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Study on Iloprost for Improving Bone Healing in Patients with Upper Arm Fracture

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What is this trial about?

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

This clinical trial is focused on studying the healing of fractures in the upper arm bone, specifically known as a proximal humeral fracture. The treatment being investigated is a medication called Iloprost, which is used in a concentrated form for infusion. The purpose of the study is to determine the safety of applying Iloprost directly to the fracture site during surgery to help improve bone healing.

Participants in the study will receive either the Iloprost treatment or a placebo. The study will monitor the healing process of the bone and assess any potential side effects or reactions to the treatment. The trial will also evaluate the overall quality of life, pain levels, and the function of the arm and shoulder after treatment.

The study will take place over a period of time, with regular follow-ups to check on the progress of bone healing and to ensure the safety of the treatment. The goal is to gather information that could lead to better treatment options for individuals with upper arm bone fractures in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Eligibility is determined based on age (40 to 80 years), type of fracture, and health status. A signed consent form is required.

  2. Step 2

    Surgery preparation

    Preparation for surgery involves planning for the use of a PHILOS plate, which is a specific type of metal plate used to stabilize the fracture.

  3. Step 3

    Surgical procedure

    During surgery, Iloprost is applied directly to the fracture site. This medication is a concentrate for infusion, intended to aid in bone healing.

  4. Step 4

    Post-surgery monitoring

    Monitoring for any adverse reactions or toxicity related to the treatment is conducted. This includes checking for any harmful responses.

  5. Step 5

    Follow-up assessments

    Regular assessments are conducted to evaluate the healing process. These include checking the angle of the humeral head, pain levels, and overall quality of life.

    Specific scores such as the Constant-Murley Score and the Disabilities of the Arm, Shoulder, and Hand score are used to measure recovery progress.

  6. Step 6

    Completion of study

    The study is expected to conclude by March 31, 2026. Final evaluations will be conducted to assess the overall effectiveness and safety of the treatment.

Who can join the trial?

4 criteria

  • Adults, both men and women, who are between 40 to 80 years old.
  • Patients who are scheduled to receive a specific type of surgery using a PHILOS plate for a broken bone in the upper arm near the shoulder. This is for a specific type of fracture classified as type 3 or 4 according to the Neer classification, which is a way doctors categorize the severity of the fracture.
  • Patients with an **ASA Score** of 2 or less. The ASA Score is a system used by doctors to assess the physical health of a patient before surgery, with lower scores indicating better health.
  • Patients must have signed a written informed consent form, which means they agree to participate in the study after being informed about all the details and risks.

Who cannot join the trial?

3 criteria

  • Patients with a **proximal humeral fracture** cannot participate. This is a type of break in the upper part of the arm bone near the shoulder.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population cannot participate. This means people who might need extra protection or care.
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Investigated drugs

Iloprost is a medication being studied for its potential to help heal bone fractures. In this trial, it is applied directly to the fracture site during surgery to see if it can improve the healing process for patients with a specific type of shoulder fracture.

What is already known about the treatment

Iloprost – Iloprost is administered locally at the fracture site during surgery to aid in bone healing. It is currently being studied in clinical trials to determine its safety and effectiveness for this purpose. The main therapeutic indication for Iloprost in this context is to promote healing in patients with proximal humeral fractures. At the molecular level, Iloprost works by mimicking prostacyclin, a natural compound in the body that helps to widen blood vessels and improve blood flow, which can enhance the healing process. It is classified pharmacologically as a prostacyclin analog.

Investigated diseases

Proximal humeral fracture – This condition involves a break in the upper part of the arm bone near the shoulder. It often occurs due to a fall or direct impact on the shoulder. The fracture can vary in severity, from a simple crack to a complete break with bone fragments. As the fracture heals, the bone may realign naturally or require intervention to ensure proper alignment. During the healing process, patients may experience pain, swelling, and limited shoulder movement. Over time, with appropriate care, the bone typically regains strength and function.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-512468-71-00Protocol codeIlobone (SIFU17)Estimated enrolment30 patientsSponsorCharite Universitaetsmedizin Berlin KöR

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