Kinesiotape Treatment for Postoperative Edema After Joint Replacement Surgery of the Knee- The KNEETAPE Study

Study Overview
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Brief Summary
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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.

Official Title
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Kinesiotape Treatment for Postoperative Edema After Joint Replacement Surgery of the Knee -The KNEETAPE Study

Conditions
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Postoperative Edema

Intervention / Treatment
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* Device: lymphtaping using Easytape®
* Procedure: compression treatment
* Device: sham taping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Joint replacement surgery of the knee including conversion from partial to total joint replacement or revision surgery Informed Consent as documented by signature Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Intervention (treatment / medical device)<br>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. | Device: lymphtaping using Easytape®<br>* lymphtaping using Easytape® on day 1 after surgery by specifically trained physiotherapists. If possible the taping will be left for 7 days.<br>|
| Active Comparator: Control Intervention (compression treatment )<br>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. | Procedure: compression treatment<br>* manual lymphatic drainage followed by compression treatment using compressive stockings or compressive bandaging<br>|
| Sham Comparator: Control Intervention (sham taping)<br>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®. | Device: sham taping<br>* sham taping with Leukotape® Classic, a non-elastic tape, that in all other respects resembles Easytape®.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | day 1 postoperatively before start of intervention and every day thereafter for 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total knee replacement, Kinesiotape treatment, manual lymphatic drainage, compressive bandages, Kinesiotaping