Long-term Follow-up of a Wide Diameter Bone Anchored Hearing Implant: the 10-year Experience on Stability, Survival and Tolerability of the BIA300®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- implant stability
研究概览
简要总结
A single centre, open, comparative, parallel group, prospective clinical investigation with a single 10 year follow up visit.
详细描述
This study is a continuation of two previous conducted trials:
-
Stability, long term survival and tolerability of a novel Baha® implant system, a multi-centre investigation new BIA300 (test) implant vs previous generation (control) implant:
-
CAG5173: 6-month(1) and 3-year(2) data.
-
CBAS5562: 5-year data(3).
-
3 weeks loading: stability, long term survival and tolerability of a novel Baha® implant system, a multi-centre investigation 3 week loading vs 6+ week loading (= same group as control group trial 1). 6- month(4) and 3-year(5) data.
In this study the (5-year data for trial 2 and) 10-year data regarding stability, survival and soft tissue tolerability from the above mentioned trials will be evaluated and compared. The previous trials were multicentre, but the current study will be single-centred and therefore only include the participants of the Radboud site. Data will be collected at a visit at (5 years, for trial 2 and) 10 years (+/- 6 months) after implantation.
Up to now, no RCT of these implants (with the loading of 3 weeks after implantation) has assessed stability, survival and tolerability over a 10-year follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •To be included in the original trials, patients had to be at least 18 years old.
排除标准
- •Exclusion criteria were an inability to follow investigational procedures, any factor at the discretion of the investigator that was considered to contraindicate participation, and any disease or treatment known to compromise the bone quality at the implant site. For patients who had lost or removed the implant, the time to implant loss was recorded. Patients who could not attend the 5 or 10 year follow-up visit for other reasons were included in the implant survival analysis as well; the last available information regarding implant survival was obtained verbally from the patient, from medical records, or from information captured from the original investigations. Furthermore, patients were excluded if they had a bone thickness less than 4 mm at the implant site during implantation.
结局指标
主要结局
implant stability
时间窗: 10 years after implantation
Implant Stability Quotiënt (ISQ) will be measured at the 10y-visit. The resonance frequency analysis renders an ISQ value ranging from 1 to 100. Measurements shall be performed at the abutment level, as is done in the previous investigations. The highest and lowest ISQ value out of two perpendicular measurements shall be recorded as ISQ High and ISQ low. The measurement should preferably be done by the same Osstell instrument (Osstell, Gothenburg, Sweden) that was used in the previous completed study. SmartPeg Type 43 and 55 shall be used during the measurement (Osstell, Gothenburg, Sweden). The procedures for obtaining ISQ values is described in the manufacturer's instruction that will be handed out to the investigators.
次要结局
- soft tissue reaction(10 years after implantation)
- implant survival(10 years after implantation)
- device use(10 years after surgery)