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

NCT03947307 | Completed

• 1 other identifier: 2019-00219; ch19Saxer3
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Edema

Keywords

total knee replacement; Kinesiotape treatment; manual lymphatic drainage; compressive bandages; Kinesiotaping

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in leg circumference between day 0 and day 8 (in cm)

  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)

  day 0 preoperative and after 6 weeks and 12 weeks after start of intervention

• Change in range of motion of knee (in degree)

  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 (3)

• Change in Quality of life assessment (EQ5D-5L)

  assessed on day 0 preoperative, day 8 and week 12 after start of intervention

• Change in patient satisfaction with the received treatment (VAS)

  assessed on day 8 and week 12 after start of intervention

• Change in Knee disability and Osteoarthritis Outcome Score (KOOS)

  assessed on day 8 and week 12 after start of intervention

Study Arms (3)

Experimental Intervention (treatment / medical device)

EXPERIMENTAL

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®

Control Intervention (compression treatment )

ACTIVE COMPARATOR

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

Control Intervention (sham taping)

SHAM COMPARATOR

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

Interventions

lymphtaping using Easytape® DEVICE

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

Experimental Intervention (treatment / medical device)

compression treatment PROCEDURE

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

Control Intervention (compression treatment )

sham taping DEVICE

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

Control Intervention (sham taping)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Joint replacement surgery of the knee including conversion from partial to total joint replacement or revision surgery
• Informed Consent as documented by signature

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Department of Orthopaedics and Trauma Surgery (DOTS).

Basel, 4031, Switzerland

Location

Study Officials

• Christian Egloff, Dr. med.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 13, 2019
• Study Start: August 1, 2020
• Primary Completion: February 8, 2023
• Study Completion: February 9, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

CH (1)