About this trial
The goal of this observational study is to measure the diagnostic accuracy of the Multiplex PCR technique in identifying pathogens during the diagnostic stage of resolving pre-implantation infection, in the context of treatment according to two-stage protocol for PJIs. This evaluation will be conducted by comparing the results obtained by Multiplex PCR with those derived from standard culture examination.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of periprosthetic infection of hip, knee, shoulder on primary or already revised implant.
treatment of infection with two-stage protocol.
Obtaining informed consent
Age ≥18 years
Disqualifiers
Isolates obtained during explantation not included in MULTIPLEX PCR panel
Trial population
The analysis will be performed on patients treated at the Department of Orthopaedics and Traumatology of IRCCS Azienda Ospedaliero Universitaria di Bologna, Policlinico di S.Orsola, from study approval until two years after study approval. The study population will be hip, knee and shoulder joint replacement patients diagnosed with PJI and undergoing prosthetic explantation surgery.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Accuracy, sensitivity and specificity of the PCR technique in identifying the pathogen responsible for PJIs
comparison with the current diagnostic gold standard, represented by culture examination
Sponsors and contacts
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