RECRUITING

Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty on Postoperative Pain and Range of Motion: A Randomized Control Trial

Quick Facts

Study Start:2024-06-10

Study Completion:2025-03-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06479161

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* - All patients undergoing either manual or robotic primary TKA * Performed by participating 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	* Revision TKA * No exclusion based on gender * Patients \<18 and \>89 years old * Exclusion for IV 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: * Chronic opioid use (opioid use within the 4 weeks prior to surgery) * Allergies to 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.

Inclusion Criteria

Exclusion Criteria

* - All patients undergoing either manual or robotic primary TKA
* Performed by participating 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

* Revision TKA
* No exclusion based on gender
* Patients \<18 and \>89 years old
* Exclusion for IV 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:
* Chronic opioid use (opioid use within the 4 weeks prior to surgery)
* Allergies to 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.

Contacts and Locations

Study Contact

Gina Panek, BS

CONTACT

860-714-4164

gpanek@trinityhealthofne.org

Czarina Weinz

CONTACT

860-714-0467

Czarina.Weinz@trinityhealthofne.org

Study Locations (Sites)

Trinity Health Of New England/CT Joint Replacement Institute

Hartford, Connecticut, 06105

United States

Collaborators and Investigators

Sponsor: Matthew Grosso, MD

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-10

Study Completion Date2025-03-30

Study Record Updates

Study Start Date2024-06-10

Study Completion Date2025-03-30

Terms related to this study

Additional Relevant MeSH Terms

Postoperative Pain