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

Condition(s) studied

Study 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.

Eligibility

Primary outcome measure(s)

• White blood cell count (WBC, cells/μL) — 7 days
• Erythrocyte sedimentation rate (ESR, mm/hour) — 7 days
• C-reactive Protein (CRP, mg/L) — 7 days
• D-dimer (ng/ml) — 7 days
• IL-6 (pg/ml) — 7 days
• Procalcitonin (ng/ml) — 2 months
• Soluble Intercellular Adhesion Molecule-1 (sICAM-1, ng/L) — 7 days
• Synovial WBC (sWBC, cells/μL) — 7 days
• Percentage of polymorphonucleates (%PMM, %) in synovial fluid — 7 days
• Synovial C-reactive Protein (sCRP, mg/L) — 7 days
• Synovial alpha-defensin (positive or negative) — 7 days
• Synovial leukocyte esterase (positive or negative) — 7 days
• Synovial IL-6 (pg/ml) — 7 days
• Synovial cathelicidin LL-37 (μg/ml) — 7 days
• Synovial calprotectin (ng/ml) — 7 days

Trial sites (1)

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