Post Marketing Clinical Follow Up for the Evaluation of the METS™ Proximal Humeral System Using Retrospective Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Safety Evaluation of adverse events that occurred within 12 months post implantation
研究概览
简要总结
This study is a single centre, non-randomised, post market clinical follow up examining retrospective patient data from a series of surgical cases; which involved the endoprosthetic replacement of the proximal humerus using the Stanmore Implant Worldwide METS (Modular Endoprosthetic Tumour System) Proximal Humeral system.
The objective of this study is to evaluate the retrospective patient data where patients have been followed up for at least 12 months post operation; to demonstrate the safety of the METS Proximal Humeral replacement system.
详细描述
The METS™ Proximal Humeral system is an endoprosthetic replacement designed to restore the length and the function of an arm after the resection of a significant amount of bone tissue; due to a malignant tumour in the proximal humerus. This Post Market Clinical Follow up (PMCF) study is designed to further support the existing evidence that the system is safe and performs as expected, when analysing retrospective patient data that have had a METS™ Proximal Humeral replacement. The target population is male or female subjects aged between 18 years and over who have been implanted with a METS™ Proximal Humeral system at the Royal National Orthopaedic Hospital, Stanmore; and the patient has been followed up for at least 12 months following implantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Patient aged 18 and over who has been implanted with a METS™ Proximal Humeral system implant at the Royal National Orthopaedic Hospital, Stanmore.
- •Patient has been followed up for at least 12 months following implant surgery
- •Patient had their surgery on or after January 2007
排除标准
- •Patient is currently or has been involved in pending litigation or worker's compensation
- •Patient has participated in another clinical investigation or study with an investigational medical device within the last 60 days
结局指标
主要结局
Safety Evaluation of adverse events that occurred within 12 months post implantation
时间窗: Follow Up of 12 months
Adverse events within the first 12 months will be assessed and evaluated
次要结局
未报告次要终点