Clinical Trial

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

Study acronym: INFECTIOGEN
Active, Not Recruiting
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Record status
This record was last updated June 6, 2025 (before its estimated June 15, 2026 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT07009392
Lead Sponsor GCS Ramsay Santé pour l'Enseignement et la Recherche
Conditions ACL - Anterior Cruciate Ligament Rupture
Enrollment 100 participants
Start Date 2025-05-15
Primary Completion 2026-06-15 (estimated)
Study Completion 2026-06-15 (estimated)
Updated on ClinicalTrials.gov 2025-06-06