Cone Beam CT Versus Multislice CT: Radiologic Diagnostic Agreement in the Postoperative Assessment of Cochlear Implantation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Concordance between MDCT and CBCT for assessing the scalar position of the electrodes
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Cone Beam
Patients included will have first a MultiSlice Computed tomography (MSCT) as usual and then a Cone Beam Computed Tomography (CBCT)
Intervention: Cone Beam Computed Tomography (CBCT) (Radiation)
Cone Beam
Patients included will have first a MultiSlice Computed tomography (MSCT) as usual and then a Cone Beam Computed Tomography (CBCT)
Intervention: Multiple Detector Computed Tomography (MDCT) (Radiation)
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)