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

University Hospital Basel

Status: Completed

Conditions: Postoperative Edema

Treatments: Device: lymphtaping using Easytape®; Device: sham taping; Procedure: compression treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03947307

2019-00219 ch19Saxer3;

Details and patient eligibility

About

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.

Enrollment: 190 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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190 participants in 3 patient groups

Experimental Intervention (treatment / medical device)

Experimental group

Description:

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.

Treatment:

Device: lymphtaping using Easytape®

Control Intervention (compression treatment )

Active Comparator group

Description:

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.

Treatment:

Procedure: compression treatment

Control Intervention (sham taping)

Sham Comparator group

Description:

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®.

Treatment:

Device: sham taping