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Completed

NCT Number: NCT03947307

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

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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Key information

Conditions

Postoperative Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthopaedics and Trauma Surgery (DOTS).

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

compression treatment

Procedure

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

Sham Taping

Device

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

Primary outcomes

  1. Change in leg circumference between day 1 and day 8 (in cm)

    Time frame: day 1 postoperatively before start of intervention and every day thereafter for 7 days

    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

Secondary outcomes

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

    Time frame: day 0 preoperative and day 1 postoperatively before start of intervention and every day thereafter for 7 days

    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

  2. Change in leg circumference between day 0 and after 6 weeks and 12 weeks (in cm)

    Time frame: day 0 preoperative and after 6 weeks and 12 weeks after start of intervention

    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

  3. Change in range of motion of knee (in degree)

    Time frame: 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

    range of motion measured using the neutral zero method

Other outcomes

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

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

    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"

  2. Change in patient satisfaction with the received treatment (VAS)

    Time frame: assessed on day 8 and week 12 after start of intervention

    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

  3. Change in Knee disability and Osteoarthritis Outcome Score (KOOS)

    Time frame: assessed on day 8 and week 12 after start of intervention

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: KNEETAPE

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 13, 2019
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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