Evaluation of the Proximal Femoral Nail Antirotation With Cement Augmentation in Osteoporotic Femoral Neck Fractures
试验速览
- 阶段
- 1 期
- 试验地点
- 1
- 主要终点
- Proportion of patients reaching union at the 3-month and 6-month follow up
研究概览
简要总结
This is an open multicenter study, evaluating a new operative technique in femur neck fractures. The treatment consist of augmentated nails in cases of subtrochanteric or inter fracture due to osteoporosis.There two routine surgical techniques in femoral neck fractures:
- Insertion an intramedullary nail (without augmentation) to the bone.
- insertion a nail and metal plateto the bone. The major disadvantage of these methods is the relative high rate (4-10 precentages) of failure because of the femur head bone which is very brittle and osteoporotic.
This new approach enables the nail a better grip as a result of the cement augmentation which consists of PMMA (Polymethyl methacrylate).
The investigators main goal is to evaluate the use of this surgical technique
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
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PFNA augmentation is indicated for severe osteoporotic fractures (Subtrochanteric or intertrochanteric) in the proximal femur.
- •Men and women above 80 years old that fuffer from fracture in the proximal femur.
排除标准
- •Patient can not come to the follow up clinic visits.
结局指标
主要结局
Proportion of patients reaching union at the 3-month and 6-month follow up
Proportion of patients reaching union at the 3-month and 6-month follow up will be assessed. Union is defined by both clinical evaluation-pain and weight bearing status, and radiological evaluation- three out of four cortices must be bridged as viewed on plain X-ray (AP and lateral views).
次要结局
未报告次要终点