Stapes Footplate Thickness Measured With UHR-CT
1 other identifier
observational
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2023
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2022
CompletedFirst Posted
Study publicly available on registry
April 5, 2023
CompletedStudy Start
First participant enrolled
April 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2023
CompletedApril 5, 2023
April 1, 2023
2 months
December 5, 2022
April 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
stapes footplate thickness in mm in the stapes axial plane
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
october 2020-october 2022
Secondary Outcomes (1)
interobserver variability
october 2020-october 2022
Study Arms (3)
otosclerosis
otosclerosis patients
chronic otitis media
otitis media with middle ear opacities
controls
sudden ear loss, pre-implantatory imaging, vertigo, tympanic perforation
Interventions
stapes footplate thickness measurement
Eligibility Criteria
patients refered to our department between october 2020 and October 2022 for an ultra high resolution CT of the temporal bone
You may qualify if:
- Ultra high resolution CT of the temporal bone available
You may not qualify if:
- previous surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 32700991BACKGROUNDTang 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.
PMID: 34058698BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
romain gillet, MD
CHRU de Nancy
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, MSK Radiologist
Study Record Dates
First Submitted
December 5, 2022
First Posted
April 5, 2023
Study Start
April 28, 2023
Primary Completion
June 28, 2023
Study Completion
June 28, 2023
Last Updated
April 5, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share