A Metagenomic Next-generation Sequencing (mNGS)-Guided Sequential Culture Strategy for Postoperative Cruciate Ligament Reconstruction Infection (CLRI): a Retrospective Cohort Study
1 other identifier
observational
80
1 country
1
Brief Summary
This retrospective cohort study evaluates a sequential diagnostic strategy for patients with postoperative cruciate ligament reconstruction infection (CLRI). Diagnosing these infections is often difficult because conventional laboratory cultures can easily miss fastidious or slow-growing microorganisms. This study investigates whether using a rapid DNA-based test called metagenomic next-generation sequencing (mNGS) to guide and customize subsequent laboratory culture conditions can improve the detection rate of viable, live pathogens. The study includes 50 patients with CLRI and 30 patients with aseptic failure (non-infectious complications). The ultimate goal is to determine if this mNGS-guided modified culture strategy can help doctors identify the exact infection-causing germs more accurately, thereby allowing them to provide targeted, individualized antibiotic and surgical treatments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 5, 2026
CompletedFirst Submitted
Initial submission to the registry
September 25, 2026
CompletedFirst Posted
Study publicly available on registry
October 1, 2026
CompletedOctober 1, 2026
September 1, 2026
11 years
September 25, 2026
September 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pathogen Detection Rate
The percentage of patients in whom potential or viable microorganisms were successfully detected from pre-therapy synovial fluid. This measure compares the diagnostic yield among pre-therapy conventional culture, pre-therapy metagenomic next-generation sequencing (mNGS), and the mNGS-guided modified culture strategy.
Up to 14 days after synovial fluid aspiration (based on the maximum culture incubation period).
Secondary Outcomes (1)
Rate of Clinical Infection Control (Treatment Success)
At the last follow-up (minimum 6 months after discharge).
Study Arms (2)
CLRI Group
Patients clinically diagnosed with postoperative cruciate ligament reconstruction infection (CLRI) who underwent preoperative joint aspiration.
Aseptic Failure (AF) Group
Comparator patients undergoing revision surgery for aseptic failure (AF), defined by the absence of clinical, laboratory, imaging, and microbiological evidence of infection.
Interventions
Pre-therapy synovial fluid was analyzed by mNGS to rapidly detect microbial nucleic acids and identify potential pathogens.
A subsequent synovial fluid culture protocol customized based on pre-therapy mNGS results, utilizing specialized media, prolonged incubation, or specific atmospheric conditions to improve viable pathogen recovery.
Routine aerobic and anaerobic microbiological culture methods used as the standard baseline test.
Eligibility Criteria
The study population consists of patients who were evaluated and treated for suspected postoperative cruciate ligament reconstruction infection (CLRI) or who underwent revision surgery for aseptic failure (AF) at a single tertiary referral center (The First Affiliated Hospital of Fujian Medical University) between January 2015 and January 2026. This includes both patients treated primarily at this center and those referred from other hospitals.
You may qualify if:
- Clinically diagnosed cruciate ligament reconstruction infection (CLRI) or patients who underwent revision surgery for aseptic failure (AF).
- Preoperative joint aspiration performed at our institution.
- Adequate preoperative samples available for concurrent microbial culture and metagenomic next-generation sequencing (mNGS) testing.
- Complete clinical and laboratory data.
You may not qualify if:
- Specimen contamination (e.g., specimens clearly contaminated during collection or processing, or microorganisms isolated from only a single culture that did not align with the clinical judgement of the expert team).
- Concomitant systemic inflammatory disease or malignancy that could interfere with laboratory test results.
- Long-term use of immunosuppressive drugs or corticosteroids.
- Missing key clinical data.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Liu Zhang
First Affiliated Hospital of Fujian Medical University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief physician
Study Record Dates
First Submitted
September 25, 2026
First Posted
October 1, 2026
Study Start
January 1, 2015
Primary Completion
January 5, 2026
Study Completion
February 5, 2026
Last Updated
October 1, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ANALYTIC CODE
The datasets analysed during the current study are not publicly available because they contain information that could compromise patient privacy, but are available from the corresponding author on reasonable request.