Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Postoperative Pain

In brief

The primary purpose of this study is to evaluate postoperative pain. Secondary outcomes evaluated in this study will include range of motion (ROM), opioid consumption, and ambulation. Each outcome measure will be evaluated, oral tranexamic acid (TXA) in the experiment arm and placebo in the control arm, after total knee arthroplasty (TKA) at postoperative days 0-3, and weeks 1, 2, 6, and 12.

Key facts

Study ID

NCT06479161

Run by

Matthew Grosso, MD

People needed

80

Starts

2024-06-10

Expected to finish

2025-03-30

Last updated by the study team

2024-12-13

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• - All patients undergoing either manual or robotic primary total knee arthroplasty (TKA)
• Performed by participating Connecticut Joint Replacement Institute (CJRI) surgeons (Dr. Matthew Grosso, Dr. Robert McAllister, Dr. Chad Daniel, Dr. Eric Silverstein, Dr. Alex Dukas, Dr. Michael Joyce, Dr. Brett Wasserlauf).
• Male and female patient age 18-89
• Primary diagnosis of knee osteoarthritis

You may not qualify if…

• Revision TKA
• No exclusion based on gender
• Patients <18 and >89 years old
• Exclusion for IV oral tranexamic acid (TXA):
• TXA allergy - there are NO absolute contraindications for TXA use.
• History of stent placed within one year of surgery - patient will receive topical TXA as an alternative.
• Exclusion for oral TXA:
• o Actively treated cancer or deep vein thrombosis (DVT)
• Chronic opioid use (opioid use within the 4 weeks prior to surgery)
• Allergies to nonsteroidal Anti-inflammatory drugs (NSAIDs) and acetaminophen
• Patients with clinically significant drug interactions
• Pre-existing neuropathy
• Current or previous venous thrombosis (DVT or venous stasis disease)
• Immuno-compromised secondary to medical condition
• Immune-suppressive medications, chemotherapy
• Pregnancy, breast feeding
• History of pain catastrophizing. Major depressive disorder
• History of suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
• Currently on a neuroleptic agent [e.g., gabapentin, pregabalin (Lyrica), duloxetine (Cymbalta) etc.].
• Non-English speaking and reading patient populations
• Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that, in the opinion of the investigator, renders the subject medically unstable or complicates the subject's post-operative course.

Where it is running

• Trinity Health Of New England/CT Joint Replacement Institute — Hartford, Connecticut, United States (enrolling)

Full record on ClinicalTrials.gov

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