A Prospective Multi-Centre Study on the Performance of the Ponto BHX Implant System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Implant/abutment complex capability to provide a reliable Anchorage for a sound processor
研究概览
简要总结
This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Spain, Denmark). Patients with a hearing loss and that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study. A total of 50 patients will be included in the study.
The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto Biohelix (BHX) Implant system.
详细描述
This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Spain, Denmark). Patients with a hearing loss and that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study. A total of 50 patients will be included in the study.
The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto BHX Implant system. The implant, coupled to a skin-penetrating abutment, is implanted in the bone behind the ear and is later loaded with a sound processor which transforms sound waves to sound vibrations that can be sent directly to the inner ear via the skull bone. The primary objective of this study is to investigate the proportion of implant/abutment complexes providing a reliable anchorage for a sound processor, 3 months after implantation/surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •18 years of age or older
- •Patients indicated for surgical intervention with a bone anchored hearing system according to local clinic's standard guidelines
- •Adequate bone quality to allow for a Ponto BHX implant insertion, as judged by the investigator, and an expected bone thickness above 3 mm, where no complications during surgery are expected
排除标准
- •Patients undergoing re-implantation
- •Patients who are unable or unwilling to follow investigational procedures/requirements, e.g. to complete quality of life scales.
- •Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus
- •Known conditions (e.g. uncontrolled diabetes) that could jeopardize skin condition and wound healing over time as judged by the investigator
- •Any other known condition that the investigator determines could interfere with compliance or study assessments
结局指标
主要结局
Implant/abutment complex capability to provide a reliable Anchorage for a sound processor
时间窗: 3 months after implant surgery
The variables assessed to determine reliable anchorage in the study are implant survival and stability, skin reactions, skin over-growth and pain preventing use of the sound processor. For a positive outcome of the primary endpoint (reliable anchorage), the implant should be in place and stable. without any adverse skin reactions or skin over-growth and pain preventing usage of the sound processor.
次要结局
- Implant/abutment complex capability to provide reliable anchorage for sound processor(12 months after implant surgery)
- Patient-perceived magnitude of pain around implant/abutment(12 months after implant surgery)
- Skin/soft tissue overgrowth(12 months after implant surgery)
- IPS (Inflammation, Pain, Skin height) scores(12 months after implant surgery)
- Patient-perceived presence of pain around implant/abutment(12 months after implant surgery)
- Patient-perceived magnitude of numbness around implant/abutment(12 months after implant surgery)
- Implant survival(12 months after implant surgery)
- Implant stability(12 months after implant surgery)
- Duration of surgery(At implant surgery)
- Wound healing time(12 months after implant surgery)
- Patient-perceived presence of numbness around implant/abutment(12 months after implant surgery)
- Wound dehiscence(12 months after implant surgery)
- Holgers score ratings(12 months after implant surgery)
- Implant/abutment usage(12 months after implant surgery)
- Subjective benefit after implant surgery(12 months after implant surgery)