Application of "Evicel" hemostatic matrix during operation for unilateral total knee replacement surgery (TKA) will result in decreased bleeding and postoperative drain output, a reduction in transfusion requirements, and less reduction of hemoglobin.
No additional data desired
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
200
Used for hemostasis to control bleeding. It has been shown to stop bleeding in 2 minutes or less. It is a combination of a biologic activated component containing human fibrinogen and topical thrombin functioning on wet, actively bleeding tissue.
Hospital for Special Surgery
New York, New York, United States
Change in Hemoglobin on Day 0 Compared to Preoperatively
Time frame: preoperatively and on the day of surgery
Change in Hematocrit on Day 0 Compared to Preoperatively
Time frame: preoperatively and day of surgery
Change in Hemoglobin On Day 1 Compared to Preoperatively
Time frame: preoperatively and one day after surgery
Change in Hematocrit on Day 1 Compared to Preoperatively
Time frame: preoperatively and one day after surgery
Change in Hemoglobin on Day 2 Compared to Preoperatively
Time frame: preoperatively and two days after surgery
Change in Hematocrit on Day 2 Compared to Preoperatively
Time frame: preoperatively and two days after surgery
Drain Output
A measurement of the amount of blood drained from the knee.
Time frame: 24 hours post-operatively
Number of Autologous Transfusion Units Over the Course of the Hospital Stay
Units of autologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.
Time frame: perioperatively
Units of Homologous Transfusion Over the Course of the Hospital Stay
Units of homologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.
Time frame: three days postoperatively
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Change in International Normalized Ratio (INR) Level on Day 2 Compared to Preoperatively
The INR, a measure of the clotting tendency of blood, is a ratio of a patient's prothrombin time (the time a blood plasma takes to clot after the addition of tissue factor) to a normal prothrombin time.
Time frame: preoperatively and two days after surgery
Range of Motion on Day 3
A measurement of the degrees of motion of the operated knee three days after surgery.
Time frame: 3 days postoperatively
Visual Analog Pain Scale on Day 3
The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale.
Time frame: 3 days postoperatively
Range of Motion at 6 Weeks
A measurement of the degrees of motion of the operated knee six weeks after surgery.
Time frame: 6 weeks postoperatively
Visual Analog Pain Scale (at Rest) at 6 Weeks
The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain at rest, the patient indicates their level of pain while seated or lying down, not moving.
Time frame: 6 weeks postoperatively
Visual Analog Pain Scale (During Activity) at 6 Weeks
The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain during, the patient indicates their level of pain while doing activities of daily living such as walking and moving from sitting to standing.
Time frame: 6 weeks postoperatively
Visual Analog Pain Scale (During Therapy) at 6 Weeks
The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain during, the patient indicates their level of pain during physical therapy.
Time frame: 6 weeks postoperatively
Visual Analog Pain Scale (At Night) At 6 Weeks
The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain at night, the patient indicates their level of pain during or before sleep.
Time frame: 6 weeks postoperatively