Postoperative EdemaKNEETAPENCT03947307
Kinesiotape Treatment for Postoperative Edema After Joint Replacement Surgery of the Knee- The KNEETAPE Study
A study testing lymphtaping using Easytape® and compression treatment in people with Postoperative Edema, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Postoperative edema is a common condition affecting wound healing and function. Traditionally, manual lymphatic drainage and compressive bandages have been employed to reduce swelling. Kinesiotaping might be an alternative approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Edema
- What is being tested?
- lymphtaping using Easytape® and compression treatment
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2020to 9 Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Joint replacement surgery of the knee including conversion from partial to total joint replacement or revision surgery
- Informed Consent as documented by signature
Who cannot join
- Isolated retropatellar replacement or revision surgery for infection
- Contraindications to manual lymphatic drainage and compression treatment (i.e. compressive stockings or bandages) e.g. heart failure
- Contraindication to kinesiotape treatment, e.g. hypersensitivity to medical glue
- Dermatoses at or around the surgical site
- Suspected or confirmed local infection
- Participation in another trial with investigational drug within the 30 days preceding and during the present trial
- Enrolment of the investigator, his/her family members, employees and other dependent persons
- Inability for consent or assent by the patient, or lack of proxy consent in assenting patients with signs of incapacity.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Orthopaedics and Trauma Surgery (DOTS).
Basel, 4031
About this study
Official title: Kinesiotape Treatment for Postoperative Edema After Joint Replacement Surgery of the Knee -The KNEETAPE Study
Postoperative edema is a common condition affecting wound healing and function. Traditionally, manual lymphatic drainage and compressive bandages have been employed to reduce swelling. Kinesiotaping might be an alternative approach. To analyse the efficacy, cost-effectiveness, satisfaction, quality of life, functional outcome and and morbidity of the use of kinesiotape for the treatment of postoperative edema after knee replacement surgery, compared to standard manual lymphatic drainage with compression (i.e. compressive stockings or bandages) or sham taping.
- Conditions
- Postoperative Edema
- Being tested
- lymphtaping using Easytape®, compression treatment, sham taping
- Keywords
- total knee replacement, Kinesiotape treatment, manual lymphatic drainage, compressive bandages, Kinesiotaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lymphtaping using Easytape®Device
lymphtaping using Easytape® on day 1 after surgery by specifically trained physiotherapists. If possible the taping will be left for 7 days.
compression treatmentProcedure or surgery
manual lymphatic drainage followed by compression treatment using compressive stockings or compressive bandaging
sham tapingDevice
sham taping with Leukotape® Classic, a non-elastic tape, that in all other respects resembles Easytape®.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Intervention (treatment / medical device) | Experimental | Patients in the experimental group will receive lymphtaping using Easytape® according to common practice on day 1 after surgery by specifically trained physiotherapists. The tape has an elasticity of 150%. The material is moisture- and air-permeable with a hypoallergenic adhesive coating that is activated by body temperature to increase durability of contact. If possible the taping will be left for 7 days, in case of insufficient adhesion taping will be repeated. Receives: Device: lymphtaping using Easytape® |
| Control Intervention (compression treatment ) | Active comparator | Patients in the control group will be treated with manual lymphatic drainage followed by compression treatment using compressive stockings if accepted or compressive bandaging in cases with pronounced swelling depending on medical necessity. Receives: Procedure: compression treatment |
| Control Intervention (sham taping) | Sham comparator | Patients in the control group will be treated by sham taping with Leukotape® Classic, a non-elastic tape, that in all other respects resembles Easytape®. Receives: Device: sham taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in leg circumference between day 1 and day 8 (in cm)
Leg circumference will be measured at three levels (joint space, 5cm proximal, 5cm distal) with each three measurements performed by one assessor in all patients and time points. The primary endpoint will be the mean of the three measurements
Measured: day 1 postoperatively before start of intervention and every day thereafter for 7 days
Secondary outcomes (3)
Change in leg circumference between day 0 and day 8 (in cm)
Leg circumference will be measured at three levels (joint space, 5cm proximal, 5cm distal) with each three measurements performed by one assessor in all patients and time points. The primary endpoint will be the mean of the three measurements
Measured: day 0 preoperative and day 1 postoperatively before start of intervention and every day thereafter for 7 days
Change in leg circumference between day 0 and after 6 weeks and 12 weeks (in cm)
Leg circumference will be measured at three levels (joint space, 5cm proximal, 5cm distal) with each three measurements performed by one assessor in all patients and time points. The primary endpoint will be the mean of the three measurements
Measured: day 0 preoperative and after 6 weeks and 12 weeks after start of intervention
Change in range of motion of knee (in degree)
range of motion measured using the neutral zero method
Measured: day 1 postoperatively before start of intervention and at day 8 after start of intervention and after 6 and 12 weeks after start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start1 Aug 2020
- Primary completion8 Feb 2023
- Study completion9 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative EdemaStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- comparing the use of kinesiotape for the treatment of postoperative edema after knee joint arthroplasty to standard treatment (manual lymphatic drainage and compression in form of stockings or compressive bandages), as well as to sham interventional treatment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Egloff, Dr. med., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947307
- Sponsor's protocol ID
- 2019-00219; ch19Saxer3
- Other IDs
- 2019
- Acronym
- KNEETAPE
- Status last verified
- Feb 2024
- First submitted
- 8 May 2019
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinesiotape Treatment for Postoperative Edema After Joint Replacement Surgery of the Knee -The KNEETAPE Study
- ClinicalTrials.gov ID
- NCT03947307
- Acronym / sponsor ID
- KNEETAPE / 2019-00219; ch19Saxer3
- Conditions
- Postoperative Edema
- Keywords
- total knee replacement, Kinesiotape treatment, manual lymphatic drainage, compressive bandages, Kinesiotaping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 8 Feb 2023 (actual)
- Study completion
- 9 Feb 2023 (actual)
- First posted
- 13 May 2019 (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.
