Influence of Closed Suction Drainage After Total Knee Replacement.

Total Knee Replacement Clinical Trial

— TKR  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03995160
• Other study ID #: TKR/ Warsaw MU
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: October 2021
• Source: Medical University of Warsaw
• Contact: Bartosz Maciag
• Phone: +48 881568144
• Email: bartosz.maciag94[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 1, 2023
• Est. primary completion date: November 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Total Knee Replacement

Intervention

Procedure:
• Use of closed suction drainage following total knee arthroplasty
Use of closed suction drainage following total knee arthroplasty
• Abstain of using a closed suction drainage
Abstain of using a closed suction drainage following total knee arthroplasty

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Warsaw	Centre of Postgraduate Medical Education

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Influence of using CSD on costs of hospitalization	Comparing cost of hospitalization between two analyzed groups	from baseline to the one year postoperatively