EUCTR2017-003813-24-DE进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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