Back to resultsThe Post-operative Effect on Formation of Oedema After Total Knee Arthroplasty With or Without the Use of a Nerve Stimulator (the gekoTM Device)
Primary Purpose
Osteoarthritis, Knee, Edema Leg, Joint Diseases
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
gekoTM
Sponsored by
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
Arm Type
No Intervention
Experimental
Arm Label
Group 1: SC (moveUP)
Group 2: SC (moveUP) with 10 days of geko
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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))
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)
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.
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
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.
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)
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
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.
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
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.
Dosage Painkiller intake
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.
Dosage NSAID intake
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).
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).
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).
Number of days of crutches use
Resume driving a car
Number of days post-operative
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
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
Full Information
NCT ID
NCT05042492
First Posted
January 8, 2021
Last Updated
April 26, 2022
Sponsor
moveUP bv
Collaborators
Firstkind Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05042492
Brief Title
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 14, 2021 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
moveUP bv
Collaborators
Firstkind Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Edema Leg, Joint Diseases, Rehabilitation
Keywords
Total Knee Arthroplasty, Osteoarthritis, Arthritis, Edema, Patient reported outcomes (PROMs), Telerehabilitation, Physiotherapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1: SC (moveUP)
Arm Type
No Intervention
Arm Description
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
Arm Title
Group 2: SC (moveUP) with 10 days of geko
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
gekoTM
Intervention Description
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
Primary Outcome Measure Information:
Title
The primary objective of the study is to assess the post-operative effect of gekoTM on formation of oedema following Total Knee Arthroplasty (TKA)
Description
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.
Time Frame
until end of rehabilitation (+- 3 months after TKA operation)
Secondary Outcome Measure Information:
Title
Incidence of Adverse Events
Description
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.
Time Frame
until end of rehabilitation (+- 3 months after TKA operation)
Title
Incidence of Device Deficiency
Description
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))
Time Frame
during 10 days after TKA operation
Title
Oedema measurements - subjective slider
Description
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)
Time Frame
until end of rehabilitation (+- 3 months after TKA operation)
Title
Oedema measurements - photographic evaluation
Description
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.
Time Frame
until end of rehabilitation (+- 3 months after TKA operation)
Title
Patient Reported Outcome Measures (PROM's)
Description
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
Time Frame
2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Title
Patient Reported Outcome Measures (PROM's)
Description
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.
Time Frame
2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Title
Patient Reported Outcome Measures (PROM's)
Description
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)
Time Frame
2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Title
Patient Reported Outcome Measures (PROM's)
Description
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
Time Frame
2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Title
Patient Reported Outcome Measures (PROM's)
Description
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.
Time Frame
2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Title
Pain level
Description
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
Time Frame
2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Title
Number of days of Painkiller intake
Description
PK intake stop is defined as no PK consumption for 3 consecutive days with no new 3 day-period of PK intake.
Time Frame
2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Title
Dosage Painkiller intake
Time Frame
2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Title
Number of days of NSAID intake
Description
NSAID intake stop is defined as no NSAID consumption for 3 consecutive days with no new 3 day-period of NSAID intake.
Time Frame
2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Title
Dosage NSAID intake
Time Frame
2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Title
Sleep duration
Description
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).
Time Frame
2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Title
Sleep quality
Description
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).
Time Frame
2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Title
Recovery of physical activity (PA)
Description
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).
Time Frame
2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Title
Number of days of crutches use
Time Frame
until end of rehabilitation (+- 3 months after TKA operation)
Title
Resume driving a car
Description
Number of days post-operative
Time Frame
until end of rehabilitation (+- 3 months after TKA operation)
Title
Overall Net Promotor Score (NPS) of the rehabilitation in general
Description
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
Time Frame
2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)
Title
Satisfaction and feedback on the geko device (only for patients using the geko)
Description
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
Time Frame
during 10 days after TKA operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ward Servaes
Phone
+32 800 88 008
Email
support@moveup.care
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Van Overschelde
Organizational Affiliation
Algemeen Ziekenhuis Maria Middelares
Official's Role
Study Director
Facility Information:
Facility Name
AZ maria middelares
City
Ghent
State/Province
East-Flanders
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study- and scientific coordinator Hip & Knee Unit
Phone
+32 9 220 88 68
Email
Wouter.VanLysebettens@azmmsj.be
Email
secretariaat.heupknie@azmmsj.be
First Name & Middle Initial & Last Name & Degree
Pieter Vansintjan, dr.
12. IPD Sharing Statement
Learn more about this trial
The Post-operative Effect on Formation of Oedema After Total Knee Arthroplasty With or Without the Use of a Nerve Stimulator (the gekoTM Device)
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