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Search / Trial NCT06153446

Infection Consortium Study#1

Launched by ZIMMER BIOMET · Nov 22, 2023

Trial Information

Current as of July 09, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

The Infection Consortium Study#1 is a clinical trial aimed at improving the way infections in joints, known as Periprosthetic Joint Infections (PJI), are diagnosed. Researchers want to see how well a new test called the PJI Panel works compared to current methods, which use multiple scoring systems. The goal is to determine if this new panel can provide more accurate results for diagnosing PJI.

To participate in this study, individuals must be between the ages of 65 and 74 and have had samples taken for PJI testing at specific medical centers. Participants will have their samples analyzed to see if the new PJI Panel can diagnose infections more effectively. It’s important to note that samples must come from specific joint locations, like the knees and hips, and meet other criteria to be eligible. If you or a loved one is interested in joining this study, you’ll be contributing to important research that could improve diagnosis and treatment for joint infections in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Samples included in the Synovasure R\&D database from patients tested for PJI through the PJI Panel at CDL.
  • Exclusion Criteria:
  • 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

About Zimmer Biomet

Zimmer Biomet is a leading global medical technology company specializing in the design, development, and manufacturing of innovative orthopedic and surgical products. With a commitment to enhancing patient outcomes, Zimmer Biomet focuses on advancing musculoskeletal health through a broad range of solutions, including joint reconstruction, surgical instrumentation, and dental implants. The company emphasizes research and development, conducting numerous clinical trials to evaluate the safety and effectiveness of its products, while fostering collaboration with healthcare professionals to address the evolving needs of patients and providers alike.

Locations

Philadelphia, Pennsylvania, United States

Patients applied

0 patients applied

Trial Officials

Yale Fillingham, M.D.

Principal Investigator

Rothman Institute

Paul Edwards, M.D.

Principal Investigator

Bowen Hefley Orthopedics

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported