NCT06479161 · Matthew Grosso, MD
Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty
What this study 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.
View original scientific 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.
Interventions
DRUG
Tranexamic acid
1.95 grams oral
Primary outcome measures
Visual Analogue Scale (VAS) Pain scores
Time frame: postoperative day (POD) 0, 1, 2, 3 (+/- 0 days) and weeks 1 (+/- 0 days), 2 (+/- 2 days), 6 and 12 (+/- 7 days).
Patient reported pain score from 0 to 10 where 0 is no pain and 10 is the most pain. Higher scores are a worse outcome.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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.
- 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
- Hartford, Connecticut
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 13, 2024 · Source of record for eligibility and locations