Trials / Unknown
UnknownNCT02222792
BJI Inoplex 2 : Test for Diagnosis of Prosthetic Infections
Evaluation of the BJI Inoplex 2 Kit for the Multiplex Serological Diagnosis of Bone and Joint Prosthetic Device Infections
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 540 (estimated)
- Sponsor
- Diaxonhit · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Timeline
- Start date
- 2012-06-01
- Primary completion
- 2014-05-01
- Completion
- 2016-07-01
- First posted
- 2014-08-21
- Last updated
- 2014-08-21
Locations
2 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02222792. Inclusion in this directory is not an endorsement.