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临床试验/NCT03444571
NCT03444571Unknown不适用

PRO-DIAG: Improved Diagnosis of Prosthetic Joint Infections

Aalborg University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年2月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
2
主要终点
Improved diagnostic accuracy

研究概览

简要总结

Implantation of joint prostheses is currently the second largest diagnosis-related group in the Danish health service, and in view of the demographic development and spread of lifestyle diseases, this type of intervention is expected to continue to increase.

Unfortunately, 5% of patients experience significant discomforts and complications. The second most frequent and serious complication is infection. While the established laboratory analyses (culture of tissue biopsies) are good at diagnosing acute infections, they are not satisfactory to diagnose a large group of patients especially with chronic infections. This can lead to prolonged diagnosing time and even to wrong diagnosis.

Several studies have shown that analyses of prosthetic parts and the use of molecular biological methods for detecting infecting microorganisms can significantly improve diagnostics accuracy.

The purpose of this project is primarily to demonstrate that analyses of bacterial specific DNA (16S rRNA genes) can confirm or rule out infection as fast (or faster) as cultivation methods. Rapid clarification can promote targeted treatment and in order to demonstrate this, the trial is conducted as a randomized study. .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • revision of hip platelets (THA) or knee replacement (TKA) on indication of likely infection

排除标准

  • surgery within the last 4 months. The same applies to patients with short history of illness, pronounced acute symptoms and systemic response (reducing the likelihood of biofilm infection).

研究组 & 干预措施

Control

No Intervention

DNA based diagnosis

Experimental

干预措施: revision surgery (Procedure)

结局指标

主要结局

Improved diagnostic accuracy

时间窗: 6 months post surgery

DNA based method can detect patients with hidden chronic infections more often than culture

次要结局

未报告次要终点

研究者

发起方
Aalborg University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yijuan Xu

Post Doc

Aalborg University

研究点 (2)

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