Treatment of Humerus Fractures by a Multiloc Nail, Through a Minimally Invasive Procedure.
Proximal humerus fractures are more common in older people. They can be caused by a minor trauma on an osteoporotic bone.
Non- or little-displaced proximal humerus fractures are treated orthopedically. When the displacement is more important, the choice of the treatment is crucial and the algorithm of treatment is in permanent evolution. The technology and design of the implants and the operative techniques of osteosynthesis and arthroplasty have evolved. Patients live longer, they lead a more active life and their expectations have changed. The goals of the treatment should be an increase in shoulder function and a decrease in treatment failure.
This study analyzes the results of the treatment by intramedullary osteosynthesis using a Multiloc nail from Synthes between 2012 and June 2017. The study will compare the functional results obtained after fixation by a Multiloc nail, a Philos plate or arthroplasty.The functionality of the shoulder and the quality of life will be evaluated according to the type of treatment.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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Brussels、比利时、1020
- CHU Brugmann
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
All patients being treated for a proximal humerus fracture within the CHU Brugmann hospital between 2012 and 2017.
Exclusion Criteria:
None
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Multiloc nail
Fracture treated with a Multiloc nail (patients treated between 2012 and 2017)
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Assessment of the different outcomes by means of a phone contact
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Philos plate
Fracture treated with a Philos plate (patients treated between 2012 and 2017)
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Assessment of the different outcomes by means of a phone contact
|
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arthroplasty
Fracture treated by arthroplasty (patients treated between 2012 and 2017)
|
Assessment of the different outcomes by means of a phone contact
|
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 |
|---|---|---|
|
Fracture classification (AO)
大体时间：one year
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Fracture classification according to the "Müller AO Classification of fractures - long bones"
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one year
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Fracture classification (NEER)
大体时间：one year
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Fracture classification according to the "Neer classification of proximal humeral fractures"
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one year
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Dash score
大体时间：one year
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The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities.
The score is computed according to this formula: ([(sum of n responses)/n] -1)(25) where n represents the number of completed items.
A higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability.The score ranges from 0 (no disability) to 100 (most severe disability).
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one year
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Constant score
大体时间：one year
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The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters.
These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.
The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury.
The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points).
The higher the score, the higher the quality of the function.
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one year
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QoL 36
大体时间：one year
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The QoL 36 quality of life questionnaire consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower the score the more disability.
The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
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one year
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合作者和调查者
赞助
调查人员
- 首席研究员：Victorien Gauchez、CHU Brugmann
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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.
肱骨骨折的临床试验
Phone contact的临床试验
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