National, Multicentre, Prospective, Observational Study, to Evaluate the Clinical Efficacy of Y-STRUT® Medical Device Implanted for Contralateral Percutaneous Internal Fixation of Proximal Femur, in Patient With a Low Energy Per Trochanteric Fracture on the First Side
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Hyprevention
- 入组人数
- 10
- 试验地点
- 5
- 主要终点
- Frequency of post-operative fracture [Clinical efficacy of the device]
研究概览
简要总结
HIP50 is a national, multicentre, prospective, observational study, in patients presenting a first low energy per trochanteric hip fracture on one side and treated with Y-STRUT® device implanted on the contralateral proximal femur as percutaneous internal fixation to prevent contralateral hip fracture in case of osteoporosis.
The primary objective of this study is to evaluate the clinical efficacy of the studied medical device by measuring the frequency of patient with a fracture at the implantation site within 1 year after implantation.
A total of 50 patients from France will be enrolled (until December 2020) and followed up to 24 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient of 60 years and older, according to CE indication;
- •Patient with information form signed to participate in the study;
- •Patients presenting a first low energy hip fracture on one side and having a Y-STRUT® device implanted on the contralateral hip between 0 and 120 days after the treatment of the fracture of the first hip;
排除标准
- •Patient who refuse to participate to this study;
- •Patient implanted with Y-STRUT® for another indication;
- •Patient already enrolled in a clinical study, excluding his participation to HIP50.
结局指标
主要结局
Frequency of post-operative fracture [Clinical efficacy of the device]
时间窗: At 12 months
Frequency of Y-STRUT® implanted patients with a fracture at the implantation site
次要结局
- Frequency of post-operative fracture [Clinical efficacy of the device](At 3 and 24 months)
- Surgical procedure duration [learning curve of the procedure](At the end of the inclusion period (24 months from the first included patient))
- Rate of complications [learning curve of the procedure](At the end of the inclusion period (24 months from the first included patient))
- Hospitalisation duration [learning curve of the procedure](At the end of the inclusion period (24 months from the first included patient)])
- Recording of concomitants treatments [safety and feasibility of the device](At 3, 12 and 24 months)
- Walking conditions [safety and feasibility of the device](At 3, 12 and 24 months)
- Pain [safety and feasibility of the device](At 3, 12 and 24 months)
- Recording of adverse events and device effects [safety and feasibility of the device](At 3, 12 and 24 months)