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Tranexamic Acid versus Placebo for Reducing Infection after Mid‑and Hind‑Foot Arthrodesis in Adults with Deformity or Osteoarthritis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study looks at people who have a foot deformity caused by osteoarthritis and who need a hind‑ or mid‑foot arthrodesis, a type of surgery that fuses bones to correct the shape and relieve pain. During the operation participants receive either an intravenous dose of tranexamic acid or a control infusion containing sodium chloride as a placebo. The medication is given through a vein while the surgeon is working, and its goal is to reduce bleeding and possibly lower the chance of problems after the operation.

The purpose of the trial is to see whether giving tranexamic acid during surgery changes the rate of post‑operative infections within one year. After the procedure, participants are followed for up to twelve months with check‑ups at two weeks, three months and one year. During these visits doctors look at how the wound is healing, whether the skin has opened up (wound dehiscence), how much blood loss occurred by measuring blood‑type protein levels, and if any additional surgery is needed. Bone healing (fusion) is checked at the final visit using a special imaging test called computed tomography, which produces detailed pictures of the bones. All participants receive the same standard care apart from the study medication, and the study records any infections, wound problems, extra surgeries, and the overall success of the bone fusion.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and baseline assessment

    After signing the consent form, you will provide information about your medical history, current medications, and the conditions being treated, such as deformity or osteoarthritis.

    Baseline laboratory tests, including blood samples, will be taken to record your health status before any study procedures.

  2. Step 2

    Pre‑operative preparation

    You will receive instructions on fasting and any necessary medication adjustments before the day of surgery.

    The scheduled date for the hind or midfoot arthrodesis surgery will be confirmed.

  3. Step 3

    Surgical day – administration of study medication

    On the day of surgery you will be admitted to the hospital and taken to the operating room for the arthrodesis procedure.

    During the operation a single intravenous infusion will be given. the infusion will contain either tranexamic acid (1000 mg in 100 ml) or a placebo consisting of sodium chloride solution (100 ml). the infusion is administered once, directly into a vein, while the surgeon performs the bone fusion.

    The purpose of the infusion is to assess whether the medicine reduces bleeding and influences the rate of postoperative infection.

  4. Step 4

    Immediate postoperative monitoring

    After surgery you will stay in a recovery area where nurses will monitor vital signs, wound condition, and blood loss.

    Blood samples will be taken before and after the operation to measure haemoglobin levels, which indicate the amount of blood lost during surgery.

  5. Step 5

    Hospital discharge and home care

    Once you meet the discharge criteria, you will go home with written instructions for wound care, activity restrictions, and signs of infection to watch for.

    You will be asked to keep the wound clean and dry, and to report any unusual swelling, redness, or drainage.

  6. Step 6

    First follow‑up visit (2 weeks)

    At approximately two weeks after surgery you will attend a clinic visit where a specialised nurse or surgeon will examine the wound.

    The assessment will look for wound dehiscence (partial or total separation of the wound edges) and any signs of infection.

  7. Step 7

    Second follow‑up visit (3 months)

    At about three months you will return for another wound examination and may have additional blood tests to evaluate healing.

    The clinician will again check for infection, wound separation, and overall recovery.

  8. Step 8

    Final follow‑up visit (12 months)

    One year after the operation you will attend a comprehensive visit that includes:

    • a wound inspection for infection or dehiscence,
    • a computed tomography scan to determine whether the bones have successfully fused,
    • blood tests to assess any late changes,
    • completion of questionnaires such as the Manchester–Oxford foot questionnaire, the Patient Acceptable Symptom State, and a pain numerical rating scale to record your symptoms and quality of life.

    Any additional surgery performed on the same foot for any reason will also be recorded during this visit.

Who can join the trial?

3 criteria

  • Age ≥ 18 years – you must be an adult, at least 18 years old.
  • Hind‑ or midfoot arthrodesis suitability – a foot and ankle surgeon must decide that you are a good candidate for a surgery that joins (fuses) the bones in the back (hind) or middle (mid) part of the foot.
  • Understanding trial information – you must be able to read and answer study questions in either Finnish or Swedish.

Who cannot join the trial?

8 criteria

  • Recent serious injury (acute trauma) that could affect the foot or ankle.
  • A known condition that makes your blood clot too easily (hypercoagulable disorder), whether you were born with it or developed it later.
  • Having had seizures (sudden, uncontrolled electrical activity in the brain) in the past.
  • Any infection of the bone or joint near the foot within the last year.
  • Current bacterial infection or an open sore (ulcer) on the lower leg.
  • Diabetes with poor blood‑sugar control, measured by an A1C level higher than 6.4% (the A1C test shows average blood sugar over several months).
  • Severe problems with blood flow in the lower leg, especially if a doctor cannot feel a pulse in the foot (absence of palpable pulses).
  • Inability to give permission to join the study (cannot provide informed consent).
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Investigated drugs

Tranexamic acid is a medication given through an IV during the foot surgery. It works by helping the blood clot stay stable, which reduces the amount of bleeding that can happen while the operation is being performed. In this study, doctors are testing whether using tranexamic acid during the procedure can lower the chance of infection after the surgery, looking at patients one year after their hind‑foot or mid‑foot joint fusion.

What is already known about the treatment

  • Sodium Chloride

    This medication is given as a sterile 0.9% saline solution that is infused directly into a vein. It is a well‑established electrolyte used worldwide as a fluid replacement and as a neutral control in many studies. It helps keep the body’s water and salt balance normal but has no specific disease‑treating effect in this trial. It is classified as an electrolyte solution and works by simply providing sodium and chloride ions that the body can use.

  • Tranexamic Acid

    This drug is supplied as a clear solution for injection or infusion that is administered intravenously during surgery. It is an approved medication used to reduce bleeding in many types of surgery and trauma, and its safety is well documented in medical literature. It works by blocking the breakdown of blood clots, which helps keep bleeding under control, and it belongs to the class of antifibrinolytic agents. In this trial it is being tested to see if it can lower infection rates after foot surgery.

Investigated diseases

  • Deformity

    A deformity is an abnormal shape or alignment of a bone or joint that develops over time. It can result from growth disturbances, injury, or long‑standing pressure on the structure. As the condition progresses, the affected part may become more visibly misshapen and may limit normal movement. The surrounding muscles and ligaments can adapt to the altered shape, sometimes causing discomfort or reduced function.

  • Osteoarthritis

    Osteoarthritis is a joint disease where the cartilage that cushions the ends of bones gradually wears away. This loss of cartilage leads to the bones rubbing together, which can cause the joint surface to become rough. Over time, the joint may develop small bone growths and the surrounding tissue can become inflamed. The condition usually progresses slowly, with increasing stiffness and reduced range of motion. The affected joint may feel less stable as the disease advances.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-526142-27-01Estimated enrolment450 patientsSponsorHUS-yhtymae

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