Molecular Biology in the Identification of Pathogens at Reimplantation in the Two-Stage Treatment of Periprosthetic Infections

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
up to 100 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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