BACKGROUND: The implementation of perioperative intravenous tranexamic acid (TXA) protocols in total knee arthroplasty (TKA) has led to improved outcomes related to decreased blood loss and decreased transfusion rates. A recent randomized controlled trial (RCT) demonstrated that there may be additional benefits to extended oral TXA (EOTXA) for improving pain and function in the early postoperative period. In this double-blind RCT, we examined the effects of EOTXA following primary TKA on postoperative pain, range of motion (ROM), opioid usage, and ambulation status.
METHODS: There were 86 patients undergoing primary total knee arthroplasty randomized to two groups: EOTXA versus placebo. All patients received one gram of intravenous TXA prior to incision and in the postoperative recovery area. Patients in the EOTXA group (n = 43) received 1.95 grams of oral TXA daily from postoperative day one through POD three. The primary outcome in this study was the visual analog scale (VAS) pain score in the three-month postoperative period. The secondary outcomes included ROM, ambulation status (assistive device usage), and opioid consumption.
RESULTS: There was no statistically significant difference in VAS pain scores at any time point: POD one Placebo 4.7 versus EOTXA 5.4 (P = 0.16); POD two 4.1 versus 4.4 (P = 0.33); POD three 3.7 versus 4.0 (P = 0.49); POD7 3.6 versus 3.7 (P = 0.66); two weeks 3.0 versus 2.8 (P = 0.63); six weeks 2.2 versus 1.8 (P = 0.22); and 12 weeks 1.2 versus 1.1 (P = 0.86). In addition, there were no significant differences in ROM, daily opioid consumption, and ambulation status at two, six, and 12 weeks postoperatively (P > 0.10).
CONCLUSIONS: In the largest RCT to date, this study found no significant difference in pain scores, opioid consumption, functional outcomes, or ambulation status with the addition of extended oral TXA following primary TKA. Based on these results, broad utilization of this protocol in primary TKA may not be warranted.
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