Status:
COMPLETED
Validation of the French Version of the Stapesplasty Outcome Test 25 (SPOT-25)
Lead Sponsor:
Fondation Ophtalmologique Adolphe de Rothschild
Conditions:
Otosclerosis
Eligibility:
All Genders
18+ years
Brief Summary
Inclusion (J0): * Audiometry (as part of the treatment, only for cases) * Clinical evaluation (within the framework of care, only for cases) * Passage of the French version of the SPOT-25 questionnai...
Detailed Description
Inclusion (J0): * Audiometry (as part of the treatment, only for cases) * Clinical evaluation (within the framework of care, only for cases) * Passage of the French version of the SPOT-25 questionnai...
Eligibility Criteria
Inclusion
- Patient aged\> 18 years
- Diagnosis of otosclerosis with indication for primary stapes surgery by the combination of the arguments:
- Clinical: normal eardrum and audiometry revealing conductive or mixed hearing loss with audiometric Rinne of\> 15 dB and absence of stapedial reflex.
- Radiological: otosclerotic foci on preoperative CT scan
- Non-opposition to participating in the study
- Good understanding of French
- Affiliate or beneficiary of a health insurance plan
- Inclusion criteria for witnesses:
- Person aged\> 18 years
- Absence of known otological pathology
- Without otological surgical history
- Non-opposition to participating in the study
- Good understanding of French
Exclusion
- Comorbidity that may interfere with the interpretation of results
- History of stapes surgery
- Person benefiting from a legal protection measure
Key Trial Info
Start Date :
September 9 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 6 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04908839
Start Date
September 9 2021
End Date
April 6 2022
Last Update
February 14 2023
Active Locations (2)
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1
Fondation Adolphe de Rothschild
Paris, France, 75019
2
Amélie YAvchitz
Paris, Île-de-France Region, France, 75019