NCT03807713已完成不适用
Clinical Study of Minimally Invasive Ponto Surgical Technique (MIPS) - Design Iteration
适应症
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 the implant
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 the implant
时间窗: 6 months post surgery
Total numbness around the implant will be assessed as a combination of gnostic and vital sensibility.
次要结局
- Wound dehiscence(36 months)
- Implant stability as measured with resonance frequency analysis, RFA.(36 months)
- Quality of Life Assessment(36 months)
- Implant survivability(36 months)
- Surgical wound healing time(36 months)
- Length of surgery(At surgery)
- Pain perception by patient(36 months)
- Unplanned visits(36 months)
- Adverse skin reactions(36 months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Clinical Survey of Minimally Invasive Ponto Surgical Technique (MIPS)Bone Conduction DeafnessUnilateral DeafnessMiddle Ear DeafnessMixed Hearing LossNCT03281967Oticon Medical25
已完成
不适用
Comparison of Surgical Outcomes Between MPCNL and RIRSRenal StoneNCT02067221Seoul National University Hospital70
Unknown
不适用
the Effect of Minimally Invasive Technique Assisted by Magnetic Resonance NeurographyOrthopedic SurgeryNCT06260839He Xiang44
已完成
不适用
Assessing the Perioperative Outcomes of Minimally Invasive Posterior Approach Versus Direct Anterior Approach Total Hip Arthroplasty.Total Hip Replacement SurgeryNCT06659198I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio50
已完成
4 期
Comparing Minimal Invasive Surgery en Conventional Total Knee ArthroplastyOsteoarthritis, KneeNCT02625311Maastricht University Medical Center69