Department of Otorhinolaryngology, Donders Center for Neurosciences, Radboud University Medical Center, Nijmegen, The Netherlands.
Department of Otorhinolaryngology/Head and Neck Surgery, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.
Otol Neurotol. 2021 Sep 1;42(8):1192-1200. doi: 10.1097/MAO.0000000000003195.
To compare 6-months outcomes of the modified minimally invasive Ponto surgery (m-MIPS) to both the linear incision technique with soft tissue preservation (LIT-TP), and original MIPS (o-MIPS) for inserting bone-anchored hearing implants (BAHIs).
Exploratory pilot study with one test group and two historical control groups.
Tertiary referral center.
In the test group, 24 patients (25 implants) were prospectively included. Each control group comprised 25 patients (25 implants) who participated in previously conducted clinical trials.
The test group received a BAHI using m-MIPS. The two control groups underwent surgery using the LIT-TP and o-MIPS, respectively.
Implant survival, implant stability, and surgery-related variables were compared between the test and control groups. Soft tissue status, skin sensibility, and subjective numbness were compared between m-MIPS and LIT-TP only.
Implant survival was comparable between m-MIPS and LIT-TP, whereas implant stability measurements were slightly lower for m-MIPS. M-MIPS resulted in comparable adverse skin reactions and skin sensibility, significantly reduced surgical time and slightly improved subjective numbness, compared with LIT-TP. Between m-MIPS and o-MIPS, no statistically significant differences in implant survival, implant stability and surgical time were observed.
A trend toward lower implant loss rates after m-MIPS was observed, when compared with o-MIPS. M-MIPS seems to be a good alternative to LIT-TP for inserting BAHIs, since most clinical outcomes were either comparable or slightly better for m-MIPS. Upon deciding on which technique to use, larger studies on implant survival should be performed. Furthermore, other aspects such as costs, training aspects and surgical experience should be evaluated.
比较改良微创经皮 Pontos 手术（m-MIPS）与保留软组织的直线切口技术（LIT-TP）和原始 MIPS（o-MIPS）植入骨锚式听力植入物（BAHI）的 6 个月的结果。
具有一个实验组和两个历史对照组的探索性试点研究。
三级转诊中心。
在实验组中，前瞻性纳入了 24 名患者（25 个植入物）。每个对照组包括 25 名患者（25 个植入物），他们参加了之前进行的临床试验。
实验组使用 m-MIPS 接受 BAHI。两个对照组分别接受 LIT-TP 和 o-MIPS 手术。
比较实验组和对照组之间的植入物存活率、植入物稳定性和手术相关变量。仅比较 m-MIPS 和 LIT-TP 之间的软组织状况、皮肤敏感性和主观麻木感。
m-MIPS 和 LIT-TP 的植入物存活率相当，而 m-MIPS 的植入物稳定性测量值略低。与 LIT-TP 相比，m-MIPS 导致相似的不良皮肤反应和皮肤敏感性，手术时间明显缩短，主观麻木感略有改善。m-MIPS 和 o-MIPS 之间，植入物存活率、植入物稳定性和手术时间无统计学差异。
与 o-MIPS 相比，m-MIPS 后观察到植入物丢失率呈下降趋势。对于植入 BAHI，m-MIPS 似乎是 LIT-TP 的一个很好的替代方法，因为大多数临床结果对于 m-MIPS 来说要么相当，要么略好。在决定使用哪种技术时，应进行更大规模的关于植入物存活率的研究。此外，还应评估其他方面，如成本、培训方面和手术经验。
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