Early Postoperative Imaging of the Labyrinth by Cone Beam CT After Stapes Surgery for Otosclerosis With Correlation to Audiovestibular Outcome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 80
- Primary Endpoint
- Speech Discrimination
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
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
intravestibular length of the prosthesis
Time Frame: 1 day after surgery
computerized tomography with cone beam
incidence of nystagmus
Time Frame: 1 day after surgery
clinical assessment
bone conduction hearing thresholds
Time Frame: 7 days, 1 month and 3 months after surgery
location of the medial tip of the prosthesis within the vestibule
Time Frame: 1 day after surgery
computerized tomography with cone beam
incidence of vertigo
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
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
incidence of postoperative pneumolabyrinth
Time Frame: 1 day after surgery
computerized tomography with cone beam
Pure-tone audiometry
Time Frame: 7 days, 1 month and 3 months after surgery
Secondary Outcomes
No secondary outcomes reported