Clinical trial NCT02901093: Quantification of Prosthesis Penetration With Conebeam in Otosclerosis
Official title: Early Postoperative Imaging of the Labyrinth by Cone Beam CT After Stapes Surgery for Otosclerosis With Correlation to Audiovestibular Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Otosclerosis
Keywords: Stapes surgery
Sensorineural complications
Inner ear
Imaging
Cone Beam CT
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-09-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing stapes surgery for otosclerosis

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).


Eligibility 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

Primary outcomes:
measure: location of the medial tip of the prosthesis within the vestibule
timeFrame: 1 day after surgery
measure: intravestibular length of the prosthesis
timeFrame: 1 day after surgery
measure: incidence of postoperative pneumolabyrinth
timeFrame: 1 day after surgery
measure: incidence of vertigo
timeFrame: 1 day after surgery
measure: incidence of nystagmus
timeFrame: 1 day after surgery
measure: change in pure-tone bone conduction hearing thresholds
timeFrame: between baseline and 1 day after surgery
measure: Pure-tone audiometry
timeFrame: 7 days, 1 month and 3 months after surgery
measure: bone conduction hearing thresholds
timeFrame: 7 days, 1 month and 3 months after surgery
measure: Speech Discrimination
timeFrame: baseline, 1 month and 3 months after surgery
measure: Speech Reception
timeFrame: baseline, 1 month and 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.