Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2025-12-24 @ 12:43 PM
NCT ID:
NCT06479161
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
89 Years
Study:
NCT06479161
Study Brief:
Protocol Section:
NCT06479161