Actively Recruiting
Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty
Led by Matthew Grosso, MD · Updated on 2024-12-13
80
Participants Needed
1
Research Sites
41 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All patients undergoing either manual or robotic primary total knee arthroplasty (TKA)
- Surgery performed by participating Connecticut Joint Replacement Institute surgeons
- Male and female patients aged 18 to 89 years
- Primary diagnosis of knee osteoarthritis
You will not qualify if you...
- Revision total knee arthroplasty
- Patients younger than 18 or older than 89 years
- Allergy to tranexamic acid
- History of stent placed within one year of surgery (topical TXA used instead)
- Actively treated cancer or deep vein thrombosis
- Chronic opioid use within 4 weeks prior to surgery
- Allergies to NSAIDs or acetaminophen
- Clinically significant drug interactions
- Pre-existing neuropathy
- Current or previous venous thrombosis or venous stasis disease
- Immunocompromised due to medical condition
- Use of immune-suppressive medications or chemotherapy
- Pregnancy or breastfeeding
- History of pain catastrophizing or major depressive disorder
- History of addiction or abuse of illicit drugs, prescription medicines, or alcohol within past 2 years
- Current use of neuroleptic agents (e.g., gabapentin, pregabalin, duloxetine)
- Non-English speaking or reading patients
- Any medically unstable condition or surgical complication discovered during surgery
AI-Screening
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Trial Site Locations
Total: 1 location
1
Trinity Health Of New England/CT Joint Replacement Institute
Hartford, Connecticut, United States, 06105
Actively Recruiting
Research Team
G
Gina Panek, BS
CONTACT
C
Czarina Weinz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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