DRKS00022404招募中2 期
Core decompression versus core decompression followed by infusion of Iloprost in thetreatment of non-traumatic avascular necrosis of the femoral head - ILONA
niversität Leipzig0 个研究点目标入组 38 人开始时间: 2021年8月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 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
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1. non-traumatic avascular necrosis of the femural head
- •2. 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) AND
- •b.MRI of both sides of the hip
- •Note: In patients where both hips are affected, the clinically more severely affected hip schould be considered for inclusion. (Cases, where both hips are affected may be discussed with the coordinating investigator upfront to trial participation.)
- •3. Age 18 - 65 years (for patients older than 50 years the differential diagnosis rapidly destructive osteoarthritis must be ruled out)
- •4. Body weight 50 - 110 kg
- •5. Written informed consent
排除标准
- •1. patients with N-ANFH of other known aetiology:
- •a. ongoing chemotherapy or Chemotherapy within the last 12 months
- •b. ongoing alcohol abuse or alcohol abuse within the last 6 months
- •c. renal insufficiency
- •d. kidney transplantation within the last 12 months
- •e. sickle cell anaemia
- •f. Gaucher’s dieseas (morbus gaucher)
- •2. patients who previously underwent core decompression on one side of the hip
- •3. patients previously treated with iloprost
- •4. contraindications to Iloprost
- •5. situations 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)
- •6. severe coronary heart disease or unstable angina
- •7. myocardial infarction within the last six months
- •8. decompensated cardiac failure if not under close medical supervision
- •9. Severe arrhythmias
- •10. Suspected pulmonary congestion
- •11. Cerebrovascular events (e.g. transient ischaemic attack, stroke) within the last three months
- •12. acute or chronic congestive heart failure staged NYHA II-IV
- •13. pulmonary hypertension due to venous occlusive disease
- •14. congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension
- •15. liver cirrhosis
- •16. infection with SARS-2-CoV requiring hospitalisation in the last seven weeks prior to core decompression
- •17. known vascular aneurysm
- •18. fertile women without appropriate contraceptive measures
- •19. previous participation in the ILONA trial
- •20. participation in other interventional trials
- •21. patients under legal supervision or guardianship
- •22. physiological, psychological/mental or other inabilities to supply required information (e.g. fill out the questionnaire due to dementia, language difficulties, ...)
- •23. suspected lack of compliance
- •24. pregnant or nursing women
研究者
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