A Clinical Trial Investigating Iloprost as Medication to Improve Bone Healing in Patients With Proximal Humeral Fracture (Ilobone)
Proximal Humeral Fracture
About this trial
This is an interventional treatment trial for Proximal Humeral Fracture focused on measuring proximal humeral fracture, proximale Humerusfraktur, Ilomedin, Iloprost
Eligibility Criteria
Inclusion Criteria:
- Signed written informed consent.
- Adult male or female subjects between 60 to 80 years old at the time of screening visit.
- Scheduled Proximal Humerus Internal Locking System (PHILOS) with 3 holes plate length for proximal humerus fracture type 3 or 4 according to Neer classification.
- Patient with American Society of Anesthesiologists (ASA) score of ≤ 2.
- Single, low energy fracture.
- Absence of neurovascular complications at the time of trauma.
- Surgery done within the first 96 hours from injury.
Exclusion Criteria:
- Subjects unable to freely give their informed consent (e.g. individuals under legal guardianship).
- Immunosuppression due to illness or medication.
- Subject with malignancy and undergoing treatment including chemotherapy, radiotherapy or immunotherapy.
- Known allergies to Iloprost.
- Conditions where the effects of Iloprost on platelets might increase the risk of haemorrhage (e.g.active peptic ulcers, or intracranial hemorrhage).
- 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.
- Acute or chronic congestive heart failure (NYHA II-IV)
- Pulmonary hypertension due to venous occlusive disease.
- Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension.
- Subject who is currently enrolled in or has not yet completed a period of at least ( a period of time equal to 5 times as the half-life time of the drug used in the previous trial) since ending other investigational device or drug trial(s).
- Patients who are dependent on the sponsor, investigator or study site.
- History of previous proximal humerus surgery on the same side.
- History of proximal humerus deformity on the same side.
- Pathological or open fracture.
- Polytrauma patient.
- 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).
- Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the Investigator, may invalidate communication with the Investigator and/or designated study personnel.
- Patients who are committed to an institution by virtue of an order issued by either the judicial or the administrative authorities.
- Patients with a history of cerebral circulatory disorders.
- Patients with any symptomatic or treatable heart disease (including stenting), hypertension treated with a β-receptor blocker, calcium agonists, vasodilator or ACE (Angiotensin-converting-enzyme) inhibitor at more than moderate doses.
Sites / Locations
- Center for Muskuloskeletal Surgery, Charité - Universitätsmedizin BerlinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Other
First intervention group (0.125 ng/kg/min Iloprost)
Second intervention group (0.25 ng/kg/min Iloprost)
Control intervention group
The first intervention group will receive open reduction and internal fixation with an angular stable plate (PHILOS™ - Depuy Synthes) + Iloprost treatment. Patients will locally receive a dose of 0.125 ng/kg/min of Iloprost over 24 hours via a catheter and an electronic pump system. The catheter will be inserted during the surgical procedure. Infusion of Iloprost will start 24hrs post-operatively and the dose will be delivered over 24h.
The second intervention group will also receive open reduction and internal fixation with an angular stable plate (PHILOS™ - Depuy Synthes) + Iloprost treatment. Patients will locally receive a dose of 0.25 ng/kg/min of Iloprost over 24 hours via a catheter and an electronic pump system. Infusion will start 24hrs post-operatively and the dose will be delivered over 24h.
Control intervention: Patients will receive the standard of care procedure for such fractures, i.e. standard of care open reduction and internal fixation with an angular stable plate (PHILOS™ - Depuy Synthes).