Vancogenx-space for hip and knee: gentamicin and vancomycin levels in serum and urine from a multicenter trial

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. Toxic serum levels are > 10 mg/l for G and > 60 mg/l for V, respectively. Industrial spacers loaded with Gentamicin and Vancomycin (Vancogenx-Space, Tecres, Verona) 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), mainly when the spacer devices are utilized along with the antimicrobial systemic therapy. Fourteen centres specialized in Orthopaedics and Traumatology were involved in the study. Serum and urine concentrations of G and V were determined by FPIA method at different time (24, 48, 72, and 120 hours) after spacer implant. Renal function parameters (renal clearance, serum creatinine, and BUN) have been evaluated during the trial.