Composite Nailing System for the Intramedullary Fixation of Humerus Fractures Without Intramedullary Reaming
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Bone union and callus formation,bone alignment, nail and screws resistance over time
研究概览
简要总结
The purpose of the study is to evaluate the safety and efficacy of the composite Nail - the Quantum interlocking intramedullary nailing system in the reduction of humeral fractures.
详细描述
The study will include 20 patients who have an acute mid shaft diaphyseal humeral fracture due to injury. The patients will undergo lateral and AP X- ray evaluation of the fracture. Following General anesthesia, closed reduction of the fracture will be performed. It will be followed by nail insertion, percutaneously, according to standard surgical techniques, with the help of the insertion handle and without preliminary reaming. Following insertion the nail will be locked both distally and proximally using interlocking screws. The nail and screws insertion will be monitored by fluoroscopy. Patients will remain under follow up for 6 months following the procedure. In the follow up sessions the fracture will be evaluated by fluoroscopy or X-ray for correct bone alignment, callus formation, and fracture union.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Above 18 years old.
- •Mid shaft diaphyseal fracture
- •Acute fracture
排除标准
- •Patients with metabolic or hormonal diseases that could affect bone healing such as diabetes.
- •Ongoing infection in fracture site.
结局指标
主要结局
Bone union and callus formation,bone alignment, nail and screws resistance over time
时间窗: up to 6 months
次要结局
未报告次要终点