Quantification of Prosthesis Penetration With Conebeam in Otosclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-25

Study Completion Date

2015-12-31

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).

Detailed Description

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Conditions

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Otosclerosis

Keywords

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Stapes surgery Sensorineural complications Inner ear Imaging Cone Beam CT

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

References

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Vandevoorde A, Williams MT, Ukkola-Pons E, Daval M, Ayache D. Early Postoperative Imaging of the Labyrinth by Cone Beam CT After Stapes Surgery for Otosclerosis With Correlation to Audiovestibular Outcome. Otol Neurotol. 2017 Feb;38(2):168-172. doi: 10.1097/MAO.0000000000001306.

Reference Type RESULT

PMID: 28068300 (View on PubMed)

Other Identifiers

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DAE_2014_15

Identifier Type: -

Identifier Source: org_study_id