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NCT Number: NCT07685743

Extended Post-operative Oral TXA in Primary THA

The goal of this clinical trial is to learn if extended post-operative oral tranexamic acid (TXA) - a medication that reduces bleeding by slowing the breakdown of blood clots - can improve functional recovery following surgery in adults undergoing primary total knee or hip arthroplasty for osteoarthritis. The main question it aims to answer is: Does extended post-operative oral TXA improve functional outcomes at 6 weeks post-operatively compared to standard perioperative TXA alone? Researchers will compare patients receiving extended oral TXA to patients receiving matching placebo capsules on the same schedule to see if the extended TXA regimen reduces blood loss, improves early functional outcomes, and reduces pain without increasing complication rates. Participants will receive standard perioperative oral TXA (1.95 g) prior to surgical incision, along with standard VTE prophylaxis. They will be randomly assigned to receive either oral TXA or matching placebo capsules once daily on post-operative days 1, 2, and 3. Participants will attend follow-up visits at 2, 6, and 12 weeks post-operatively to complete functional outcome questionnaires, pain assessments, and - for knee replacement patients - range of motion measurements.

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Key information

Conditions

Osteoarthritis (OA) of the Hip Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis (OA) of the Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • Undergoing primary total knee arthroplasty (TKA) or total hip arthroplasty (THA) for osteoarthritis
  • Ability to provide written informed consent
  • Willingness to comply with study protocol

Exclusion criteria

  • History of venous thromboembolism (DVT or PE)
  • Active malignancy
  • Allergy or contraindication to tranexamic acid (TXA)
  • Post-operative anticoagulation therapy other than aspirin
  • History of color blindness or retinal disease

Treatment and study plan

Extended oral tranexamic acid regimen

Drug

Participants in the intervention group will receive 1.95mg of oral tranexamic acid on post-operative day 1, 2, and 3.

Placebo

Drug

Patients will receive an oral placebo medication on post-operative day 1, 2, and 3.

Primary outcomes

  1. 6-week Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) score

    Time frame: At 6 weeks from timing of surgical intervention

    Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) for patients undergoing Total Knee Arthroplasty or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) for patients undergoing Total Hip Arthroplasty at 6 weeks post-operatively. Scale for booth outcome scores is 0 to 100, with a higher score representing improved patient-reported knee or hip health.

Secondary outcomes

  1. 2-week Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) score

    Time frame: At 2 weeks from timing of surgical intervention

    Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) for patients undergoing Total Knee Arthroplasty or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) for patients undergoing Total Hip Arthroplasty at 2 weeks post-operatively. Scale for both outcome scores is 0 to 100, with a higher score representing improved patient-reported knee or hip health.

  2. 12-week Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) score

    Time frame: At 12 weeks from timing of surgical intervention

    Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) for patients undergoing Total Knee Arthroplasty or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) for patients undergoing Total Hip Arthroplasty at 12 weeks post-operatively. Scale for both outcome scores is 0 to 100, with a higher score representing improved patient-reported knee or hip health.

  3. 2-week Visual Analog Scale (VAS) pain score

    Time frame: At 2 weeks from timing of surgical intervention

    Visual analog scale (VAS) pain score at 2 weeks post-operatively. Scale is 0-10 with higher scores representing more pain.

  4. 6-week Visual Analog Scale (VAS) pain score

    Time frame: At 6 weeks from timing of surgical intervention

    Visual analog scale (VAS) pain score at 6 weeks post-operatively. Scale is 0-10 with higher scores representing more pain.

  5. 12-week Visual Analog Scale (VAS) pain score

    Time frame: At 12 weeks from timing of surgical intervention

    Visual analog scale (VAS) pain score at 12 weeks post-operatively. Scale is 0-10 with higher scores representing more pain.

  6. 6-week absolute knee flexion

    Time frame: At 6 weeks from timing of surgical intervention

    Degrees of knee flexion achieved at the 6 week post-operative mark for patients undergoing Total Knee Arthroplasty

  7. Transfusion rate

    Time frame: From enrollment to end of treatment at 12 weeks from timing of surgical intervention

    Percentage of patients per arm requiring post-operative transfusion of blood products

  8. Blood product units transfused

    Time frame: From enrollment to end of treatment at 12 weeks from timing of surgical intervention

    For each arm, the average number of blood product units transfused per patient

  9. Incidence of Symptomatic DVT

    Time frame: From enrollment to end of treatment at 90 days from timing of surgical intervention

    The number of post-operative symptomatic deep vein thromboses identified in each arm

  10. Incidence of Symptomatic PE

    Time frame: From enrollment to end of treatment at 90 days from timing of surgical intervention

    The number of post-operative symptomatic pulmonary embolisms identified in each arm

  11. Incidence of Acute Coronary Sndrome

    Time frame: From enrollment to end of treatment at 90 days from timing of surgical intervention

    The number of cases of post-operative acute coronary syndrome, defined as an ST-elevation myocardial infarction (STEMI), a non-ST-elevation myocardial infarction (NSTEMI), or unstable angina.

  12. Incidence of Cerebrovascular Accident

    Time frame: From enrollment to end of treatment at 90 days from timing of surgical intervention

    The number of post-operative cerebrovascular accidents (CVAs), defined as ischemic or hemorrhagic stroke.

  13. Rate of Readmission

    Time frame: From enrollment to end of treatment at 12 weeks from timing of surgical intervention

    The number of patients per arm requiring readmission for any reason within 90 days of surgical intervention.

  14. Rate of Reoperation

    Time frame: From enrollment to end of treatment at 90 days from timing of surgical intervention

    The number of patients per arm requiring reoperation for any indication within 90 days of surgical intervention.

  15. All-cause Mortality Rate

    Time frame: From enrollment to end of treatment at 90 days from timing of surgical intervention

    The number of patients deceased of any cause within 90 days of surgical intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Madison Hayes-Lattin, MD

CONTACT

[email protected]

503) 494-6400

Ryland Kagan, MD

CONTACT

[email protected]

503 494-6400

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

Extended Post-operative Oral TXA vs.Standard Perioperative TXA in Primary TJA: A Randomized, Double-Blind, Placebo-Controlled Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 6, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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