ACL - Anterior Cruciate Ligament RuptureINFECTIOGENNCT07009392
Microbiological Molecular Profile of the Knee Joint During Primary Reconstruction or Revision Surgery of the ACL
A study testing NGS Analysis in people with ACL - Anterior Cruciate Ligament Rupture, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ACL - Anterior Cruciate Ligament Rupture
- What is being tested?
- NGS Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2025to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Privé Jean Mermoz
Lyon, 69008
Bertrand SONNERY-COTTET, MD, +33437530022, sonnerycottet@aol.com
Bertrand SONNERY-COTTET, MD
About this study
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.
Read more
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.
- Conditions
- ACL - Anterior Cruciate Ligament Rupture
- Being tested
- NGS Analysis
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGS AnalysisDiagnostic test
NGS (Next Generation Sequencing) analysis is performed on tissue from ACL
| Study group | Role | What they receive |
|---|---|---|
| NGS arm | Experimental | Not described Receives: Diagnostic Test: NGS Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee microbiome description
Presence/absence of bacteria in knee joint of patients with ACL reconstruction
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start25 Jun 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL - Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009392
- Sponsor's protocol ID
- 2025-A00235-44
- Acronym
- INFECTIOGEN
- Status last verified
- Aug 2026
- First submitted
- 29 May 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiological Molecular Profile of the Knee Joint During Primary Reconstruction or Revision Surgery of the ACL
- ClinicalTrials.gov ID
- NCT07009392
- Acronym / sponsor ID
- INFECTIOGEN / 2025-A00235-44
- Conditions
- ACL - Anterior Cruciate Ligament Rupture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 6 Jun 2025 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NGS arm | Experimental | Diagnostic Test: NGS Analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| NGS AnalysisNGS (Next Generation Sequencing) analysis is performed on tissue from ACL | Diagnostic test | NGS arm |
Primary outcome
Knee microbiome description
Time frame: Day 1
Presence/absence of bacteria in knee joint of patients with ACL reconstruction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NGS Analysis in people with ACL - Anterior Cruciate Ligament Rupture, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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 8 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: looking for participants now, as of the sponsor's last update on 20 Aug 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bertrand SONNERY-COTTET, MD (+33437530022, sonnerycottet@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee microbiome description (time frame: Day 1). 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 20 Aug 2026.