Long Term Follow-up of the Ponto Wide Implant: 10 Years of Clinical Evaluation
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Implant survival
研究概览
简要总结
The goal of this single center, prospective study is to investigate the survival of the Ponto Wide Implant at least 10 years after implantation.
Secondary objectives are:
- To determine the amount and causes of implant loss and implant and/or abutment removal.
- To establish the stability of the implant.
- To assess skin complications.
- To investigate daily usage and the number of hours of use of the sound processor.
- To determine the quality of life.
During a check-up of the implant at the outpatient clinic, the skin around the implant will be assessed, the stability of the implant will be measured, and the patient will be asked to complete two questionnaires.
详细描述
Patients who participated in the previous studies concerning the Ponto Wide implant from Oticon (3 years after implantation) will be approached. If consent is given, they will be added to the database of the already completed studies, and new data will be stored in the same database. The patients were already pseudonymized in the previous studies, and the database is secured with a code that is only accessible to individuals directly involved in the research
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Implantation with Ponto Wide implant (diameter 4.5 mm, length 4.0 mm)
- •Ten or more years of post-operative follow-up.
- •Valid informed consent
排除标准
- •No specific exclusion criteria have been set for the study.
结局指标
主要结局
Implant survival
时间窗: It will be assessed during the clinic visit between November 2024 and March 2025.
The number of Ponto Wide implants that have survived 10 years after implantation.
次要结局
- Amount of implant loss(This will be examined during the period from November 2024 to March 2025)
- Amount of abutment removal(This will be examined during the period from November 2024 to March 2025)
- Reasons of implant loss(This will be examined during the period from November 2024 to March 2025)
- Amount of abutment loss(This will be examined during the period from November 2024 to March 2025)
- Reasons of abutment loss(This will be examined during the period from November 2024 to March 2025)
- Amount of implant removal(This will be examined during the period from November 2024 to March 2025)
- Reasons of abutment removal(This will be examined during the period from November 2024 to March 2025)
- Reasons of implant removal(This will be examined during the period from November 2024 to March 2025)
- Implant stability Quotient (ISQ) measured using Osstell(It will be assessed during the clinic visit between November 2024 and March 2025.)
- Skin complication(It will be assessed during the clinic visit between November 2024 and March 2025.)
- Sound processor use(It will be assessed during the clinic visit between November 2024 and March 2025.)
- Glasgow Benefit Inventory (GBI)(It will be assessed during the clinic visit between November 2024 and March 2025.)
- International Outcome Inventory for Hearing Aids (IOI-HA)(It will be assessed during the clinic visit between November 2024 and March 2025.)
研究者
Carine Hajema
Investigator
University Medical Center Nijmegen