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Quantification of Prosthesis Penetration With Conebeam in Otosclerosis (QUIPROCOS)

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ClinicalTrials.gov Identifier: NCT02901093
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):
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).


Condition or disease
Otosclerosis

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Early Postoperative Imaging of the Labyrinth by Cone Beam CT After Stapes Surgery for Otosclerosis With Correlation to Audiovestibular Outcome
Actual Study Start Date : September 25, 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : December 2015



Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients undergoing stapes surgery for otosclerosis
Criteria

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

Publications of Results:
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02901093     History of Changes
Other Study ID Numbers: DAE_2014_15
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: March 2017
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
Stapes surgery
Sensorineural complications
Inner ear
Imaging
Cone Beam CT
Additional relevant MeSH terms:
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Otosclerosis
Ear Diseases
Otorhinolaryngologic Diseases