Infection Consortium Study#1

NCT06153446 | Completed DMC FDA Device

• 1 other identifier: DTU2023-02DI
• Study Type: observational
• Target: 810
• Locations: 1 country
• Sites: 1

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.

Conditions

PJI

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (1)

• Positive/Negative Predictive Value of PJI RISC Panel

  1 year

Study Arms (1)

CDL PJI Database

Patients tested for PJI through the PJI Panel at CD Laboratories (CDL)

Diagnostic Test: Synovasure® Comprehensive Infection Panel

Interventions

Synovasure® Comprehensive Infection Panel DIAGNOSTIC_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.

CDL PJI Database

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient tested for PJI through the PJI Panel at CD Laboratories (CDL).

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Rothman Orthopedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Study Officials

• Yale Fillingham, M.D.

  Rothman Institute

  PRINCIPAL INVESTIGATOR

• Paul Edwards, M.D.

  Bowen Hefley Orthopedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 1, 2023
• Study Start: December 10, 2023
• Primary Completion: September 4, 2025
• Study Completion: September 4, 2025
• Last Updated: October 27, 2025

Record last verified: 2025-10

Locations

US (1)