H80.9
Conditions
Interventions
Group 1: NitiFLEX® stapes prosthesis (0.4mm piston diameter)
Group 2: NitiFLEX® stapes prosthesis (0.6mm piston diameter)
Sponsors
Universitätsklinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Otosclerosis First operation Patient consent
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Postoperative speech audiometric differences (50% threshold for numbers, Freiburg monosyllabic test , maximum Freiburg monosyllabic comprehension) Speech comprehension of sentences in noise (Oldenburger sentence test - OLSA) Disease-related quality of life (Stapes Plasty Outcome Test 25 - SPOT-25) | — |
Countries
Germany
Contacts
Public ContactJan Wittlinger
Universitätsklinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie
Outcome results
None listed