Clinical Trial: Quantification of Prosthesis Penetration With Conebeam in Otosclerosis

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary:
Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Current Primary Outcome:

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

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Fondation Ophtalmologique Adolphe de Rothschild

    Dates:
    Date Received: September 7, 2016
    Date Started:
    Date Completion:
    Last Updated: March 8, 2017
    Last Verified: March 2017