Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty

Description

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.

Conditions

Postoperative Pain

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Study Overview

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Study Details

Study overview

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.

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

Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty

Condition
Postoperative Pain
Intervention / Treatment

-

Contacts and Locations

Hartford

Trinity Health Of New England/CT Joint Replacement Institute, Hartford, Connecticut, United States, 06105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * - All patients undergoing either manual or robotic primary TKA
  • * Performed by participating 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
  • * Revision TKA
  • * No exclusion based on gender
  • * Patients \<18 and \>89 years old
  • * Exclusion for IV 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:
  • * Chronic opioid use (opioid use within the 4 weeks prior to surgery)
  • * Allergies to 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.

Ages Eligible for Study

18 Years to 89 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Matthew Grosso, MD,

Study Record Dates

2025-03-30