DRKS00027081招募中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 - A Clinical Trial Investigating Iloprost as Medication to Improve Bone Healing in Patients With Proximal Humeral Fracture
Campus Virchow-KlinikumAugustenburger Platz 113353 BerlinCharité Campus Charité Mitte0 个研究点目标入组 30 人开始时间: 2021年11月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 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
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 40 Years 至 80 Years（—）
- 性别
- All
入选标准
- •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
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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