Prosthesis-Related InfectionsVECTOR-PJINCT05582460
Exploring Novel Diagnostic Tools for Periprosthetic Joint Infection
An observational study of Prosthesis-Related Infections and Arthroplasty, Replacement, Hip, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
Joint replacement is a valuable surgical intervention that improves quality of life, provides pain relief, and restores function of patients. However, some patients need revision surgery due to failure of the implant, with periprosthetic joint infection (PJI) remaining a rare but serious complication following total… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthesis-Related Infections, Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
- What is being tested?
- Reporter Gene Assay and Flow Cytometry
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2023to 23 Jul 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients visiting the outpatient clinic of the participating hospitals and planned for elective revision surgery of their THA or TKA.
Who may be able to join
- All patients planned for elective THA or TKA revision surgery with revision of one or more fixed components will be eligible to participate in this study.
Who cannot join
- are planned for a revision of single mobile parts only;
- have received intravenous and/or oral antibiotics within 2 weeks before the diagnostic workup and/or surgery;
- are unable to provide their consent for use of their human tissues for medical research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Value of the Reporter Gene Assay and Flow Cytometry of Synovial Fluid in Total Hip and Knee Arthroplasty as a Diagnostic Tool for Periprosthetic Joint Infection
Joint replacement is a valuable surgical intervention that improves quality of life, provides pain relief, and restores function of patients. However, some patients need revision surgery due to failure of the implant, with periprosthetic joint infection (PJI) remaining a rare but serious complication following total hip (THA) and knee (TKA) arthroplasty. Diagnosing PJI is a major challenge as no diagnostic test with absolute accuracy exists. The diagnosis is based on a combination of clinical findings, laboratory results from peripheral blood and synovial fluid, microbiological culture, histological evaluation of periprosthetic tissue, and intraoperative findings. However, the preoperative diagnosis can be inconclusive and operative criteria are required for the definitive diagnosis. Therefore, novel diagnosing tools for identification of PJI are necessary.
A recent study using a gene reporter assay, identified biomarkers in synovial fluid that define joint states in patients with osteoarthritis.However, no previous studies have investigated cellular signaling in synovial fluid of patients with PJI. With this study we want to explore the potential of a reporter gene assay of synovial fluid in patients with PJI and without PJI of their TKA and THA.
Read more
Also, flow cytometry analysis of biological fluids has recently received increased attention as a potentially valuable method in diagnosing infections. For example, the method is already used to analyze urine samples for urinary tract infections. Recently, researchers have now also used this method to screen for the presence of bacteria. The most important limitation of flow cytometry analysis of synovial fluids for bacteria to date is that it is unclear as to which bacteria count value - the cutoff value - represent patients with PJI and which represent patients without PJI. With this study we want to explore the potential of flow cytometry analysis of synovial fluid in categorizing patients with PJI and without PJI.
Our primary objective is to explore the value of synovial fluid analysis using a reporter gene assay and flow cytometry in the detection of a periprosthetic joint infection.
- Conditions
- Prosthesis-Related Infections, Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
- Being tested
- Reporter Gene Assay, Flow Cytometry
- Medical subject headings
- Prosthesis-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reporter Gene AssayDiagnostic test
Transcription factor reporter gene assay using luciferase
Flow CytometryDiagnostic test
Flow Cytometry Analysis using the Sysmex UF-4000, analyzing for bacteria, mononuclear and polymorphonuclear cells, and red blood cell and white blood cell count.
| Study group | Role | What they receive |
|---|---|---|
| PJI | Patients diagnosed with a PJI based on the EBJIS criteria ('Infection confirmed') Receives: Diagnostic Test: Reporter Gene Assay; Diagnostic Test: Flow Cytometry | |
| No PJI | Patients not diagnosed with a PJI based on EBJIS criteria Receives: Diagnostic Test: Reporter Gene Assay; Diagnostic Test: Flow Cytometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fold change of luciferase assay
Diagnostic performance of the reporter gene assay of synovial fluid by calculating fold change data from the reporter gene measurements.
A luciferase assay will be performed using the collected synovial fluid and the amount of luciferase activity will be measured by luminometer and expressed in relative light units (RLU). A background control (e.g., medium or buffer alone) will be used to evaluate raw RLU values that will be subtracted from all the sample values for better accuracy. The data for the reporter assay will be expressed using an equation to determine normalized fold change in activity between the two groups.
Measured: Within 30 days of surgery
Diagnostic performance of flow cytometric analysis
Diagnostic performance of the flow cytometry analysis of synovial fluid by determining difference in results between two groups using ROC curve analysis.
If a cut-off point has been determined, sensitivity (SN), specificity (SP), negative (NPV) and positive predictive value (PPV) can be calculated.
