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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2023-02-09

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.

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Detailed Description

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Conditions

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Postoperative Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Patients will be blind to the difference between kinesio- and sham-taping, allowing a double blinded design for the evaluation of the effect of kinesio- versus other tapes. Patient blinding for kinesiotaping versus manual lymphatic drainage is not feasible. The assessment of the primary outcome i.e. the assessment of leg circumference on day 1 and 8 will be performed by a blinded assessor unaware of the treatment allocation.

Study Groups

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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.

Group Type EXPERIMENTAL

lymphtaping using Easytape®

Intervention Type DEVICE

lymphtaping using Easytape® on day 1 after surgery by specifically trained physiotherapists. If possible the taping will be left for 7 days.

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.

Group Type ACTIVE_COMPARATOR

compression treatment

Intervention Type PROCEDURE

manual lymphatic drainage followed by compression treatment using compressive stockings or compressive bandaging

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®.

Group Type SHAM_COMPARATOR

sham taping

Intervention Type DEVICE

sham taping with Leukotape® Classic, a non-elastic tape, that in all other respects resembles Easytape®.

Interventions

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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.

Intervention Type DEVICE

compression treatment

manual lymphatic drainage followed by compression treatment using compressive stockings or compressive bandaging

Intervention Type PROCEDURE

sham taping

sham taping with Leukotape® Classic, a non-elastic tape, that in all other respects resembles Easytape®.

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No