2017 ISAKOS Biennial Congress Paper #133

 

Prospective, Randomized Trial to Evaluate the Efficacy of Floseal and Tranexamic Acid After Primary Total Knee Arthroplasty

Camilo P. Helito, MD, PhD, São Paulo, SP BRAZIL
Marcelo B. Bonadio, MD, São Paulo, SP BRAZIL
Pedro N. Giglio, MD, São Paulo, SP BRAZIL
Roberto Freire da Mota e Albuquerque, MD, PhD, São Paulo, SP BRAZIL
Riccardo Gomes Gobbi, MD, PhD, São Paulo, SP BRAZIL
José R. Pécora, Prof., São Paulo, SP BRAZIL
Gilberto L. Camanho, MD, São Paulo, SP BRAZIL
Marco K. Demange, MD, PhD, São Paulo, SP BRAZIL

University of São Paulo, São Paulo, São Paulo, BRAZIL

FDA Status Cleared

Summary

Floseal and Tranexamic Acid showed to be effective in controlling blood loss after total knee arthroplasty. The clinical superiority of one over another is uncertain. Studies about cost-effective of using hemostatic agentes should be performed.

Abstract

Introduction

Total knee arthroplasty (TKA) is the gold standard treatment for advanced osteoarthritis refractory to nonoperative management; however, the procedure involves approximately 2,000 mL of perioperative blood loss, which often results in complications and necessitates transfusion. Thus, research has been pursued for minimal blood loss with use of various agents, such as Floseal (hemostatic matrix) and Tranexamic acid (TA). So far, TA showed to be effective compared to control groups and Floseal seems to be effective as well, although some controversy still exists. No study that we are aware of compared Floseal with TA.

Methods

We performed a prospective randomized controlled trial on the use of Floseal or TA in patients undergoing unilateral TKA. A total of 90 TKA patients were enrolled in three groups: TA group, Floseal group and control group. Patients with previous knee surgery (except arthroscopy), inflammatory diseases or clinical comorbidities that could increase blood loss were not included. Drain output, hemoglobina (Hb) drop level, transfusion rates, and complications were accessed.

Results

Both Floseal and TA showed to have better results than the control group for the studied variables. Hb drop level was 4.81 for control group, 3.03 for TA group and 3.5 for Floseal group. No difference was observed between Floseal and TA. Drain output was 901ml for control group, 546ml for TA group and 331ml for Floseal group. Floseal had better results than TA for this variable (p<0.05). Transfusion rate was very low for all three groups. Regarding complications, the control group presented one superficial infection and one deep vein thrombosis (DVT), the TA group presented one deep infection and the Floseal group presented one DVT.

Conclusion

Floseal and TA showed to be effective in controlling blood loss after total knee arthroplasty. The clinical superiority of one over another is uncertain. Studies about cost-effective of using hemostatic agentes should be performed.