Randomised Study Between Intramedullary Locking Nails and Locking Plates for Treatment of Proximal Humerus Fractures in Patients After 40-year-old
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Constant and MURLEY Score
研究概览
简要总结
Primary purpose of this study was to compare functional outcomes after displaced and proximal humerus fracture between nails and locked plates.
The hypothesis is that intramedullary nails provides satisfactory fixation and functional outcome compared to locked plate.
详细描述
: Proximal humerus fractures have a higher occurrence in elderly patients and therefore represent a public health problem.
Prognosis depends on greater and lesser tuberosity status, where rotator tendons of the shoulder have their insertion site.
Surgical treatment is recommended in case of tuberosities displacement. Goals are their anatomic reduction and stable primary fixation that will allow good bone healing and early mobilization. It has been demonstrated that an extended immobilization can result in stiffness by capsular retraction. On the contrary a too early mobilization can lead to secondary displacement of tuberosities and malunion.
These sequelae can be responsible for real disability when occuring in active patients, in particular when dominant limb is affected.
Internal fixation by locking intramedullary nails is currently the first choice technique because less invasive. However it doesn't always provide a good bone fixation, leading to tuberosities displacement or longer immobilization that decrease shoulder function prognosis. Locking plates represent a good alternative to avoid these complications by offering a better fixation of tuberosities in osteoporotic bone.
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients between 40 and 85-years-old, who didn't expressed opposition to inclusion, with type III or IV displaced CEPHALOTUBEROSITY fracture( classification of Neer and DUPARC).
排除标准
- •CEPHALOTUBEROSITY fractures type IV - CT4 will not be included because it can correspond to posterior or anterior fracture-dislocation of humeral head and therefore be associated to very high risk level of avascular necrosis . In this case a surgical treatment by arthroplasty is recommended.
- •Dislocated fracture Patient who express opposition to inclusion polytrauma
结局指标
主要结局
Constant and MURLEY Score
时间窗: 12 months
comparison of shoulder function outcome between 2 groups using Constant- Murley score after 12 months( mobility, function, pain and strength)
次要结局
- Quick Dash, complication (mal union, necrosis, infection)(6 and 18 months)