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

Not Applicable

Completed

• Conditions: Cochlear Implants
• Interventions: Radiation: Cone Beam Computed Tomography (CBCT); Radiation: Multiple Detector Computed Tomography (MDCT)

• Registration Number: NCT02892552
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2016-08
• Study First Submitted: 2016-09-02
• Study First Submitted QC: 2016-09-02
• Study First Posted: 2016-09-08
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• CI surgery for severe to profound bilateral deafness
• affiliated with the French health insurance

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Exclusion Criteria

• pregnancy
• Patients weighing more than 160 kg

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cone Beam	Multiple Detector Computed Tomography (MDCT)	Patients included will have first a MultiSlice Computed tomography (MSCT) as usual and then a Cone Beam Computed Tomography (CBCT)
Cone Beam	Cone Beam Computed Tomography (CBCT)	Patients included will have first a MultiSlice Computed tomography (MSCT) as usual and then a Cone Beam Computed Tomography (CBCT)

Primary Outcome Measures

Name	Time	Method
Concordance between MDCT and CBCT for assessing the scalar position of the electrodes	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 Outcome Measures

Name	Time	Method
length of the intracochlear electrode array	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.; This measurement was performed in the oblique coronal plane of the cochlea.
percentage of implanted cochlea	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.; This measurement was performed in the oblique coronal plane of the cochlea.
number of intracochlear electrodes	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.; This measurement was performed in the oblique coronal plane of the cochlea.
radiation dose	At inclusion	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).

Trial Locations

Locations (1)

Service imagerie pavillon B, Hopital E. Herriot; 🇫🇷 Lyon, France