Evaluation of Implant Stability and Audiological Benefit of Oticon Medicals BHX Implant in Children Undergoing Surgery for a Percutaneous Bone Anchored Hearing System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Implant stability
研究概览
简要总结
The purpose of this study is to in a proactive manner collect high quality data from pediatric patients who have undergone a bone anchored hearing surgery, using the Ponto BHX implant, in clinical practice. This to further increase the knowledge of bone anchored hearing systems in the pediatric population.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have decided to undergo a Bone Anchored Hearing Surgery and receive a Ponto system.
- •Signed informed consent.
- •Patients between 5 - 16 years of age.
- •Patients eligible for one stage surgery.
- •Patients who have been using Ponto sound processor on a soft band for at least 2 weeks.
排除标准
- •Patients who cannot attend follow up visits.
- •Patients with single side deafness (SSD).
- •In surgeon's opinion, any other disorder and condition that may deem the patient unfit to participate in the study.
- •Patients who receive other implant than the Ponto BHX.
结局指标
主要结局
Implant stability
时间窗: 6 months post surgery
Implant stability will be assessed using resonance frequency analysis (RFA). This is a non-invasive technique using a SmartPeg (no 55) introduced into the abutment top. A probe is directed to the SmartPeg measuring the vibrations as a test for the stability of the interface between the fixture and the bone (osseointegration). The measurement renders Implant Stability Quotient (ISQ) 'numerical values from 1 to 100'; the higher the ISQ value, the higher the stability. Two perpendicular measurements will be performed at each site. The highest and lowest ISQ value obtained at each time point aree recorded. The Osstell ISQ instrument and SmartPegs from Osstell (Gothenburg, Sweden) will be used. Difference in mean of ISQ low at 6 months compared to surgery.
次要结局
未报告次要终点