Cone Beam vs MDCT for Diagnosis and Pre-operative Evaluation of Otosclerosis

NCT ID: NCT05214053

Last Updated: 2022-10-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-18
• Study Completion Date: 2022-08-01

Brief Summary

This study aims to compare the Cone Beam and the multi-detector computed tomography for diagnosis and pre-operative evaluation of otosclerosis in patients addressed for conductive hearing loss with intact tympanic membrane. The study aims to show that the Cone Beam offers equivalent performances with lower radiation dosage in this indication

Detailed Description

Otosclerosis is an inflammatory bone remodeling disorder of the otic capsule, characterized by spongiotic new bone formation, causing stamped ankylosis that can result in conductive hearing loss. Until now, the gold standard imaging technique for diagnosis and pre-operative evaluation of otosclerosis has been multi-detector computed tomography (MDCT). Cone Beam computed tomography is a relatively recent imaging modality. It is associated with a lower radiation dosage compared to MDCT, and a high spatial resolution that allows a more precise analysis of bone structures. During the last 15 years, its use has been increasingly common in odontology and craniofacial surgery. Several studies have already studied the utility of Cone Beam for temporal bone pathologies, including recent retrospective studies that showed satisfying diagnostic performances for otosclerosis. Up to now, very few prospective studies have compared those two imaging modalities for otosclerosis diagnosis and pre-operative evaluation.

Therefore, those two exams will be performed in patients addressed to the hospital for conductive hearing loss with intact tympanic membrane. Thus, the performance of Cone Beam will be compared to MDCT, regarding the positive diagnosis of otosclerosis, the analysis of anatomical structures of the temporal bone for pre-operative evaluation, and also the benefits in terms of irradiation. The MDCTs will include fewer slices than routine MDCTs and will be centered on the area of interest, in order to keep a total radiation dosage smaller or equivalent to routine care

Conditions

Otosclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Cone Beam CT

Each patient will undergo a Cone Beam CT and a MDCT

Group Type: EXPERIMENTAL

Cone Beam CT

Intervention Type: DEVICE

Each patient will undergo a Cone Beam CT and a MDCT

Interventions

Cone Beam CT

Each patient will undergo a Cone Beam CT and a MDCT

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult patients (18 years and older)
• Requiring radiological assessment for conductive hearing loss with intact tympanic membrane, confirmed by otoscopy and audiogram
• Signed informed consent
• Affiliated or beneficiary of health insurance

Exclusion Criteria

• Absence of otosclerosis on the MDCT
• History of middle ear surgery
• Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control
• Patient under legal protection

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Bordeaux

Bordeaux, , France

Countries

France

Other Identifiers

CHUBX 2021/21

Identifier Type: -

Identifier Source: org_study_id