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

Postoperative Edema Clinical Trial

— KNEETAPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03947307
• Other study ID #: 2019-00219; ch19Saxer3
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: February 9, 2023

Study information

• Verified date: February 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: February 9, 2023
• Est. primary completion date: February 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Edema
• Postoperative Edema

Intervention

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.

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

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

Locations

Country	Name	City	State
Switzerland	Department of Orthopaedics and Trauma Surgery (DOTS).	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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