Clinical and Radiological Evaluation of Two Mastoid Filling Products

University Hospital, Brest20 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

Conditions

Prospective Study

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult with cholesteatoma surgery Accepting the protocol and the radiological follow-up Exclusion Criteria: * patient less than 18 years old

Locations (1)

CHRU De Brest

Brest, France

RECRUITING

Outcomes

Primary Outcomes

Hounsfield Unit

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)

Time frame: one year

Secondary Outcomes

decibel

Auditory level pre and postoperative evaluation clinical

Time frame: one year

decibel

audiological evaluation

Time frame: one year

Central Contacts

remi Marianowski, MD, PhD

CONTACT

33298223333 remi.marianowski@chu-brest.fr

sonia Sahli Vivi Corsi, MD

CONTACT

33298223052 soni.sahli@chu-brest.fr

Data from ClinicalTrials.gov

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