Reverse Total Shoulder Arthroplasty Versus Open Reduction Internal Fixation of 3 & 4-Part Proximal Humerus Fractures: A Randomized Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- To measure the change using the chi-square tests for lowering the pain score of the patients
研究概览
简要总结
Will patients who suffer complex humerus fractures have better functional outcomes and less implant failure with shoulder replacement (reverse total shoulder arthroplasty, RTSA) compared to shoulder repair (open reduction and internal fixation, ORIF)?
详细描述
The purpose of this study is to compare validated clinical and functional outcomes between patients who acutely present with 3 and 4-part proximal humerus fractures treated with either ORIF or RTSA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Neer 3 and 4-part proximal humerus fractures.
- •Age greater than and equal to 70 years old.
- •Functional deltoid musculature (axillary nerve intact).
- •Less than 70 years old.
- •Dementia or inability to provide adequate follow up.
- •Associated injuries: injuries of ipsilateral limb, complete brachial plexopathy, vascular injury and polytrauma.
排除标准
- 未提供
研究组 & 干预措施
Open Reduction Internal Fixation Proximal Humerus
The patients randomized into the ORIF group will receive standard surgical treatment of their proximal humerus fracture with a proximal humeral locking plate.
干预措施: Fracture repair (Procedure)
Reverse Total Shoulder Arthroplasty
The patients randomized into the RTSA group will receive standard surgical treatment of their proximal humeral fracture with a Reverse Total Shoulder Arthroplasty.
干预措施: Fracture repair with joint replacement (Procedure)
结局指标
主要结局
To measure the change using the chi-square tests for lowering the pain score of the patients
时间窗: base line to 2 years
threshold of statistical significance will be set at α = 0.05.
次要结局
未报告次要终点
研究者
Joaquin Sanchez-Sotelo, M.D., Ph.D.
Professor of Orthopedics
Mayo Clinic