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Extended Oral Tranexamic Acid After Primary Total Knee Arthroplasty

ConditionKnee Arthropathy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

350 Participants
are divided into 2 treatment groups
Group A: Tranexamic AcidExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR) Score

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

Secondary outcomes

1

Knee Range of Motion (ROM): Flexion

Assessed in degrees.

Time frame
Baseline, Week 6, Month 3, Month 12
2

Knee Range of Motion (ROM): Extension

Assessed in degrees.

Time frame
Baseline, Week 6, Month 3, Month 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: