Cone Beam CT Versus Multislice CT in the Postoperative Assessment of Cochlear Implantation

Study Overview
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Brief Summary
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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.

Official Title
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Cone Beam CT Versus Multislice CT: Radiologic Diagnostic Agreement in the Postoperative Assessment of Cochlear Implantation

Conditions
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Cochlear Implants

Intervention / Treatment
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* Radiation: Cone Beam Computed Tomography (CBCT)
* Radiation: Multiple Detector Computed Tomography (MDCT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cone Beam<br>Patients included will have first a MultiSlice Computed tomography (MSCT) as usual and then a Cone Beam Computed Tomography (CBCT) | Radiation: Cone Beam Computed Tomography (CBCT)<br>* Patients had an additional Cone Beam Computed Tomography, after the usual MDCT<br>Radiation: Multiple Detector Computed Tomography (MDCT)<br>* Patients had a usual MDCT, before having an additional Cone Beam Computed Tomography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance between MDCT and CBCT for assessing the scalar position of the electrodes | 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). | At inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of the intracochlear electrode array | 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. This measurement was performed in the oblique coronal plane of the cochlea. | At inclusion | 
| percentage of implanted cochlea | 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. This measurement was performed in the oblique coronal plane of the cochlea. | At inclusion | 
| number of intracochlear electrodes | 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. This measurement was performed in the oblique coronal plane of the cochlea. | At inclusion | 
| radiation dose | Radiation dose was estimated using Computed Tomography Dose Index (CTDI, in Gy.cm) for each patient and scanner. These data are collected directly from the data sheet for each examination (also anonymised). | At inclusion |