Bone Conduction Implant and MRI

Bone conduction implants (BCI) are widely used in cases of conductive/ mixed hearing loss or single side deafness when surgical treatment or air hearing aids are not feasible. There are two types of BCI, abutments (which pass through the skin) and magnets (where a subcutaneous magnet is coupled to an external magnet). Pathologies (such as cholesteatoma) leading to the insertion of this hearing implant often require prolonged MRI follow-up. However, both the abutment and the magnet are responsible for imaging artifacts that limit its interpretation. Frequency and extent of these artifacts remain unclear in the literature. In our experience, the magnet, due to its size and composition, produces larger artifacts than the abutment. The main objective of our study is to compare MRI artifacts for each of these device types (abutment and magnet).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bone Anchored Devices Artifacts MRI Scans Osseo-Integrated Implants

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondation Ophtalmologique Adolphe de Rothschild (FOR)

Paris, 75019, France

About this study

The patients included in the study will all have a cerebral MRI as part of the cholesteatoma follow-up or for the assessment of cerebral or inner ear pathology.

ENT evaluation: The position of the implant will be evaluated. The distance from the external ear canal (center of the abutment or center of the magnet) will be measured on the patient using a ribbon meter. The angle between the implant and the orbital plane (in degrees) will be evaluated on a profile photograph.
Imaging evaluation: MRI examinations will be anonymized and sent to a single core laboratory for reading. One reader, a board-certified neuroradiologist with 5 years of experience in inner ear imaging, blinded to all data, will review all MRI examinations on a dedicated workstation with the Carestream Vue PACS software (Carestream Health, Rochester, NY). The main outcome measures will be the size of artifacts and the interpretability of sequences. The following MRI sequences will be performed on a 1.5T scanner (1.5T Philips®, Ingenia), covering the temporal bones :

ROUTINE SEQUENCES

2D Diffusion weighted-imaging (WI)
High-resolution 3D T2-WI TSE (DRIVE)
Post-contrast 2D T1-WI TSE (axial and coronal planes)

ADDITIONAL SEQUENCES (approximately 20 minutes of additional acquisition time) :

2D DWI (axial and coronal) phase inverted
2D T2-WI TSE (axial and coronal planes)
High-resolution 3D T2-WI gradient echo (bFFE)
post contrast 3D T1-WI TSE and gradient echo (THRIVE)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient over 18 years old Patient with a Baha bone conduction hearing implant, who must perform an MRI examination of the brain, internal auditory canal or middle ear, with or without injection Affiliate or beneficiary of a social security scheme Express consent to participate in the study Exclusion Criteria Patient benefiting from a legal protection measure Pregnant or lactating woman MRI examination not feasible Contraindications to the practice of an MRI: ocular metallic foreign body,certain implanted materials, pacemakers, claustrophobia Contraindications to gadolinium injection, if an MRI is prescribed with gadolinium contrast agent injection allergy, known renal failure: glomerular filtration rate inferior to 30mL by min

Treatment and study plan

MRI

Other

The patients included in the study will all have a cerebral MRI as part of the cholesteatoma follow-up or for the assessment of cerebral or inner ear pathology.

ENT evaluation

Primary outcomes

Artifact size, measured in millimeters, on MRI sequences.

Time frame: baseline

mm

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Official study title

Baha Bone Conduction Implants and Magnetic Resonance Imaging

Acronym: BAHA-IRM

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2023
First posted: Jun 26, 2020
Registry last updated: Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting