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| Name | Class |
|---|---|
| Centre of Postgraduate Medical Education | OTHER |
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The aim of the study will be to compare functional outcomes, basic morphology results, number of blood transfusions, costs of hospitalization, and inflammation factors, following total knee replacement (with use of one type of endoprosthesis) comparing use of closed suction drainage (CSD). Use of closed suction drainage may have influence on patients functional outcome.
Patients with primary knee osteoarthritis will be included in a randomized controlled trial and assigned to total knee arthroplasty with or without closed suction drainage. Subjects will be evaluated preoperatively, 1-day, 3-, 6- and 12-month postoperatively.
Change in morphology results will be measured by comparing preoperative and postoperative levels of haematocrite, haemoglobin, erythrocytes, and platelets.
Change in the number of blood transfusions will be measured by analyzing the number of needed transfusion of packed red blood cells in the postoperative period during stay in the hospital.
Change in levels of inflammation factors will be measured by analyzing the level of C-reactive protein in first and third day postoperatively.
Change in body temperature wille be measured daily by analyzing body temperature from day of the surgery until the day of discharge from the hospital
Presence of haematoma will be evaluated daily in the postoperative period by clinical examination.
Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Score will be measured from baseline (can be measured anytime to a maximum of one month before surgery) 3,6 and 12 months post-operatively
Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Function Score will be measured from baseline (can be measured anytime to a maximum of one month before surgery) 3,6 and 12 months post-operatively
Costs of hospitalization will be measured by comparing cost of hospitalization between two analyzed groups
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total knee replacement with use of closed suction drainage | Active Comparator | Use of closed suction drainage following total knee replacement in treatment of knee primary osteoarthritis |
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| Total knee replacement without use of closed suction drainage | Active Comparator | Without the use of closed suction drainage following total knee replacement in treatment of knee primary osteoarthritis |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of closed suction drainage following total knee arthroplasty | Procedure | Use of closed suction drainage following total knee arthroplasty |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in haematocrite levels | Measuring results of haematocrite (in percentage in 1 ml of blood sample) | from baseline (can be measured anytime to a maximum of one month before surgery) to 1-day, 3,6 and 12 months post-operatively |
| Change in the number of blood transfusions | Measuring the number of needed transfusion of packed red blood cells in the postoperative period | from baseline to the 1-,2-,3- days postoperatively |
| Change in levels of inflammation factors | Measuring the level of C-reactive protein | from baseline (can be measured anytime to a maximum of one month before surgery) to 1-day, 3,6 and 12 months post-operatively |
| Change in haemoglobin levels | Measuring results of haemoglobin (g/dL) | from baseline (can be measured anytime to a maximum of one month before surgery) to 1-day, 3,6 and 12 months post-operatively |
| Change in erythrocytes levels | Measuring results of erythrocytes (number/ml) | from baseline (can be measured anytime to a maximum of one month before surgery) to 1-day, 3,6 and 12 months post-operatively |
| Change in platelets levels | Measuring results of platelets (number/ml) | from baseline (can be measured anytime to a maximum of one month before surgery) to 1-day, 3,6 and 12 months post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Score from baseline | The WOMAC Pain score is derived from a sub-section of the Knee injury and Osteoarthritis Outcome Score (KOOS) Knee Survey. The WOMAC Pain scores range from 0-100 with lower scores considered lower pain. | from baseline (can be measured anytime to a maximum of one month before surgery) 3,6 and 12 months post-operatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bartosz Maciąg | Contact | +48 881568144 | bartosz.maciag94@gmail.com | |
| Marcin Wojewodzki | Contact | +48 60446187 | dlamarcinawoj@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Artur Stolarczyk, MD, PhD | Medical University of Warsaw | Study Director |
| Marcin Wojewodzki | Medical University of Warsaw | Principal Investigator |
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| ID | Term |
|---|---|
| D006406 | Hematoma |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Abstain of using a closed suction drainage | Procedure | Abstain of using a closed suction drainage following total knee arthroplasty |
|
| Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Function Score from baseline | The WOMAC Function score is derived from a sub-section of the Knee injury and Osteoarthritis Outcome Score (KOOS) Knee Survey. The WOMAC Function scores range from 0-100 with lower scores considered to have better function. | from baseline (can be measured anytime to a maximum of one month before surgery) 3,6 and 12 months post-operatively |
| Change in body temperature | Measuring body temperature from day of the surgery to the hospital until the day of discharge from the hospital | from baseline to the 1-,2-,3- days postoperatively |
| Influence of using CSD on costs of hospitalization | Comparing cost of hospitalization between two analyzed groups | from baseline to the one year postoperatively |