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

Medical University of Warsaw

Status: Unknown

Conditions: Total Knee Replacement

Treatments: Procedure: Abstain of using a closed suction drainage; Procedure: Use of closed suction drainage following total knee arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT03995160

TKR/ Warsaw MU

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Total knee replacement with use of closed suction drainage

Active Comparator group

Description:

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

Treatment:

Procedure: Use of closed suction drainage following total knee arthroplasty

Total knee replacement without use of closed suction drainage

Active Comparator group

Description:

Without the use of closed suction drainage following total knee replacement in treatment of knee primary osteoarthritis

Treatment:

Procedure: Abstain of using a closed suction drainage