Stapes Footplate Thickness Measured With UHR-CT

• Sponsor: Central Hospital, Nancy, France (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05799404
• Collaborator: (none)
• Enrollment: 100
• Anticipated Duration (Months): 2

Study Details

Study Description

Brief Summary

The aim of this study is to compare the thickness of the stapes footplate measured with ultra high resolution CT in control patients, otosclerosis patients and chronic otitis media patients.

Condition or Disease	Intervention/Treatment	Phase
Otosclerosis; Otitis Media	Diagnostic Test: ultra-high resolution CT

Detailed Description

Stapes footplate thickness will be measured under its anterior crus, its posterior crus and at its midpoint, in both the stapes axial plane and the laletral semi-circular canal planes.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Stapes Footplate Thickness Measured With UHR-CT
• Anticipated Study Start Date: Apr 28, 2023
• Anticipated Primary Completion Date: Jun 28, 2023
• Anticipated Study Completion Date: Jun 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
otosclerosis otosclerosis patients	Diagnostic Test: ultra-high resolution CT; stapes footplate thickness measurement
chronic otitis media otitis media with middle ear opacities	Diagnostic Test: ultra-high resolution CT; stapes footplate thickness measurement
controls sudden ear loss, pre-implantatory imaging, vertigo, tympanic perforation	Diagnostic Test: ultra-high resolution CT; stapes footplate thickness measurement

Outcome Measures

Primary Outcome Measures

1. stapes footplate thickness in mm in the stapes axial plane [october 2020-october 2022]

   stapes footplate thickness measured with a digital caliper on our PACS system with the accuracy of a tenth of a millimetre, under the anterior crus of the stapes, under the posterior crus of the stapes, and at its midpoint, in the stapes axial plane and in the lateral semi circular canal plane, to compare both values and find out wich one is the most pertinent

Secondary Outcome Measures

1. interobserver variability [october 2020-october 2022]

   interobserver variability

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Ultra high resolution CT of the temporal bone available

Exclusion Criteria:

• previous surgery

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Central Hospital, Nancy, France

Investigators

• Principal Investigator: romain gillet, MD, CHRU de Nancy

Study Documents (Full-Text)

None provided.

More Information

Publications

• Akazawa Y, Ganaha A, Higa T, Kondo S, Oyakawa Y, Hirakawa H, Suzuki M, Yamashiro T. Measurement of stapes footplate thickness in otosclerosis by ultra-high-resolution computed tomography. Acta Otolaryngol. 2020 Nov;140(11):899-903. doi: 10.1080/00016489.2020.1788225. Epub 2020 Jul 23.
• Tang R, Yin H, Wang Z, Zhang Z, Zhao L, Zhang P, Li J, Zhao P, Lv H, Zhang L, Yang Z, Wang Z. Stapes visualization by ultra-high resolution CT in cadaveric heads: A preliminary study. Eur J Radiol. 2021 Aug;141:109786. doi: 10.1016/j.ejrad.2021.109786. Epub 2021 May 21.

• Responsible Party: GILLET Romain, MD, MSK Radiologist, Central Hospital, Nancy, France
• ClinicalTrials.gov Identifier: NCT05799404
• Other Study ID Numbers: N°3-RCB/EUDRACT
• First Posted: Apr 5, 2023
• Last Update Posted: Apr 5, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by GILLET Romain, MD, MSK Radiologist, Central Hospital, Nancy, France: ultra high resolution; ct; stapes; footplate; otosclerosis; otitis media
• Additional relevant MeSH terms: Otitis; Otitis Media; Otosclerosis

Study Results

No Results Posted as of Apr 5, 2023