Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Tranexamic acid

Detailed Description

Randomized controlled trial with 1:1 allocation, selected through computer-based randomization.

This study will review prospectively collected data, including patient demographic information, surgeon, use of oral tranexamic acid (TXA) or placebo regimen, and postoperative outcomes up to 3 months after surgery. Collaboration with Saint Francis' pharmacy team will be performed to ensure appropriate blinded administering of the oral TXA and placebo medication.

This will be a double blinded study, with both patient and surgeon blinded to study group.

6.0 TXA dosing protocol TXA day of surgery [All patients]

• Administer 1-gram IV TXA intraoperatively at the start of the case (hold for history of stent within 1 year of surgery)

  o AND

• Administer 1-gram IV TXA postoperatively before leaving PACU (hold for history of stent within 1 year of surgery)

  o OR

• Exception: Administer 2 grams TXA in 50cc normal saline topically during the case for patients with a history of stent placed within one year of surgery.

TXA postoperative day (POD) 1-3 [Experimental group]

• Administer 1.95 grams oral (3- 650 mg tablets) TXA each morning for three days following surgery.
• Patients discharged home before POD 3 will be sent home with remaining oral TXA doses.

Placebo POD 1-3 [Control group]

• Administer oral placebo (3 tablets) each morning for three days following surgery.
• Patients discharged home before POD 3 will be sent home with remaining oral placebo doses.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Gina Panek, BS; Phone Number: 860-714-4164; Email: gpanek@trinityhealthofne.org
• Study Contact Backup: Name: Czarina Weinz; Phone Number: 860-714-0467; Email: Czarina.Weinz@TrinityHealthofNE.org

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06105
      • Recruiting
      • Trinity Health Of New England/CT Joint Replacement Institute
      • Contact: Gina Panek, BS; Phone Number: 860-714-4164; Email: gpanek@trinityhealthofne.org
      • Contact: Czarina Weinz; Phone Number: 860-714-0467; Email: Czarina.Weinz@TrinityHealthofNE.org
      • Principal Investigator: Matthew Grosso, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TXA; - 1.95 grams oral TXA (tranexamic acid) (3- 650 mg tablets) administered postop day one, postop day two and postop day three. Compounded by registered pharmacist and labeled with subject name and instructions for use.	Drug: Tranexamic acid; 1.95 grams oral
Placebo Comparator: Placebo; - 3 tablets administered postop day one, postop day two and postop day three. Compounded by registered pharmacist and labeled with subject name and instructions for use.	Drug: Tranexamic acid; 1.95 grams oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS) Pain scores	Patient reported pain score from 0 to 10 where 0 is no pain and 10 is the most pain. Higher scores are a worse outcome.	postoperative day (POD) 0, 1, 2, 3 (+/- 0 days) and weeks 1 (+/- 0 days), 2 (+/- 2 days), 6 and 12 (+/- 7 days).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of Motion	Clinical measurement of passive, pain-free range of motion of knee in degrees from 0 to 180 from maximum extension to maximum flexion	at 2, 6 and 12 week follow up visits
Opioid consumption	Subjects will keep a log recording opioid consumption. Research staff will ask subjects to report opioids during postoperative telephone calls.	POD 1, 2, 3 (+/- 0 days) and weeks 1 (+/- 0 days), 2 (+/- 2 days), 6 and 12 (+/- 7 days)
Ambulation Status	Surgeon or physical therapist will record if patient is using a walker, cane or no assistive devices.	at 2, 6 and 12 week follow up visits

Collaborators and Investigators

• Sponsor: Matthew Grosso, MD

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2024
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): June 28, 2024

Study Record Updates

• Last Update Posted (Estimated): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Molecular Mechanisms of Pharmacological Action; Antifibrinolytic Agents; Fibrin Modulating Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: SFH 24-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No