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RecruitingAccepts healthy volunteersPhase 2

Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty

Matthew Grosso, MD · NCT06479161

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–89 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 2
Target enrollment
80
US sites recruiting
1
Study start
June 10, 2024
Record last updated
December 13, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the 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. 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.

Being studied: Tranexamic acid

Conditions: Postoperative Pain

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Trinity Health Of New England/CT Joint Replacement Institute

    Hartford, CT 06105

    Site contact: Gina Panek, BS · 860-714-4164 · gpanek@trinityhealthofne.org

Study contacts (from the official record)

  • Gina Panek, BS · 860-714-4164 · gpanek@trinityhealthofne.org
  • Czarina Weinz · 860-714-0467 · Czarina.Weinz@trinityhealthofne.org
All pain studies in Connecticut →
Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty (NCT06479161) | Bored Studies