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

C

Central Hospital, Nancy, France

Status

Not yet enrolling

Conditions

Otosclerosis

Treatments

Radiation: ultra high resolution CT
Procedure: stapedectomy

Study type

Observational

Funder types

Other

Identifiers

NCT06323863
N°4-RCB/EUDRACT

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • stapes prosthesis Ultra-high resolution CT available

Exclusion criteria

no materiovigilance report available

Trial design

20 participants in 1 patient group

patients who underwent stapes surgery at our instution
Description:
patients with otosclerosis who underwent stapedectomy in our institution
Treatment:
Radiation: ultra high resolution CT
Procedure: stapedectomy

Trial contacts and locations

1

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Central trial contact

romain gillet, md

Data sourced from clinicaltrials.gov

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