ossification Otosclerosis
Conditions
Interventions
Primary stapedotomy, either with a 0.4 mm piston or a 0.6 mm piston.
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age * 18 years; Otosclerosis based on a clinical history of progressive hearing loss and pure-tone audiometry showing conductive hearing loss with an air-bone gap > 20 dB nHL in the range of 500, 1000, 2000 and 4000 Hz; Eligible for stapedotomy; Willingness and ability to participate in all scheduled procedures outlined in this research protocol; General health allowing general anesthesia; Good understanding of the Dutch language.
Exclusion criteria
Exclusion criteria: Previous middle ear surgery; Known aberrant (middle ear) anatomy in one or both ears; Co-morbid middle or inner ear pathology, osteogenesis imperfecta, an active ear infection in one or both ears or active otosclerosis with Schwartze sign; Disability that could interfere with audiologic evaluation and/or questionnaire fulfillment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure is postoperative air-bone gap closure on pure-tone audiometry at 12 months follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures are hearing improvement on pure-tone and speech audiometry, disease-specific and general quality of life and complications (with specific attention for tinnitus and vertigo). | — |
Countries
Netherlands
Outcome results
None listed