Tranexamic Acid for Knee Osteoarthritis

DW
Overseen ByDaniel Warren
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
Must be taking: Aspirin

What You Need to Know Before You Apply

What is the purpose of 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).

Who Is on the Research Team?

AC

Anna Cohen-Rosenblum, MD, MSc

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

Inclusion Criteria

I am scheduled to have my first total knee replacement surgery.
I am having a total knee replacement with spinal anesthesia.
I will receive 1g IV TXA before surgery and 1g IV TXA at the end of surgery.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either extended oral TXA 1.95g daily or placebo for 7 days postoperatively

1 week
1 visit (in-person)

Follow-up

Participants are monitored for function, pain, and postoperative complications with evaluations at 6 weeks, 3 months, 12 months, and 24 months

24 months
4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Tranexamic acid

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Tranexamic AcidExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+