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

NCT06323863 | Unknown

• 1 other identifier: N°4-RCB/EUDRACT
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Otosclerosis

Keywords

stapes; titanium; computed tomography

Outcome Measures

Primary Outcomes (1)

• length

  length of the prosthesis on CT

  february 2020 - novembre 2023

Study Arms (1)

patients who underwent stapes surgery at our instution

patients with otosclerosis who underwent stapedectomy in our institution

Procedure: stapedectomy; Radiation: ultra high resolution CT

Interventions

stapedectomy PROCEDURE

stapes removal and replacement by a prosthesis

patients who underwent stapes surgery at our instution

ultra high resolution CT RADIATION

imaging study

patients who underwent stapes surgery at our instution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \- stapes prosthesis Ultra-high resolution CT available

You may not qualify if:

• no materiovigilance report available

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Chu Nancy

Nancy, 54000, France

Location

Related 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.

  PMID: 19727746 BACKGROUND

• 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.

  PMID: 26927761 BACKGROUND

• 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.

  PMID: 31298596 BACKGROUND

MeSH Terms

Conditions

Otosclerosis

Interventions

Stapes Surgery

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Otologic Surgical Procedures; Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• romain gillet

  CHRU de Nancy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

romain gillet, md

CONTACT

00.33680987216; r.gillet@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 21, 2024
• Study Start: April 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 21, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)