NCT03579212终止不适用
National, Multicentre, Prospective, Retrospective, Observational Study, to Evaluate the Performance of Y-STRUT® Medical Device to Strengthen Pre-fractural Tumour-induced Lesions at the Level of the Proximal Femur
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Hyprevention
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Frequency of post-operative fracture [Performance of the device]
研究概览
简要总结
HIPPON 100 is a national, multicentre, prospective, retrospective, descriptive and non-interventional study, in patients having a Y-STRUT® medical device implanted to prevent a high risk of impending pathological fracture.
The primary objective of this study is to evaluate the performance 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 100 patients from France will be enrolled (until November 2018) 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient ≥ 18 years old
- •Patient with information form signed to participate in the study;
- •Patient presenting a cancer with bone metastases at the level of the proximal femur and having a Y-STRUT® medical device implanted;
- •Patient able to complete a questionnaire.
排除标准
- •Patient who refuse to participate to this study;
- •Patient already enrolled in a clinical study, excluding his participation to HIPPON100.
结局指标
主要结局
Frequency of post-operative fracture [Performance of the device]
时间窗: At 12 months
Frequency of patient with a fracture at the implantation site
次要结局
- Quality of life [Tolerance of the device](pre-operative, immediate post-op, and at 6, 12 and 24 months)
- Hospitalisation duration [feasibility of the procedure](At inclusion (day 1))
- Frequency of post-operative fracture [Performance of the device](At 6 and 24 months)
- Rates of complications [feasibility of the procedure](At inclusion (day 1))
- Pain [Tolerance of the device](immediate post-op, and at 6, 12 and 24 months)
- Surgical procedure duration [feasibility of the procedure](At inclusion (day 1))
- Resumption of weight-bearing [Tolerance of the device](immediate post-op, and at 6, 12 and 24 months)
- Recording of adverse events and device effects [Safety of the device](At 6, 12 and 24 months)
- Calculation of associated costs [Economic impact of the procedure](At the end of the study (24 months from the last included patient))
研究者
研究点 (4)
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