Measured: Within 4 hours of surgery
Secondary outcomes (4)
Sensitivity of the flow cytometric analysis
Measured: Within 4 hours of surgery
Specificity of the flow cytometric analysis
Measured: Within 4 hours of surgery
Positive predictive value of the flow cytometric analysis
Measured: Within 4 hours of surgery
Negative predictive value of the flow cytometric analysis
Measured: Within 4 hours of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start1 Jan 2023
- Primary completion1 May 2024
- Study completion23 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis-Related InfectionsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582460
- Sponsor's protocol ID
- 2022-2054
- Acronym
- VECTOR-PJI
- Status last verified
- Aug 2025
- First submitted
- 13 Oct 2022
- Last updated
- 8 Aug 2025
- 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 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Value of the Reporter Gene Assay and Flow Cytometry of Synovial Fluid in Total Hip and Knee Arthroplasty as a Diagnostic Tool for Periprosthetic Joint Infection
- ClinicalTrials.gov ID
- NCT05582460
- Acronym / sponsor ID
- VECTOR-PJI / 2022-2054
- Conditions
- Prosthesis-Related Infections, Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 23 Jul 2025 (actual)
- First posted
- 17 Oct 2022 (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.
Joint replacement is a valuable surgical intervention that improves quality of life, provides pain relief, and restores function of patients. However, some patients need revision surgery due to failure of the implant, with periprosthetic joint infection (PJI) remaining a rare but serious complication following total hip (THA) and knee (TKA) arthroplasty. Diagnosing PJI is a major challenge as no diagnostic test with absolute accuracy exists. The diagnosis is based on a combination of clinical findings, laboratory results from peripheral blood and synovial fluid, microbiological culture, histological evaluation of periprosthetic tissue, and intraoperative findings. However, the preoperative diagnosis can be inconclusive and operative criteria are required for the definitive diagnosis. Therefore, novel diagnosing tools for identification of PJI are necessary.
A recent study using a gene reporter assay, identified biomarkers in synovial fluid that define joint states in patients with osteoarthritis.However, no previous studies have investigated cellular signaling in synovial fluid of patients with PJI. With this study we want to explore the potential of a reporter gene assay of synovial fluid in patients with PJI and without PJI of their TKA and THA.
Also, flow cytometry analysis of biological fluids has recently received increased attention as a potentially valuable method in diagnosing infections. For example, the method is already used to analyze urine samples for urinary tract infections. Recently, researchers have now also used this method to screen for the presence of bacteria. The most important limitation of flow cytometry analysis of synovial fluids for bacteria to date is that it is unclear as to which bacteria count value - the cutoff value - represent patients with PJI and which represent patients without PJI. With this study we want to explore the potential of flow cytometry analysis of synovial fluid in categorizing patients with PJI and without PJI.
Our primary objective is to explore the value of synovial fluid analysis using a reporter gene assay and flow cytometry in the detection of a periprosthetic joint infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PJI | – | Diagnostic Test: Reporter Gene Assay, Diagnostic Test: Flow CytometryPatients diagnosed with a PJI based on the EBJIS criteria ('Infection confirmed') |
| No PJI | – | Diagnostic Test: Reporter Gene Assay, Diagnostic Test: Flow CytometryPatients not diagnosed with a PJI based on EBJIS criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients visiting the outpatient clinic of the participating hospitals and planned for elective revision surgery of their THA or TKA.
Key inclusion criteria (1 listed)
- All patients planned for elective THA or TKA revision surgery with revision of one or more fixed components will be eligible to participate in this study.
Key exclusion criteria (3 listed)
- are planned for a revision of single mobile parts only;
- have received intravenous and/or oral antibiotics within 2 weeks before the diagnostic workup and/or surgery;
- are unable to provide their consent for use of their human tissues for medical research.
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 |
|---|---|---|
| Reporter Gene AssayTranscription factor reporter gene assay using luciferase | Diagnostic test | No PJI, PJI |
| Flow CytometryFlow Cytometry Analysis using the Sysmex UF-4000, analyzing for bacteria, mononuclear and polymorphonuclear cells, and red blood cell and white blood cell count. | Diagnostic test | No PJI, PJI |
Primary outcome
Fold change of luciferase assay
Time frame: Within 30 days of surgery
Diagnostic performance of the reporter gene assay of synovial fluid by calculating fold change data from the reporter gene measurements. A luciferase assay will be performed using the collected synovial fluid and the amount of luciferase activity will be measured by luminometer and expressed in relative light units (RLU). A background control (e.g., medium or buffer alone) will be used to evaluate raw RLU values that will be subtracted from all the sample values for better accuracy. The data for the reporter assay will be expressed using an equation to determine normalized fold change in activity between the two groups.
Diagnostic performance of flow cytometric analysis
Time frame: Within 4 hours of surgery
Diagnostic performance of the flow cytometry analysis of synovial fluid by determining difference in results between two groups using ROC curve analysis. If a cut-off point has been determined, sensitivity (SN), specificity (SP), negative (NPV) and positive predictive value (PPV) can be calculated.
4 secondary outcomes
Sensitivity of the flow cytometric analysis
Time frame: Within 4 hours of surgery
Specificity of the flow cytometric analysis
Time frame: Within 4 hours of surgery
Positive predictive value of the flow cytometric analysis
Time frame: Within 4 hours of surgery
Negative predictive value of the flow cytometric analysis
Time frame: Within 4 hours of surgery
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 8 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Prosthesis-Related Infections and Arthroplasty, Replacement, Hip, run by Rijnstate Hospital at 1 site in Netherlands.
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 1 inclusion and 3 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 8 Aug 2025. 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 Netherlands. 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?
Fold change of luciferase assay (time frame: Within 30 days of surgery). The study lists 2 primary outcomes in all. 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 8 Aug 2025.