Total Knee Replacement
Conditions
Keywords
total, knee, arthroplasty, tkr, drainage, haematoma
Brief summary
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
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
Interventions
PROCEDUREUse of closed suction drainage following total knee arthroplasty
Use of closed suction drainage following total knee arthroplasty
PROCEDUREAbstain of using a closed suction drainage
Abstain of using a closed suction drainage following total knee arthroplasty
Sponsors
Centre of Postgraduate Medical Education
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in platelets levels | from baseline (can be measured anytime to a maximum of one month before surgery) to 1-day, 3,6 and 12 months post-operatively | Measuring results of platelets (number/ml) |
| Change in the number of blood transfusions | from baseline to the 1-,2-,3- days postoperatively | Measuring the number of needed transfusion of packed red blood cells in the postoperative period |
| Change in levels of inflammation factors | from baseline (can be measured anytime to a maximum of one month before surgery) to 1-day, 3,6 and 12 months post-operatively | Measuring the level of C-reactive protein |
| Change in haemoglobin levels | from baseline (can be measured anytime to a maximum of one month before surgery) to 1-day, 3,6 and 12 months post-operatively | Measuring results of haemoglobin (g/dL) |
| Change in erythrocytes levels | from baseline (can be measured anytime to a maximum of one month before surgery) to 1-day, 3,6 and 12 months post-operatively | Measuring results of erythrocytes (number/ml) |
| Change in haematocrite levels | from baseline (can be measured anytime to a maximum of one month before surgery) to 1-day, 3,6 and 12 months post-operatively | Measuring results of haematocrite (in percentage in 1 ml of blood sample) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Function Score from baseline | from baseline (can be measured anytime to a maximum of one month before surgery) 3,6 and 12 months post-operatively | 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. |
| Change in body temperature | from baseline to the 1-,2-,3- days postoperatively | Measuring body temperature from day of the surgery to the hospital until the day of discharge from the hospital |
| Influence of using CSD on costs of hospitalization | from baseline to the one year postoperatively | Comparing cost of hospitalization between two analyzed groups |
| Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Score from baseline | from baseline (can be measured anytime to a maximum of one month before surgery) 3,6 and 12 months post-operatively | 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. |
Contacts
Primary ContactBartosz Maciąg
Backup ContactMarcin Wojewodzki
Outcome results
None listed