Comparison Between Anterior Approach (Deltopectoral) and Lateral Approach (Deltoid Splitting) in Shoulder Reverse Arthroplasty for Proximal Humerus Fracture
赞助:
University Hospital, Clermont-Ferrand
合作者:
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追踪信息 | |||
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首次提交日期 ICMJE | October 1, 2018 | ||
首次发布日期e ICMJE | October 3, 2018 | ||
最后更新发布日期 | October 3, 2018 | ||
预计研究开始日期 ICMJE | November 2, 2018 | ||
预计主要完成日期 | November 30, 2020 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Constant Murley Score[ Time Frame: 12 months ] Constant Murley Score it a clinical method of functional assessment of the shoulder. The score varies between 0 and 100, more the value is better brought up is the score |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | Comparison Between Anterior Approach (Deltopectoral) and Lateral Approach (Deltoid Splitting) in Shoulder Reverse Arthroplasty for Proximal Humerus Fracture | ||
正式标题 ICMJE | Comparison Between Anterior Approach (Deltopectoral) and Lateral Approach (Deltoid Splitting) in Shoulder Reverse Arthroplasty for Proximal Humerus Fracture | ||
简要概况 | The aim of the study consists in comparing two surgical approaches (deltopectoral versus lateral deltoid splitting) in the treatment of proximal humerus fractures treated with a reversed total shoulder arthroplasty The assessment will focus on clinical (clinical scores, efficacy, safety…) and radiological results, between these two types of surgical approaches by using a prospective, randomized analysis. |
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详细说明 | The 2 main surgical approaches in total shoulder arthroplasty (TSA) are the anterior approach (deltopectoral) and the lateral one (deltoid splitting) (18). Their advantages and drawbacks have not been clearly evaluated in proximal humerus fracture treated with an arthroplasty. The goal of the study is to compare the results between patients (older than 65yo) presenting a proximal humerus fracture treated with a reversed shoulder arthroplasty performed through an anterior approach or a lateral one. | ||
研究类型 ICMJE | Interventional | ||
研究阶段 | N/A | ||
研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述:no masking 主要目的: Treatment |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Not yet recruiting | ||
预计入组 ICMJE |
80 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | June 30, 2021 | ||
预计主要完成日期 | November 30, 2020 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - Patient older than 65yo with a proximal humerus fracture (Neer 3-4 and 2 dislcated) - Patient registered to the national health system - Patient able to understand information about the protocol and answer to questionnaire Exclusion Criteria: - Non-displaced fracture or no need of surgical treatment. - Existing bone disease - Infection - Neurological deficit (axillary nerve) - Multi-injured patients - Patient no able to fulfill the questionnaire - Patient refuses the study | ||
性别 |
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年龄 | 最小年龄:65 Years ,最大年龄:N/A | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | France | ||
管理信息 | 数据检测委员会 | ||
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | , | ||
研究赞助商 ICMJE | University Hospital, Clermont-Ferrand | ||
合作者 ICMJE | |||
研究员 ICMJE |
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验证日期 | October 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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