Back to resultsKinesiotape Treatment for Postoperative Edema After Joint Replacement Surgery of the Knee- The KNEETAPE Study (KNEETAPE)
Primary Purpose
Postoperative Edema
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
lymphtaping using Easytape®
compression treatment
sham taping
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Edema focused on measuring total knee replacement, Kinesiotape treatment, manual lymphatic drainage, compressive bandages, Kinesiotaping
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.
Sites / Locations
- Department of Orthopaedics and Trauma Surgery (DOTS).Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Sham Comparator
Arm Label
Experimental Intervention (treatment / medical device)
Control Intervention (compression treatment )
Control Intervention (sham taping)
Arm Description
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.
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.
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®.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Change in range of motion of knee (in degree)
range of motion measured using the neutral zero method
Full Information
NCT ID
NCT03947307
First Posted
May 8, 2019
Last Updated
December 5, 2022
Sponsor
University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT03947307
Brief Title
Kinesiotape Treatment for Postoperative Edema After Joint Replacement Surgery of the Knee- The KNEETAPE Study
Acronym
KNEETAPE
Official Title
Kinesiotape Treatment for Postoperative Edema After Joint Replacement Surgery of the Knee -The KNEETAPE Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Edema
Keywords
total knee replacement, Kinesiotape treatment, manual lymphatic drainage, compressive bandages, Kinesiotaping
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
198 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Intervention (treatment / medical device)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Intervention (compression treatment )
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Intervention (sham taping)
Arm Type
Sham Comparator
Arm Description
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®.
Intervention Type
Device
Intervention Name(s)
lymphtaping using Easytape®
Intervention Description
lymphtaping using Easytape® on day 1 after surgery by specifically trained physiotherapists. If possible the taping will be left for 7 days.
Intervention Type
Procedure
Intervention Name(s)
compression treatment
Intervention Description
manual lymphatic drainage followed by compression treatment using compressive stockings or compressive bandaging
Intervention Type
Device
Intervention Name(s)
sham taping
Intervention Description
sham taping with Leukotape® Classic, a non-elastic tape, that in all other respects resembles Easytape®.
Primary Outcome Measure Information:
Title
Change in leg circumference between day 1 and day 8 (in cm)
Description
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
Time Frame
day 1 postoperatively before start of intervention and every day thereafter for 7 days
Secondary Outcome Measure Information:
Title
Change in leg circumference between day 0 and day 8 (in cm)
Description
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
Time Frame
day 0 preoperative and day 1 postoperatively before start of intervention and every day thereafter for 7 days
Title
Change in leg circumference between day 0 and after 6 weeks and 12 weeks (in cm)
Description
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
Time Frame
day 0 preoperative and after 6 weeks and 12 weeks after start of intervention
Title
Change in range of motion of knee (in degree)
Description
range of motion measured using the neutral zero method
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
Other Pre-specified Outcome Measures:
Title
Change in Quality of life assessment (EQ5D-5L)
Description
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"
Time Frame
assessed on day 0 preoperative, day 8 and week 12 after start of intervention
Title
Change in patient satisfaction with the received treatment (VAS)
Description
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
Time Frame
assessed on day 8 and week 12 after start of intervention
Title
Change in Knee disability and Osteoarthritis Outcome Score (KOOS)
Description
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.
Time Frame
assessed on day 8 and week 12 after start of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Egloff, Dr. med
Phone
+41 613152761
Email
Christian.Egloff@usb.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Egloff, Dr. med.
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthopaedics and Trauma Surgery (DOTS).
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Egloff, Dr. med
Phone
+41 613152761
Email
Christian.Egloff@usb.ch
12. IPD Sharing Statement
Learn more about this trial
Kinesiotape Treatment for Postoperative Edema After Joint Replacement Surgery of the Knee- The KNEETAPE Study
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