Retrospective Study of OSSURE LOEP in Osteopenic and Osteoporotic Subjects in the Commercial European Market
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 305
- 试验地点
- 1
- 主要终点
- Incidence of fragility fractures of AGN1 LOEP treated hip
研究概览
简要总结
The study is designed as a retrospective, multicenter study for subjects previously treated with the AGN1 LOEP Kit in the proximal femur as part of standard hospital practice. This will be a non-randomized and non-blinded study. The study will collect retrospective data on the safety and performance of AGN1 LOEP of all subjects treated between September 2019 and January 2026. Subjects treated as part of an AgNovos prior protocoled study are excluded. Investigators are asked to reach out to all subjects that were previously treated with the AGN1 LOEP Kit in the proximal femur. Subject informed consent is obtained before a subject is enrolled into the study. Subjects treated but not enrolled are documented in a log with the reason why a subject did not participate. This log is kept on site. Enrolled subjects will be contacted per telephone to collect information about any fractures sustained post-AGN1 LOEP treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has previously received AGN1 LOEP treatment in the proximal femur after September 2019 and before January
- •Subject can give written informed consent to allow for data collection. Obtaining informed consent is not required for deceased subjects.
排除标准
- •The subject's AGN1 LOEP treatment was previously performed as part of an AgNovos prior protocoled clinical study.
结局指标
主要结局
Incidence of fragility fractures of AGN1 LOEP treated hip
时间窗: Through study completion, an average of 6 months.
Incidence of all adverse events and serious adverse events occurring intraoperative and post-AGN1 LOEP determined to be at least possibly related to the procedure and/or device
时间窗: Through study completion, an average of 6 months.
次要结局
未报告次要终点