Quantification of Prosthesis Penetration With Conebeam in Otosclerosis

Completed

• Conditions: Otosclerosis

• Registration Number: NCT02901093
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

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

Not available

Study Timeline

• Study Start: 2014-09-25
• Primary Completion: 2015-09
• Study Completion: 2015-12
• Study First Submitted: 2016-09-07
• Study First Submitted QC: 2016-09-09
• Study First Posted: 2016-09-15
• Status Verified: 2017-03
• Last Update Submitted: 2017-11-23
• Last Update Posted: 2017-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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