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临床试验/NCT02093806
NCT02093806Unknown不适用

Clinical Applications of Round Window High Resolution Computerised Tomography Anatomy in Cochlear Implant Surgery

Bnai Zion Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
the size of round window niche and its relation to the cochlea

研究概览

简要总结

The purpose of this study is to measure the size of the round window niche and its relation to the mastoid segment of the facial nerve and the mastoid cortex, using high resolution computerized tomography of the temporal bone, in order to assess preoperatively what is the extent of obstruction of the round window membrane and whether there is a surgical possibility of round window approach in the insertion of electrode array into the cochlea

详细描述

The assessment of the anatomy of the round window will be executed using the stractured measuring software used for imaging of the Bnai Zion medical center (CARESTREAM PACS Ver. 11.0, CARSTREAM HEALTH INC.) in IAC window (centered at 700 with a total width of 4000) in the available zoom by the software (usually 400-800%).

Measuring the length (mm) and angle will be executed by the software's structured rulers.

Measuring protocol:

  1. Measured scans: one taken in an orbito-meatal plane

  2. Chosen slices: where both the round window niche and the external ear canal are seen on the same slice

  3. Distances measured:

  4. Distance 1: between the anterior edge of the round window niche and the cortex of the mastoid, with a minimal distance of 0.5mm to the posterior wall of the external ear canal

  5. Distance 2: between the posterior edge of the round window niche and the cortex of the mastoid, with a minimal distance of 0.3mm to the anterior edge of the mastoid segment of the facial nerve.

  6. Distance 3: the size of the round window niche (from its anterior to posterior edges)

  7. Distance 4: between the anterior (most medial) edge of the round window membrane to a point at least 0.3mm anterior to the mastoid segment of the facial nerve.

  8. Distance 5: between the posterior (most lateral) edge of the round window membrane to a point at least 0.3mm anterior to the mastoid segment of the facial nerve

  9. Distance 6: size of round window membrane (anterior/medial to posterior/lateral)

  10. Distance 7: between the lateral edges of distance 1 and 2 marking the cortical size of the "working channel" created between the lines (from the cortex to the round window).

  11. Angles measured:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 20 years old or older
  • high resolution computerized tomography of the temporal bone (slices ≤1mm) before the surgery
  • on the measured slices both the round window niche and the posterior wall of the external ear canal are seen

排除标准

  • inner, middle or external ear malformation
  • temporal bone malformation
  • status post cochlear implant
  • status post temporal bone trauma
  • slices were the round window niche and the posterior wall of the external ear canal are not seen on the same slice

结局指标

主要结局

the size of round window niche and its relation to the cochlea

时间窗: january-june 2014 (six months)

次要结局

  • sizes of working channel from the mastoid cortex into the round window membrane and its relation to the mastoid sagment of the facial nerve(january-june 2014 (six months))

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

MICHAL.LUNTZ

Prof. Michal Luntz

Bnai Zion Medical Center

研究点 (1)

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