Effect of Combining Filling of the Posterior Superior Notch of the Humerus With a Coracoid Stop on the Rate of Return to Sports at the Same Level: a Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Number of Participants returning to sports at the same level after surgery, in each arms, at 12months
研究概览
简要总结
The goal of this interventional study is to demonstrate the benefit of combining filling of the posterosuperior notch of the humerus with a coracoid stop on the rate of return to sports at the same level as before at 12 months post-surgery.
The level of sport will be categorized as recreational, competitive, or professional.
This is a prospective, single-center, comparative study of two parallel randomized groups, using a single-blind design.
The patients included will be randomized into two groups with a 1:1 ratio: one group will undergo the filling technique, while the second group will not. The rest of the surgery will be similar.
Randomization will be stratified according to initial athletic level.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient affiliated with or entitled to social security coverage
- •Patient who has received informed consent about the study and signed a consent form
- •Patient presenting with previous shoulder instability associated with a compromising humeral lesion determined by CT scan measurement
排除标准
- •Patient non-compliant with follow-up over 1 year
- •Recurrence of a previously operated shoulder
- •Patient under judicial protection, guardianship, or trusteeship.
结局指标
主要结局
Number of Participants returning to sports at the same level after surgery, in each arms, at 12months
时间窗: 12 months
Difference between the two arms for returning to sports at the same level as before, categorized into three levels: recreational, competitive, or professional, 12 months after surgery.
次要结局
未报告次要终点