+- 3 months after TKA operation)
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Oedema measurements - photographic evaluation
Time Frame: until end of rehabilitation (+- 3 months after TKA operation)
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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. |
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)
|
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 |
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)
|
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. |
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)
|
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) |
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)
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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 |
2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
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Patient Reported Outcome Measures (PROM's)
Time Frame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
|
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. |
2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
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Pain level
Time Frame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
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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
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2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
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Number of days of Painkiller intake
Time Frame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
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PK intake stop is defined as no PK consumption for 3 consecutive days with no new 3 day-period of PK intake.
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2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
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Dosage Painkiller intake
Time Frame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
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2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
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Number of days of NSAID intake
Time Frame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
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NSAID intake stop is defined as no NSAID consumption for 3 consecutive days with no new 3 day-period of NSAID intake.
|
2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
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Dosage NSAID intake
Time Frame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
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2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
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Sleep duration
Time Frame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
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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).
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2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
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Sleep quality
Time Frame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
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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).
|
2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
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Recovery of physical activity (PA)
Time Frame: 2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
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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).
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2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
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Number of days of crutches use
Time Frame: until end of rehabilitation (+- 3 months after TKA operation)
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until end of rehabilitation (+- 3 months after TKA operation)
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Resume driving a car
Time Frame: until end of rehabilitation (+- 3 months after TKA operation)
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Number of days post-operative
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until end of rehabilitation (+- 3 months after TKA operation)
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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)
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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
|
2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
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Satisfaction and feedback on the geko device (only for patients using the geko)
Time Frame: during 10 days after TKA operation
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Including:
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during 10 days after TKA operation
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Philippe Van Overschelde, Algemeen Ziekenhuis Maria Middelares
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MMS.2020.058
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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