Influence of Closed Suction Drainage After Total Knee Replacement.

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Influence of Closed Suction Drainage After Total Knee Replacement on Patient's Reported Outcome and Basic Morphology Results, and Inflammation Factors

Conditions
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Total Knee Replacement

Intervention / Treatment
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* Procedure: Use of closed suction drainage following total knee arthroplasty
* Procedure: Abstain of using a closed suction drainage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient's consent for anticipation in the study arthroplasty in one knee Exclusion Criteria: patient's lack of consent for anticipation in the study haematological diseases reoperations in the area of endoprosthesis medical history of any surgical intervention on the lower limb

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 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: Total knee replacement with use of closed suction drainage<br>Use of closed suction drainage following total knee replacement in treatment of knee primary osteoarthritis | Procedure: Use of closed suction drainage following total knee arthroplasty<br>* Use of closed suction drainage following total knee arthroplasty<br>* Other names: Redon's drain;|
| Active Comparator: Total knee replacement without use of closed suction drainage<br>Without the use of closed suction drainage following total knee replacement in treatment of knee primary osteoarthritis | Procedure: Abstain of using a closed suction drainage<br>* Abstain of using a closed suction drainage following total knee arthroplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total, knee, arthroplasty, tkr, drainage, haematoma