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骨锚定式听力植入物的六个月临床结果:微创耳内 Pont 手术与保留组织的线性切口技术的比较。

Six-Month Clinical Outcomes for Bone-Anchored Hearing Implants: Comparison Between Minimally Invasive Ponto Surgery and the Linear Incision Technique With Tissue Preservation.

机构信息

Department of Otorhinolaryngology, Donders Center for Neurosciences, Radboud University Medical Center, Nijmegen, The Netherlands.

出版信息

Otol Neurotol. 2020 Apr;41(4):e475-e483. doi: 10.1097/MAO.0000000000002562.

DOI:10.1097/MAO.0000000000002562
PMID:32176135
Abstract

OBJECTIVES

The aim of this study is to investigate and compare the clinical outcomes of minimally invasive ponto surgery (MIPS) to the linear incision technique with soft tissue preservation (LIT-TP) for percutaneous bone-anchored hearing implants (BAHI).

STUDY DESIGN

Prospective cohort study with a historical control group.

SETTING

Tertiary referral center.

PATIENTS

Twenty-five patients were prospectively included in the test group. The control group consisted of 25 patients who previously participated in another clinical trial and already underwent BAHI surgery.

INTERVENTION

All patients were implanted with a 4.5-mm-wide implant, using MIPS in the test group and the LIT-TP in the control group. Follow-up visits were scheduled 7 days, 21 days (sound processor fitting), 12 weeks and 6 months after surgery.

MAIN OUTCOME MEASURES

The primary outcome measure was skin sensibility around the abutment 6 months after surgery. Secondary outcomes were subjective numbness, surgery time, wound healing, adverse soft tissue reactions, cosmetic outcomes, implant stability quotient (ISQ), implant survival, and sound processor use.

RESULTS

Skin sensibility, adverse soft tissue reactions, and sound processor use were comparable between groups. The test group had a shorter surgery time and better cosmetic outcomes. More skin dehiscences and a statistically nonsignificant higher implant loss rate (12% vs 0%, p = 0.079) were observed in the test group.

CONCLUSION

MIPS is comparable to the LIT-TP regarding skin sensibility at 6 months and soft tissue tolerability. With MIPS, surgery time is further reduced and better cosmetic outcomes are reported. More research into MIPS, exact drill protocol, used instruments, and associated implant loss is warranted.

摘要

目的

本研究旨在比较微创桥小脑角入路(MIPS)与保留软组织的直线切口技术(LIT-TP)在经皮骨锚式听力植入(BAHI)中的临床效果。

设计

前瞻性队列研究,设有历史对照组。

地点

三级转诊中心。

患者

25 例患者前瞻性纳入实验组。对照组由 25 例先前参与另一项临床试验并已行 BAHI 手术的患者组成。

干预

所有患者均植入 4.5mm 宽的植入物,实验组采用 MIPS,对照组采用 LIT-TP。术后 7 天、21 天(声音处理器适配)、12 周和 6 个月进行随访。

主要观察指标

术后 6 个月时,主要观察指标为基台周围皮肤感觉。次要观察指标为主观麻木、手术时间、伤口愈合、不良软组织反应、美容效果、种植体稳定性指数(ISQ)、种植体存活率和声音处理器使用情况。

结果

两组间皮肤感觉、不良软组织反应和声音处理器使用情况无差异。实验组手术时间更短,美容效果更好。实验组皮肤裂开更多,种植体失效率(12%比 0%,p=0.079)略高,但无统计学意义。

结论

MIPS 与 LIT-TP 在 6 个月时的皮肤感觉和软组织耐受性方面相当。与 LIT-TP 相比,MIPS 可进一步缩短手术时间,并获得更好的美容效果。需要进一步研究 MIPS,包括确切的钻孔方案、使用的器械和相关的种植体失效率。

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