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

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What is this study about?

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.

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 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 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 post-surgery monitoring

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

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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Charite Universitaetsmedizin Berlin KöR Berlin Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
21.09.2022

Trial locations

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.

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 ID:
2024-512468-71-00
Protocol code:
Ilobone (SIFU17)
NCT ID:
NCT04543682
Trial Phase:
Human Pharmacology (Phase I) – Other

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