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Can a common bleeding drug make knee realignment surgery safer?

NCT ID NCT07825350

Symptom relief Sponsor: Western University, Canada Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers are testing whether tranexamic acid, a drug that helps prevent bleeding, reduces blood loss and wound complications during high tibial osteotomy. This surgery realigns bow-legged knees to ease osteoarthritis pain and slow joint damage. The trial enrolls 200 adults with knee osteoarthritis and varus alignment who are scheduled for the procedure. Participants receive either tranexamic acid or standard care, and researchers track hemoglobin levels and patient-reported outcomes like knee function and scar quality.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tranexamic acid, a medication that helps prevent bleeding
What this could lead to
If it works, tranexamic acid could become a routine addition to knee realignment surgery, helping patients lose less blood and heal with fewer wound problems.
What could go wrong
This is a focused surgical study, not a cure for knee arthritis. Tranexamic acid may not meaningfully change blood loss or scarring in this procedure, and it carries rare risks such as allergic reactions or blood clots.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jan 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with mechanical varus alignment and knee OA according to Rheumatology classification criteria (Altman, 1986), with the greatest severity in the medial compartment of the tibiofemoral joint * Undergoing Medial opening wedge high tibial osteotomy by or under guidance from Fellowship Trained Sports Orthopaedic Surgeons Exclusion Criteria: * Allergy to tranexamic acid. Acquired disturbances of colour vision, preoperative use of anticoagulants within 5 days of surgery, coagulopathy as described by pre-op platelet count of \<150,000/mm3, pregnancy, breast feeding (From Wong, 2010) * Inflammatory or infectious arthritis. Major neurologic deficit. (From Birmingham, 2009) * Prior history of venous thrombotic event being treated with life-long anticoagulation. * Patients known to have congenital thrombophilia, and patients who have had a known venous thromboembolic event within 1 year preceding surgery. (From Ralley 2010) * Patients taking hormonal contraceptives, Factor IX complex concentrates, anti-inhibitor coagulant concentrates, thrombin, batroxobin or haemocoagulase. These medications could potentially increase thrombotic risk if taken concomitantly with tranexamic acid (McCormack, 2012)

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Conditions

The condition(s) this trial relates to.

osteoarthritis osteoarthritis, knee

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteoarthritis, knee

How to take part

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  1. The official record

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