Postoperative Edema
Conditions
Keywords
total knee replacement, Kinesiotape treatment, manual lymphatic drainage, compressive bandages, Kinesiotaping
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.
Interventions
DEVICElymphtaping using Easytape®
lymphtaping using Easytape® on day 1 after surgery by specifically trained physiotherapists. If possible the taping will be left for 7 days.
PROCEDUREcompression treatment
manual lymphatic drainage followed by compression treatment using compressive stockings or compressive bandaging
DEVICEsham taping
sham taping with Leukotape® Classic, a non-elastic tape, that in all other respects resembles Easytape®.
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes 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.
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in leg circumference between day 1 and day 8 (in cm) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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) | 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 |
| 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 | range of motion measured using the neutral zero method |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in patient satisfaction with the received treatment (VAS) | 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 |
| Change in Knee disability and Osteoarthritis Outcome Score (KOOS) | 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. |
| Change in Quality of life assessment (EQ5D-5L) | 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 |
Countries
Switzerland
Outcome results
None listed