In a Reverse Shoulder Arthroplasty, Does Function Depend on the Humeral Version? A Prospective Randomized Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- External rotation of the shoulder
研究概览
简要总结
The goal of this clinical trial is to compare function in reverse shoulder arthroplasty (RSA) using two different degrees of humeral retroversion (RV). The main question it aims to answer is:
• Does external rotation improves when using a higher retroversion?
Participants will randomly receive a 0 degree or 30 degree RV for their RSA.
They will be followed for two years and clinical outcomes will be recorded and analyzed.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients > 60 years
- •primary rotator cuff arthropathy
- •implantation of reverse shoulder arthroplasty
排除标准
- •previous surgeries in the shoulder
- •post-traumatic arthropathy
结局指标
主要结局
External rotation of the shoulder
时间窗: 2 years
External rotation of the shoulder will be measured in degrees with the help of a goniometer in two ways. First: External rotation 1 (ER1): arm adducted at zero degrees Second: External rotation 2 (ER2): arm in 90 degrees of abduction.
Constant-Murley Score
时间窗: 2 years
The Constant-Murley score is a multi-item functional scale assessing pain, daily activities, range of motion and strength of the affected shoulder. Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively
次要结局
未报告次要终点
研究者
José Carlos Minarro
Principal investigator
Hospital Universitario Reina Sofia de Cordoba