Stapesplasty in otosclerosis treatment is commonly performed using a wide variety of alloplastic prosthesis. In stapes surgery attaching these prosthesis onto the incus is regularly done by crimping, clipping or heating.
In a prospective, monocentric study a cohort of 32 otosclerosis cases participated in implanting the crimped mAXIS prosthesis. Perforation of the stapes footplate was performed using ether a CO2- or a Diodlaser. Comprehensive clinical assessments, including pre- and postoperative audiometric measurements, were conducted to evaluate hearing outcome. Additionally, postoperative complication was gathered.
In all cases, the application of the prosthesis was successful and straight forward. Direct comparison of the preoperative (29.1 ± 8.2 dB) to short term (24.1 ± 15.1 days, n=32) postoperative ABG (10.9 ± 5.2 dB) revealed a statistic highly significant improvement (p<0.0001, paired t-test). The audiometric data of the long term follow up (152.7 ± 64.8 days, n=11) revealed no significant changes in comparison to short term follow up (10.2 ± 3.9 dB, p=0.6, paired t-test) showing a comparable effectiveness of the mAXIS stapes prosthesis to commonly used prosthesis in otosclerosis treatment.
In conclusion, findings of this study show that the mAXIS stapes prosthesis is a safe and effective prosthesis in otosclerosis treatment. Future investigations will contribute its long-term efficacy and safety profile.
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