Influence of Closed Suction Drainage After Total Knee Replacement.

NCT ID: NCT03995160

Last Updated: 2021-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-03-01

Brief Summary

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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

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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

Conditions

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Total Knee Replacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Total knee replacement with use of closed suction drainage

Use of closed suction drainage following total knee replacement in treatment of knee primary osteoarthritis

Group Type ACTIVE_COMPARATOR

Use of closed suction drainage following total knee arthroplasty

Intervention Type PROCEDURE

Use of closed suction drainage following total knee arthroplasty

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

Group Type ACTIVE_COMPARATOR

Abstain of using a closed suction drainage

Intervention Type PROCEDURE

Abstain of using a closed suction drainage following total knee arthroplasty

Interventions

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Use of closed suction drainage following total knee arthroplasty

Use of closed suction drainage following total knee arthroplasty

Intervention Type PROCEDURE

Abstain of using a closed suction drainage

Abstain of using a closed suction drainage following total knee arthroplasty

Intervention Type PROCEDURE

Other Intervention Names

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Redon's drain

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre of Postgraduate Medical Education

OTHER

Sponsor Role collaborator

Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Artur Stolarczyk

Head of the Department of Orthopaedics and Rehabilitation, Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Artur Stolarczyk, MD, PhD

Role: STUDY_DIRECTOR

Medical University of Warsaw

Marcin Wojewodzki

Role: PRINCIPAL_INVESTIGATOR

Medical University of Warsaw

Central Contacts

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Bartosz MaciÄ…g

Role: CONTACT

+48 881568144

Marcin Wojewodzki

Role: CONTACT

+48 60446187

Other Identifiers

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TKR/ Warsaw MU

Identifier Type: -

Identifier Source: org_study_id

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