跳至主要内容
临床试验/NCT06804265
NCT06804265招募中不适用

Molecular Biology (Multiplex PCR) in the Identification of Pathogens at Reimplantation in the Two-Stage Treatment of Periprosthetic Infections (PJI)

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月7日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Accuracy, sensitivity and specificity of the PCR technique in identifying the pathogen responsible for PJIs

研究概览

简要总结

The goal of this observational study is to measure the diagnostic accuracy of the Multiplex PCR technique in identifying pathogens during the diagnostic stage of resolving pre-implantation infection, in the context of treatment according to two-stage protocol for PJIs. This evaluation will be conducted by comparing the results obtained by Multiplex PCR with those derived from standard culture examination.

详细描述

The data that will be collected are:

  1. Pre-implantation data: timing of infection, bacterial population involved, type of surgery (primary or revision implantation). Baseline characteristics of patients, such as gender, age, history of previous interventions (including date, number and type of interventions), comorbidities, ASA score, and lifestyle habits (such as smoking and alcohol) will also be recorded. Local problems of the operated limb and investigations performed, including instrumental and laboratory tests, will be documented.
  2. Data on explant surgery and postoperative course: details of whether or not spacer cement was used according to the two-stage protocol, the type of spacer cement used, the occurrence of intraoperative complications and the characteristics and duration of postoperative antibiotic therapy will be recorded. Results of molecular investigations will be documented, both pre-operative on ultrasound aspirate, intraoperative and 15 days after discontinuation of antibiotic therapy. Results of histological and culture examinations of the preoperative and intraoperative aspirate, postoperative complications will be included.
  3. Data related to reimplantation: timing of reimplantation, result of molecular, culture, and histological examinations on intraoperative specimens, post-reimplantation antibiotic therapy, intraoperative and postoperative complications, clinical status at follow-up (recurrence/persistence of infection), and duration of follow-up.

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

  • Diagnosis of periprosthetic infection of hip, knee, shoulder on primary or already revised implant.
  • treatment of infection with two-stage protocol.
  • Obtaining informed consent
  • Age ≥18 years

排除标准

  • Isolates obtained during explantation not included in MULTIPLEX PCR panel

结局指标

主要结局

Accuracy, sensitivity and specificity of the PCR technique in identifying the pathogen responsible for PJIs

时间窗: up to 100 weeks

comparison with the current diagnostic gold standard, represented by culture examination

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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