Compliance of Wearing of Compressive Stockings, Total Knee Arthroplasty
Conditions
Brief summary
Due to swelling after total knee arthroplasty, postoperative mobilization and training is impeded in addition to higher pain level in patients. With postoperative compressive stockings to prevent oedema, haematoma and postoperative pain we would like to investigate if compressive stockings reduce postoperative swelling and pain and furthermore improve mobilization and knee function. In this randomized controlled trial, 88 patients are randomized in two groups. One group receives postoperatively compressive stockings for a period of 6 weeks. The control group is treated without compressive stockings. The patients compressive stockings wearing compliance is controlled with a temperature sensitive sensor. The patients will be informed about the implantation of the sensor. Outcome measures are knee- calf- and ankle swelling in mm, pain, WOMAC and KSS score preoperatively and at 12 weeks, 12 months and 24 months.
Interventions
DEVICECompressive stockings
Compressive stockings with built in Orthotimer Sensor
Sponsors
Balgrist University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients receiving a total knee replacement * Written consent of the study participant
Exclusion criteria
* Peripheral arterial disease II, III or IV * Diabetes mellitus * Systemic inflammatory diseases * Benign or malignant neoplasms * Revision interventions * Right heart failure * pulmonary edema * Open / chronic skin lesions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain 1 year postoperative | 1 year postoperative | Visuelle Analogskala - VAS (1-10) |
| Knee Function WOMAC 12 weeks postoperative | 12 weeks postoperative | Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC |
| Knee Function WOMAC 1 year postoperative | 1 year postoperative | Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC |
| Pain 6 weeks postoperative | 6 weeks postoperative | Visuelle Analogskala - VAS (1-10) |
| Pain 12 weeks postoperative | 12 weeks postoperative | Visuelle Analogskala - VAS (1-10) |
| Knee Function KSS 6 weeks postoperative | 6 weeks postoperative | Knee Society Score - KSS |
| Knee Function KSS 12 weeks postoperative | 12 weeks postoperative | Knee Society Score - KSS |
| Knee Function KSS 1 year postoperative | 1 year postoperative | Knee Society Score - KSS |
| Knee Function WOMAC 6 weeks postoperative | 6 weeks postoperative | Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Swelling 12 weeks postoperative | 12 weeks postoperative | Swelling in mm |
| Swelling 1 year postoperative | 1 year postoperative | Swelling in mm |
| Compliance first 6 weeks postoperativ | First 6 weeks postoperativ | Measured with Orthotimer sensor |
| Swelling 6 weeks postoperative | 6 weeks postoperative | Swelling in mm |
Countries
Switzerland
Outcome results
None listed