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A clinical trial investigating Iloprost as medication to improve bone healing in patients with upper arm bone fracture.
EU CTIS ID: 2024-512468-71-00
What this study is testing
The main objective of this study is to establish the safety of intraoperative local insertion of Iloprost at the fracture site for bone healing of the proximal humeral fracture.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult male or female subjects between 40 to 80 years of age old at the time of screening visit
- Scheduled PHILOS plate for proximal humeral fracture with angle stable plate (3 holes PHILOS plate, synthes) for proximal humerus fracture type 3 or 4 according to Neer classification
- ASA Score score ≤ 2;
- Signed written informed consent;
You likely can't join if
- Immunosuppression due to illness or medication
- Polytrauma patient
- Subject has malignancy undergoing treatment including chemotherapy, radiotherapy or immunotherapy
- Known allergies to Iloprost
- Past history of same side proximal humeral fracture or deformity
- Pregnant or breast-feeding women or women of childbearing potential not protected by an effective contraceptive method of birth control (defined as pearl index < 1)
See the full eligibility criteria
- Adult male or female subjects between 40 to 80 years of age old at the time of screening visit
- Scheduled PHILOS plate for proximal humeral fracture with angle stable plate (3 holes PHILOS plate, synthes) for proximal humerus fracture type 3 or 4 according to Neer classification
- ASA Score score ≤ 2;
- Signed written informed consent;
- Immunosuppression due to illness or medication
- Polytrauma patient
- Subject has malignancy undergoing treatment including chemotherapy, radiotherapy or immunotherapy
- Known allergies to Iloprost
- Past history of same side proximal humeral fracture or deformity
- Pregnant or breast-feeding women or women of childbearing potential not protected by an effective contraceptive method of birth control (defined as pearl index < 1)
- Conditions where the effects of Iloprost on platelets might increase the risk of haemorrhage (e.g.active peptic ulcers or intracranial haemorrhage).
- Severe coronary heart disease or unstable angina; myocardial infarction within the last six months; decompensated cardiac failure if not under close medical supervision; severe arrhythmias; suspected pulmonary congestion; cerebrovascular events (e.g., transient ischaemic attack, stroke) within the last 3 months.
- Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension.
- Pathological or open fracture.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.