A new ossicle homograft inactivation/preservation procedure: clinical results.

A new NaOH-autoclaving inactivation/preservation procedure (IPP) for ossicle homografts, complying with the actual infectious disease guidelines, has been developed and used in our institution for 5 years. This study compares the clinical and audiological results of middle ear reconstruction using the new NaOH-autoclaving inactivated ossicle homografts (22 patients) and the previously used cialit-formaldehyde inactivation procedure (28 patients). During the follow-up period, no homograft extrusion, resorption or disease transmission was observed either for the NaOH-autoclaving or for the cialit-formaldehyde protocol. A postoperative air-bone gap of less than 20 dB in 44% and a postoperative hearing improvement of 10-50 dB in 70% of patients complies with the published success rates of homograft ossiculoplasty in the literature. The analysis and comparison of both tested IPP-patient groups showed no statistically significant differences in the clinical and the audiological results. The NaOH-autoclaving inactivation/preservation protocol should increase ossicle homograft safety even with respect to prion exposure. The good anatomic and audiological long-term results of the new IPP protocol confirm homograft ossicles as a valid and inexpensive approach for middle ear reconstruction.