Abstract
Aseptic loosening attributed to cement fracture and subsequent disruption of fixation interfaces remains a major long-term mode of failure of arthroplasties performed with cement1 (Fig. 1). The fracture strength of bone cement, especially in fatigue, is an important indicator of cement integrity and the potential for fixation failure. In current practice, orthopaedic surgeons may choose to utilize antibiotics in bone cement for prophylaxis or treatment of a known infection. However, the antibiotics, bone cement, and mixing method employed lead to variability in the quality of the end product2-5. To date, several United States orthopaedic manufacturers have received Food and Drug Administration (FDA) 510(k) clearance for use of their prepackaged antibiotic-loaded bone cement for the second stage of a two-stage revision after the initial infection has been eradicated. This availability provides a more uniform cement mix with known mechanical and elution characteristics at the level of 0.5 to 1.0 g of antibiotic per 40 g of polymer powder. In this study, we evaluated the influence of antibiotic inclusion on the porosity, strength, and fatigue life of six contemporary bone cements. Six surgical quality and commercially available surgical bone cements were evaluated: Endurance and Endurance Gentamicin (DePuy Orthopaedics, Warsaw, Indiana), Surgical Simplex P and Simplex P with Tobramycin (Stryker Orthopaedics, Mahwah, New Jersey), and VersaBond and VersaBond AB with Gentamicin (Smith and Nephew, Memphis, Tennessee). Ten 1.2-g doses of Tobramycin for Injection USP (United States Pharmacopeia) (Pharma-Tek, Huntington, New York), which is the base quantity supplied to the operating theater when antibiotics are hand-mixed with bone cement, were acquired. Three vacuum-mixing systems (Figs. 2-A, 2-B, and 2-C)—the Cemvac (DePuy Orthopaedics), the ACM (Advanced Cement Mixing System; Stryker), and the Vortex (Smith and Nephew)—were acquired directly from their manufacturers. Nine study samples were created: hand-mixed …
Published Version
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