Periprosthetic Joint Infections: Diagnostic Accuracy and Cost-effectiveness Analysis of Serum and Synovial Markers

Total joint replacement (TJR) is an increasing effective procedure in orthopedics. However, TJR failure due to aseptic or septic loosening remains an important problem, often due to predisposing factors of the patient, which determine the need to perform a revision surgery. In light of the recent conclusions emerged on the still open problems concerning the diagnostic accuracy of serum and synovial fluid markers in the diagnosis of peri-prosthetic joint infection (PJI), the project aims at evaluating the diagnostic accuracy and cost-effectiveness of the combination of serum and/or synovial markers in the diagnosis of PJI. Through a diagnostic clinical study on patients hospitalized for revision surgery the project would provide evidences on the potentiality of the combination of some markers in accelerating the PJI diagnosis for the best selection of surgical strategy, choosing the suitable cutoff thresholds to mitigate the effect of some factors on markers' discriminatory capability.

NCT Number	NCT04858217
Lead Sponsor	Istituto Ortopedico Rizzoli Collaborators: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Conditions	Prosthetic Joint Infection
Enrollment	270 participants
Start Date	2022-02-01
Primary Completion	2025-06-17 (estimated)
Study Completion	2026-03-31 (estimated)
Updated on ClinicalTrials.gov	2025-09-22