Quantification of Prosthesis Penetration With Conebeam in Otosclerosis

Otosclerosis Clinical Trial

— QUIPROCOS  

Official title:

Early Postoperative Imaging of the Labyrinth by Cone Beam CT After Stapes Surgery for Otosclerosis With Correlation to Audiovestibular Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02901093
• Other study ID #: DAE_2014_15
• Status: Completed
• Phase: N/A
• First received: September 7, 2016
• Last updated: November 23, 2017
• Start date: September 25, 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2017
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Sensorineural complications of stapes surgery are rare but potentially serious. Imaging is usually performed to identify an underlying cause, such as excessive intravestibular penetration of the prosthesis or pneumolabyrinth suggesting perilymphatic fistula.

Unfortunately, there is very little data in an unselected series of uneventful patients.

The aim of this study is to analyze the depth of prosthesis penetration within the vestibule and the rate of pneumolabyrinth the day or the day after the procedure by performing a Cone Beam CT (CBCT) of the temporal bone in a cohort of unselected patients, and to correlate imaging findings to clinical outcome. This prospective monocentric study is conducted in a tertiary referral medical center. A CBCT is performed in 80 consecutive patients having undergone stapes surgery for otosclerosis, the day or the day after the procedure. Penetration length and location of the prosthesis within the vestibule, as well as presence or absence of a pneumolabyrinth are recorded, and compared to clinical data (vertigo, nystagmus, hearing measurement).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age >= 18 years old

• patients undergoing stapes surgery for otosclerosis

Exclusion Criteria:

• patient's refusal to participate in the study

• patient under legal protection

• no medical insurance coverage

• pregnant or breast feeding patient

Related Conditions & MeSH terms

• Otosclerosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

References & Publications (1)

Vandevoorde A, Williams MT, Ukkola-Pons E, Daval M, Ayache D. Early Postoperative Imaging of the Labyrinth by Cone Beam CT After Stapes Surgery for Otosclerosis With Correlation to Audiovestibular Outcome. Otol Neurotol. 2017 Feb;38(2):168-172. doi: 10.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	location of the medial tip of the prosthesis within the vestibule	computerized tomography with cone beam	1 day after surgery
Primary	intravestibular length of the prosthesis	computerized tomography with cone beam	1 day after surgery
Primary	incidence of postoperative pneumolabyrinth	computerized tomography with cone beam	1 day after surgery
Primary	incidence of vertigo	clinical assessment	1 day after surgery
Primary	incidence of nystagmus	clinical assessment	1 day after surgery
Primary	change in pure-tone bone conduction hearing thresholds	measured at 250, 500, 1000, 2000, 3000, 4 000 Hz	between baseline and 1 day after surgery
Primary	Pure-tone audiometry		7 days, 1 month and 3 months after surgery
Primary	bone conduction hearing thresholds		7 days, 1 month and 3 months after surgery
Primary	Speech Discrimination	audiometry: Speech Discrimination Score at a standard presentation level of 60 decibels (SDS60) expressed in percentages	baseline, 1 month and 3 months after surgery
Primary	Speech Reception	audiometry: Speech Reception Threshold at 50% (SRT50) and/or 100% (SRT100) expressed in dB	baseline, 1 month and 3 months after surgery