The efficacy of a thrombin-based hemostatic agent in unilateral total knee arthroplasty: a randomized controlled trial.

INTRODUCTION: Blood loss following total knee arthroplasty can lead to substantial morbidity and the need for blood transfusions. Hemostatic agents have been used to minimize blood loss and to decrease transfusion rates. Floseal is a thrombin-based hemostatic agent with unknown efficacy for achieving these goals in patients undergoing total knee arthroplasty.

METHODS: We performed a prospective randomized controlled trial on the use of Floseal in patients undergoing total knee arthroplasty, with the primary end point being blood loss as measured through drain output. Demographic characteristics, operative side, diagnosis, intraoperative details, implant choice, hospital course, laboratory values, visual analog scale pain scores, knee range of motion, adverse events, transfusion rates, and deviations from protocol were recorded.

RESULTS: A total of 196 patients were enrolled, with ninety-seven patients being randomized to the Floseal group and ninety-nine patients being randomized to the control group. There were no significant differences between the Floseal and control groups in terms of drain output at twenty-four hours (711 compared with 702 mL; p = 0.823). No differences were noted between the groups in terms of operative side, diagnosis, intraoperative details, implant choice, hospital course, laboratory values, visual analog scale pain scores, knee range of motion, or transfusion rates. Complications occurred infrequently. In the acute postoperative period, there were two cases of cellulitis (one in each group), two deep venous thromboses (one in each group), and one paralytic ileus (in the control group), all of which resolved with nonoperative measures. At the six-week follow-up, one patient in the Floseal group had died from a cause unrelated to surgery, two patients (one in each group) had suture abscesses with cellulitis that resolved with postoperative antibiotics, and four patients (two in each group) underwent knee manipulation under anesthesia to achieve improved knee motion. With the numbers available, there was no significant association between Floseal use and the occurrence of these adverse events.

CONCLUSIONS: The present study showed that Floseal had no demonstrable effect on blood loss as measured through drain output following total knee arthroplasty. There were also no notable adverse events associated with its use. The usefulness of Floseal as a hemostatic agent in total knee arthroplasty remains unclear.