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临床试验/NCT02424903
NCT02424903Unknown不适用

European Prosthetic Joint Infection Cohort Study (EPJIC): Evaluation of the Treatment Approach for Hip, Knee and Shoulder Prosthetic Joint Revision Surgery

Pro-Implant Foundation1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
5,000
试验地点
1
主要终点
Infection outcome

研究概览

简要总结

The purpose of the study is to compare different approaches for the treatment of prosthetic joint revisions and to optimize the outcomes in patients with prosthetic joint infections (PJI) by improving the treatment concept of PJI.

详细描述

The aim of the study is to assess the impact of different surgical and antibiotic therapies on patients admitted for a septic or aseptic revision of the hip, knee or shoulder prosthesis. The decision whether the implant will be retained or removed or antimicrobial treatment is based on criteria of each participating center specialists.The success of different treatment algorithms will be measured in terms of infection free interval, functional outcome and quality of life. All consecutive patients who need a revision surgery to the hip, knee or shoulder will be included. Furthermore the study will investigate different diagnostic tests (microbiological and histological) for the diagnosis and the discrimination of septic and aseptic causes in prosthesis failures. Pathogens (microorganisms isolated from puncture of the joint, tissue samples sonication fluid and blood) will be collected to establish a biobank.The samples are obtained preoperatively and intraoperatively as part of routine care practice. The study is not randomized.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • subject is older than 18 years of Age
  • written informed consent has been obtained
  • subject Needs a Revision surgery of the hip, knee or shoulder prosthesis

排除标准

  • subject is currently enrolled in another investigational study
  • inability to read and understand the participant's Information
  • subject is younger than 18 years of age

结局指标

主要结局

Infection outcome

时间窗: 12 months after surgery

The infection-free status is defined as absence of clinical (e.g. no fistula), laboratory (e.g. normal C-reactive protein) and radiological signs of infection (e.g. no septic loosening).

次要结局

  • Functional outcome(12 months after surgery)
  • lifequality evaluation(12 months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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