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Background <p>Periprosthetic joint infection (PJI) remains one of the most serious complications after joint arthroplasty, and accurate diagnosis continues to pose significant challenges. A reliable distinction between septic and aseptic failure is essential for appropriate surgical and antibiotic management. This systematic review and meta-analysis evaluate the most recent clinical evidence on the diagnostic accuracy, methodological quality, and standardization potential of established “classical” and emerging serum and synovial biomarkers for PJI diagnosis.</p> Methods <p>This systematic review and meta-analysis were conducted in accordance with PRISMA-DTA guidelines, with PRISMA used as a general reporting framework. Selected items from the STARD checklist were used solely to inform data extraction and were not applied as a reporting guideline. Clinical studies published between January 1, 2020, and October 31, 2025, were identified through PubMed, Scopus, and Web of Science. Eligible studies reported sensitivity, specificity, and/or diagnostic thresholds for serum or synovial biomarkers based on MSIS, ICM, or EBJIS criteria for PJI definition. Study quality was assessed using the QUADAS-C tool, and a meta-analysis of chronic PJI cohorts was performed.</p> Results <p>Twenty-six studies were included (8 serum, 18 synovial). Among serum biomarkers, C-reactive protein and erythrocyte sedimentation rate showed moderate diagnostic accuracy (Area Under the ROC curve [AUC] 0.82–0.90), while fibrinogen demonstrated comparable performance in selected cohorts. D-dimer and other coagulation indices showed variable results. Synovial biomarkers demonstrated superior diagnostic performance. α-defensin, D-lactate, calprotectin (CP), and neutrophil gelatinase-associated lipocalin achieved excellent accuracy (AUC &gt; 0.90; sensitivity and specificity &gt; 90%). Synovial white blood cell count (WBC) and polymorphonuclear percentage (PMN%) remained reliable and cost-effective. Meta-analysis confirmed high pooled diagnostic performance for WBC (0.88/0.97) and PMN% (0.84/0.97).</p> Conclusions <p>Traditional serum biomarkers remain useful first-line diagnostic tools, whereas synovial biomarkers—particularly α-defensin, D-lactate, CP, and WBC indices—demonstrate superior diagnostic accuracy and may be especially valuable in culture-negative PJI. However, substantial heterogeneity and risk of bias identified by QUADAS-C—particularly in patient selection, reference standards, and threshold derivation—suggest that pooled estimates may represent optimistic upper-bound performance, limiting generalizability. Future diagnostic strategies should integrate multimodal biomarker panels with molecular diagnostics and artificial intelligence-based approaches to improve diagnostic precision and clinical applicability.</p>

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Diagnostic accuracy of serum and synovial biomarker thresholds for diagnosing periprosthetic joint infection: a QUADAS-C-guided systematic review and meta-analysis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月11日

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  • Maria Sartori,
  • Silvia Brogini,
  • Deyanira Contartese,
  • Francesco Rosa,
  • Mirco Lo Presti,
  • Maria Pia Neri,
  • Matteo Romagnoli,
  • Dante Dallari,
  • Angelo Toscano,
  • Stefano Zaffagnini,
  • Milena Fini,
  • Gianluca Giavaresi

摘要

Background

Periprosthetic joint infection (PJI) remains one of the most serious complications after joint arthroplasty, and accurate diagnosis continues to pose significant challenges. A reliable distinction between septic and aseptic failure is essential for appropriate surgical and antibiotic management. This systematic review and meta-analysis evaluate the most recent clinical evidence on the diagnostic accuracy, methodological quality, and standardization potential of established “classical” and emerging serum and synovial biomarkers for PJI diagnosis.

Methods

This systematic review and meta-analysis were conducted in accordance with PRISMA-DTA guidelines, with PRISMA used as a general reporting framework. Selected items from the STARD checklist were used solely to inform data extraction and were not applied as a reporting guideline. Clinical studies published between January 1, 2020, and October 31, 2025, were identified through PubMed, Scopus, and Web of Science. Eligible studies reported sensitivity, specificity, and/or diagnostic thresholds for serum or synovial biomarkers based on MSIS, ICM, or EBJIS criteria for PJI definition. Study quality was assessed using the QUADAS-C tool, and a meta-analysis of chronic PJI cohorts was performed.

Results

Twenty-six studies were included (8 serum, 18 synovial). Among serum biomarkers, C-reactive protein and erythrocyte sedimentation rate showed moderate diagnostic accuracy (Area Under the ROC curve [AUC] 0.82–0.90), while fibrinogen demonstrated comparable performance in selected cohorts. D-dimer and other coagulation indices showed variable results. Synovial biomarkers demonstrated superior diagnostic performance. α-defensin, D-lactate, calprotectin (CP), and neutrophil gelatinase-associated lipocalin achieved excellent accuracy (AUC > 0.90; sensitivity and specificity > 90%). Synovial white blood cell count (WBC) and polymorphonuclear percentage (PMN%) remained reliable and cost-effective. Meta-analysis confirmed high pooled diagnostic performance for WBC (0.88/0.97) and PMN% (0.84/0.97).

Conclusions

Traditional serum biomarkers remain useful first-line diagnostic tools, whereas synovial biomarkers—particularly α-defensin, D-lactate, CP, and WBC indices—demonstrate superior diagnostic accuracy and may be especially valuable in culture-negative PJI. However, substantial heterogeneity and risk of bias identified by QUADAS-C—particularly in patient selection, reference standards, and threshold derivation—suggest that pooled estimates may represent optimistic upper-bound performance, limiting generalizability. Future diagnostic strategies should integrate multimodal biomarker panels with molecular diagnostics and artificial intelligence-based approaches to improve diagnostic precision and clinical applicability.