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骨锚式助听器及软组织保留手术技术的对照临床试验

Controlled Clinical Trial on Bone-anchored Hearing Implants and a Surgical Technique With Soft-tissue Preservation.

作者信息

den Besten Christine A, Bosman Arjan J, Nelissen Rik C, Mylanus Emmanuel A M, Hol Myrthe K S

机构信息

Department of Otorhinolaryngology, Radboud University Medical Centre, Nijmegen, The Netherlands.

出版信息

Otol Neurotol. 2016 Jun;37(5):504-12. doi: 10.1097/MAO.0000000000000994.

Abstract

OBJECTIVE

To compare the clinical and audiological outcomes after linear incision with soft-tissue preservation and standard linear incision with soft-tissue reduction for placement of percutaneous bone-anchored hearing implants.

STUDY DESIGN

Clinical trial with historical control-group from a previous randomized controlled trial.

SETTING

Tertiary referral center.

PATIENTS AND INTERVENTIONS

Twenty-five patients were enrolled in a prospective cohort of bone-anchored hearing implant placement with linear incision and tissue preservation with a follow-up of 6 months. The control-group consisted of 25 patients from a previous randomized controlled trial in the same tertiary referral center. All sound processors were fitted 3 weeks after surgery.

MAIN OUTCOME MEASURES

Numbness around the abutment, length of surgery, soft-tissue reactions according to Holgers' classification, Patient and Observer Scar Assessment Scale, implant loss, Implant Stability Quotient, and audiological outcome.

RESULTS

Tissue preservation resulted in better results on sensibility (mean percentage correct responses 98% [SD 4.4] versus 89% [SD 15.0], p = 0.003), on the Patient and Observer Scar Assessment Scale (mean observer score 15.3 [SD 4.3] versus 19.4 [SD 6.3], p = 0.006), and shorter total surgery time (mean 24.6 min [SD 6.2] versus 31.9 min [SD 6.5], p < 0.001). More adverse soft-tissue reactions as measured by the Holgers classification were observed in the test-group (n = 7 [28%] versus n = 1 [4%], p = 0.049). For Implant Stability Quotient and audiology the study did not provide evidence that tissue preservation is better or worse compared with tissue reduction.

CONCLUSION

Tissue preservation compared with tissue reduction leads to a generally favorable clinical outcome, comparable audiology results, and significantly shorter surgery time. Longer follow-up is warranted to conclude on the increased adverse soft-tissue reactions after 6 months.

摘要

目的

比较经皮骨锚式听力植入物植入时采用保留软组织的线性切口与采用减少软组织的标准线性切口后的临床和听力学结果。

研究设计

采用来自先前随机对照试验的历史对照组进行临床试验。

研究地点

三级转诊中心。

患者和干预措施

25例患者纳入前瞻性队列,采用线性切口并保留组织进行骨锚式听力植入物植入,随访6个月。对照组由同一三级转诊中心先前一项随机对照试验中的25例患者组成。所有声音处理器均在术后3周安装。

主要观察指标

基台周围麻木感、手术时长、根据霍尔格斯分类法的软组织反应、患者和观察者瘢痕评估量表、植入物丢失、植入物稳定性商数以及听力学结果。

结果

保留组织在感觉方面(正确反应的平均百分比为98%[标准差4.4],而对照组为89%[标准差15.0],p = 0.003)、在患者和观察者瘢痕评估量表方面(观察者平均评分为15.3[标准差4.3],而对照组为19.4[标准差6.3],p = 0.006)以及总手术时间更短(平均24.6分钟[标准差6.2],而对照组为31.9分钟[标准差6.5],p < 0.001)方面取得了更好的结果。试验组中观察到更多按照霍尔格斯分类法测量的不良软组织反应(n = 7[28%],而对照组为n = 1[4%],p = 0.049)。对于植入物稳定性商数和听力学,该研究未提供证据表明保留组织与减少组织相比更好或更差。

结论

与减少组织相比,保留组织导致总体上更有利的临床结果、相当的听力学结果以及显著更短的手术时间。需要更长时间的随访以得出关于6个月后不良软组织反应增加的结论。

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