Comparison of stapes surgery with and without a vein graft in patients with otosclerosis: a randomised controlled trial

Phase 2

Completed

Conditions: ossification
Otosclerosis
10027584

Registration Number: NL-OMON34834

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

-Age >= 18 years
-Otosclerosis, diagnosed by an ear, nose and throat specialist in Utrecht or Hannover
-Primary otosclerosis
-Mean ABG >20 dB based on the ABG values at 0.5, 1, 2, and 4 kHz
-Willingness and ability to participate in all scheduled procedures
-General health allowing general anaesthesia for the potential stapes surgery

Exclusion Criteria

-Age < 18 years
-Previous middle-ear surgery
-Co-morbidities: pregnancy, osteogenesis imperfecta, other middle- or inner-ear pathology (besides otosclerosis) In case of chronic/active ear infection in one or both ears; first treatment of this infection
-Abnormal anatomy in one or both ears
-Disability which could interfere with audiologic measurements or questionnaire fulfilment
-Inability or unwillingness to participate in the follow-up procedures

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome will be postoperative hearing improvement in terms of the<br /><br>average ABG closure 12 months after surgery. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-Postoperative average air-bone gap closure (dB), after 3 and 6 months.<br /><br><br /><br>-Bone conduction thresholds at 0.5, 1, 2, 3 and 4 kHz, after 3, 6 and 12 months.<br /><br>-Air conduction thresholds at 0.5, 1, 2, 3 and 4 kHz, after 3, 6 and 12 months.<br /><br><br /><br>-Air bone gap at 0.5, 1, 2, 3 and 4 kHz, after 3, 6 and 12 months.<br /><br><br /><br>-Postoperative complications, after 3, 6 and 12 months:<br /><br>-Tinnitus<br /><br>-Vertigo<br /><br>-Dizziness<br /><br>-Postoperative sensorineural hearing loss (cochlear damage)<br /><br>-Dead ear (total deafness after surgery)<br /><br><br /><br><br /><br>-Subjective patient*s perception, after 3, 6 and 12 months.<br /><br>-Quality of Life, after 3, 6 and 12 months.<br /><br>-Spending/costs-log, after 3, 6 and 12 months.<br /><br></p><br>