Skip to main content
OpenTrials
Completed

NCT Number: NCT02901093

Quantification of Prosthesis Penetration With Conebeam in Otosclerosis

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Otosclerosis Ear Diseases Otorhinolaryngologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. location of the medial tip of the prosthesis within the vestibule

    Time frame: 1 day after surgery

    computerized tomography with cone beam

  2. intravestibular length of the prosthesis

    Time frame: 1 day after surgery

    computerized tomography with cone beam

  3. incidence of postoperative pneumolabyrinth

    Time frame: 1 day after surgery

    computerized tomography with cone beam

  4. incidence of vertigo

    Time frame: 1 day after surgery

    clinical assessment

  5. incidence of nystagmus

    Time frame: 1 day after surgery

    clinical assessment

  6. 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

  7. Pure-tone audiometry

    Time frame: 7 days, 1 month and 3 months after surgery

  8. bone conduction hearing thresholds

    Time frame: 7 days, 1 month and 3 months after surgery

  9. 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

  10. Speech Reception

    Time frame: baseline, 1 month and 3 months after surgery

    audiometry: Speech Reception Threshold at 50% (SRT50) and/or 100% (SRT100) expressed in dB

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Official study title

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

Acronym: QUIPROCOS

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 15, 2016
Registry last updated
Nov 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.