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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Use of closed suction drainage following total knee arthroplasty
Abstain of using a closed suction drainage following total knee arthroplasty
Change in haematocrite levels
Measuring results of haematocrite (in percentage in 1 ml of blood sample)
Time frame: 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
Time frame: from baseline to the 1-,2-,3- days postoperatively
Change in levels of inflammation factors
Measuring the level of C-reactive protein
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Score from baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: from baseline to the one year postoperatively