Extended Oral Tranexamic Acid After Primary Total Knee Arthroplasty: A Double-Blind, Randomized Controlled Trial
NYU Langone Health
Summary
This study is a prospective double-blind randomized controlled trial to evaluate the effect of extended oral TXA after primary total TKA on short-term and mid-term postoperative outcomes, including function, pain, and postoperative complications over a 24-month period, with evaluations at 6 weeks, 3 months, 12 months, and 24 months. Each group of 175 patients will receive either extended oral TXA 1.95g daily or placebo for 7 days postoperatively. Function will be assessed by Knee Injury and Osteoarthritis Outcome Score, Joint Replacement (KOOS, JR) scores measured at all post operative time points as well as range of motion (ROM) (measured at all visits).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients are candidates for elective primary total knee arthroplasty. * Patients ≥18 years of age * Patients have been medically evaluated and scheduled for primary total knee arthroplasty. * Patients undergo primary total knee arthroplasty with spinal anesthesia * Patients receive 1g IV TXA prior to incision and 1g IV TXA at closure * Patients are prescribed aspirin 81mg twice a day for postoperative VTE prophylaxis Exclusion Criteria: * Patients with an allergy to TXA * Patients taking a preoperative anticoagulant other than aspirin * Patients with a history of VTE *…
Interventions
- DrugTranexamic acid (TXA)
Oral TXA 650mg dosed three times daily for 7 days, with a total dosage of 1.95g.
- DrugPlacebo
Placebo administered at the same intervals as the oral TXA.
Location
- NYU Langone HealthNew York, New York