Otosclerosis
Conditions
Keywords
Stapes surgery, Sensorineural complications, Inner ear, Imaging, Cone Beam CT
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).
Interventions
None listed
Sponsors
Fondation Ophtalmologique Adolphe de Rothschild
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| location of the medial tip of the prosthesis within the vestibule | 1 day after surgery | computerized tomography with cone beam |
| intravestibular length of the prosthesis | 1 day after surgery | computerized tomography with cone beam |
| incidence of postoperative pneumolabyrinth | 1 day after surgery | computerized tomography with cone beam |
| incidence of vertigo | 1 day after surgery | clinical assessment |
| incidence of nystagmus | 1 day after surgery | clinical assessment |
| change in pure-tone bone conduction hearing thresholds | between baseline and 1 day after surgery | measured at 250, 500, 1000, 2000, 3000, 4 000 Hz |
| 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 | 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 | baseline, 1 month and 3 months after surgery | audiometry: Speech Reception Threshold at 50% (SRT50) and/or 100% (SRT100) expressed in dB |
Outcome results
None listed