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RECRUITING
NCT04858217

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

Sponsor: Istituto Ortopedico Rizzoli

View on ClinicalTrials.gov

Summary

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.

Official title: Diagnostic Accuracy and Cost-effectiveness Analysis of Serum and Synovial Fluid Markers for the Diagnosis of Periprosthetic Hip and Knee Joint Infections

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

270

Start Date

2022-02-01

Completion Date

2026-03-31

Last Updated

2025-09-22

Healthy Volunteers

No

Locations (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, Italy