Department of Otorhinolaryngology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center Nijmegen, The Netherlands.
Otol Neurotol. 2012 Feb;33(2):192-8. doi: 10.1097/MAO.0b013e318241c0bf.
This study assesses soft tissue reactions and implant stability of 1,132 percutaneous titanium implants (970 patients) for bone conduction devices (BCDs). In addition, it examines BCD usage and comparisons between different patient groups.
Retrospective survey. Mean follow-up time of 4.6 years.
Tertiary care referral center.
The surveyed cohort was divided into 3 different age groups (children, adults, and the elderly). In addition, 4 groups with variable loading times (i.e., the time between placement of the implant and loading the BCD sound processor) were identified as well as a subgroup of patients with mental retardation.
Soft tissue reactions around the percutaneous implants as classified by the Holgers grading system, implant failure, and revision surgery rates.
In 95.5% of the 7,415 observations of 1,132 implants, there were no adverse soft tissue reactions. Implant loss was 8.3%. Significantly more soft tissue reactions and implant failures were observed in children compared with adults and the elderly (p < 0.05). Implant survival was lower in patients with mental retardation compared with patients without mental retardation (p = 0.001). The loading time did not influence the occurrence of soft tissue reactions and implant survival rates.
Children and patients with mental retardation are the most vulnerable to soft tissue reactions and implant losses. Additional and more frequent care needs to be given during outpatient consultations. Because loading as early as 3 to 5 weeks did not negatively affect skin reactions or implant survival, full BCD installation can occur earlier without risk.
本研究评估了 1132 个经皮钛植入物（970 例患者）用于骨导式听力设备（BCD）的软组织反应和种植体稳定性。此外，还研究了 BCD 的使用情况以及不同患者群体之间的比较。
回顾性调查。平均随访时间为 4.6 年。
三级转诊中心。
被调查的队列分为 3 个不同的年龄组（儿童、成人和老年人）。此外，还确定了 4 个具有不同加载时间（即植入物放置与 BCD 声音处理器加载之间的时间）的组，以及一组智力障碍患者的亚组。
根据 Holgers 分级系统分类的经皮植入物周围的软组织反应、种植体失败和翻修手术率。
在 1132 个种植体的 7415 次观察中，有 95.5%没有出现不良的软组织反应。种植体丢失率为 8.3%。与成人和老年人相比，儿童的软组织反应和种植体失败明显更多（p < 0.05）。与无智力障碍的患者相比，智力障碍患者的种植体存活率较低（p = 0.001）。加载时间不会影响软组织反应和种植体存活率。
儿童和智力障碍患者最容易发生软组织反应和种植体丢失。在门诊咨询期间需要给予额外和更频繁的护理。因为在 3 至 5 周内加载不会对皮肤反应或种植体存活率产生负面影响，因此可以更早地进行完整的 BCD 安装而不会带来风险。
