The primary objective of this study is to evaluate the effectiveness of two differently sized pistons used in primary stapedotomy for otosclerosis in terms of hearing improvement, complication rate and general and disease-specific quality of life.
ID
Source
Brief title
Condition
- Middle ear disorders (excl congenital)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure is postoperative air-bone gap closure on pure-tone
audiometry at 12 months follow-up.
Secondary outcome
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).
Background summary
Otosclerosis is characterized by bony deposits in the middle ear, resulting in
stapes fixation and progressive hearing loss. It can be treated effectively by
surgically removing (part of) the stapes and replacing it with a
prosthesis/piston. Since Shea first introduced stapes surgery as a treatment
option for otosclerosis in 1956, a large number of prostheses or pistons have
been developed. Shape, size and type of material have been the main focus in
enhancing pistons. The piston shaft diameter ranges from 0.3 mm up to 0.8 mm.
Available evidence from clinical studies, mathematical models and temporal bone
studies suggests that a larger diameter piston is associated with better
hearing outcomes. However, a lack of high quality, clinical studies precludes
firm evidence based recommendations.
Study objective
The primary objective of this study is to evaluate the effectiveness of two
differently sized pistons used in primary stapedotomy for otosclerosis in terms
of hearing improvement, complication rate and general and disease-specific
quality of life.
Study design
Single-blinded randomized controlled trial. Both patients and audiologists are
blinded.
Intervention
Primary stapedotomy, either with a 0.4 mm piston or a 0.6 mm piston.
Study burden and risks
Compared to routine clinical practice, the study requires that half of the
participants receive a 0.6 mm diameter piston instead of a 0.4 mm diameter
piston. A larger diameter piston might be more beneficial based on the
available evidence with regards to hearing outcome.
Heidelberglaan 100
Utrecht 3508 AB
NL
Heidelberglaan 100
Utrecht 3508 AB
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL45622.041.13 |
| OMON | NL-OMON28170 |