Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
810 participants
OBSERVATIONAL
2023-12-10
2025-09-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of the Development of an Advanced, Conformable Prosthetic Socket, Study II
NCT01455324
Contribution of the Sonication of Implants to the Diagnosis of Joint Prosthesis Infection: A Retrospective Cohort Study
NCT05867108
New Markers for Diagnosis of Prosthetic Infections
NCT03769337
Evaluation of the Development of an Advanced, Conformable Prosthetic Socket, Study I
NCT01309347
Biofilm Investigation on Bearing Components of Explanted Hip Joint Prosthesis
NCT02853461
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CDL PJI Database
Patients tested for PJI through the PJI Panel at CD Laboratories (CDL)
Synovasure® Comprehensive Infection Panel
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Synovasure® Comprehensive Infection Panel
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zimmer Biomet
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yale Fillingham, M.D.
Role: PRINCIPAL_INVESTIGATOR
Rothman Institute
Paul Edwards, M.D.
Role: PRINCIPAL_INVESTIGATOR
Bowen Hefley Orthopedics
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rothman Orthopedic Institute
Philadelphia, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DTU2023-02DI
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.