Histological evaluation of novel ossicular chain replacement prostheses: an animal study in rabbits

Conclusion. The improved biocompatibility of Bioveri((R)) II coated with a nanostructured surface shows promising qualities for use in human reconstructive middle ear surgery. In the case of chitosan-hydroxyapatite composite prostheses, further investigations regarding composition of the material, degree of purity and design are necessary before clinical application. Objective. The selection of optimal materials for reconstructive middle ear surgery continues to be a problem. In the present study novel materials were tested as total ossicular replacement prostheses (TORPs) in an animal model. Materials and methods. Bioverit((R)) 11 coated with a nanostructured surface and chitosan-hydroxyapatite composites were placed in the middle ear of 40 rabbits. Uncoated Bioveri((R)) II was used as control. After an implantation period of 28, 84 or 300 days petrous bones were extracted, embedded in epoxy resin and examined by light microscopy. Results. Uncoated and coated Bioverit((R)) prostheses revealed a mucosal coverage and a little osseogenic response after 28 days. The results of the coated Bioverit((R)) prostheses slightly surpassed those of the plain prostheses. Chitosan-hydroxyapatite composite prostheses were mostly found to be dislocated after 28 days. Formations of granulation tissue and fibrotic capsules were observed around these implants. This reaction could be caused by the instability of the composite material or may be due to impurities present in the chitosan.