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

NCT06804265 | Recruiting

• 1 other identifier: MOLPJI
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periprosthetic Joint Infection (PJI)

Keywords

Multiplex PCR

Outcome Measures

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

  up to 100 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• Isolates obtained during explantation not included in MULTIPLEX PCR panel

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

Study Officials

• Massimiliano - De Paolis, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Massimiliano De Paolis, MD

CONTACT

0512144332; massimiliano.depaolis@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: February 3, 2025
• Study Start: January 7, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: February 3, 2025

Record last verified: 2024-12

Locations

IT (1)