Clinical trial NCT03995160: Influence of Closed Suction Drainage After Total Knee Replacement.
Official title: Influence of Closed Suction Drainage After Total Knee Replacement on Patient's Reported Outcome and Basic Morphology Results, and Inflammation Factors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Knee Replacement
Keywords: total
knee
arthroplasty
tkr
drainage
haematoma
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: Centre of Postgraduate Medical Education
First posted: 2019-06-21
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility 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

Primary outcomes:
measure: Change in haematocrite levels
timeFrame: from baseline (can be measured anytime to a maximum of one month before surgery) to 1-day, 3,6 and 12 months post-operatively
measure: Change in the number of blood transfusions
timeFrame: from baseline to the 1-,2-,3- days postoperatively
measure: Change in levels of inflammation factors
timeFrame: from baseline (can be measured anytime to a maximum of one month before surgery) to 1-day, 3,6 and 12 months post-operatively
measure: Change in haemoglobin levels
timeFrame: from baseline (can be measured anytime to a maximum of one month before surgery) to 1-day, 3,6 and 12 months post-operatively
measure: Change in erythrocytes levels
timeFrame: from baseline (can be measured anytime to a maximum of one month before surgery) to 1-day, 3,6 and 12 months post-operatively
measure: Change in platelets levels
timeFrame: 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:
measure: Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Score from baseline
timeFrame: from baseline (can be measured anytime to a maximum of one month before surgery) 3,6 and 12 months post-operatively
measure: Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Function Score from baseline
timeFrame: from baseline (can be measured anytime to a maximum of one month before surgery) 3,6 and 12 months post-operatively
measure: Change in body temperature
timeFrame: from baseline to the 1-,2-,3- days postoperatively
measure: Influence of using CSD on costs of hospitalization
timeFrame: from baseline to the one year postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of Warsaw
name: Artur Stolarczyk, MD, PhD
role: STUDY_DIRECTOR
affiliation: Medical University of Warsaw
name: Marcin Wojewodzki
role: PRINCIPAL_INVESTIGATOR
References: