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Ultra-high Resolution CT: the End of Stapes Prosthesis Measurement Misestimation

Ultra-high Resolution CT: the End of Stapes Prosthesis Measurement Misestimation

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06323863
Enrollment
20
Registered
2024-03-21
Start date
2024-04-01
Completion date
2024-12-01
Last updated
2024-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otosclerosis

Keywords

stapes, titanium, computed tomography

Brief summary

Actual CT scanners overestimate stapes piston size, and do not represent a valuable technique for their follow-up, especially in case of complication. Ultra-high resolution has not yet been evaluated in this setting.

Detailed description

Modern temporal bone imaging systems, using 0.5 mm slice thickness, are reputed not yet able to depict the stapes piston position with a sufficient degree of accuracy, as high-resolution CT measurements consistently overestimated intravestibular piston dimensions (width by 44%, length by 6.25%) and vestibular intrusion (by 39%) because of metallic artifacts. . The exact limits of intravestibular depth are also unclear. The safe intravestibular prosthesis depth varies widely between studies and has been reported to range from 0.2 to 2.5 mm, so 39% may represent up to 0.9 mm of misestimation. Ultra-high resolution CT (UHR-CT) has improved spatial resolution to 0.12 mm by using ultra-small detector elements (0.25 x 0.25 mm), allowing better visualization of temporal bone structures compared to high-resolution temporal bone CT (HR-CT). However, this technique has not been described for stapes prosthesis measurement.

Interventions

PROCEDUREstapedectomy

stapes removal and replacement by a prosthesis

RADIATIONultra high resolution CT

imaging study

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

\- stapes prosthesis Ultra-high resolution CT available

Exclusion criteria

no materiovigilance report available

Design outcomes

Primary

MeasureTime frameDescription
lengthfebruary 2020 - novembre 2023length of the prosthesis on CT

Countries

France

Contacts

Primary Contactromain gillet, md
r.gillet@chru-nancy.fr00.33680987216

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026