Single-blinded, randomized monocentric study of the use of two different piston diameters for stapesplasty with a stapes prosthesis with superelastic Nitinol-CliP
Not Applicable
Recruiting
- Conditions
- H80.9Otosclerosis, unspecified
- Registration Number
- DRKS00032064
- Lead Sponsor
- niversitätsklinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Otosclerosis
First operation
Patient consent
Exclusion Criteria
other chronic ear diseases in the ear to be operated
revision surgery
nickel or titanium allergy
Dizziness
alcohol or drug influence
physical or cognitive limitations that do not permit testing
pregnancy
no patient consent
persons accommodated in institutions
Intraoperative study exclusion:
Diagnoses beside otosclerosis (malleus head fixation, other post-inflammatory auditory bone fixation, chain disruption, malformations, that can only be detected intraoperatively).
Contraindications for a standardised laser stapedotomy (exposed facial nerve)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Postoperative tonaudiometric air-bone-gap differences in the low frequencies (500 and 1000 Hz) of two different piston diameters (0,4 vs 0,6mm) that were used for stapesplasty with the NiTiFLEX® stapes prosthesis after 8-12 weeks
- Secondary Outcome Measures
Name Time Method Postoperative speech audiometric differences (50% threshold for numbers, Freiburg monosyllabic test , maximum Freiburg monosyllabic comprehension) <br>Speech comprehension of sentences in noise (Oldenburger <br>sentence test - OLSA) Disease-related quality of life (Stapes Plasty Outcome Test 25 - SPOT-25)