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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Otosclerosis
• Intervention / Treatment: Procedure: stapedectomy; Radiation: ultra high resolution CT

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.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: romain gillet, md; Phone Number: 00.33680987216; Email: r.gillet@chru-nancy.fr

Study Locations

• France
  • Nancy, France, 54000
    • CHU Nancy
    • Contact: romain gillet, md; Phone Number: 00383851811; Email: r.gillet@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with otosclerosis who underwent stapes replacement by a prosthesis and underwent ultra high resolution CT for follow-up

Description

Inclusion Criteria:

- stapes prosthesis Ultra-high resolution CT available

Exclusion Criteria:

no materiovigilance report available

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients who underwent stapes surgery at our instution; patients with otosclerosis who underwent stapedectomy in our institution	Procedure: stapedectomy; stapes removal and replacement by a prosthesis; Radiation: ultra high resolution CT; imaging study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length	length of the prosthesis on CT	february 2020 - novembre 2023

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: romain gillet, CHRU de NANCY

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 15, 2024
• First Submitted That Met QC Criteria: March 15, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: computed tomography; titanium; stapes
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otosclerosis
• Other Study ID Numbers: N°4-RCB/EUDRACT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: because CT-scanner are the patient's proprety

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No