Clinical validation study of percutaneous cochlear access using patient-customized microstereotactic frames

使用患者定制的微型立体定向框架进行经皮耳蜗入路临床验证研究

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Abstract

OBJECTIVE: Percutaneous cochlear implant (PCI) surgery consists of drilling a single trough from the lateral cranium to the cochlea avoiding vital anatomy. To accomplish PCI, we use a patient-customized microstereotactic frame, which we call a "microtable" because it consists of a small tabletop sitting on legs. The orientation of the legs controls the alignment of the tabletop such that it is perpendicular to a specified trajectory. STUDY DESIGN: Prospective. SETTING: Tertiary referral center. PATIENTS: Thirteen patients (18 ears) undergoing traditional cochlear implant surgery. INTERVENTIONS: With institutional review board approval, each patient had 3 fiducial markers implanted in bone surrounding the ear. Temporal bone computed tomographic scans were obtained, and the markers were localized, as was vital anatomy. A linear trajectory from the lateral cranium through the facial recess to the cochlea was planned. A microtable was fabricated to follow the specified trajectory. MAIN OUTCOME MEASURES: After mastoidectomy and posterior tympanotomy, accuracy of trajectories was validated by mounting the microtables on the bone-implanted markers and then passing sham drill bits across the facial recess to the cochlea. The distance from the drill to vital anatomy was measured. RESULTS: Microtables were constructed on a computer-numeric-control milling machine in less than 5 minutes each. Successful access across the facial recess to the cochlea was achieved in all 18 cases. The mean +/- SD distance was 1.20 +/- 0.36 mm from midportion of the drill to the facial nerve and 1.25 +/- 0.33 mm from the chorda tympani. CONCLUSION: These results demonstrate the feasibility of PCI access using customized microstereotactic frames.

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