Prospective Study
Conditions
Keywords
osteoingration, surgery, cholesteatome
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
Interventions
None listed
Sponsors
University Hospital, Brest
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult with cholesteatoma surgery Accepting the protocol and the radiological follow-up
Exclusion criteria
* patient less than 18 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| decibel | one year | Auditory level pre and postoperative evaluation clinical |
Countries
France
Contacts
Primary Contactremi Marianowski, MD, PhD
Backup Contactsonia Sahli Vivi Corsi, MD
Outcome results
None listed