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New treatment option for Postoperative Pain
Official title Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT06479161
What this study is testing
What is Tranexamic acid?
Tranexamic acid is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for postoperative pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 89. Healthy volunteers may be eligible.
You may be able to join if
- \- 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...
- Male and female patient age 18-89
- Primary diagnosis of knee osteoarthritis
You likely can't join if
- Revision TKA
- No exclusion based on gender
- Patients \ 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.
See the full eligibility 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...
- Male and female patient age 18-89
- Primary diagnosis of knee osteoarthritis
- Revision TKA
- No exclusion based on gender
- Patients \ 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...
The study team makes the final eligibility decision.
Where it's taking place
- Hartford, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 89 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hartford, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.