Postoperative edema is a common condition affecting wound healing and function. Traditionally, manual lymphatic drainage and compressive bandages have been employed to reduce swelling. Kinesiotaping might be an alternative approach. To analyse the efficacy, cost-effectiveness, satisfaction, quality of life, functional outcome and and morbidity of the use of kinesiotape for the treatment of postoperative edema after knee replacement surgery, compared to standard manual lymphatic drainage with compression (i.e. compressive stockings or bandages) or sham taping.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- comparing the use of kinesiotape for the treatment of postoperative edema after knee joint arthroplasty to standard treatment (manual lymphatic drainage and compression in form of stockings or compressive bandages), as well as to sham interventional treatment
| Arm | Type | Receives |
|---|---|---|
| Experimental Intervention (treatment / medical device) | Experimental | Device: lymphtaping using Easytape®Patients in the experimental group will receive lymphtaping using Easytape® according to common practice on day 1 after surgery by specifically trained physiotherapists. The tape has an elasticity of 150%. The material is moisture- and air-permeable with a hypoallergenic adhesive coating that is activated by body temperature to increase durability of contact. If possible the taping will be left for 7 days, in case of insufficient adhesion taping will be repeated. |
| Control Intervention (compression treatment ) | Active comparator | Procedure: compression treatmentPatients in the control group will be treated with manual lymphatic drainage followed by compression treatment using compressive stockings if accepted or compressive bandaging in cases with pronounced swelling depending on medical necessity. |
| Control Intervention (sham taping) | Sham comparator | Device: sham tapingPatients in the control group will be treated by sham taping with Leukotape® Classic, a non-elastic tape, that in all other respects resembles Easytape®. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Joint replacement surgery of the knee including conversion from partial to total joint replacement or revision surgery
- Informed Consent as documented by signature
Key exclusion criteria (8 listed)
- Isolated retropatellar replacement or revision surgery for infection
- Contraindications to manual lymphatic drainage and compression treatment (i.e. compressive stockings or bandages) e.g. heart failure
- Contraindication to kinesiotape treatment, e.g. hypersensitivity to medical glue
- Dermatoses at or around the surgical site
- Suspected or confirmed local infection
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 |
|---|---|---|
| lymphtaping using Easytape®lymphtaping using Easytape® on day 1 after surgery by specifically trained physiotherapists. If possible the taping will be left for 7 days. | Device | Experimental Intervention (treatment / medical device) |
| compression treatmentmanual lymphatic drainage followed by compression treatment using compressive stockings or compressive bandaging | Procedure or surgery | Control Intervention (compression treatment ) |
| sham tapingsham taping with Leukotape® Classic, a non-elastic tape, that in all other respects resembles Easytape®. | Device | Control Intervention (sham taping) |
Primary outcome
Change in leg circumference between day 1 and day 8 (in cm)
Time frame: day 1 postoperatively before start of intervention and every day thereafter for 7 days
Leg circumference will be measured at three levels (joint space, 5cm proximal, 5cm distal) with each three measurements performed by one assessor in all patients and time points. The primary endpoint will be the mean of the three measurements
3 secondary outcomes
Change in leg circumference between day 0 and day 8 (in cm)
Time frame: day 0 preoperative and day 1 postoperatively before start of intervention and every day thereafter for 7 days
Change in leg circumference between day 0 and after 6 weeks and 12 weeks (in cm)
Time frame: day 0 preoperative and after 6 weeks and 12 weeks after start of intervention
Change in range of motion of knee (in degree)
Time frame: day 1 postoperatively before start of intervention and at day 8 after start of intervention and after 6 and 12 weeks after start of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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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.
Christian Egloff, Dr. med. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lymphtaping using Easytape® and compression treatment in people with Postoperative Edema, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 20 Feb 2024. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in leg circumference between day 1 and day 8 (in cm) (time frame: day 1 postoperatively before start of intervention and every day thereafter for 7 days). 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 20 Feb 2024.