Extended Oral Tranexamic Acid After Primary Total Knee Arthroplasty

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT07494032
Status
Not Yet Recruiting

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Conditions

  • Knee Arthropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tranexamic acid (TXA) — DRUG
    Oral TXA 650mg dosed three times daily for 7 days, with a total dosage of 1.95g.
  • Placebo — DRUG
    Placebo administered at the same intervals as the oral TXA.

Study Details

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).

Key Dates

Start date
May 1, 2026
Status verified
Mar 2026
Primary completion
May 1, 2029
Completion
May 1, 2029

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Tranexamic Acid
    Patients treated with tranexamic acid 1.95g per day for 7 days postoperative.
  • Placebo Comparator: Placebo
    Patients treated with placebo daily for 7 days postoperative.

Primary Outcome Measure

Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR) Score [ Time Frame: Baseline, Week 6, Month 3, Month 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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By research site
NYU Langone Health· New York, NY

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