NCT03289845已完成不适用
Clinical Survey of Oticon Medical Ponto BHX Implant
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Implant stability quotient (ISQ) at surgery
研究概览
简要总结
Investigation of stability of the BHX implant in adult patients indicated and counselled for a bone anchored hearing aid system. Patients are followed according to clinical practice for a total of 12 months in the study. Stability of the implant is evaluated by implant stability quotient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients eligible for treatment with a bone anchored hearing aid
- •18 years or older
排除标准
- •Inability to participate in follow-up
- •Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.
结局指标
主要结局
Implant stability quotient (ISQ) at surgery
时间窗: At surgery
Initial implant stability measured directly after surgery
次要结局
- Surgical torque setting measured in Ncm(At surgery)
- Implant stability quotient (ISQ) after 12 months of follow up(12 months post surgery)
- Implant survivability measured as percentage successful implants after 12 months(12 months post surgery)
- Possibility to fit the sound processor, yes/no(5-12 days post surgery)
研究者
研究点 (3)
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