Long-term Stability and Survival Rates of a Novel Oticon Medical Bone Conduction Device Implant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- ISQ (Implant Stability Quotient)
研究概览
简要总结
The overall aim of the study is to investigate the Ponto wide implant considering; initial implant stability, stability over time, skin reaction and long term success when loaded at 3 weeks post surgery. Patients' quality of life improvements following implantation will also be surveyed.
More specifically the primary objective of this clinical study is to test the hypothesis
- The new Ponto wide diameter implant offers increased implant stability measured as ISQ (implant stability quotient) compared to the previous generation Ponto implant.
And the secondary objective is to
- Investigate when in time implant stability is the lowest as the initial mechanical stability is gradually replaced by biological stability
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Bone thickness at the implant site of at least 4 mm
排除标准
- •Longer abutment (>6mm) required
- •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.
研究组 & 干预措施
Wide diameter implant
Bone anchored hearing implant For the wide diameter arm (test group), the Ponto wide implant (diameter 4,5mm, length 4mm) and abutment 6mm developed by Oticon Medical AB (Gothenburg, Sweden) will be installed.
干预措施: Bone anchored hearing implant (Device)
Control group
Bone anchored hearing implant For the control group, the previous generation Ponto implant (diameter 3,75mm, length 4mm) and 6mm abutment (Oticon Medical AB, Gothenburg, Sweden) will be installed.
干预措施: Bone anchored hearing implant (Device)
结局指标
主要结局
ISQ (Implant Stability Quotient)
时间窗: 36 months after surgery
次要结局
- Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire(36 months after surgery)
- Glasgow Health Status Inventory (GHSI) questionnaire(36 months after surgery)
- ISQ (Implant stability quotient) gradient(0, 7, 14, 21 and 28 days, 6 weeks, 12weeks, 6 months after surgery)
- Skin condition according to Holgers score(36 months after surgery)
- Glasgow Benefit Inventory Questionnaire(12 months after surgery)
- Time of minimum ISQ (Implant stability quotient)(0, 7, 14, 21 and 28 days after surgery)