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临床试验/DRKS00014555
DRKS00014555招募中不适用

Assessment of metal concentrations in cerebrospinal fluid, whole blood and serum of patients with arthroplasty implants in situ – a pilot study - NeuroWear I

Centrum für Muskuloskeletale Chirurgie, Charité - Universitätsmedizin Berlin, Campus Charité Mitte & Campus Virchow-Klinikum0 个研究点目标入组 60 人开始时间: 2018年4月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 Years 至 one(—)
性别
All

入选标准

  • written informed consent
  • age: = 18 years
  • denial of concurrent participation in interventional trial(s) affecting the German Drug Act (AMG / Arzneimittelgesetz)
  • scheduled for elective surgery under spinal anesthesia
  • only for the study group, not for the control group: at least one arthroplasty implant of the hip, knee, ankle, shoulder or elbow joint in situ
  • only for the control group: no arthroplasty implant of the hip, knee, ankle, shoulder or elbow joint in situ; matched on age (+/- 5 years) and sex with the study group

排除标准

  • no written informed consent
  • incapability to give informed consent
  • symptomatic heart failure NYHA = III
  • symptomatic heart valve disease = II°
  • hepatic insufficiency CHILD = B
  • acute or chronic renal failure necessitating dialysis
  • history of current or previous alcohol or other drug abuse
  • psychiatric disorder
  • prevalence of contraindications of lumbar puncture or spinal anesthesia

研究者

发起方
Centrum für Muskuloskeletale Chirurgie, Charité - Universitätsmedizin Berlin, Campus Charité Mitte & Campus Virchow-Klinikum

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