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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

ACL - Anterior Cruciate Ligament Rupture Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Privé Jean Mermoz

Lyon, 69008, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

NGS Analysis

Diagnostic Test

NGS (Next Generation Sequencing) analysis is performed on tissue from ACL

Primary outcomes

Knee microbiome description

Time frame: Day 1

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

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Acronym: INFECTIOGEN

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jun 6, 2025
Registry last updated: Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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