Efficacy of Low-dose Intra-articular Tranexamic Acid in Total Knee Replacement

Not Applicable

Completed

Brief Summary: The purpose of this study is to determine 1) the effective dosage of intra-articular tranexamic acid injection for controlling blood loss and blood transfusion requirement in conventional total knee replacement, and 2) whether the blood loss reduction effect depended on the dose of tranexamic acid used.

Recruitment & Eligibility

Inclusion Criteria

patients diagnosed as primary knee osteoarthritis and underwent unilateral primary cemented conventional total knee replacement
no risk of abnormal bleeding tendency or bleeding disorder (normal coagulogram, serum creatinine < 2.0 mg/dL, stop nonsteroidal anti-inflammatory drugs and antiplatelet drugs more than 7 days
no contra-indication for tranexamic acid use (no active intravascular clotting process, no acquired defective colour vision, no subarachnoid hemorrhage, no hypersensitivity to TXA, and no any of history of serious adverse effects, thrombotic disorder and hematuria)

Exclusion Criteria

incomplete data collection, for example, malfunctioned drain or accidental drain removal.

Arm && Interventions

Group	Intervention	Description
Control group	Physiologic saline	physiologic saline 25 ml
TXA-250 group	Tranexamic Acid	A total of 25-ml solution with 250-mg tranexamic acid
TXA-250 group	Physiologic saline	A total of 25-ml solution with 250-mg tranexamic acid
TXA-500 group	Tranexamic Acid	A total of 25-ml solution with 500-mg tranexamic acid
TXA-500 group	Physiologic saline	A total of 25-ml solution with 500-mg tranexamic acid

Primary Outcome Measures

Name	Time	Method
Perioperative Blood Loss	5 days after surgery	* Drainage blood loss measured by accumulating total drainage volume postoperatively * Calculated total blood loss measured by using specific formula and difference between hematocrit preoperatively and the fourth postoperative day
Total Hemoglobin Loss	5 days after surgery	Total hemoglobin loos measured by difference between hemoglobin preoperatively and the fourth postoperative day

Secondary Outcome Measures

Name	Time	Method
Knee Function Scores	1 year after surgery	Knee function score was measured with 2 methods, and were evaluated preoperatively and then postoperatively at 3-month, 6-month, and 1-year period. 1. Knee Society Knee Score using for rating knee function measurement and subdivided into two parts; knee score and function score 1.1. Knee score : calculated from pain, presence of deformity, total range of flexion, alignment, and stability. Total score is 100 (0-100), more score means better. 1.2. Function score : calculated from patient's ability to walk and climb stairs. The score ranges from 0-100, more score means better. 2. Western Ontario and McMaster Universities Arthritis Index or WOMAC score : a widely used, standardized questionnaires for evaluating the condition of patients with knee osteoarthritis, including pain (score = 0-20), stiffness (0-8), and functional limitation (0-68). Total score ranges from 0-68, lower score means better.
Number of Patients Required Blood Transfusion	postoperative period (5 days after surgery)
Number of Patients Having Postoperative Complications	postoperative 1-year period	Postoperative complications were measured as an incidence of the following complications; * wound hematoma * surgical site infection * systemic infection * deep vein thrombosis * pulmonary embolism * knee stiffness requiring manipulation * medical complication such as myocardial infarction, congestive hear failure