Bone and Joint Prosthetic Infections Clinical Trial
Official title:
Evaluation of the BJI Inoplex 2 Kit for the Multiplex Serological Diagnosis of Bone and Joint Prosthetic Device Infections
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.
n/a
Time Perspective: Prospective