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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
350
Oral TXA 650mg dosed three times daily for 7 days, with a total dosage of 1.95g.
Placebo administered at the same intervals as the oral TXA.
NYU Langone Health
New York, New York, United States
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR) Score
The KOOS, JR is a 7-item survey measuring overall knee health for individuals post total knee arthroplasty (TKA) by evaluating stiffness, pain, function, and activities of daily living. Each item is rated on a scale from 0-4; the total score is the sum of responses and ranges from 0-28; lower scores indicate more positive outcomes.
Time frame: Baseline, Week 6, Month 3, Month 12
Knee Range of Motion (ROM): Flexion
Assessed in degrees.
Time frame: Baseline, Week 6, Month 3, Month 12
Knee Range of Motion (ROM): Extension
Assessed in degrees.
Time frame: Baseline, Week 6, Month 3, Month 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.