Status:
COMPLETED
Infection Consortium Study#1
Lead Sponsor:
Zimmer Biomet
Conditions:
PJI
Eligibility:
All Genders
18+ years
Brief 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.
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 retrospec...
Eligibility Criteria
Inclusion
- Samples included in the Synovasure R\&D database from patients tested for PJI through the PJI Panel at CDL.
Exclusion
- 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
- 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
Key Trial Info
Start Date :
December 10 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 4 2025
Estimated Enrollment :
810 Patients enrolled
Trial Details
Trial ID
NCT06153446
Start Date
December 10 2023
End Date
September 4 2025
Last Update
October 27 2025
Active Locations (1)
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1
Rothman Orthopedic Institute
Philadelphia, Pennsylvania, United States, 19107