Single-stage Bone-anchored Hearing Implant Surgery in the Pediatric Population Using the BHX Implant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Implant loss
研究概览
简要总结
Over the last few decades, the classical two-stage surgical procedure for inserting bone-anchored hearing implants (BAHIs) has been modified in adults into a single-stage procedure. This approach has several advantages since it avoids a second surgical procedure. The single-stage approach is proven to be safe and feasible in adults and is nowadays referred to as the standard surgical technique in adults. Despite favorable outcomes and advantages of the single-stage surgery, most Ear Nose Throat (ENT) surgeons still perform two-stage surgery when inserting BAHI in the pediatric population. Therefore, the aim of this study is to compare implant loss between single-stage BAHI surgery and two-stage BAHI surgery in children aged 4 to 9 years.
详细描述
General description:
A prospective comparative study with historical control group will be performed.The test group will consist of 22 children aged 4-9 years old who are found to be suitable candidates for treatment with a BAHI (BHX implant and abutment). The control group consists of approximately 50 children, aged 4-9 years old, who already underwent insertion with a wide diameter implant between 2012 and 2018. In the test group, BAHI insertion will be performed using single-stage surgery. Patients in the control group already underwent BAHI insertion using two-stage surgery.
Recruitment and consent:
All children planned for implantation with bone-anchored hearing implants will be screened for inclusion in the present study. Patients who meet the inclusion criteria will be approached for participation by their ENT-specialist, after patients' and parents/caretakers' approval they will be informed and screened for participation by one of the researchers. The study protocol will be discussed with the potential study participant and his/her parents/caretakers by the researcher. The potential study participant and his/her parents/caretakers will be given/sent the Informed Consent Form to read. Potential study participants will be encouraged to discuss the study with family members and personal physician(s) before deciding whether to participate in the study. Patients and their parents/caretakers have 14 days to consider their decision. In order to participate in the study, both parents/caretakers need to sign the informed consent form.
Data handling:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Implant loss
时间窗: 1 year
The number of lost implants
次要结局
- Soft-tissue status according to Holgers scale(1 year)
- Duration of surgery(through study completion, an average of 1 year)
- Soft-tissue status according to IPS(1 year)
- Time to loading(through study completion, an average of 1 year)