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A study of local iloprost therapy to improve bone healing in patients with high‑risk fractures

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What is this trial about?

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

The study investigates patients with a bone fracture who are considered at high risk for poor healing because they have high levels of a type of immune cell called CD8+ T effector memory cells re‑expressing CD45RA (TEMRA). The treatment being tested is a single local dose of iloprost given directly at the fracture site, compared with a saline solution used as a placebo. The purpose is to see whether the iloprost injection helps the bone heal faster.

Participants are identified before surgery, receive either the iloprost injection or the placebo during the operation, and then are followed for up to one year. Follow‑up visits include pain questionnaires, quality‑of‑life surveys, and imaging tests such as CT scans to look at bone healing at 18 weeks and later time points. Safety is also monitored by recording any side effects.

The research process

The trial runs in 10 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Join the Study (Baseline Visit)

    You attend the first study visit after giving consent to participate. The study team records your medical history, performs a physical examination, and draws blood to measure CD8+ T‑cell levels that identify a high risk of delayed bone healing.

    Standard X‑ray images of the fracture are taken to document the initial condition.

  2. Step 2

    Baseline Assessments

    Additional baseline tests are performed, including laboratory analyses and a review of any current medications.

    All information is entered into the study database before any treatment is given.

  3. Step 3

    Randomization

    You are assigned by a computer‑generated process to receive either the study medication iloprost or a placebo (saline solution). Neither you nor the clinical staff knows which treatment you receive, ensuring a double‑blind design.

  4. Step 4

    Local Administration of Study Medication

    During the surgical procedure to fix the fracture, a single local dose is given directly at the fracture site.

    If you are assigned to the active group, the dose is 0.36 µg per kilogram of body weight of iloprost prepared as a concentrate for infusion.

    If you are assigned to the control group, a 2.4 ml infusion of isotonic saline (placebo) is administered in the same manner.

    The medication is delivered by infusion through the surgical wound, and the administration lasts only a few minutes.

  5. Step 5

    Immediate Post‑operative Monitoring

    After the surgery, you are observed in the recovery area for a short period. Vital signs and the surgical site are checked regularly to ensure there are no immediate complications.

  6. Step 6

    Week 6 Follow‑up Visit

    You return to the clinic six weeks after surgery.

    A questionnaire is completed that includes a visual analog scale (VAS) pain score, where you rate your pain from 0 (no pain) to 10 (worst pain).

    Additional patient‑reported outcome measures (EQ‑5D‑5L, SMFA) are collected to assess overall health and function.

  7. Step 7

    Week 18 Follow‑up Visit (Primary Imaging)

    A computed tomography (CT) scan of the fracture is performed to evaluate bone healing, which is the primary endpoint of the study.

    You also repeat the pain and health questionnaires used at week 6.

  8. Step 8

    Week 36 Follow‑up Visit (Secondary Imaging)

    X‑ray images of the fracture are taken and assessed using the RUSH and mRUST scoring systems, which provide additional information about bone healing.

    The same set of patient‑reported outcome questionnaires is completed again.

  9. Step 9

    Week 52 Final Follow‑up Visit

    You attend the final study visit one year after surgery.

    The visit focuses on patient‑reported outcomes, including pain level, health status, and return‑to‑work status.

    No additional imaging is required unless clinically indicated.

  10. Step 10

    End of Study

    All study data are compiled, and your participation in the trial is concluded.

    You receive a summary of the study results when they become publicly available.

Who can join the trial?

7 criteria

  • Signed a written agreement called informed consent before any study procedures are done.
  • Be a man or woman aged between 18 and 80 years at the time of screening.
  • Have a recent acute fracture, meaning the broken bone is no more than 10 days old when screened.
  • Have a fracture that fits the AO classification system, which includes specific types of clavicle, humerus, radius, ulna, femur, or tibia breaks.
  • Plan to be treated with ORIF (open reduction and internal fixation), a surgery that realigns the bone and holds it with plates or screws.
  • Show a CD8+ TEMRA‑high immune profile, defined as at least 38% of certain immune cells called late‑stage effector memory CD8+ T cells in your peripheral blood.
  • If you have more than one eligible fracture, the study will use the fracture with the highest complexity according to the AO classification (A = low, C = high).

Who cannot join the trial?

5 criteria

  • You must be able to understand the study and give your informed consent (a clear, voluntary agreement after being fully explained).
  • You cannot have a condition or be taking medicines that cause immunosuppression (weakening of the body's ability to fight infections).
  • You cannot have an active cancer (malignancy) that is being treated with chemotherapy (drug treatment), radiotherapy (radiation treatment), immunotherapy (treatment that uses the immune system), or any other active cancer therapy.
  • You must not be allergic (hypersensitivity) to the study drug iloprost or any of its inactive ingredients (excipients).
  • You cannot have health problems that raise the chance of bleeding because of medicines that stop platelets from clumping (platelet inhibition), such as an ongoing peptic ulcer disease (stomach or duodenal sore) or a bleeding in the brain (intracranial hemorrhage).
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Investigated drugs

Ilomedin is a medication that contains the active ingredient iloprost. In this study it is given directly to the place where the bone is broken, using a small infusion. The purpose of the drug is to help the bone heal faster and more completely in patients who are at high risk of not healing well. Researchers are testing whether a single local dose of iloprost can improve bone healing compared with not receiving the active drug.

What is already known about the treatment

  • Iloprost

    Iloprost is supplied as a concentrate that is mixed with fluid and given by infusion directly at the fracture site. It is an approved medicine for conditions like pulmonary hypertension and is being studied for bone healing. The drug works by widening small blood vessels and stopping platelets from clumping, which improves blood flow to the injured bone. It belongs to the prostacyclin‑analog class of vasodilators and antiplatelet agents.

  • Sodium chloride

    Sodium chloride is provided as a 0.9 % isotonic saline solution for infusion and is used in this trial as a placebo. It is a standard fluid used worldwide to replace lost water and electrolytes and has no specific effect on bone repair. The solution simply restores normal salt and water balance in the body. It is classified as an electrolyte solution, also known as an isotonic crystalloid.

Investigated diseases

Bone fracture - A bone fracture is a break or crack in a bone that disrupts its normal structure. After a fracture, the body initiates a repair process that forms new bone tissue to restore strength. In some individuals, elevated levels of certain immune cells (CD8+ TEMRA cells) before surgery can make the healing process slower or incomplete. These patients are considered at high risk for impaired fracture healing. The condition progresses from the initial break through stages of inflammation, soft callus formation, hard callus formation, and finally bone remodeling.
Trial detailsLast updated 15 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-527568-34-00Protocol codePRE-26Estimated enrolment60 patientsSponsorCharite Universitaetsmedizin Berlin KöR

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