Clinical Survey of Minimally Invasive Ponto Surgical Technique (MIPS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Numbness (sensibility) around surgery area
研究概览
简要总结
The objective of the study is to compare the outcomes after a surgical procedure with minimally invasive Ponto surgery (MIPS, test group) and tissue preservation surgery (control) for placing Oticon Medical Ponto implants and abutments.
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 or older.
- •Patient indicated for an ear level bone anchored sound processor.
- •Healthy bone quality to allow for 4mm implant insertion.
排除标准
- •Intraoperative switch to an alternative surgical technique
- •Patients undergoing re-implantation (on the side being included in the study)
- •Previous participation in the C47 study.
- •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 >12mm (as there will be additional skin reduction needed)
结局指标
主要结局
Numbness (sensibility) around surgery area
时间窗: 6 months post surgery
The primary objective of the study is to investigate the difference in numbness around implant after MIPS procedure (test, this investigation) and a surgery with soft tissue preservation (control, from a previous study, C47) for implanting Oticon Medical implants and abutments. Two different sensibilities will be tested by means of a broken wooden cotton swab/bud (q-tip): gnostic (with cotton side) and vital (with broken, sharp wooden side) sensibility. The measurement locations will be standardized at specific positions from surgery location, and the same location (with respect to the surgery site) will be used for sensibility measurement for each patient visit. Both the area (diameter in cm) and the degree (scale form 0 (no complaints) to 10 (maximum complaints)) will be monitored. Additionally, patients' subjective sensibility judgment around surgery area on a scale of 0-10 will be recorded.
次要结局
- Time needed for surgery(At surgery)
- Unplanned visit(36 months)
- Adverse Events(36 months)
- Pain perception by patient(36 months)
- Implant survivability(36 months)
- Implant stability as measures by Implant stability quotient.(36 months)
- Surgical wound healing time(36 months)
- Quality of Life Assessment(36 months)
- Aesthetic Assessment(36 months)