Knee Arthropathy
Conditions
Brief 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).
Interventions
DRUGTranexamic acid (TXA)
Oral TXA 650mg dosed three times daily for 7 days, with a total dosage of 1.95g.
DRUGPlacebo
Placebo administered at the same intervals as the oral TXA.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR) Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Range of Motion (ROM): Flexion | Baseline, Week 6, Month 3, Month 12 | Assessed in degrees. |
| Knee Range of Motion (ROM): Extension | Baseline, Week 6, Month 3, Month 12 | Assessed in degrees. |
Countries
United States
Contacts
CONTACTDaniel Warren
PRINCIPAL_INVESTIGATORAnna Cohen-Rosenblum, MD, MSc
NYU Langone Health
Outcome results
None listed