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RecruitingNCT07009392INFECTIOGENUpdated Aug 20, 2026

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

An interventional study of NGS Analysis in ACL - Anterior Cruciate Ligament Rupture, sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • ACL - Anterior Cruciate Ligament Rupture
03

In context

Anterior Cruciate Ligament Injuries

511 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 163 are open to participants now.

This study's planned enrollment of 100 is above the median of 56 across 372 interventional studies indexed under Anterior Cruciate Ligament Injuries.

Browse Anterior Cruciate Ligament Injuries studies →

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche is the lead sponsor of 198 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    NGS arm

    Diagnostic Test: NGS Analysis

Interventions

  • Diagnostic testNGS Analysis

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

06

What researchers measure

Primary outcomes

  1. Knee microbiome description

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

    Time frame: Day 1

07

Study locations

1 of 1 sites recruiting
  • Hôpital Privé Jean Mermoz
    Lyon, 69008, France
    • Bertrand SONNERY-COTTET, MD · Contact · sonnerycottet@aol.com · +33437530022
    • Bertrand SONNERY-COTTET, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07009392
Lead sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
Responsible party
Sponsor
First posted
Jun 6, 2025
Start date
Jun 25, 2025
Primary completion
Sep 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Aug 20, 2026

Study contacts

Bertrand SONNERY-COTTET, MD
Contact
sonnerycottet@aol.com
+33437530022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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