Tranexamic acid (TXA) is proven to reduce blood loss following total knee arthroplasty (TKA), but there are limited data on the impact of similar dosing regimens in revision TKA that is associated with greater blood loss. The purpose of this multi-center randomized trial was to determine the optimal regimen to maximize the blood-sparing properties of TXA in revision TKA. 233 Septic and aseptic revision TKA from six-centers were randomized to either receive 1g pre-incision intravenous (IV) TXA, 1g pre- and post-incision IV TXA, 1g pre-incision IV and 1g intra-operative topical TXA, or three doses of 1950mg oral TXA given 2 hours pre-operatively, 6 hours post-operatively, and the morning of postoperative day 1. Randomization was performed based on type of revision to ensure equivalent distribution among groups. The primary outcome was reduction in hemoglobin. Power analysis determined 40 patients per group were necessary to identify a 1g/dL difference with an alpha of 0.05 and beta of 0.80. Per-protocol analysis involved regression analysis and two one-sided t-tests for equivalence.Introduction
Methods
The purpose of this randomized controlled trial is to evaluate the efficacy of using dilute betadine versus sterile saline lavage in aseptic revision total knee (TKA) and hip (THA) arthroplasty to prevent acute postoperative deep periprosthetic joint infection (PJI). Of the 450 patients that were randomized, 5 did not have 90-day follow-up, 9 did not receive the correct treatment, and 4 were excluded for intraoperative findings consistent with PJI. 221 Patients (144 knees and 77 hips) received saline lavage only and 211 (136 knees and 75 hips) received a three-minute dilute betadine lavage (0.35%) prior to wound closure. Patients were observed for the incidence of acute postoperative deep PJI within 90 days of surgery. Statistical analysis was performed using t-tests or Fisher's exact test where appropriate. Power analysis determined that 285 patients per group are needed to detect a reduction in the rate of PJI from 5% to 1% (alpha=0.05, beta=0.20). There were seven PJIs in the saline group and one in the betadine lavage group (3.2% vs. 0.5%, p=0.068). There were no significant differences in any baseline demographics between groups suggesting appropriate randomization. Although we believe the observed difference between treatments is clinically relevant, it was not statistically significant with the sample size enrolled thus far and enrollment is ongoing. Nonetheless, we believe that these data suggests that dilute betadine lavage is a simple method to reduce the rate of acute postoperative PJI in patients undergoing aseptic revision procedures.
