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not enough study participants and missing compliance to perform analysis
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Compressive stockings group | Active Comparator | Group receives postoperatively compressive stockings for a period of 6 weeks. |
|
| Control group | No Intervention | The control group is treated without compressive stockings. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compressive stockings | Device | Compressive stockings with built in Orthotimer Sensor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Knee Function KSS 6 weeks postoperative | Knee Society Score - KSS | 6 weeks postoperative |
| Knee Function KSS 12 weeks postoperative | Knee Society Score - KSS | 12 weeks postoperative |
| Knee Function KSS 1 year postoperative | Knee Society Score - KSS | 1 year postoperative |
| Knee Function WOMAC 6 weeks postoperative | Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC | 6 weeks postoperative |
| Knee Function WOMAC 12 weeks postoperative | Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC | 12 weeks postoperative |
| Knee Function WOMAC 1 year postoperative | Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC | 1 year postoperative |
| Pain 6 weeks postoperative | Visuelle Analogskala - VAS (1-10) | 6 weeks postoperative |
| Pain 12 weeks postoperative | Visuelle Analogskala - VAS (1-10) | 12 weeks postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Swelling 6 weeks postoperative | Swelling in mm | 6 weeks postoperative |
| Swelling 12 weeks postoperative | Swelling in mm | 12 weeks postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinik Balgrist | Zurich | 8008 | Switzerland |
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| Pain 1 year postoperative | Visuelle Analogskala - VAS (1-10) | 1 year postoperative |
| Swelling 1 year postoperative | Swelling in mm | 1 year postoperative |
| Compliance first 6 weeks postoperativ | Measured with Orthotimer sensor | First 6 weeks postoperativ |