DRKS00032064招募中Unknown
Single-blinded, randomized monocentric study of the use of two different piston diameters for stapesplasty with a stapes prosthesis with superelastic Nitinol-CliP
niversitätsklinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie0 个研究点目标入组 40 人开始时间: 2024年5月23日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Otosclerosis
- •First operation
- •Patient consent
排除标准
- •other chronic ear diseases in the ear to be operated
- •revision surgery
- •nickel or titanium allergy
- •alcohol or drug influence
- •physical or cognitive limitations that do not permit testing
- •no patient consent
- •persons accommodated in institutions
- •Intraoperative study exclusion:
- •Diagnoses beside otosclerosis (malleus head fixation, other post-inflammatory auditory bone fixation, chain disruption, malformations, that can only be detected intraoperatively).
- •Contraindications for a standardised laser stapedotomy (exposed facial nerve)
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