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Recruiting Observational

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

NCT06804265 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-01-07
Last updated
2025-02-03

Condition(s) studied

Periprosthetic Joint Infection (PJI)

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * Isolates obtained during explantation not included in MULTIPLEX PCR panel

Primary outcome measure(s)

  • Accuracy, sensitivity and specificity of the PCR technique in identifying the pathogen responsible for PJIs — up to 100 weeks
    comparison with the current diagnostic gold standard, represented by culture examination

Trial sites (1)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06804265 on ClinicalTrials.gov ↗ ← All trials in Italy