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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Edema
• Intervention / Treatment: Device: lymphtaping using Easytape®; Procedure: compression treatment; Device: sham taping

• Study Type: Interventional
• Enrollment (Actual): 190
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Department of Orthopaedics and Trauma Surgery (DOTS).

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of life assessment (EQ5D-5L)	assessment of 5 dimensions of life: mobility, self-care, activities of daily living, pain and psychological well-being in each 5 categories ranging from "no problems" to "extreme problems"	assessed on day 0 preoperative, day 8 and week 12 after start of intervention
Change in patient satisfaction with the received treatment (VAS)	visual analogous scale (VAS) on which the patient can rate satisfaction with the received treatment; Scale from 0 = not at all satisfied to10 = very satisfied	assessed on day 8 and week 12 after start of intervention
Change in Knee disability and Osteoarthritis Outcome Score (KOOS)	Patient reported score. The KOOS results in summary scores for five subscales. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec) and knee-related Quality of Life (QOL). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee Problems.	assessed on day 8 and week 12 after start of intervention

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Christian Egloff, Dr. med., University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): February 8, 2023
• Study Completion (Actual): February 9, 2023

Study Registration Dates

• First Submitted: May 8, 2019
• First Submitted That Met QC Criteria: May 10, 2019
• First Posted (Actual): May 13, 2019

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: total knee replacement; Kinesiotape treatment; manual lymphatic drainage; compressive bandages; Kinesiotaping
• Additional Relevant MeSH Terms: Edema
• Other Study ID Numbers: 2019-00219; ch19Saxer3

Drug and device information, study documents

• 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