Safeness of Simplex-tobramycin bone cement in patients with renal dysfunction undergoing total hip replacement.

PURPOSE: To compare the pharmacokinetic profile of tobramycin in blood, urine, and at the operative site following the use of Simplex-tobramycin bone cement in primary total hip replacement between patients with and without renal dysfunction. METHODS: Six patients with renal dysfunction underwent cemented primary total hip replacement for osteoarthritis. The elution characteristics of Simplex-tobramycin bone cement in the 6 patients with renal dysfunction were compared with 9 patients who had normal renal function. Blood, urine, and drainage fluid specimens were collected for 72 hours postoperatively. RESULTS: Very high concentrations of tobramycin were seen in the drainage fluid of the 2 groups. Mean serum tobramycin levels peaked at postoperative 3 hours, and declined rapidly to negligible levels at 72 hours in both groups. Mean urinary tobramycin concentrations peaked at postoperative 12 hours and declined rapidly until 48 hours in both groups. Urinary tobramycin was excreted significantly more slowly in renal dysfunction group in the first 12 hours, but not thereafter. Although serum creatinine levels of the renal dysfunction group were higher throughout the study period, the difference was not significant. Both groups achieved excellent local delivery of the antibiotic with minimal systemic concentrations. CONCLUSION: Simplex-tobramycin bone cement appears to be an effective and safe means to deliver antibiotic for patients with renal dysfunction who undergo total hip replacement.

The pharmacokinetics of Simplex-tobramycin bone cement.

We prospectively investigated a consecutive series of ten patients undergoing a cemented primary total hip replacement (THR) for osteoarthritis in order to establish the elution characteristics of Simplex-tobramycin bone cement (Howmedica, Limerick, Ireland). Specimens of blood, urine and drainage fluid were collected for 72 hours postoperatively. Very high concentrations of tobramycin were found in the drainage fluid, with mean levels at one hour of 103 mg/l, which steadily declined to 15.1 mg/l after 48 hours. The mean serum tobramycin levels reached a peak of 0.94 mg/l at three hours and declined rapidly to 0.2 mg/l by 48 hours. The mean urinary tobramycin levels peaked at 57.8 mg/l at 12 hours with a rapid decline to 12.6 mg/l by 24 hours. There was a direct correlation between the amount of tobramycin bone cement which was implanted and the amount of tobramycin systemically absorbed. Excellent local delivery was achieved with minimal systemic concentrations. Simplex-tobramycin bone cement is an efficient and safe method for the delivery of antibiotics after THR.