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Diagnosis and Bacterial Identification of Periprosthetic Joint Infection With Microbial-ID

NCT05320354 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2023-02-23

No results posted yet for this study

Summary

The primary objective of this study is to demonstrate the validity of the Microbial- ID test to aid in diagnosis of periprosthetic joint infection (PJI) in terms of sensitivity and specificity.

Conditions

  • Periprosthetic Joint Infection
  • PJI

Interventions

DIAGNOSTIC_TEST

Microbial ID test

In addition to the standard of care procedure for patients suspected for a periprosthetic joint infection, the MID-test will be performed using the residual synovial fluid. Individual test results of the MID-test are not reported back to the participating sites in order to not interfere with the sites' standard of care approach.

Sponsors & Collaborators

  • Zimmer Biomet

    collaborator INDUSTRY

  • UMC Utrecht

    lead OTHER

Principal Investigators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-25
Primary Completion
2025-12-01
Completion
2025-12-01

Countries

  • Germany
  • Netherlands
  • Portugal
  • Slovenia
  • Spain
  • Switzerland

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 NCT05320354 on ClinicalTrials.gov