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Arthrocentesis Study

2015年8月20日 更新者:Andrej Trampuz、Charite University, Berlin, Germany

Early Diagnostics of Septic Arthritis and Periprosthetic Joint Infections With Calorimetry and Polymerase Chain Reaction (PCR) of Synovial Aspirate Fluid

The purpose of this study is to analyze pre- and intra-operative joint aspirates of native joints and joints with suspicion of periprosthetic joint infection (PJI) of the hip, knee and shoulder acquired in clinical routine. Joint aspirates are then analyzed with new diagnostic methods (microcalorimetry, PCR, alpha-defensin, etc.). Diagnostic speed and accuracy of these methods is compared to standard diagnostic methods in clinical routine, such as blood cultures of joint aspirates, cell count/differential, intra-operative tissue culture and histology and sonication.

研究概览

地位

未知

详细说明

In this study, joint aspirate of patients that undergo joint aspiration in the context of routine pre- and intra-operative clinical diagnosis of a hip, knee or shoulder joint is collected. Routine joint punctures at our clinic are regularly performed in the emergency room, in the outpatient clinic and intra-operatively during diagnostic and revision surgery. A minimum of 5 ml aspiration fluid was required for inclusion in this study. Empty or diluted aspirations were excluded.

Joint aspirations are performed by orthopaedic surgeons with an 18-gauge needle according to standardized aseptic technique. Intraoperative punctures are performed prior to arthrotomy. A minimum of 1ml of joint aspirate is immediately transferred to a native study vial for our study, a native vial for gram stain and culture and a native vial for polarization microscopy, respectively. A minimum of 1 ml joint aspirate is transferred to an ethylenediaminetetraacetic acid (EDTA) vial for the determination of leucocyte count. Finally, a minimum of 1 ml is inoculated into a paediatric blood culture bottle.

Standard microbiological methods are performed in an external laboratory that routinely collaborates with our clinic. Leucocyte count is performed automatically with the mentioned EDTA vial. Polarization microscopy is performed at our pathohistological department in order to detect crystals and signs of infection in joint aspirate.

If written informational consent has been signed by the patient, the study vial is immediately transported to our internal laboratory for analysis with new diagnostic methods (microcalorimetry, PCR, etc.). When an immediate transportation was not feasible, the vial is stored in a cooling fridge at +3° C until transportation was possible.

Each case is individually reviewed and classified by an experienced infectiologist taking the case's clinical history and laboratory results into account.

研究类型

观察性的

注册 (预期的)

400

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Berlin、德国、17110
        • 招聘中
        • Charité University Berlin
        • 接触:
        • 首席研究员:
          • Andrej Trampuz, MD
        • 副研究员:
          • Christian Morgenstern, MD,PhD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Any patient with suspicion of septic arthritis or periprosthetic joint infection of the hip, knee and shoulder being diagnosed or treated in our facility in a clinical routine scenario willing to participate in this study (written informational consent)

描述

Inclusion Criteria:

  • adult of 18 or more years
  • written consent to participate in study
  • suspicion of septic arthritis or periprosthetic joint infection
  • joint aspirate minimum of 5 ml

Exclusion Criteria:

  • is not able to understand the aim or purpose of this study
  • empty joint aspirate

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Periprosthetic joint infection
Patients with suspected periprosthetic joint infection of the hip, knee and shoulder
Septic arthritis
Patients with suspected septic arthritis of a native joint of the hip, knee and shoulder

研究衡量的是什么?

主要结果指标

结果测量
大体时间
growth of microbial agent in culture of joint aspirate
大体时间:14 days
14 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Andrej Trampuz, MD、Charité University Berlin

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年11月1日

初级完成 (预期的)

2016年11月1日

研究完成 (预期的)

2016年11月1日

研究注册日期

首次提交

2015年8月19日

首先提交符合 QC 标准的

2015年8月20日

首次发布 (估计)

2015年8月21日

研究记录更新

最后更新发布 (估计)

2015年8月21日

上次提交的符合 QC 标准的更新

2015年8月20日

最后验证

2015年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • EA1/306/14

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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