Quantification of Prosthesis Penetration With Conebeam in Otosclerosis (QUIPROCOS)

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

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).

Study Overview

• Status: Completed
• Conditions: Otosclerosis

• Study Type: Observational
• Enrollment (Actual): 80

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients undergoing stapes surgery for otosclerosis

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: September 7, 2016
• First Submitted That Met QC Criteria: September 9, 2016
• First Posted (Estimate): September 15, 2016

Study Record Updates

• Last Update Posted (Actual): November 27, 2017
• Last Update Submitted That Met QC Criteria: November 23, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Imaging; Stapes surgery; Sensorineural complications; Inner ear; Cone Beam CT
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otosclerosis
• Other Study ID Numbers: DAE_2014_15