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.
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.
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.
A maximum number of n = 270 patients who will have to undergo hip or knee prosthetic revision surgery will be enrolled, of which n = 54 for late infection ascertained by previous microbiological analyzes, and n = 216 for prosthetic failure not from infection. Patients will be enrolled in the clinical study only after having signed and dated personally or by the patient's legal representative, the written informed consent. Therefore, enrollment in the study (exclusively of a diagnostic type) will not in any case influence the established diagnostic and therapeutic path.
Case-only
Prospective
Not listed
White blood cell count (WBC, cells/μL)
Erythrocyte sedimentation rate (ESR, mm/hour)
C-reactive Protein (CRP, mg/L)
D-dimer (ng/ml)
Serum and synovial biomarkers cut-off for prosthetic joint infections
Test various cut-off values for selected serum and synovial biomarkers for diagnosing PJI.
Assessment of antimicrobial resistances of isolated microrganisms
Bacterial gene sequencing to indentify antimicrobial resistance by Ion AmpliSeqTM Antimicrobial Resistance (AMR) Research Panel.
Assessment of biofilm formation capability of isolated microrganisms
Measure the level of cyclic dimeric bis- (3'-5 ') - guanosine monophosphate (c-di-GMP) which influences biofilm formation by proteomic analysis (MALDI-TOF).
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Istituto Ortopedico Rizzoli
Lead sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborator
