Influence of Closed Suction Drainage After Total Knee Replacement. (TKR)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Total Knee Replacement
• Intervention / Treatment: Procedure: Use of closed suction drainage following total knee arthroplasty; Procedure: Abstain of using a closed suction drainage

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

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bartosz Maciąg; Phone Number: +48 881568144; Email: bartosz.maciag94@gmail.com
• Study Contact Backup: Name: Marcin Wojewodzki; Phone Number: +48 60446187; Email: dlamarcinawoj@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Total knee replacement with use of closed suction drainage; 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; Use of closed suction drainage following total knee arthroplasty; Other Names: Redon's drain
ACTIVE_COMPARATOR: Total knee replacement without use of closed suction drainage; 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; Abstain of using a closed suction drainage following total knee arthroplasty

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Collaborators: Centre of Postgraduate Medical Education
• Investigators: Study Director: Artur Stolarczyk, MD, PhD, Medical University of Warsaw; Principal Investigator: Marcin Wojewodzki, Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2022
• Primary Completion (ANTICIPATED): November 2, 2022
• Study Completion (ANTICIPATED): March 1, 2023

Study Registration Dates

• First Submitted: April 25, 2019
• First Submitted That Met QC Criteria: June 20, 2019
• First Posted (ACTUAL): June 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 6, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: knee; arthroplasty; drainage; total; haematoma; tkr
• Other Study ID Numbers: TKR/ Warsaw MU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No