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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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®. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Egloff, Dr. med. | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthopaedics and Trauma Surgery (DOTS). | Basel | 4031 | Switzerland |
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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
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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.
| compression treatment | Procedure | manual lymphatic drainage followed by compression treatment using compressive stockings or compressive bandaging |
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| sham taping | Device | sham taping with Leukotape® Classic, a non-elastic tape, that in all other respects resembles Easytape®. |
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| 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 |
| 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 |
| 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 |
| 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 |