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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 主要终点
- Constant-Murley Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 70 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Displaced 3- or 4-part fracture of the proximal humerus
- •Age over 70 years
- •Independent living
- •Low energy trauma
排除标准
- •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
研究组 & 干预措施
Reverse Total Shoulder Arthroplasty
干预措施: Reverse Total Shoulder Arthroplasty (Procedure)
Hemiarthroplasty
干预措施: Hemiarthroplasty (Procedure)
结局指标
主要结局
Constant-Murley Score
时间窗: 24 months
The Constant-Murley score is used to assess shoulder function. The maximum score is 100 points. Higher scores represent better shoulder function.
WOOS (Western Ontario Osteoarthritis of the Shoulder) Index
时间窗: 24 months
次要结局
未报告次要终点
研究者
Per Olerud
MD, PhD, Senior Consulting Orthopedic Surgeon
Karolinska Institutet
