2024-512468-71-00招募中2 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
Charite Universitaetsmedizin Berlin KöR, Charite Universitaetsmedizin Berlin KöR1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年11月4日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 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).
研究概览
简要总结
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.
研究设计
- 分配方式
- Randomized
- 主要目的
- Ilobone
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
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;
排除标准
- •Immunosuppression due to illness or medication
- •Polytrauma patient
- •Subject has malignancy undergoing treatment including chemotherapy, radiotherapy or immunotherapy
- •Known allergies to Iloprost
- •Past history of same side proximal humeral fracture or deformity
- •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)
- •Conditions where the effects of Iloprost on platelets might increase the risk of haemorrhage (e.g.active peptic ulcers or intracranial haemorrhage).
- •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.
- •Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension.
- •Pathological or open fracture.
结局指标
主要结局
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).
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).
次要结局
- 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)
研究者
Centrum für Muskuloskeletale Chirurgie
Scientific
Charite Universitaetsmedizin Berlin KöR
研究点 (1)
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