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临床试验/NCT07009392
NCT07009392招募中不适用

Microbiological Molecular Profile of the Knee Joint During Primary Reconstruction or Revision Surgery of the ACL

GCS Ramsay Santé pour l'Enseignement et la Recherche1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年6月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Knee microbiome description

研究概览

简要总结

Anterior cruciate ligament (ACL) reconstructions are common surgical procedures, but a significant number fail for reasons that are not fully understood.

Silent infections have been shown to cause failure after other orthopedic surgical procedures such as fracture fixation and joint replacement. Silent and subclinical infections, as well as disruptions in the knee joint microbiome, could therefore be potential causes of failure after ligament reconstruction.

Traditional infection diagnostic methods (microbiological cultures) are often inadequate to detect these silent infections due to a lack of sensitivity. New molecular techniques such as high-throughput sequencing or NGS (next-generation sequencing) overcome this sensitivity problem and have proven effective in diagnosing polymicrobial infections.

Increased sensitivity compared to traditional culture has been reported in numerous studies, with some demonstrating the ability of NGS to isolate the infectious organism(s) in up to 82% of culture-negative cases.

These studies demonstrate the importance of advanced sequencing technologies for the diagnosis and management of infections after ACL reconstruction, offering promising prospects for improving clinical outcomes.

At the Jean Mermoz Private Hospital, ACL reconstruction is performed using a graft that is previously immersed in vancomycin. In this context, this study will characterize the knee joint microbiome in the context of ACL reconstruction with a graft treated with antibiotics.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • •Patient undergoing primary ACL reconstruction or revision surgery
  • •Patient for whom access to the operative report of the primary ACL reconstruction is available
  • •Patient affiliated with or beneficiary of a social security system
  • •Patient who speaks French and has signed informed consent

排除标准

  • •Patients with preoperative signs or a history of knee joint infection
  • •Patients suffering from diabetes, cancer, or a chronic inflammatory disease
  • •Patients receiving immunosuppressive therapy
  • •Patients with elevated serum inflammatory markers
  • •Patients who have used intravenous drugs in the 3 months prior to surgery
  • •Patients who have used antibiotics in the 3 months prior to surgery
  • •Protected patients: adults under guardianship, curatorship, or other legal protection, persons deprived of their liberty by a judicial or administrative decision, persons under a protective measure, persons admitted to a health or social care facility for purposes other than research, and persons unable to express consent
  • •Pregnant or breastfeeding women

研究组 & 干预措施

NGS arm

Experimental

干预措施: NGS Analysis (Diagnostic Test)

结局指标

主要结局

Knee microbiome description

时间窗: Day 1

Presence/absence of bacteria in knee joint of patients with ACL reconstruction

次要结局

未报告次要终点

研究者

发起方
GCS Ramsay Santé pour l'Enseignement et la Recherche
申办方类型
Other
责任方
Sponsor

研究点 (1)

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