Department of Otorhinolaryngology, Head and Neck Surgery, UKGM, University of Marburg, Marburg, Germany.
Clin Otolaryngol. 2013 Jun;38(3):217-24. doi: 10.1111/coa.12127.
This study had the following objectives: (i) to determine the accuracy of determination of Vibrant Soundbridge position in the spectrum of typically implanted sites in the middle ear, (ii) to assess interobserver agreement between three observers with different levels of radiology experience and (iii) to determine the suitability of cone-beam computed tomography (CT) to be used as the baseline radiological assessment post implantation, confirm ferromagnetic transducer (FMT) position.
Prospective research study. Using four fresh human cadaveric heads, different types of vibroplasty were performed. After each step, cone-beam CT was performed for each of the four cadaveric heads.
University hospital (ENT and Neuroradiology).
Four fresh cadaveric heads of human donors were operated and analysed by radiological imaging.
There are different ways of coupling an ferromagnetic transducer to the anatomical structures of the middle and inner ear. Possibilities of differentiation between these coupling variants should be presented.
The individual reconstruction view was significantly different from a standardised view for each observer (observer 1: P = 0.003; observer 2: P = 0.001; observer 3: P = 0.002) for all coupling variants combined as well as for each individual coupling variant (overall correct diagnosis: 100% versus 60%). Regarding the frequency of correct diagnosis, no significant differences were found between the three observers (P > 0.500) for each individual coupling variant as well as for all coupling variants combined. The worst rates of correct diagnosis were found in the standardised view for incus (42%), stapes (0%) and TORP (17%) vibroplasty.
Cone-beam CT as a radiological control for Vibrant Soundbridge is safe and adequately sensitive and reliable and is therefore suitable for clinical investigation. The position of the ferromagnetic transducer in the middle ear and the presence or absence of an additional coupler could be determined in this study. Therefore, cone-beam-CT is useful for the assessment of device failure when there has been gross displacement of the ferromagnetic transducer (or smaller displacements in case of a baseline postoperative cone-beam CT). Regarding the quality of imaging, cone-beam CT produced accurate results with different observers with widely varying radiological experience.
本研究有以下目的：（i）确定在中耳典型植入部位范围内确定 Vibrant Soundbridge 位置的准确性，（ii）评估具有不同放射学经验的三位观察者之间的观察者间一致性，（iii）确定锥形束 CT（CBCT）的适用性作为植入后的基线影像学评估，确认铁磁换能器（FMT）的位置。
前瞻性研究。使用四个新鲜的人体头颅标本，进行了不同类型的振动成形术。在每个步骤之后，对每个头颅标本进行了锥形束 CT。
大学医院（耳鼻喉科和神经放射科）。
对四个新鲜的人体尸体头颅进行了手术，并通过放射影像学进行了分析。
有不同的方法将铁磁换能器与中耳和内耳的解剖结构耦合。应该呈现出这些耦合变体之间的区分可能性。
对于所有组合的耦合变体以及每个单独的耦合变体，个体重建视图与每个观察者的标准化视图明显不同（观察者 1：P = 0.003；观察者 2：P = 0.001；观察者 3：P = 0.002）（整体正确诊断：100%对 60%）。关于正确诊断的频率，在每个单独的耦合变体以及所有组合的耦合变体中，三个观察者之间没有发现显著差异（P > 0.500）。在标准化视图中，砧骨（42%）、镫骨（0%）和 TORP（17%）振动成形术的正确诊断率最低。
作为 Vibrant Soundbridge 的影像学控制，锥形束 CT 是安全的，并且具有足够的敏感性和可靠性，因此适合临床研究。在这项研究中，可以确定铁磁换能器在中耳中的位置以及是否存在附加耦合器。因此，当铁磁换能器发生明显移位（或在基线术后锥形束 CT 情况下发生较小移位）时，锥形束 CT 对设备故障的评估很有用。关于成像质量，锥形束 CT 产生了不同观察者的准确结果，这些观察者的放射学经验差异很大。
