NL-OMON34834已完成2 期
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
niversitair Medisch Centrum Utrecht0 个研究点目标入组 120 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •-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
排除标准
- •-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
研究者
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