Compressive Stockings Therapy After TKA

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Compliance Controlled Postoperative Compressive Stockings Therapy After Total Knee Arthroplasty: a Randomized Controlled Trial

Conditions
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Compliance of Wearing of Compressive Stockings, Total Knee Arthroplasty

Intervention / Treatment
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* Device: Compressive stockings


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Compressive stockings group<br>Group receives postoperatively compressive stockings for a period of 6 weeks. | Device: Compressive stockings<br>* Compressive stockings with built in Orthotimer Sensor<br>|
| No Intervention: Control group<br>The control group is treated without compressive stockings. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| Pain 1 year postoperative | Visuelle Analogskala - VAS (1-10) | 1 year postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Swelling 6 weeks postoperative | Swelling in mm | 6 weeks postoperative | 
| Swelling 12 weeks postoperative | Swelling in mm | 12 weeks postoperative | 
| Swelling 1 year postoperative | Swelling in mm | 1 year postoperative | 
| Compliance first 6 weeks postoperativ | Measured with Orthotimer sensor | First 6 weeks postoperativ |