Extended Oral Tranexamic Acid After Primary Total Knee Arthroplasty

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Patients with an allergy to TXA

Patients taking a preoperative anticoagulant other than aspirin

Patients with a history of VTE

Patients with chronic kidney disease

Trial design

Treatments tested in this trial

  • Tranexamic acid (TXA)
  • Placebo

Treatment groups

350 Participants
are divided into 2 treatment groups

Sponsors and collaborators