Actively Recruiting

Age: 18Years +
All Genders
ID06804265

Molecular Biology (Multiplex PCR) in the Identification of Pathogens at Reimplantation in the Two-Stage Treatment of Periprosthetic Infections (PJI)

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-02-03

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the accuracy of the Multiplex PCR technique to identify pathogens during the diagnostic stage of resolving pre-implantation infection in patients undergoing two-stage treatment for periprosthetic joint infections (PJIs). This observational study compares results from Multiplex PCR with those from standard culture examinations to understand how well the PCR method detects infection-causing bacteria. The study gathers detailed information about patients with PJIs, including their medical history, infection timing, and surgical details. Participants will be observed through several stages. Data collected include pre-implantation details such as infection timing, bacterial types, surgery type, patient characteristics, and lifestyle habits. During explant surgery and the postoperative period, information about spacer cement use, complications, antibiotic therapy, and molecular and culture test results will be recorded. At reimplantation, further molecular, culture, and histological tests will be done, along with monitoring antibiotic use, complications, and clinical status over follow-up. Throughout the study, participants will undergo various assessments including laboratory and molecular tests, histological exams, and clinical evaluations to track infection status and recovery. Researchers will measure the accuracy, sensitivity, and specificity of the PCR technique up to 100 weeks. The study follows participants from pre-implantation through reimplantation and subsequent follow-up to monitor for infection recurrence or persistence, documenting all relevant clinical and laboratory findings.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of periprosthetic infection of hip, knee, or shoulder on primary or revised implant
  • Treatment of infection with two-stage protocol
  • Informed consent obtained
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Infections with isolates not included in the Multiplex PCR panel

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to the time of explant surgery

Participants undergo data collection including timing of infection, bacterial population involved, type of surgery, baseline characteristics, instrumental and laboratory tests, and pre-implantation molecular investigations.

Assessments occur before explant surgery

Monitoring

Duration - From explant surgery through 15 days after discontinuation of antibiotic therapy

Participants are observed during the explant surgery and postoperative course with documentation of spacer cement use, intraoperative complications, postoperative antibiotic therapy, and molecular, histological, and culture examinations.

Visits related to surgery and postoperative care

Diagnostic Evaluation

Duration - At the time of reimplantation

Participants undergo data collection at reimplantation including timing, molecular, culture, and histological examinations on intraoperative specimens, and post-reimplantation antibiotic therapy.

1 visit (in-person) at reimplantation

Long-term Monitoring

Duration - Up to 100 weeks

Participants are followed up to observe clinical status, recurrence or persistence of infection, and duration of follow-up after reimplantation.

Follow-up visits as scheduled to monitor clinical outcomes

Trial Site Locations

Total: 1 location

1

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy, 40138

Actively Recruiting

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Research Team

M

Massimiliano De Paolis, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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