Cone Beam CT Versus Multislice CT: Radiologic Diagnostic Agreement in the Postoperative Assessment of Cochlear Implantation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cochlear Implants
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Concordance between MDCT and CBCT for assessing the scalar position of the electrodes
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
Objective: To evaluate the diagnostic concordance between multislice computed tomography (MSCT) and cone beam computed tomography (CBCT) in the early postoperative assessment of patients after cochlear implantation.
Study Design: Prospective, randomized, single-center, interventional, pilot study on the diagnostic performance of a medical device.
Setting: Tertiary referral center. Patients: Patients aged over 18 years requiring a CT scan after cochlear implant surgery.
Interventions: Nine patients were implanted with electrode arrays from three different manufacturers, including one bilateral. High-resolution MSCT and CBCT were then performed, and 2 experienced radiologists blinded to the imaging modality evaluated the randomized images, twice.
Investigators
Eligibility Criteria
Inclusion Criteria
- •CI surgery for severe to profound bilateral deafness
- •affiliated with the French health insurance
Exclusion Criteria
- •pregnancy
- •Patients weighing more than 160 kg
Outcomes
Primary Outcomes
Concordance between MDCT and CBCT for assessing the scalar position of the electrodes
Time Frame: At inclusion
Blinded images were analyzed in random order by 2 radiologists with several years of experience in temporal bone imaging. Each radiologist analyzed on the workstation the images of each patient twice at 4- to 8-week intervals. A consensus reading was performed by a third experienced radiologist in case of discordance. Each radiologist determined CI localization. The cochlear implant (CI) was considered within the scala tympani if it was in the most posterior scala on axial reconstructions passing through the cochlea (behind the osseous spiral lamina often seen).
Secondary Outcomes
- length of the intracochlear electrode array(At inclusion)
- percentage of implanted cochlea(At inclusion)
- number of intracochlear electrodes(At inclusion)
- radiation dose(At inclusion)