Influence of Closed Suction Drainage After Total Knee Replacement.

NCT03995160 | Unknown

• 1 other identifier: TKR/ Warsaw MU
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Total Knee Replacement

Keywords

total; knee; arthroplasty; tkr; drainage; haematoma

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• 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

• 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

• Change in body temperature

  from baseline to the 1-,2-,3- days postoperatively

• Influence of using CSD on costs of hospitalization

  from baseline to the one year postoperatively

Study Arms (2)

Total knee replacement with use of closed suction drainage

ACTIVE COMPARATOR

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

Total knee replacement without use of closed suction drainage

ACTIVE COMPARATOR

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

Interventions

Use of closed suction drainage following total knee arthroplasty PROCEDURE

Use of closed suction drainage following total knee arthroplasty

Also known as: Redon's drain

Total knee replacement with use of closed suction drainage

Abstain of using a closed suction drainage PROCEDURE

Abstain of using a closed suction drainage following total knee arthroplasty

Total knee replacement without use of closed suction drainage

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient's consent for anticipation in the study
• arthroplasty in one knee

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead
• Centre of Postgraduate Medical Education: collaborator

MeSH Terms

Conditions

Hematoma

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Artur Stolarczyk, MD, PhD

  Medical University of Warsaw

  STUDY DIRECTOR

• Marcin Wojewodzki

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bartosz Maciąg

CONTACT

+48 881568144; bartosz.maciag94@gmail.com

Marcin Wojewodzki

CONTACT

+48 60446187; dlamarcinawoj@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Orthopaedics and Rehabilitation, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: June 21, 2019
• Study Start: March 1, 2022
• Primary Completion: November 2, 2022
• Study Completion: March 1, 2023
• Last Updated: October 6, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share