Reverse Total Shoulder Arthroplasty Versus Hemiarthroplasty for Displaced 3- and 4-part Proximal Humeral Fractures
Reverse Total Shoulder Arthroplasty Versus Hemiarthroplasty for Displaced 3- and 4-part Proximal Humeral Fractures in Patients Older Than 70 Years. A Multicenter Randomized Controlled Trial
Proximal humeral fractures are common injuries with the highest incidence being amongst the elderly. Most proximal humeral fractures are nondisplaced or minimally displaced. The majority of these are reliably treated nonoperatively with an acceptable functional outcome. The treatment of displaced fractures is more controversial. Consensus is lacking as to when surgery is indicated or what type of procedure to choose if surgery is elected. Displaced 3- and 4-part fractures where internal fixation is deemed unreliable have been considered an indication for hemiarthroplasty. Hemiarthroplasty gives reasonable control of pain but the resulting shoulder function and range of motion is unpredictable. The use of reverse total shoulder arthroplasty is increasing and might result in a better range of motion then hemiarthroplasty.
The aim of this multicenter study is to test the hypothesis that reverse total shoulder arthroplasty gives better shoulder function than hemiarthroplasty for displaced 3- and 4-part proximal humeral fractures.
研究概览
研究类型
阶段
- 不适用
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
描述
Inclusion criteria
- Displaced 3- or 4-part fracture of the proximal humerus
- Age over 70 years
- Independent living
- Low energy trauma
Exclusion criteria
- Pre-existing shoulder disease
- Severe cognitive dysfunction
- More than 14 days from injury to surgery
- Comorbidity that affects shoulder rehabilitation considerably
- Concurrent injury that affect shoulder rehabilitation considerably
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Reverse Total Shoulder Arthroplasty
|
|
|
有源比较器:Hemiarthroplasty
|
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 |
|---|---|---|
|
Constant-Murley Score
大体时间:24 months
|
The Constant-Murley score is used to assess shoulder function.
The maximum score is 100 points.
Higher scores represent better shoulder function.
|
24 months
|
|
WOOS (Western Ontario Osteoarthritis of the Shoulder) Index
大体时间:24 months
|
24 months
|
合作者和调查者
调查人员
- 首席研究员:Per Olerud, MD、Karolinska Institutet
- 研究主任:Carl Ekholm, MD、Sahlgrenska Academy
出版物和有用的链接
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
与本研究相关的术语
其他研究编号
- 2013/1053-31/3
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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.