Topical Tranexamic Acid for Total Knee Arthroplasty
Status:
Completed
Trial end date:
2009-11-01
Target enrollment:
Participant gender:
Summary
Total knee arthroplasty (TKA), the definitive treatment of osteoarthritis, is often
associated with excessive postoperative bleeding due to increased fibrinolysis. Hence, the
objective of the proposed study is to determine the role of topical application of tranexamic
acid (TA), an anti-fibrinolytic agent, into the knee joint just before closure during TKA to
reduce perioperative bleeding. The investigators' hypothesis is that in patients undergoing
unilateral primary TKA, intraoperative application of 1.5 g or 3.0g topical TA into the knee
joint before closure reduces perioperative bleeding as depicted by a decrement in the maximal
drop in hemoglobin concentration following surgery. This proposal describes a randomized,
double-blinded, placebo-controlled clinical trial with three arms. The primary outcome is the
extent of the postoperative reduction in hemoglobin levels. Secondary outcomes will include
transfusion requirements, hospital stay, joint functionality, quality of life and safety of
using topical TA. Topical application of TA is a novel intraoperative approach that has not
been used or studied in TKA. However if it is effective, it will directly reduce
postoperative intra-articular bleeding without subsequent systemic absorption and
thromboembolism. In addition, the reduction in microvascular intra-articular bleeding will
lead to less pain and infection rates as well as improved surgical functional outcomes.