NYU Langone Health
New York, 10016, United States
NCT Number: NCT07494032
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).
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
New York, 10016, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline, Week 6, Month 3, Month 12
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
Assessed in degrees.
Time frame: Baseline, Week 6, Month 3, Month 12
Assessed in degrees.
Contact information is provided by the study sponsor or research team.
NYU Langone Health
Other
Extended Oral Tranexamic Acid After Primary Total Knee Arthroplasty: A Double-Blind, Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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