Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty
Recruiting
Phase 2Interventional Study
Postoperative Pain
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
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At a Glance
Age
18 – 89
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
Matthew Grosso, MD · Other
Who this trial is looking for
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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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* \- 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.…
Inclusion Criteria:
* \- 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 Criteria:
* 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.
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