Local delivery of antibiotics is a way of reducing the infection frequency and severity. PMMA cements loaded with gentamicin or vancomycin are utilized as drug local carrier to treat prosthetic orthopaedic infections. The resistance to aminoglycosides is increasing and the combination with vancomycin (V) is useful in orthopaedic infections. Gentamicin (G) and V are known to have a potential nephrotoxic effect, especially when administered in combination for systemic use. Objectives: Industrial spacers loaded with Gentamicin and ancomycin* were studied in a multicenter clinical trial. The primary objective was to assess their safety when implanted in patients with prosthetic joint infection (two-stage revision surgery), mainly when the spacer devices were utilized along with systemic antimicrobial therapy. Methods: Eight centres (Italy and Spain) specialized in orthopaedics and traumatology participated in the study. Sixty patients, implanted with 39 knee spacers and 21 hip spacers, were included in the trial according to the inclusion/exclusion criteria. G and V concentrations in serum and urine were determined at different time after spacer implant (FPIA method). Renal function parameters (renal clearance, serum creatinine and BUN) were also recorded. Results: The concentrations of G and V in serum ranged from <0.1 to 1.8 mg/L and from <1.0 to 49.3 mg/L, respectively and in urine from 0.13 to 60 mg/L and <1.0 to 974.9 mg/L for G and V, respectively, at all time considered. Six patients showed higher V concentrations in serum (range from 11.00 to 49.3 mg/L) because of concomitant parenteral administration of V. Traces of V or levels below the sensitivity limits were determined in high percentage (72.5%) of patients; the majority of patients showed G serum levels below sensitivity limits. Renal parameters were in normal range during the study. Conclusions: The implant of industrial spacer loaded with gentamicin and vancomycin determined very low concentrations in serum and modest excretion in urine of both antibiotics, below the risk of renal toxicity in humans, without toxic systemic effects in these patients. The use of industrial spacers loaded with gentamicin -vancomycin in two-stage revision surgery for the treatment of prosthetic joint infections should be considered generally safe. *Vancogenx space®
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