Safety and Effectiveness of the Titanium mAXIS Stapes Prosthesis: Multicentric Short-Term Outcome.

IF 1.9 3区医学 Q3 CLINICAL NEUROLOGY

Otology & Neurotology Pub Date : 2025-02-19 DOI:10.1097/MAO.0000000000004462

Dirk Beutner, Nicholas Bevis, Benjamin Loader, Franz Windisch, Susan Arndt, Christian Offergeld, Wendelin Wolfram, Lisa Niederwanger, Paul Martin Zwittag, Nina Rubicz, Esther Schimanski, Christoph Arnoldner, Dominik Riss, Piotr H Skarżyński, Łukasz Plichta, Joachim Hornung, Lava Taha, Thomas Lenarz, Susan Busch, Astrid Magele, Georg Sprinzl

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引用次数: 0

Abstract

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.

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钛mAXIS镫骨假体的安全性和有效性：多中心短期疗效。

目的：耳硬化导致镫骨足板骨化，是导致大量患者听力损失的主要原因。镫骨手术是一种治疗耳硬化的方法，术后听力效果良好。本回顾性研究的目的是分析钛mAXIS假体在多中心环境下的安全性和有效性。方法：采用多中心研究方法，采用mAXIS镫骨假体植入术94例。随访59（±48.1）天，进行纯音测听。测定0.5、1、2和3 kHz （PTA-4）的纯音平均值。结果：无器械相关不良事件报告。88例患者接受了随访，随访时进行了纯音听力测量。随访时PTA-4气骨间隙（ABG）为8.8（±6.0）dB。64.8%的患者术后PTA-4 ABG在10 dB以内，94.3%的患者术后PTA-4 ABG在20 dB以内。95.5%的病例术后骨传导PTA-4阈值稳定。结论：本多中心研究结果证明了mAXIS钛镫骨假体的安全性。该假体显示出良好的听力学效果。需要进一步的研究来评估长期疗效。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Otology & Neurotology 医学-耳鼻喉科学

CiteScore

3.80

自引率

14.30%

发文量

509

审稿时长

3-6 weeks

期刊介绍： Otology & Neurotology publishes original articles relating to both clinical and basic science aspects of otology, neurotology, and cranial base surgery. As the foremost journal in its field, it has become the favored place for publishing the best of new science relating to the human ear and its diseases. The broadly international character of its contributing authors, editorial board, and readership provides the Journal its decidedly global perspective.