Extended Oral Tranexamic Acid After Primary Total Knee Arthroplasty
NCT07494032 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350
Last updated 2026-03-27
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).
Conditions
- Knee Arthropathy
Interventions
- DRUG
-
Tranexamic acid (TXA)
Oral TXA 650mg dosed three times daily for 7 days, with a total dosage of 1.95g.
- DRUG
-
Placebo administered at the same intervals as the oral TXA.
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Anna Cohen-Rosenblum, MD, MSc · NYU Langone Health
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-01
- Primary Completion
- 2029-05-01
- Completion
- 2029-05-01
Countries
- United States
Study Locations
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