Department of Otorhinolaryngology, Head and Neck Surgery, University of Erlangen-Nuremberg, FAU Medical School, Erlangen, Germany.
Otol Neurotol. 2011 Dec;32(9):1415-21. doi: 10.1097/MAO.0b013e3182355886.
The trimmable nitinol-polytetrafluoroethylene stapes prosthesis is a novel prosthesis that features a band-shaped nitinol loop. Unlike the SMart prosthesis, which uses the heat-activated self-crimping property of the alloy for fixation to the long process of the incus, this new prosthesis uses the property of superelasticity. The objective of the present study was to assess the hearing outcomes and intraoperative handling of the first 31 prostheses to be implanted in a primary stapes operation and to compare the results and experience thus obtained with those previously achieved with SMart prostheses.
Retrospective clinical study.
Tertiary reference center.
The results obtained in the first 31 patients (16 women and 15 men) in whom a nitinol prosthesis was implanted in a primary stapes operation between May 2009 and April 2010 were assessed and compared with those obtained in the first 31 patients (23 women and 8 men) to receive a SMart prosthesis between October 2004 and September 2005.
Primary stapes surgery.
Audiometry was performed preoperatively, and after a mean follow-up period of 26.9 days (standard deviation [SD], ± 16 d) in the nitinol group and 26.2 days (SD, ± 22 d) in the SMart group. Audiometry was repeated in 18 patients in the nitinol group and in 21 patients in the SMart group after a mean period of 480 days (SD, ± 118 d) and 495 days (SD, ± 160 d), respectively.
All the nitinol-polytetrafluoroethylene prostheses were implanted without problem. Fixation was simpler than with the SMart piston prosthesis. In the nitinol group, mean ABG3000 and ABG4000 were 9.5 dB (SD, ± 5.7 dB) and 10.7 dB (SD, ± 6.1 dB), respectively, with an improvement of 21.8 dB (SD, ± 8.0 dB) and 21.7 dB (SD, ± 7.9 dB), respectively. The corresponding values in the SMart piston group were 8.9 dB (± 4.3 dB) and 10.0 dB (± 5.2 dB), respectively, with an improvement of 21.2 ± 8.2 dB and 20.8 ± 8.3 dB, respectively. At the second follow-up, the values in the nitinol group were 4.4 dB (SD, ± 3.1 dB) for ABG3000 and 6.5 dB (SD, ± 4.3 dB) for ABG4000, with a mean improvement of 27.9 ± 6.0 dB and 27.0 ± 6.9 dB, respectively, whereas in the SMart group, the values were 5.7 ± 5.0 dB for ABG3000 and 6.4 ± 4.0 dB for ABG4000, with a mean improvement of 24.9 ± 7.2 and 24.7 ± 7.9 dB, respectively. These results did not differ to a statistically significant extent between the 2 groups.
The hearing outcomes obtained with the new superelastic nitinol prosthesis were similar to those that we had obtained previously with the SMart prosthesis. The fixation mechanism is simpler than with other types of prosthesis; however, the loop of the prosthesis seems not to be equally suitable for all diameters of the long process of the incus.
可调节的镍钛诺-聚四氟乙烯镫骨假体是一种新型的假体，具有一个带状的镍钛诺环。与使用合金的热激活自卷曲特性固定在砧骨长突上的 SMart 假体不同，这种新的假体使用超弹性。本研究的目的是评估第一批 31 个在初次镫骨手术中植入的假体的听力结果和术中处理，并将获得的结果和经验与之前使用 SMart 假体的结果进行比较。
回顾性临床研究。
三级参考中心。
2009 年 5 月至 2010 年 4 月期间，在 31 名患者（16 名女性和 15 名男性）中植入镍钛诺假体，评估并比较了第一批 31 名患者（23 名女性和 8 名男性）在 2004 年 10 月至 2005 年 9 月期间接受 SMart 假体的结果。
初次镫骨手术。
术前进行听力检查，在镍钛诺组平均随访 26.9 天（标准差[SD]，±16d）和 SMart 组 26.2 天（SD，±22d）后，在 18 名镍钛诺组患者和 21 名 SMart 组患者中重复听力检查，平均随访 480 天（SD，±118d）和 495 天（SD，±160d）。
所有镍钛诺-聚四氟乙烯假体均无问题植入。固定比 SMart 活塞假体更简单。在镍钛诺组中，ABG3000 和 ABG4000 的平均平均值分别为 9.5dB（SD，±5.7dB）和 10.7dB（SD，±6.1dB），分别提高了 21.8dB（SD，±8.0dB）和 21.7dB（SD，±7.9dB）。SMart 活塞组的相应值分别为 8.9dB（±4.3dB）和 10.0dB（±5.2dB），分别提高了 21.2±8.2dB 和 20.8±8.3dB。在第二次随访时，镍钛诺组 ABG3000 的数值为 4.4dB（SD，±3.1dB），ABG4000 的数值为 6.5dB（SD，±4.3dB），平均改善为 27.9±6.0dB 和 27.0±6.9dB，而在 SMart 组，ABG3000 的数值为 5.7±5.0dB，ABG4000 的数值为 6.4±4.0dB，平均改善为 24.9±7.2dB 和 24.7±7.9dB。这些结果在两组之间没有统计学上的显著差异。
新型超弹性镍钛诺假体获得的听力结果与我们之前使用 SMart 假体获得的结果相似。固定机制比其他类型的假体更简单；然而，假体的环似乎并不适用于所有砧骨长突的直径。
