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临床试验/NL-OMON56747
NL-OMON56747尚未招募不适用

*Systemic Metal Ion Concentrations in Patients with a PEEK HD coupling mechanism in the Modular Mega-prostheses of the Knee; a prospective cohort pilot study* - Metal-ions in patients with the PEEK HD coupling mechanism of the knee

eids Universitair Medisch Centrum0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
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
Observational

入排标准

年龄范围
18 至 99(—)

入选标准

  • In order to be eligible to participate in this study, a subject must meet all
  • of the following criteria: The patient
  • 1) is 18 years of age or older
  • 2) receives a MUTARS knee replacement with PEEK HD coupling mechanism, or
  • undergoes a revision (for any reason) of a MUTARS knee replacement during which
  • the MoM coupling mechanism is revised for a PEEK HD coupling mechanism
  • 3) Is able to give informed consent

排除标准

  • A potential subject who meets any of the following criteria will be excluded
  • from participation in this study:
  • 1) Anamnestic use of metal containing nutritional supplements or medications
  • 2) Contact with metal ions in the work environment
  • 3) Renal insufficiency defined as an eGFR<60 ml/min
  • 4) Presence of implants containing Cobalt and Chrome (including non-orthopaedic
  • implants such as stents and dental implants)

研究者

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