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

Comparison of stapes surgery with and without a vein graft in patients with otosclerosis: a randomised controlled trial - Stapes Surgery & Vein Graft in patients with otosclerosis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34834

Enrollment

120

Registered

2010-09-02

Start date

2010-11-09

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ossification Otosclerosis

Interventions

Stapes surgery, with and without a vein graft beneath the prosthesis.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: -Age

Design outcomes

Primary

Measure	Time frame
The primary outcome will be postoperative hearing improvement in terms of the average ABG closure 12 months after surgery.	—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)