title: Lack of toxicological side-effects in silver-coated megaprostheses in humans.
abstract: 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.
authors: Department of Orthopaedics, University of Muenster, Albert-Schweitzer-Street 33, 48149 Muenster, Germany. hardes@uni-muenster.de
authors: Jendrik
authors: J
authors: Hardes
authors: Helmut
authors: H
authors: Ahrens
authors: Carsten
authors: C
authors: Gebert
authors: Arne
authors: A
authors: Streitbuerger
authors: Horst
authors: H
authors: Buerger
authors: Michael
authors: M
authors: Erren
authors: Andreas
authors: A
authors: Gunsel
authors: Christian
authors: C
authors: Wedemeyer
authors: Guido
authors: G
authors: Saxler
authors: Winfried
authors: W
authors: Winkelmann
authors: Georg
authors: G
authors: Gosheger
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018786:Bone Substitutes / Q000737:chemistry / Q000494:pharmacology; D020099:Coated Materials, Biocompatible / Q000737:chemistry / Q000494:pharmacology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019736:Prostheses and Implants / Q000592:standards*; D016459:Prosthesis-Related Infections / Q000517:prevention & control*; D015203:Reproducibility of Results; D012834:Silver / Q000097:blood / Q000737:chemistry / Q000494:pharmacology*
chemical_list: D018786:Bone Substitutes; D020099:Coated Materials, Biocompatible; D012834:Silver