PJINCT06153446
Infection Consortium Study#1
An observational study of PJI, run by Zimmer Biomet at 1 site in United States.
Trial summary
In this study, the Sponsor wants to evaluate the performance and accuracy of the PJI Panel compared to the currently used multiple-criterion scoring systems for the diagnosis of PJI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PJI
- What is being tested?
- Synovasure® Comprehensive Infection Panel
- How many people
- 810 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2023to 4 Sep 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: Patient tested for PJI through the PJI Panel at CD Laboratories (CDL).
Who may be able to join
- Samples included in the Synovasure R\&D database from patients tested for PJI through the PJI Panel at CDL.
Who cannot join
- From Synovasure Database
- Samples not submitted to CDL for PJI testing
- Samples submitted to CDL from Institutions not participating in this study
- Samples designated as being from anatomical locations other than "left hip", "left knee", "right hip", "right knee
- Samples without SF-Cx results
- Samples without SF-CRP results
Show all 17Show fewer
- Samples without AD results
- Samples without WBC results
- Samples without %PMN results
- Samples with RBCs ≥ 1 million
- Samples not meeting A280 specification for integrity: Remove A280 < 0.342 and A280 > 1.19
- Samples received more than four (4) days after aspiration
- Patient age < 18 From Institutional Medical Record
- Patient who did not undergo surgical interventions after PJI Panel Testing
- Synovasure testing performed less than 6 weeks after index surgery
- Evidence of sinus tract communicating with the joint
- Samples aspirated from patients using a spacer at the time of aspiration
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Comparing Diagnostic Accuracy of Synovasure Comprehensive Synovial Fluid Testing to Clinical Guidelines for the Diagnosis of Periprosthetic Joint Infection
In this study, the Sponsor wants to evaluate the performance and accuracy of the PJI Panel compared to the currently used multiple-criterion scoring systems for the diagnosis of PJI.
Read the detailed description
This study aims to evaluate the performance and accuracy of the PJI Panel compared to the currently used multiple-criterion scoring systems for the diagnosis of PJI and will be executed as a retrospective review of existing data.
The Synovasure R\&D database consists of PJI Panel test results digitally transferred from the instruments to a laboratory information system (LIS), (CGM LabDAQ, CompuGroup Medical, Phoenix, AZ), which has high data-integrity architecture built on an industry standard ACID (atomicity, consistency, isolation, durability) compliant relational database management system (RDBMS), Microsoft SQL Server. These PJI Panel data come from SF samples submitted to CDL from various clinics and hospitals for clinical diagnostic testing between 2013 and 2022 (CD Laboratories, Towson, MD). The data are deidentified in accordance with an existing IRB approval (WCG-IRB #20150222). The deidentified data includes the institution, ordering physician information, anatomical location of the aspiration, number of days from aspiration to receipt of the sample at the lab, age, gender, and results of comprehensive infection testing including: specimen integrity (red blood cells (RBC) and absorbance at 280 nm (A280)), AD, HNE, CRP, WBC, %PMN, MID Panel, and SF-Cx.
The Synovasure R\&D database will be submitted to an exclusion/inclusion screening process to target samples for inclusion in this research activity. Subsequently, samples collected between 2017 and 2022 will be randomly selected for inclusion in this study. Classification of positive and negative samples will be according to the criteria for diagnosis of PJI using Synovasure Comprehensive PJI Synovial Fluid Panel as defined in Table 1. Only samples classified as Infected (positive) and Not Infected (negative) will be qualified for further enrichment.
Case report forms will be completed with data obtained through in-person or remote review of hospital and/or physician office records to enrich the PJI Panel database with the elements included in the 2011 MSIS, 2013 ICM, 2018 New Definition of PJI, 2018 ICM, and 2021 EBJIS definitions of PJI.
- Conditions
- PJI
- Being tested
- Synovasure® Comprehensive Infection Panel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synovasure® Comprehensive Infection PanelDiagnostic test
The Synovasure Comprehensive PJI Test Panel (PJI Panel) is a laboratory-developed test (LDT) panel (CD Laboratories, CLIA Registration No.: 21D0216863) intended to aid the diagnosis of PJI.
| Study group | Role | What they receive |
|---|---|---|
| CDL PJI Database | Patients tested for PJI through the PJI Panel at CD Laboratories (CDL) Receives: Diagnostic Test: Synovasure® Comprehensive Infection Panel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive/Negative Percent Agreement between PJI RISC Panel and Clinical Guidelines
The primary endpoint of this study is the rate of agreement (positive and negative) for the diagnosis of PJI between the PJI Panel and the previous and current clinical guidelines.
