Comparison Between Anterior Approach (Deltopectoral) and Lateral Approach (Deltoid Splitting) in Shoulder Reverse Arthroplasty for Proximal Humerus Fracture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Constant Murley Score
研究概览
简要总结
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.
详细描述
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
盲法说明
no masking
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Constant Murley Score
时间窗: 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
次要结局
- Quick dash score(3, 6 and 12 months)
- SF12 score(3, 6 and 12 months)
- Alder score(3, 6 and 12 months)
- The Simple Shoulder Test (SST)(3, 6 and 12 months)
- WOOS (The Western Ontario Osteosarthritis )(3, 6 and 12 months)
- intensity of pain(pre op, 3, 6 and 12 months)
- Radiologic evaluation(pre op, 3, 6 and 12 months)
- Complications(pre op, 3, 6 and 12 months)