The AAHKS Clinical Research Award: Extended Postoperative Oral Tranexamic Acid in Total Knee Arthroplasty: A Randomized Controlled Pilot Study.

BACKGROUND: Perioperative tranexamic acid (TXA) use with total knee arthroplasty (TKA) is widely accepted today. Recently, a few international groups have published on the safety and outcomes of extending TXA use in the postoperative period. Through a double-blinded, randomized control trial (RCT), we aimed to investigate the safety and clinical efficacy of extended postoperative oral TXA use in TKA performed in an American, free-standing ambulatory surgery center (ASC).

METHODS: Based on a power analysis, 40 patients undergoing primary TKA were randomized into 2 groups: extended oral TXA versus placebo. Both groups received a standard 1g intravenous TXA dose prior to incision and at the time of closure. The extended TXA group received an additional 1.95 g oral TXA dose following ambulation the day of surgery, plus on postoperative days 1,2, and 3. Patients who had a history of venous thromboembolism (VTE) or cancer were excluded. All patients received 81 mg of aspirin twice daily for VTE prophylaxis. Patients were followed on postoperative day 3 and weeks 2 and 6. Paired t-tests determined statistical significance.

RESULTS: Extended TXA patients showed significantly increased knee flexion at 6 weeks (116.05 versus 106.5, P = .0308), improved VAS at 2 (2.5 versus 3.85, P = .039) and 6 weeks (1.35 versus 2.8, P = .011), and superior KOOS JR at 2 (66.87 versus 60.63, P = .03) and 6 weeks (73.33 versus 62.47, P = .0019) compared to placebo patients. No significant differences were found for changes in hemoglobin levels at any time points. No significant differences were found at 12 weeks for any clinical endpoints. No adverse events were noted in either cohort.

CONCLUSIONS: When compared to placebo, the extended use of oral TXA in the postoperative period may safely result in improved motion, pain, and functional scores. Further investigation into 1-to-2-year outcomes, as well as the duration and dose of postoperative TXA use is warranted.