Evaluation of 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
2020年4月27日 更新者：Hyprevention
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
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.
研究概览
研究类型
观察性的
注册 (实际的)
10
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Ambérieu-en-Bugey、法国、01500
- Hôpital Privé d'Ambérieu
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Clamart、法国、92140
- Hôpital Antoine Béclère
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La Tronche、法国、38700
- Centre Hospitalier Universitaire Grenoble Alpes
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Orléans、法国、45100
- Centre Hospitalier Régional Orléans
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Tours、法国、37000
- Nouvelle Clinique de Tours Plus St Gatien
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
60年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
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.
描述
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Frequency of post-operative fracture [Clinical efficacy of the device]
大体时间：At 12 months
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Frequency of Y-STRUT® implanted patients with a fracture at the implantation site
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At 12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Frequency of post-operative fracture [Clinical efficacy of the device]
大体时间：At 3 and 24 months
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Frequency of Y-STRUT® implanted patients with a fracture at the implantation site
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At 3 and 24 months
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Recording of concomitants treatments [safety and feasibility of the device]
大体时间：At 3, 12 and 24 months
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Recording of all concomitants treatments: analgesic for pain, anti-osteoporotic treatment and other treatments.
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At 3, 12 and 24 months
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Pain [safety and feasibility of the device]
大体时间：At 3, 12 and 24 months
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Self-evaluation of hip pain using VAS (Visual Analogue Scale), going from 0 (no pain) to 10 (maximum).
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At 3, 12 and 24 months
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Walking conditions [safety and feasibility of the device]
大体时间：At 3, 12 and 24 months
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Assessment of resumption of weight-bearing (yes/no, aid)
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At 3, 12 and 24 months
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Recording of adverse events and device effects [safety and feasibility of the device]
大体时间：At 3, 12 and 24 months
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Recording of the medical device vigilance: all serious adverse events, all adverse events linked to the device or the operative technique, and any other important event reported.
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At 3, 12 and 24 months
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Surgical procedure duration [learning curve of the procedure]
大体时间：At the end of the inclusion period (24 months from the first included patient)
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Measuring mean/median intervention duration of each procedure.
Then, all the durations of successive procedures will be compared among all the investigators.
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At the end of the inclusion period (24 months from the first included patient)
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Hospitalisation duration [learning curve of the procedure]
大体时间：At the end of the inclusion period (24 months from the first included patient)]
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Measuring mean/median hospitalisation duration.
Then, all the durations of successive hospitalisations will be compared among all the investigators.
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At the end of the inclusion period (24 months from the first included patient)]
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Rate of complications [learning curve of the procedure]
大体时间：At the end of the inclusion period (24 months from the first included patient)
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Assessing types and frequencies of procedures complications (per-op and post-op).
Then, all the rate of complications will be compared among all the investigators.
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At the end of the inclusion period (24 months from the first included patient)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年12月6日
初级完成 (实际的)
2020年3月24日
研究完成 (实际的)
2020年3月24日
研究注册日期
首次提交
2018年8月21日
首先提交符合 QC 标准的
2018年8月23日
首次发布 (实际的)
2018年8月27日
研究记录更新
最后更新发布 (实际的)
2020年4月29日
上次提交的符合 QC 标准的更新
2020年4月27日
最后验证
2020年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.