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Clinical Validation of CD Diagnostics Synovasure PJI ELISA Test and Synovasure PJI Lateral Flow Test for Detection of Periprosthetic Joint Infection in Synovial Fluid

NCT02868736 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2016-08-16

No results posted yet for this study

Summary

* To demonstrate the tests' performance when compared to the detection of PJI using the Musculoskeletal Infection Society (MSIS) criteria-based definition of PJI for diagnosing PJI.1 This criteria-based definition of PJI places emphasis on culture techniques that identify pathogens, but also provides for minor criteria that can be used to diagnose PJI;
* To calculate the tests' clinical sensitivity, clinical specificity, positive predictive value (PPV), and negative predictive value (NPV).

Conditions

  • Periprosthetic Joint Infection

Interventions

DEVICE

Synovasure PJI Lateral Flow test and Synovasure PJI ELISA Test

Sponsors & Collaborators

  • CD Diagnostics

    lead INDUSTRY

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-04-30
Completion
2017-05-31

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 NCT02868736 on ClinicalTrials.gov