Extended Oral Tranexamic Acid After Primary Total Knee Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tranexamic acid (TXA), Placebo.
- Who it may be relevant to
- Registry conditions: Knee Arthropathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Extended Oral Tranexamic Acid After Primary Total Knee Arthroplasty: A Double-Blind, Randomized Controlled Trial
Overview
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).
Interventions
- Drug Tranexamic acid (TXA)
Oral TXA 650mg dosed three times daily for 7 days, with a total dosage of 1.95g. - Drug Placebo
Placebo administered at the same intervals as the oral TXA.
Primary outcome measures
- Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR) Score [Time frame: Baseline, Week 6, Month 3, Month 12]
Secondary outcome measures (2)
- Knee Range of Motion (ROM): Flexion [Time frame: Baseline, Week 6, Month 3, Month 12]
- Knee Range of Motion (ROM): Extension [Time frame: Baseline, Week 6, Month 3, Month 12]
Eligibility criteria
Inclusion criteria
- 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
- Patients receive 1g IV TXA prior to incision and 1g IV TXA at closure
- Patients are prescribed aspirin 81mg twice a day for postoperative VTE prophylaxis
Exclusion criteria
- 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
- Patients with active malignancy
- Current use of combined hormonal contraception (pill, patch, or ring)
- eGFR <60 mL/min/1.73 m² or other clinically significant renal impairment
- Use of Factor IX complex concentrates, anti-inhibitor coagulant concentrates, or all-trans retinoic acid (tretinoin)
- Anticipated need for tissue plasminogen activator (tPA) during the 7-day dosing period
- Individuals who are pregnant or breastfeeding, have a positive pre operative pregnancy test, or plan pregnancy during the 7 day dosing window. Women of childbearing potential must have a negative pre operative pregnancy test and use effective contraception through postoperative day . Individuals who are on hormonal contraceptives or hormone replacement therapies, with the exception of Progestin, are to be excluded.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT07494032 · 26-00007