Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A phase I/IIa, prospective, mono-center, randomized, open labeled, controlled study to assess the safety and efficacy of applying Iloprost locally in the fracture site to promote bone healing in patients with proximal humeral fracture - ILOBONE

This research study, called ILOBONE, is investigating a new approach to help people with a broken bone in the upper part of their arm (proximal humeral fracture). The main goal is to find out if applying a medicine called Iloprost directly to the broken bone during surgery is safe. Researchers will carefully watch for any side effects and how serious they might be. They also want to see if this medicine can help the bone heal better. This study is testing the medicine in an early stage, focusing on safety first, and then looking at how well it works to improve healing, reduce pain, and improve arm function and quality of life for patients.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Charite Universitaetsmedizin Berlin KöR

Enrolment target

Start

04 Nov 2024

Proximal humeral fracture

What is this study about?

Imagine you've broken the top part of your arm bone, near your shoulder. This is called a proximal humeral fracture. Often, surgery is needed to fix it, but sometimes the bone can take a long time to heal, or it might not heal as well as hoped. This study is exploring a new way to try and improve that healing process.

The researchers are testing a medicine called Iloprost. Instead of taking it by mouth or injection into a vein, they will apply a very small amount of this medicine directly to the broken bone area during surgery. They believe this might help improve blood flow to the area and encourage the bone to repair itself more effectively.

The main purpose of this early-stage study is to first make sure that applying Iloprost this way is safe and doesn't cause any serious or unexpected problems. They'll also be closely monitoring how well patients recover, looking at things like pain levels, arm movement, and how it impacts their daily life. The hope is that this treatment could lead to faster and better healing for people with this type of broken arm.

Key takeaways

Tests a new medicine (Iloprost) for broken upper arm bones.
Medicine applied directly to the fracture during surgery.
Main focus is on safety and monitoring for side effects.
Also looking at how well the bone heals and if pain improves.
Open to adults aged 18 and over, both men and women.

Who may be eligible?

To be part of this study, you would need to be an adult, 18 years old or older. The study is open to both men and women.

Because this study is looking at a specific type of broken arm bone (a proximal humeral fracture), you would need to have this particular injury. Before joining, a doctor would review your overall health and medical history to make sure the study treatment is suitable and safe for you to take part in.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a recent break in the upper part of your arm bone near the shoulder (proximal humeral fracture)?
Are you able to attend follow-up appointments?
Are you able to undergo surgery for your fracture?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be assigned to either receive the Iloprost medicine applied to your fracture during surgery, or to a group that receives standard care. You wouldn't know which group you are in, and neither would your doctor. After your surgery, you would have several follow-up visits with the study team. These visits would involve checks on how your arm is healing, assessments of your pain, and questions about your quality of life and how well you can use your arm and shoulder. You would also have X-rays taken to monitor bone healing. The exact number of visits and the total length of your participation would be explained in detail by the study team, but generally, studies like this involve regular check-ups over several months to a year.

Potential risks and benefits

Taking part in any study has potential upsides and downsides. A potential benefit of this study is that the Iloprost medicine might help your broken arm heal better or faster than standard care, which could lead to improved movement and less pain. However, there's also a chance that the medicine might not work, or it could cause side effects or unexpected reactions. The research team will carefully monitor you for any problems. You would be given full information about any known side effects before you decide to join. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Germany

Common questions

What kind of broken arm is this study for?

This study is for a specific break in the upper arm bone, close to the shoulder, called a proximal humeral fracture.

What is Iloprost?

Iloprost is a medicine that researchers believe might help improve blood flow and encourage bone healing when applied directly to a fracture.

Will I know if I'm getting the study medicine or not?

No, this is a 'blinded' study, meaning neither you nor your doctor will know if you're receiving the Iloprost or standard care to keep the results fair and unbiased.

What are the main things the doctors are looking for?

The main goal is to check if applying Iloprost to the broken bone is safe. They will also look at how well your arm heals, your pain levels, and your general quality of life.

Can I stop participating in the study once I've started?

Yes, you are free to leave the study at any time, for any reason, and it will not affect your medical care.