C51 - Clinical Survey of Oticon Medical Healing Cap
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Skin reactions according to Holgers
研究概览
简要总结
This study investigates the use of a new healing cap which, through altered design and choice of material, has been improved when it comes to minimizing the risk of it falling off as well as increasing patient comfort.
详细描述
This study will primarily investigate the use of a new healing cap, Healing cap II. The new healing cap has the same function as previous healing caps, but it soft instead of hard. Due to this, the healing cap is anticipated to not fall off as easily, but at the same time does not risk transferring larger forces than previously to the implant. Secondly, the patients will start using the sound processor 1-2 weeks after surgery. The implant stability will be monitored before and after loading by the use of resonance frequency analysis, an established method to evaluate and monitor osseointegrated implants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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.
研究组 & 干预措施
Use of Healing cap II
Single arm study using a new healing cap as intervention
干预措施: Healing cap II (Device)
结局指标
主要结局
Skin reactions according to Holgers
时间窗: At time of sugical follow up visit (visit window of 7-14 days after surgery)
Focus is on healing, post-operative complications and skin reactions after the first 7-14 days after surgery.
次要结局
- Fitting of sound processor at surgical follow-up visit(At time of surgical follow up visit (visit window of 7-14 days after surgery))