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Clinical Trials/NCT05214053
NCT05214053
Terminated
Not Applicable

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

University Hospital, Bordeaux1 site in 1 country1 target enrollmentJanuary 18, 2022
ConditionsOtosclerosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Otosclerosis
Sponsor
University Hospital, Bordeaux
Enrollment
1
Locations
1
Primary Endpoint
False negative rate of Cone Beam for the diagnosis of otosclerosis
Status
Terminated
Last Updated
3 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 18, 2022
End Date
August 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital, Bordeaux
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

False negative rate of Cone Beam for the diagnosis of otosclerosis

Time Frame: 1 day

False negative rate of Cone Beam for the diagnosis of otosclerosis, compared to MDCT (gold standard).

Secondary Outcomes

  • radiologic grades of otosclerosis(1 day)
  • extension to round window(1 day)
  • radiation dosage(1 day)
  • Existence of a bone canal around the labyrinthine portion of the facial nerve(1 day)

Study Sites (1)

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