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Infection Consortium Study#1

NCT06153446 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 810

Last updated 2025-10-27

No results posted yet for this study

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.

Conditions

  • PJI

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Yale Fillingham, M.D. · Rothman Institute

  • Paul Edwards, M.D. · Bowen Hefley Orthopedics

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-10
Primary Completion
2025-09-04
Completion
2025-09-04
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06153446 on ClinicalTrials.gov