NL-OMON55050已完成不适用
Single-stage bone-anchored hearing implant surgery in the pediatric population using the BI300 implant - Single-stage surgery using the BI300 implant
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
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
- 2 至 11（—）
入选标准
- •- Age 4-9 years
- •- Indication for percutaneous bone-anchored hearing implant surgery with a
- •BI300 implant
- •- Insertion using the linear incision techniqueControl group (historical)
- •- Children who underwent implantation of a wide diameter implant using
- •two-stage surgery between 2012 and 2018 at the Radboudumc
- •- Age 4-9 at the time of surgery
- •- Linear incision technique was used during surgeryideWhe
排除标准
- •1. Inability to show up at all follow-up visits
- •2. Patients undergoing re-implantation
- •3. Diseases, syndromes or treatments known to compromise the bone quality at
- •the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.
- •4. Insufficient bone thickness <=1mm, since conversion to two-stage surgery will
- •be advocatedControl group
- •1. Follow-up duration less than 1 year.
- •2. Diseases, syndromes or treatments known to compromise the bone quality at
- •the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus (at moment
- •of implantation)
研究者
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