Evaluating diagnostic markers for joint infections in hip and knee surgeries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the diagnostic accuracy and cost-effectiveness of serum and synovial markers in identifying periprosthetic joint infections (PJI) in patients undergoing revision surgery for hip or knee replacements. By analyzing the combination of these biomarkers, the research seeks to improve the speed and accuracy of PJI diagnosis, which is crucial for determining the appropriate surgical strategy. The study will involve patients hospitalized for revision surgery, utilizing existing clinical data and laboratory examinations to evaluate the effectiveness of these markers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients requiring hip or knee replacement surgery: i) for 'late' joint prosthesis infection, present for at least 90 days from the date of the arthroplasty (first surgical phase); II) for non-infectious causes (mobilization, wear, instability, misalignment, adverse reactions to local tissues or other aseptic causes), also present for at least 90 days, and which have not had other re-operations on the same joint, and which will be a one-step review;
* Previous clinical data and laboratory and radiological examinations available.

Exclusion Criteria:

* Patients affected by 'early' joint prosthesis infection, with clinical symptom latency of less than 90 days (in this specific subset of patients there is in fact still considerable heterogeneity and little consensus about the diagnostic levels of white blood cell count and percentage of neutrophils).
* Patients suffering from joint prosthesis infection involving joints other than the hip or knee.
* Severe cognitive impairment or psychiatric disorders;
* Pregnant women.

Where it's running

• IRCCS Istituto Ortopedico Rizzoli
  Bologna, Italy Recruiting

Study contacts

• Principal investigator: Gianluca Giavaresi, MD — Istituto Ortopedico Rizzoli
• Study coordinator: Gianluca Giavaresi, MD
• Email: gianluca.giavaresi@ior.it
• Phone: +39 3774548728

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.