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

Otosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06323863
• Other study ID #: N°4-RCB/EUDRACT
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2023
• Source: Central Hospital, Nancy, France
• Contact: romain gillet, md
• Phone: 00.33680987216
• Email: r.gillet[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• stapes prosthesis Ultra-high resolution CT available Exclusion Criteria: no materiovigilance report available

Related Conditions & MeSH terms

• Otosclerosis

Intervention

Procedure:
• stapedectomy
stapes removal and replacement by a prosthesis

Radiation:
• ultra high resolution CT
imaging study

Locations

Country	Name	City	State
France	Chu Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & Publications (3)

Bozzato A, Struffert T, Hertel V, Iro H, Hornung J. Analysis of the accuracy of high-resolution computed tomography techniques for the measurement of stapes prostheses. Eur Radiol. 2010 Mar;20(3):566-71. doi: 10.1007/s00330-009-1582-4. Epub 2009 Sep 2. — View Citation

Fang Y, Wang B, Galvin JJ 3rd, Tao D, Deng R, Ou X, Liu Y, Dai P, Sha Y, Zhang T, Chen B. MPR-CT Imaging for Stapes Prosthesis: Accuracy and Clinical Significance. Otol Neurotol. 2016 Apr;37(4):321-3. doi: 10.1097/MAO.0000000000000987. — View Citation

Gil Mun S, Scheffner E, Muller S, Mittmann P, Rademacher G, Mutze S, Wilms K, Boga E, Bjorn Gehl H, Sudhoff H, Todt I. Stapes piston insertion depth and clinical correlations. Acta Otolaryngol. 2019 Oct;139(10):829-832. doi: 10.1080/00016489.2019.1637019. Epub 2019 Jul 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length	length of the prosthesis on CT	february 2020 - novembre 2023