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

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ClinicalTrials.gov Identifier: NCT03995160
Recruitment Status : Not yet recruiting
First Posted : June 21, 2019
Last Update Posted : June 18, 2020
Sponsor:
Collaborator:
Centre of Postgraduate Medical Education
Information provided by (Responsible Party):
Artur Stolarczyk, Medical University of Warsaw

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.

Condition or disease Intervention/treatment Phase
Total Knee Replacement Procedure: Use of closed suction drainage following total knee arthroplasty Procedure: Abstain of using a closed suction drainage Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Influence of Closed Suction Drainage After Total Knee Replacement on Patient's Reported Outcome and Basic Morphology Results, and Inflammation Factors
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : December 2, 2020
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

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 Name: 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




Primary Outcome Measures :
  1. Change in haematocrite levels [ 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 ]
    Measuring results of haematocrite (in percentage in 1 ml of blood sample)

  2. Change in the number of blood transfusions [ Time Frame: from baseline to the 1-,2-,3- days postoperatively ]
    Measuring the number of needed transfusion of packed red blood cells in the postoperative period

  3. Change in levels of inflammation factors [ 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 ]
    Measuring the level of C-reactive protein

  4. Change in haemoglobin levels [ 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 ]
    Measuring results of haemoglobin (g/dL)

  5. Change in erythrocytes levels [ 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 ]
    Measuring results of erythrocytes (number/ml)

  6. Change in platelets levels [ 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 ]
    Measuring results of platelets (number/ml)


Secondary Outcome Measures :
  1. Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Score from baseline [ Time Frame: 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.

  2. Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Function Score from baseline [ Time Frame: 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.

  3. Change in body temperature [ Time Frame: 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

  4. Influence of using CSD on costs of hospitalization [ Time Frame: from baseline to the one year postoperatively ]
    Comparing cost of hospitalization between two analyzed groups



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995160


Contacts
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Contact: Bartosz Maciąg +48 881568144 bartosz.maciag94@gmail.com
Contact: Marcin Wojewodzki +48 60446187 dlamarcinawoj@gmail.com

Sponsors and Collaborators
Medical University of Warsaw
Centre of Postgraduate Medical Education
Investigators
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Study Director: Artur Stolarczyk, MD, PhD Medical University of Warsaw
Principal Investigator: Marcin Wojewodzki Medical University of Warsaw
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Responsible Party: Artur Stolarczyk, Head of the Department of Orthopaedics and Rehabilitation, Principal Investigator, Clinical Professor, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT03995160    
Other Study ID Numbers: TKR/ Warsaw MU
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Artur Stolarczyk, Medical University of Warsaw:
total
knee
arthroplasty
tkr
drainage
haematoma