Influence of Static Distal Locking on Outcomes of Unstable Intertrochanteric Fracture Treated With a Short Proximal Femoral Nail
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Evaluation of functional status using the Barthel index
研究概览
简要总结
Prospective, comparative, randomized, double-blind study to evaluate the outcomes of trochanteric nailing in unstable hip fractures with and without a distal interlocking screw.
详细描述
Due to the lack of first-level evidence, this study aims to evaluate the effectiveness and safety of surgical treatment for unstable hip fractures, with or without the inclusion of a distal interlocking screw in the hip nail.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Blinding of the patient included in the study and the investigator evaluating the results
入排标准
- 年龄范围
- 50 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 50 years old
- •With unstable intertrochanteric hip fracture
- •Operated in the first 48 hours after hospital admission
排除标准
- •Simultaneous associated fractures
- •Fractures with subtrochanteric line
- •Non-acute fractures
结局指标
主要结局
Evaluation of functional status using the Barthel index
时间窗: 12 months
Evaluation of functional status 12 months after hip surgery
次要结局
- Postoperative mechanical complications(12 months)
- Parker mobility scale(12 months)
研究者
Francisco Antonio Miralles-Muñoz
Head of Department of Orthopedic Surgery
Elda University Hospital
