Cruciate Ligament Reconstruction InfectionNCT07852598
A Metagenomic Next-generation Sequencing (mNGS)-Guided Sequential Culture Strategy for Postoperative Cruciate Ligament Reconstruction Infection (CLRI): a Retrospective Cohort Study
An observational study of Cruciate Ligament Reconstruction Infection and Septic Arthritis, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cruciate Ligament Reconstruction Infection, Septic Arthritis, Surgical Wound Infection
- What is being tested?
- Metagenomic next-generation sequencing (mNGS), mNGS-guided modified culture and Conventional microbiological culture
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 5 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
About this study
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.
Read the detailed description
English Version :
This is a retrospective, single-center cohort study evaluating patients evaluated for suspected postoperative cruciate ligament reconstruction infection (CLRI) between January 2015 and January 2026. The study enrolled 50 patients who were clinically diagnosed with CLRI and 30 comparator patients who underwent revision surgery for aseptic failure (AF). Study Protocol:
Pre-therapy synovial fluid was aspirated under sterile conditions and divided into at least three aliquots. Conventional Culture: The first aliquot was processed immediately using routine aerobic and anaerobic microbiological culture methods (incubated for up to 7-14 days). mNGS Testing: The second aliquot was transported immediately for metagenomic next-generation sequencing (mNGS) testing to quickly identify potential microbial nucleic acids. mNGS-Guided Modified Culture: The third aliquot was preserved at -80°C. Once the mNGS result became available (within 48 hours), a clinical microbiologist reviewed the detected microorganisms and prescribed individualized modifications to the subsequent culture protocol for the preserved aliquot. These modifications were tailored to the suspected pathogen's biological characteristics and included the use of specialized culture media (e.g., Sabouraud dextrose agar, Mycobacteria Growth Indicator Tube systems), prolonged incubation, strictly anaerobic conditions, and supplementary identification procedures. Objectives and Assessments:
The primary objective is to compare the diagnostic yield (positive detection rates of viable pathogens) among pre-therapy conventional culture, pre-therapy mNGS, and the sequential mNGS-guided modified culture strategy. The study also evaluates how this enhanced, actionable microbiological information informs individualized clinical management. Specifically, it assesses treatment decision-making algorithms-integrating pathogen characteristics, infection duration, and graft/fixation mechanical stability-to determine the feasibility of non-operative antimicrobial management or graft-preserving surgical options such as debridement, antibiotics, and implant retention (DAIR).
- Conditions
- Cruciate Ligament Reconstruction Infection, Septic Arthritis, Surgical Wound Infection, Joint Infection
- Being tested
- Metagenomic next-generation sequencing (mNGS), mNGS-guided modified culture, Conventional microbiological culture
- Keywords
- metagenomic next-generation sequencing, mNGS, synovial fluid culture, pathogen detection, antimicrobial management
- Medical subject headings
- Arthritis, Infectious, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metagenomic next-generation sequencing (mNGS)Diagnostic test
Pre-therapy synovial fluid was analyzed by mNGS to rapidly detect microbial nucleic acids and identify potential pathogens.
mNGS-guided modified cultureDiagnostic test
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.
Conventional microbiological cultureDiagnostic test
Routine aerobic and anaerobic microbiological culture methods used as the standard baseline test.
| Study group | Role | What they receive |
|---|---|---|
| CLRI Group | Patients clinically diagnosed with postoperative cruciate ligament reconstruction infection (CLRI) who underwent preoperative joint aspiration. Receives: Diagnostic Test: Metagenomic next-generation sequencing (mNGS); Diagnostic Test: mNGS-guided modified culture; Diagnostic Test: Conventional microbiological culture | |
| 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. Receives: Diagnostic Test: Metagenomic next-generation sequencing (mNGS); Diagnostic Test: mNGS-guided modified culture; Diagnostic Test: Conventional microbiological culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
The percentage of patients achieving successful infection management and clinical infection control, defined according to the consensus criteria of the Musculoskeletal Infection Society (MSIS). This evaluates the clinical outcome after individualized antimicrobial and surgical management.
