Proximal humeral fracture
Conditions
Interventions
Trade Name: Ilomedin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ILOPROST
CAS Number: 78919-13-8
Concentration unit: µg/ml microgram(s)/millilitre
Concentration ty
Sponsors
Charité-Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult male or female subjects between 60 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: •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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Not applicable;Primary end point(s): 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).;Timepoint(s) of evaluation of this end point: Post-operative (before discharge),week 3, week 6, week 12, week 26 and week 52. ;Main Objective: 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Rate of humeral head necrosis •Humeral head shaft angle •Pain assessment (VAS) •Quality of life (EQ-5D) •Constant-Murley Score (CMS) •Disabilities of the Arm, Shoulder and Hand score (DASH) ;Timepoint(s) of evaluation of this end point: Post-operative (before discharge), week 3, week 6, week 12, week 26 and week 52. | — |
Countries
Germany
Contacts
Public ContactBCRT-Clinical Development Platform
Charité Universitätsmedizin Berlin
Outcome results
None listed