NCT02901093

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
Last Updated

November 27, 2017

Status Verified

March 1, 2017

Enrollment Period

11 months

First QC Date

September 7, 2016

Last Update Submit

November 23, 2017

Conditions

Otosclerosis

Keywords

Stapes surgerySensorineural complicationsInner earImagingCone Beam CT

Outcome Measures

Primary Outcomes (10)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients undergoing stapes surgery for otosclerosis

You may qualify if:

  • age \>= 18 years old
  • patients undergoing stapes surgery for otosclerosis

You may not qualify if:

  • patient's refusal to participate in the study
  • patient under legal protection
  • no medical insurance coverage
  • pregnant or breast feeding patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28068300RESULT

MeSH Terms

Conditions

Otosclerosis

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2016

First Posted

September 15, 2016

Study Start

September 25, 2014

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

November 27, 2017

Record last verified: 2017-03