Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology · 2025
Safety and Effectiveness of the Titanium mAXIS Stapes Prosthesis: Multicentric Short-Term Outcome.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Beutner Dirk, Bevis Nicholas, Loader Benjamin, Windisch Franz, Arndt Susan, Offergeld Christian, Wolfram Wendelin, Niederwanger Lisa, Zwittag Paul Martin, Rubicz Nina, Schimanski Esther, Arnoldner Christoph, Riss Dominik, Skarżyński Piotr H, Plichta Łukasz, Hornung Joachim, Taha Lava, Lenarz Thomas, Busch Susan, Magele Astrid, Sprinzl Georg
Аннотация
OBJECTIVE: Otosclerosis leads to ossification of the stapes footplate and is responsible for a significant number of patients having hearing loss. Stapes surgery is a treatment for otosclerosis with excellent postoperative hearing outcomes. The aim of this retrospective study was to analyze the safety and effectiveness of the titanium mAXIS prosthesis in a multicentric setting.
METHODS: Ninety-four surgeries with implantation of the mAXIS stapes prosthesis took place in a multicenter study group. During follow-up at 59 (±48.1) days, pure-tone audiometry was performed. The pure-tone averages of 0.5, 1, 2, and 3 kHz (PTA-4) were determined.
RESULTS: No device-related adverse events were reported. There were 88 patients who reported for follow-up, at which pure-tone audiometry was performed. The PTA-4 air-bone gap (ABG) at follow-up was 8.8 (±6.0) dB. In 64.8% of the patients, the postoperative PTA-4 ABG was within 10 dB and in 94.3% it was within 20 dB. The postoperative PTA-4 thresholds for bone conduction were stable in 95.5% of cases.
CONCLUSION: The results of this multicentric study demonstrate the safety of the mAXIS titanium stapes prosthesis. The prosthesis shows promising audiological outcomes. Future studies are needed to assess long-term efficacy.
METHODS: Ninety-four surgeries with implantation of the mAXIS stapes prosthesis took place in a multicenter study group. During follow-up at 59 (±48.1) days, pure-tone audiometry was performed. The pure-tone averages of 0.5, 1, 2, and 3 kHz (PTA-4) were determined.
RESULTS: No device-related adverse events were reported. There were 88 patients who reported for follow-up, at which pure-tone audiometry was performed. The PTA-4 air-bone gap (ABG) at follow-up was 8.8 (±6.0) dB. In 64.8% of the patients, the postoperative PTA-4 ABG was within 10 dB and in 94.3% it was within 20 dB. The postoperative PTA-4 thresholds for bone conduction were stable in 95.5% of cases.
CONCLUSION: The results of this multicentric study demonstrate the safety of the mAXIS titanium stapes prosthesis. The prosthesis shows promising audiological outcomes. Future studies are needed to assess long-term efficacy.