Postoperative Oral Tranexamic Acid in Patients Undergoing Primary Total Joint Arthroplasty

The purpose of this study is to evaluate the impact of an extended oral Tranexamic Acid regimen on patient reported outcome scores, time to independent ambulation, postoperative range of motion, swelling, change in hemoglobin levels, 90-day complications, readmission and reoperation.

Study Overview

• Status: Not yet recruiting
• Conditions: Arthroplasty
• Intervention / Treatment: Drug: Oral Tranexamic Acid

• Study Type: Interventional
• Enrollment (Estimated): 101
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic in Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Adults aged > 18 years (All women of childbearing potential undergo pregnancy testing prior to THA as per our institutional protocol)
• Written informed consent
• Patients undergoing primary THA diagnosis of end-stage osteoarthritis
• Patients receiving spinal anesthesia
• Patients being discharged on postoperative day 1

Exclusion Criteria

• Patients with a TXA allergy
• Patients undergoing revision procedures
• Patients undergoing primary THA for a diagnosis other than end-stage osteoarthritis
• Patients receiving general anesthesia
• Patients being discharged on the same day of surgery
• Cancer patients
• Patients with a history of prior VTE event
• Patients on preoperative anticoagulants other than ASA
• Pregnant patients (All women of child bearing potential undergo pregnancy testing prior to THA as per our institutional protocol)
• Female patients who are on hormonal contraception
• Patients with history of retinal vein or artery occlusion

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group
Experimental: Oral tranexamic acid	Drug: Oral Tranexamic Acid; Subjects will receive a 1.95 g dose of oral TXA at the following timepoints: (1) following ambulation, (2) postoperative day 1, (3) postoperative day 2, and (4) postoperative day 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Score	The VAS is a 11-item questionnaire assessing pain. Using a scale of 0 = no pain to 10 = worst pain. Total scores range from 0 - 110, lower scores indicating lower pain and higher scores indicating greater pain.	Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks
Hip Disability and Osteoarthritis Outcome Score (HOOS) for Joint Replacement (JR)	The Hip Disability and Osteoarthritis Outcome Score (HOOS) for Joint Replacement (JR) is a questionnaire designed to measure outcomes for patients with hip replacements. Results are scored 0-11. 0 = total hip disability, 100 = perfect hip health.	Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin	Hemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An A1C level below 5.7 percent is considered normal. Reported as percentage of glycated hemoglobin	Baseline, prior to discharge, day 3 postoperatively
Harris Hip Score (HHS)	The Harris Hip Score (HHS) is a tool used to assess hip function and the results of hip treatments, such as hip replacements. It's a 100-point scale that measures four areas: pain, function, deformity, and range of motion. A higher score indicates less dysfunction and better outcomes. A score of less than 70 is considered poor, 70-80 is fair, 80-90 is good, and 90-100 is excellent.	Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks
Short Form Health Survey (SF-12)	The 12-Item Short Form Health Survey (SF-12) is a questionnaire which consists of 12 questions covering physical and mental health domains. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.	Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks
Time to Independent Ambulation	Duration of time post-operation until the subject can walk without any support or assistance, reported in days	12 weeks
Oxford Hip Score	The Oxford Hip Score (OHS) is a standard patient-reported outcome (PRO) measure, or PROM, developed to assess function and pain in patients undergoing total hip replacement (THR) surgery, particularly in the context of clinical trials. The OHS has also been used for the assessment of patient outcomes, including physical therapy, and use of joint supplements (disease specific and general health measure are two other outcome measures).	Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Joshua Bingham, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 13, 2025
• First Submitted That Met QC Criteria: February 13, 2025
• First Posted (Actual): February 18, 2025

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Carboxylic Acids; Acids, Carbocyclic; Cyclohexanecarboxylic Acids; Tranexamic Acid
• Other Study ID Numbers: 24-008865

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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