NCT06479161 Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty
| NCT ID | NCT06479161 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Matthew Grosso, MD |
| Condition | Postoperative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-06-10 |
| Primary Completion | 2025-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2024-06-10 with a primary completion date of 2025-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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. 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06479161 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Postoperative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06479161 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06479161 currently recruiting?
Yes, NCT06479161 is actively recruiting participants. Contact the research team at gpanek@trinityhealthofne.org for enrollment information.
Where is the NCT06479161 trial being conducted?
This trial is being conducted at Hartford, United States.
Who is sponsoring the NCT06479161 clinical trial?
NCT06479161 is sponsored by Matthew Grosso, MD. The trial plans to enroll 80 participants.