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BJI Inoplex 2 : Test for Diagnosis of Prosthetic Infections

NCT02222792 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 540

Last updated 2014-08-21

No results posted yet for this study

Summary

A national, prospective, open-label, non-interventional, multicentre, controlled study designed to evaluate a diagnostic method in patients undergoing hip, knee or shoulder prosthetic removal regardless of whether or not infection is suspected. Serological test results will have no impact on the therapeutic approach.

Study objective: To evaluate the diagnostic performance of an antibody detection kit for the serological diagnosis of bone and joint prosthetic device infections cause by Staphylococci, Streptococci, Propionibacterium acnes (P. acnes) and Gram-negative bacteria versus the reference method: the bacterial culture of deep intraoperative samples.

Conditions

  • Bone and Joint Prosthetic Infections

Sponsors & Collaborators

  • Diaxonhit

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-05-31
Completion
2016-07-31

Countries

  • France

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 NCT02222792 on ClinicalTrials.gov