Quantification of Prosthesis Penetration With Conebeam in Otosclerosis

Study Overview
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Brief Summary
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Sensorineural complications of stapes surgery are rare but potentially serious. Imaging is usually performed to identify an underlying cause, such as excessive intravestibular penetration of the prosthesis or pneumolabyrinth suggesting perilymphatic fistula. Unfortunately, there is very little data in an unselected series of uneventful patients. The aim of this study is to analyze the depth of prosthesis penetration within the vestibule and the rate of pneumolabyrinth the day or the day after the procedure by performing a Cone Beam CT (CBCT) of the temporal bone in a cohort of unselected patients, and to correlate imaging findings to clinical outcome. This prospective monocentric study is conducted in a tertiary referral medical center. A CBCT is performed in 80 consecutive patients having undergone stapes surgery for otosclerosis, the day or the day after the procedure. Penetration length and location of the prosthesis within the vestibule, as well as presence or absence of a pneumolabyrinth are recorded, and compared to clinical data (vertigo, nystagmus, hearing measurement).

Official Title
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Early Postoperative Imaging of the Labyrinth by Cone Beam CT After Stapes Surgery for Otosclerosis With Correlation to Audiovestibular Outcome

Conditions
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Otosclerosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age >= 18 years old patients undergoing stapes surgery for otosclerosis Exclusion Criteria: patient's refusal to participate in the study patient under legal protection no medical insurance coverage pregnant or breast feeding patient

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| location of the medial tip of the prosthesis within the vestibule | computerized tomography with cone beam | 1 day after surgery | 
| intravestibular length of the prosthesis | computerized tomography with cone beam | 1 day after surgery | 
| incidence of postoperative pneumolabyrinth | computerized tomography with cone beam | 1 day after surgery | 
| incidence of vertigo | clinical assessment | 1 day after surgery | 
| incidence of nystagmus | clinical assessment | 1 day after surgery | 
| change in pure-tone bone conduction hearing thresholds | measured at 250, 500, 1000, 2000, 3000, 4 000 Hz | between baseline and 1 day after surgery | 
| Pure-tone audiometry |  | 7 days, 1 month and 3 months after surgery | 
| bone conduction hearing thresholds |  | 7 days, 1 month and 3 months after surgery | 
| Speech Discrimination | audiometry: Speech Discrimination Score at a standard presentation level of 60 decibels (SDS60) expressed in percentages | baseline, 1 month and 3 months after surgery | 
| Speech Reception | audiometry: Speech Reception Threshold at 50% (SRT50) and/or 100% (SRT100) expressed in dB | baseline, 1 month and 3 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stapes surgery, Sensorineural complications, Inner ear, Imaging, Cone Beam CT