Hardes Jendrik, Ahrens Helmut, Gebert Carsten, Streitbuerger Arne, Buerger Horst, Erren Michael, Gunsel Andreas, Wedemeyer Christian, Saxler Guido, Winkelmann Winfried, Gosheger Georg
Department of Orthopaedics, University of Muenster, Albert-Schweitzer-Street 33, 48149 Muenster, Germany.
Biomaterials. 2007 Jun;28(18):2869-75. doi: 10.1016/j.biomaterials.2007.02.033. Epub 2007 Mar 3.
Deep infection of megaprostheses remains a serious complication in orthopedic tumor surgery. Furthermore, reinfection gets a raising problem in revision surgery of patients suffering from infections associated with primary endoprosthetic replacement of the knee and hip joint. These patients will need many revision surgeries and in some cases even an amputation is inevitable. Silver-coated medical devices proved their effectiveness on reducing infections, but toxic side-effects concerning some silver applications have been described as well. Our study reports about a silver-coated megaprosthesis for the first time and can exclude side-effects of silver-coated orthopedic implants in humans. The silver-levels in the blood did not exceed 56.4 parts per billion (ppb) and can be considered as non-toxic. Additionally we could exclude significant changes in liver and kidney functions measured by laboratory values. Histopathologic examination of the periprosthetic environment in two patients showed no signs of foreign body granulomas or chronic inflammation, despite distant effective silver concentrations up to 1626 ppb directly related to the prosthetic surface. In conclusion the silver-coated megaprosthesis allowed a release of silver without showing any local or systemic side-effects.
大假体深部感染仍然是骨科肿瘤手术中的一个严重并发症。此外，在因初次膝关节和髋关节假体置换相关感染而接受翻修手术的患者中，再感染问题日益突出。这些患者需要多次翻修手术，在某些情况下甚至不可避免地需要截肢。涂银医疗设备已证明其在减少感染方面的有效性，但也有一些关于银应用的毒性副作用的描述。我们的研究首次报道了一种涂银大假体，并可以排除涂银骨科植入物在人体中的副作用。血液中的银含量不超过十亿分之56.4（ppb），可被视为无毒。此外，我们可以排除实验室检测的肝肾功能的显著变化。尽管与假体表面直接相关的远处有效银浓度高达1626 ppb，但对两名患者假体周围环境的组织病理学检查未显示异物肉芽肿或慢性炎症的迹象。总之，涂银大假体能够释放银，且未显示任何局部或全身副作用。