Measured: At the last follow-up (minimum 6 months after discharge).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Jan 2015
- Primary completion5 Jan 2026
- Study completion5 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cruciate Ligament Reconstruction InfectionStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinyu Fang, First Affiliated Hospital of Fujian Medical University
- Investigators
- Liu Zhang, Study director, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852598
- Sponsor's protocol ID
- MTCA,ECFAH FMU (2026) 357
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Metagenomic Next-generation Sequencing (mNGS)-Guided Sequential Culture Strategy for Postoperative Cruciate Ligament Reconstruction Infection (CLRI): a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07852598
- Acronym / sponsor ID
- MTCA,ECFAH FMU (2026) 357
- Conditions
- Cruciate Ligament Reconstruction Infection, Septic Arthritis, Surgical Wound Infection, Joint Infection
- Keywords
- metagenomic next-generation sequencing, mNGS, synovial fluid culture, pathogen detection, antimicrobial management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 5 Jan 2026 (actual)
- Study completion
- 5 Feb 2026 (actual)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
English Version :
This is a retrospective, single-center cohort study evaluating patients evaluated for suspected postoperative cruciate ligament reconstruction infection (CLRI) between January 2015 and January 2026. The study enrolled 50 patients who were clinically diagnosed with CLRI and 30 comparator patients who underwent revision surgery for aseptic failure (AF). Study Protocol:
Pre-therapy synovial fluid was aspirated under sterile conditions and divided into at least three aliquots. Conventional Culture: The first aliquot was processed immediately using routine aerobic and anaerobic microbiological culture methods (incubated for up to 7-14 days). mNGS Testing: The second aliquot was transported immediately for metagenomic next-generation sequencing (mNGS) testing to quickly identify potential microbial nucleic acids. mNGS-Guided Modified Culture: The third aliquot was preserved at -80°C. Once the mNGS result became available (within 48 hours), a clinical microbiologist reviewed the detected microorganisms and prescribed individualized modifications to the subsequent culture protocol for the preserved aliquot. These modifications were tailored to the suspected pathogen's biological characteristics and included the use of specialized culture media (e.g., Sabouraud dextrose agar, Mycobacteria Growth Indicator Tube systems), prolonged incubation, strictly anaerobic conditions, and supplementary identification procedures. Objectives and Assessments:
The primary objective is to compare the diagnostic yield (positive detection rates of viable pathogens) among pre-therapy conventional culture, pre-therapy mNGS, and the sequential mNGS-guided modified culture strategy. The study also evaluates how this enhanced, actionable microbiological information informs individualized clinical management. Specifically, it assesses treatment decision-making algorithms-integrating pathogen characteristics, infection duration, and graft/fixation mechanical stability-to determine the feasibility of non-operative antimicrobial management or graft-preserving surgical options such as debridement, antibiotics, and implant retention (DAIR).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLRI Group | – | Diagnostic Test: Metagenomic next-generation sequencing (mNGS), Diagnostic Test: mNGS-guided modified culture, Diagnostic Test: Conventional microbiological culturePatients clinically diagnosed with postoperative cruciate ligament reconstruction infection (CLRI) who underwent preoperative joint aspiration. |
| Aseptic Failure (AF) Group | – | Diagnostic Test: Metagenomic next-generation sequencing (mNGS), Diagnostic Test: mNGS-guided modified culture, Diagnostic Test: Conventional microbiological cultureComparator patients undergoing revision surgery for aseptic failure (AF), defined by the absence of clinical, laboratory, imaging, and microbiological evidence of infection. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metagenomic next-generation sequencing (mNGS)Pre-therapy synovial fluid was analyzed by mNGS to rapidly detect microbial nucleic acids and identify potential pathogens. | Diagnostic test | Aseptic Failure (AF) Group, CLRI Group |
| mNGS-guided modified cultureA 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. | Diagnostic test | Aseptic Failure (AF) Group, CLRI Group |
| Conventional microbiological cultureRoutine aerobic and anaerobic microbiological culture methods used as the standard baseline test. | Diagnostic test | Aseptic Failure (AF) Group, CLRI Group |
Primary outcome
Pathogen Detection Rate
Time frame: Up to 14 days after synovial fluid aspiration (based on the maximum culture incubation period).
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.
1 secondary outcome
Rate of Clinical Infection Control (Treatment Success)
Time frame: At the last follow-up (minimum 6 months after discharge).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liu Zhang study director
First Affiliated Hospital of Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cruciate Ligament Reconstruction Infection and Septic Arthritis, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathogen Detection Rate (time frame: Up to 14 days after synovial fluid aspiration (based on the maximum culture incubation period).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.