Clinical trial NCT03947307: Kinesiotape Treatment for Postoperative Edema After Joint Replacement Surgery of the Knee- The KNEETAPE Study
Official title: Kinesiotape Treatment for Postoperative Edema After Joint Replacement Surgery of the Knee -The KNEETAPE Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Edema
Keywords: total knee replacement
Kinesiotape treatment
manual lymphatic drainage
compressive bandages
Kinesiotaping
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-05-13
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in leg circumference between day 1 and day 8 (in cm)
timeFrame: day 1 postoperatively before start of intervention and every day thereafter for 7 days
Secondary outcomes:
measure: Change in leg circumference between day 0 and day 8 (in cm)
timeFrame: day 0 preoperative and day 1 postoperatively before start of intervention and every day thereafter for 7 days
measure: Change in leg circumference between day 0 and after 6 weeks and 12 weeks (in cm)
timeFrame: day 0 preoperative and after 6 weeks and 12 weeks after start of intervention
measure: Change in range of motion of knee (in degree)
timeFrame: 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 outcomes:
measure: Change in Quality of life assessment (EQ5D-5L)
timeFrame: assessed on day 0 preoperative, day 8 and week 12 after start of intervention
measure: Change in patient satisfaction with the received treatment (VAS)
timeFrame: assessed on day 8 and week 12 after start of intervention
measure: Change in Knee disability and Osteoarthritis Outcome Score (KOOS)
timeFrame: assessed on day 8 and week 12 after start of intervention
Locations:
city: Basel
country: Switzerland
facility: Department of Orthopaedics and Trauma Surgery (DOTS).
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Christian Egloff, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: