Clinical Survey of Oticon Medical Ponto Implants and a Surgical Technique With Tissue Preservation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Numbness around implant, specifically mean Total sensibility
研究概览
简要总结
A bone anchored hearing system is used to improve hearing for patients with e.g. conductive/mixed hearing loss or single sided deafness.
With this type of system, a titanium implant is installed in the temporal bone, where it osseointegrates, i.e. integrates with the bone. An abutment (also in titanium) is attached to the implants and penetrates the skin. The sound processor (hearing aid) is then connected to the abutment, and can be attached and removed by the patient via a snap-coupling. This type of system has been successfully implanted in more than 100.000 patients. Recently, a simplified surgical procedure, where no skin thinning around the abutment is made, was approved. The results after using this installation technique, here called soft tissue preservation, are the focus of this study.
The objective of the study is to compare the outcomes after a surgical procedure with soft tissue preservation (test) and a surgery with soft tissue reduction (control) for placing Oticon Medical Ponto implants and abutments. The main hypothesis is that patient numbness around the implant is less in the test group compared to the control group.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Patient indicated for an ear level bone anchored sound processor
- •Bone thickness at the implant site of at least 4 mm
排除标准
- •Inability to participate in follow-up
- •Psychiatric disease in the medical history
- •Mental disability
- •Presumed doubt, for any reason, that the patient will be able to show up on all follow ups
- •Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.
- •Patients with natural skin height of >10 mm
结局指标
主要结局
Numbness around implant, specifically mean Total sensibility
时间窗: 36 months after surgery
次要结局
- Time to implant loss(0-36 months)
- Length of surgery(At surgery)
- Sum of number of unplanned visits, revision surgeries, medications related to implant, and other treatments requiring medical staff per patient(0-36 months)
- Skin condition according to Holgers(3 years after surgery)
- Proportion of patients with complete wound healing at first surgical visit(7 days)
- Abbreviated profile of hearing aid benefit (APHAB) scores(36 months)
- Bone conduction (BC) audiometric threshold(6 months)
- Mild/Adverse skin reaction(0-36 months)
- Postoperative complications(7 days to 36 months)
- Glasgow Benefit Inventory (GBI) scores(12 months)
- Glasgow Health Status Inventory (GHSI) scores(36 months)
- Mean hours of use of the sound processor(0-36 months)
- Bone conduction (BC) in-situ audiometric thresholds(6 months)
- Mean total sensibility around implant(36 months)
- Implant stability quotient (ISQ)(36 months post surgery)
- Patient and Observer scar assessment score(36 months)