RecruitingPhase 2NCT06479161

Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty

Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty on Postoperative Pain and Range of Motion: A Randomized Control Trial

Sponsor

Matthew Grosso, MD

Enrollment

80 participants

Start Date

Jun 10, 2024

Study Type

INTERVENTIONAL

Conditions

Postoperative Pain

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 89 Years

Inclusion Criteria4

\- 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

Exclusion Criteria21

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.