Status:
UNKNOWN
BJI Inoplex 2 : Test for Diagnosis of Prosthetic Infections
Lead Sponsor:
Diaxonhit
Conditions:
Bone and Joint Prosthetic Infections
Eligibility:
All Genders
18+ years
Brief 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 regardle...
Eligibility Criteria
Inclusion
- Male or female patients
- Patients 18 years of age or older
- Patient with a bone and joint prosthetic device: total hip prosthesis (THP) or total knee prosthesis (TKP) or total shoulder prosthesis (TSP)
- Patients with a revision of a failed prosthesis, regardless of the cause and whether septic or not
- Patients who have not expressed their opposition to the use of their personal medical data and blood samples
Exclusion
- Patients already enrolled or clinically reviewed following a relapse
- Patients with several prostheses requiring at least two revisions during the same surgical procedure
- Patients for whom the microbiologist and/or doctor responsible for the care refuses that these patients participate in the study
- HIV+ patients
- Patients undergoing chemotherapy for a blood disease or solid tumour
- Patients under guardianship or trusteeship
- Patients who are expected to be difficult to monitor (life expectancy less than 1 year, or homeless people, foreigner in transit)
Key Trial Info
Start Date :
June 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2016
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT02222792
Start Date
June 1 2012
End Date
July 1 2016
Last Update
August 21 2014
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Hôpital Ambroise Paré
Boulogne-Billancourt, France, 92100
2
Groupe hospitalier Diaconesses Croix Saint Simon
Paris, France, 75012