EUCTR2020-000624-20-DE进行中（未招募）1 期
Core decompression versus core decompression followed by infusion of Iloprost in thetreatment of idiopathic non-traumatic avascular necrosis of the femoral head - ILONA
eipzig University0 个研究点目标入组 38 人开始时间: 2021年4月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 38
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
- •1.Idiopathic non-traumatic avascular necrosis of the femural head
- •2.Core Lab evaluation: ARCO stage I or II diagnosed and confirmed by:
- •a.X-ray of both sides of the hip (Pelvis overview and both sides of the hip in Lauenstein position)
- •b.MRI of both sides of the hip
- •Note: In patients where both hips are affected, the clinically more severely affected hip will be considered for inclusion.
- •3.Age 18 - 50 years (maximum of 50 years is defined to prevent confusion with rapidly destructive osteoarthritis)
- •4. body weight 50 - 110 kg
- •5.Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 38
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Patients with N-ANFH of other known aetiology
- •a.Ongoing systemic cortisol therapy or local treatment at the hip joint or
- •b.Chemotherapy or
- •c.Alcohol abuse (anamnestic assessment) or
- •d.Renal insufficiency [GFR <50ml/min/1,73m2 (compensated renal insufficiency) or <60ml for the duration of more than three months]
- •e.Kidney transplantation
- •f.Rheumatism
- •g.Sickle cell anaemia
- •h.Gaucher’s dieseas (Morbus Gaucher)
- •i.Caisson disease
- •j.Systemic lupus erythematosus
- •2.Patients with multiple osteonecrosis
- •3.Patients who previously underwent core decompression on one side of the hip
- •4.Patients previously treated with Iloprost
- •5.Contraindications to Iloprost such as hypersensitivity to Iloprost or its excipients (Trometamol, Ethanol 96%, sodium chloride, hydrochloric acid)
- •6.Situations or parallel treatment in which the effect of the drug on the platelets could increase the risk of bleeding complications (e.g. active peptic ulcer, trauma, intracranial hemorrhage, treatment with NSAR in the last 4 days (or longer until the 5-fold half-life is reached)
- •7.Severe coronary heart disease or unstable angina
- •8.Myocardial infarction within the last six months
- •9.Decompensated cardiac failure if not under close medical supervision
- •10.Severe arrhythmias
- •11.Suspected pulmonary congestion
- •12.Cerebrovascular events (e.g. transient ischaemic attack, stroke) within the last three months
- •13.Acute or chronic congestive heart failure staged NYHA II-IV
- •14.Pulmonary hypertension due to venous occlusive disease
- •15.Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension
- •16.Liver cirrhosis
- •17.Infection with SARS-2-CoV requiring hospitalisation in the last seven weeks prior to core decompression
- •18.Known vascular aneurysm
- •19. Fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy) while participating in the trial (participants using a hormone-based method have to be informed of possible effects of the trial medication on contraception).
- •20.Previous participation in the ILONA trial
- •21.Participation in other interventional trials
- •22.Patients under legal supervision or guardianship
- •23.Physiological, psychological/mental or other inabilities to supply required information (e.g. fill out the questionnaire due to dementia, language difficulties, ...).
- •24.Suspected lack of compliance
- •25.Pregnant or nursing women (negative pregnancy test is required)
研究者
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