Measured: 1 year
Secondary outcomes (1)
Positive/Negative Predictive Value of PJI RISC Panel
The secondary endpoint is defined by the estimate of positive predictive value (PPV) and negative predictive value (NPV) of the PJI Panel compared to the previous and current clinical guidelines.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start10 Dec 2023
- Primary completion4 Sep 2025
- Study completion4 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PJIStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe 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
- 810 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yale Fillingham, M.D., Principal investigator, Rothman InstitutePaul Edwards, M.D., Principal investigator, Bowen Hefley Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153446
- Sponsor's protocol ID
- DTU2023-02DI
- Status last verified
- Oct 2025
- First submitted
- 22 Nov 2023
- Last updated
- 27 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Diagnostic Accuracy of Synovasure Comprehensive Synovial Fluid Testing to Clinical Guidelines for the Diagnosis of Periprosthetic Joint Infection
- ClinicalTrials.gov ID
- NCT06153446
- Acronym / sponsor ID
- DTU2023-02DI
- Conditions
- PJI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 810 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2023 (actual)
- Primary completion
- 4 Sep 2025 (actual)
- Study completion
- 4 Sep 2025 (actual)
- First posted
- 1 Dec 2023 (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.
In this study, the Sponsor wants to evaluate the performance and accuracy of the PJI Panel compared to the currently used multiple-criterion scoring systems for the diagnosis of PJI.
Detailed description
This study aims to evaluate the performance and accuracy of the PJI Panel compared to the currently used multiple-criterion scoring systems for the diagnosis of PJI and will be executed as a retrospective review of existing data.
The Synovasure R\&D database consists of PJI Panel test results digitally transferred from the instruments to a laboratory information system (LIS), (CGM LabDAQ, CompuGroup Medical, Phoenix, AZ), which has high data-integrity architecture built on an industry standard ACID (atomicity, consistency, isolation, durability) compliant relational database management system (RDBMS), Microsoft SQL Server. These PJI Panel data come from SF samples submitted to CDL from various clinics and hospitals for clinical diagnostic testing between 2013 and 2022 (CD Laboratories, Towson, MD). The data are deidentified in accordance with an existing IRB approval (WCG-IRB #20150222). The deidentified data includes the institution, ordering physician information, anatomical location of the aspiration, number of days from aspiration to receipt of the sample at the lab, age, gender, and results of comprehensive infection testing including: specimen integrity (red blood cells (RBC) and absorbance at 280 nm (A280)), AD, HNE, CRP, WBC, %PMN, MID Panel, and SF-Cx.
The Synovasure R\&D database will be submitted to an exclusion/inclusion screening process to target samples for inclusion in this research activity. Subsequently, samples collected between 2017 and 2022 will be randomly selected for inclusion in this study. Classification of positive and negative samples will be according to the criteria for diagnosis of PJI using Synovasure Comprehensive PJI Synovial Fluid Panel as defined in Table 1. Only samples classified as Infected (positive) and Not Infected (negative) will be qualified for further enrichment.
Case report forms will be completed with data obtained through in-person or remote review of hospital and/or physician office records to enrich the PJI Panel database with the elements included in the 2011 MSIS, 2013 ICM, 2018 New Definition of PJI, 2018 ICM, and 2021 EBJIS definitions of PJI.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CDL PJI Database | – | Diagnostic Test: Synovasure® Comprehensive Infection PanelPatients tested for PJI through the PJI Panel at CD Laboratories (CDL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient tested for PJI through the PJI Panel at CD Laboratories (CDL).
Key inclusion criteria (1 listed)
- Samples included in the Synovasure R\&D database from patients tested for PJI through the PJI Panel at CDL.
Key exclusion criteria (17 listed)
- From Synovasure Database
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 |
|---|---|---|
| Synovasure® Comprehensive Infection PanelThe Synovasure Comprehensive PJI Test Panel (PJI Panel) is a laboratory-developed test (LDT) panel (CD Laboratories, CLIA Registration No.: 21D0216863) intended to aid the diagnosis of PJI. | Diagnostic test | CDL PJI Database |
Primary outcome
Positive/Negative Percent Agreement between PJI RISC Panel and Clinical Guidelines
Time frame: 1 year
The primary endpoint of this study is the rate of agreement (positive and negative) for the diagnosis of PJI between the PJI Panel and the previous and current clinical guidelines.
1 secondary outcome
Positive/Negative Predictive Value of PJI RISC Panel
Time frame: 1 year
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 27 Oct 2025.
- Individual participant dataSharing planned: Undecided
Related trials for PJI
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Evaluation of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Knee Arthroplasty
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A Phase 1/2 Study to Evaluate the Safety, PK and Efficacy of TNP-2092 Administered Via IA Injection in PJI Participants
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CLinical Evaluation of ANtiseptic Skin Preparation in Revision Total Joint Arthroplasty of the Hip and Knee
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Not yet recruitingPhase 2
A Phase 2b Study to Evaluate the Efficacy, Safety, and PK Profiles of TNP-2092 Administered Via IA Injection in PJI Participants
Prosthetic Joint Infection (PJI)
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.
Yale Fillingham, M.D. principal investigator
Rothman Institute
Paul Edwards, M.D. principal investigator
Bowen Hefley Orthopedics
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 PJI, run by Zimmer Biomet at 1 site in United States.
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 17 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 27 Oct 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 United States. 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?
Positive/Negative Percent Agreement between PJI RISC Panel and Clinical Guidelines (time frame: 1 year). 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 27 Oct 2025.