Clinical and Radiological Evaluation of Two Mastoid Filling Products

• Conditions: Prospective Study

• Registration Number: NCT05072678
• Lead Sponsor: University Hospital, Brest

Brief Summary

to compare, the osseous density in the mastoid of two products used to obliterate the mastoid during surgery for cholesteatoma

Detailed Description

Primary objective: To compare the radiological aspect in the petrous bone of two obliteration products in adults, one year after surgery (Bioactive Glass S53P4 and biological Hydroxy apatite) secondary objective : To evaluate the cutaneous and the inner ear tolerance of bioactive glass S53P4 and biological hydroxy apatite when used in the mastoid and epitympanic obliteration for chronic otitis surgery

Study Timeline

• Status Verified: 2021-04
• Study Start: 2021-04-25
• Study First Submitted: 2021-04-29
• Study First Submitted QC: 2021-09-28
• Last Update Submitted: 2021-09-28
• Study First Posted: 2021-10-11
• Last Update Posted: 2021-10-11
• Primary Completion: 2022-04-25
• Study Completion: 2023-04-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Adult with cholesteatoma surgery Accepting the protocol and the radiological follow-up

Exclusion Criteria

• patient less than 18 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hounsfield Unit	one year	The attenuation and osseointegration of the BG granules: The quantitative analysis included bone attenuation measurements (in Hounsfield units, HU) in the circular region of interest (34mm2) of BGand of surrounding cortical bone and otic capsule using the otic capsule adjacent to the LSCC and the posterior fossa dural plate (DP)

Secondary Outcome Measures

Name	Time	Method
decibel	one year	audiological evaluation

Trial Locations

Locations (1)

CHRU De Brest; 🇫🇷 Brest, France