[Ionomer cement prostheses in reconstructive middle ear surgery].

Animal experiments with microbiologic examinations and studies in cell cultures have shown that ionomer cement is a biocompatible and biostable bone replacement material in the head and neck region. Clinical and functional results of its use in the human middle ear have proven to be satisfactory during a maximal period of 2.5 years observation. The present trial was continued in order to determine the long-term behavior of ionomer cement (Ionos partial and total ossicles) after reconstruction of the ossicular chain. The ossicular chain was reconstructed in 343 cases and included various losses of one or more of the ossicles (i.e., incus, incus and malleus, incus and stapes superstructure, and malleus, incus and stapes superstructure). Follow-up extended over a maximum period of 5.5 years. Patients were examined under a surgical microscope and a pure-tone audiogram was performed at regular intervals. Clinical and audiological results were obtained 3 months postoperatively in all reconstructive procedures performed (partial and total ossicular replacement prostheses). These were mainly stable but revision surgery was necessary in 9% of the cases. In 5% the prosthesis was displaced and in 3% the prosthesis had partially migrated through the eardrum. Complete rejection of the implants was observed in the course of infections in 1% of the cases. Ionomer cement as a bone replacement material was found to have all required criteria for its use in the middle ear (biocompatibility, biostability, stable audiologic results and easy workability). These findings show that ionomer cement can be recommended in all cases of ossicular reconstruction.