Evaluation of Clinical Performance of Ponto Implantation Using a Minimally Invasive Surgical Technique - a Prospective Multicentre Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 7
- 主要终点
- Number of Implants With 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, Sweden, Denmark and the Netherlands). In total, 50 adult patients with a hearing loss that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study.
The purpose of the study is to investigate the rate of successful BAHS use after implantation of the Ponto implant system using a minimally invasive surgical technique.
详细描述
This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Sweden, Denmark and the Netherlands). In total, 50 adult patients with a hearing loss that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study.
The purpose of the study is to investigate the rate of successful BAHS use after implantation of the Ponto implant system using a minimally invasive surgical technique. 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 three months after implantation/surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •18 years of age or older
- •Patient indicated for surgical intervention with a bone anchored hearing system
- •Signed informed consent
- •Adequate bone quality to allow for a Ponto implant insertion, as judged by the investigator, and an expected bone thickness above 5 mm, where no complications during surgery are expected
- •Skin thickness of 12 mm or less at the implant site
排除标准
- •Patient undergoing re-implantation
- •Patient who are unable or unwilling to follow investigational procedures/requirements, e.g. to complete quality of life scales
- •Known condition or previous treatment that could jeopardize skin condition and wound healing over time as judged by the investigator (e.g. uncontrolled diabetes, previous radiotherapy in the area of interest)
- •Known medical condition that contraindicate surgery as judged by the investigator
- •Known and/or planned pregnancy at time of surgery
- •Any other known condition that the investigator determines could interfere with compliance or investigation assessments
- •Simultaneous participation in another clinical investigation with pharmaceutical and/or medical device which might cause interference with investigation participation
研究组 & 干预措施
Single-arm
In this single-arm study the patients will be undergoing a minimally invasive surgery after which they will re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery.
干预措施: Minimally invasive surgery (Procedure)
Single-arm
In this single-arm study the patients will be undergoing a minimally invasive surgery after which they will re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery.
干预措施: Glasgow Benefit Inventory (GBI) (Other)
Single-arm
In this single-arm study the patients will be undergoing a minimally invasive surgery after which they will re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery.
干预措施: Additional follow-up visits after surgery (Other)
结局指标
主要结局
Number of Implants With 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 overgrowth 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, skin overgrowth or pain preventing usage of the sound processor.
次要结局
- Number of Implants With Reliable Anchorage for a Sound Processor(12 months after implant surgery)
- Implant Survival(12 months after implant surgery)
- Implant Stability(12 months after implant surgery)
- Holgers Score Distribution(9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits)
- Max Holgers Score(12 months after implant surgery)
- Mild/Adverse Skin Reaction(12 months after implant surgery)
- IPS (Inflammation, Pain, Skin Height) Scores(9 days, 5 weeks, 3-, 6- and 12 months after implant surgery, and unplanned visits)
- Wound Healing(9 days, 5 weeks and 3 months after implant surgery, and unplanned visits)
- Skin Overgrowth(9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits)
- Post-operative Events Around Abutment(9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits)
- Patient-perceived Presence of Pain Around Abutment(9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits)
- Patient-perceived Presence of Numbness Around Abutment(9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits)
- Duration of Surgery(3 months after implant surgery)
- Sound Processor Usage(12 months after implant surgery)
- Subjective Benefit After Surgery(3 months after surgery)