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
- Conditions
- Proximal humeral fracture
- Registration Number
- DRKS00027081
- Lead Sponsor
- Campus Virchow-KlinikumAugustenburger Platz 113353 BerlinCharité Campus Charité Mitte
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
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;
Single low energy fracture;
Surgery done within the first 96 hours from injury
•Immunosuppression due to illness or medication
•Subject has malignancy undergoing treatment including chemotherapy, radiotherapy or immunotherapy
•Known allergies to Iloprost
•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)
•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).
•Subjects who are legally detained in an official institute
•Patients who are dependent on sponsor, investigator or study site
•Past history of previous same side proximal humeral surgery
•Past history of same side proximal humeral deformity
•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
•Subjects unable to freely give their informed consent (e.g. individuals
under legal guardianship)
•Patients who are committed to an institution by virtue of an order
issued either by the judicial or the administrative authorities
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Identification of any noxious response or toxicity that has a causal relationship to the treatment. Toxicity shall be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).<br>Efficacy analysis using the Tip Apex Distance (TAD) readout Time Frame: 12 weeks after surgery <br>
- Secondary Outcome Measures
Name Time Method Rate of humeral head necrosis,<br>Humeral head shaft angle,<br>Pain assessment (VAS),<br>Quality of life (EQ-5D),<br>Constant-Murley Score (CMS),<br>Disabilities of the Arm, Shoulder and Hand score (DASH)