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临床试验/NCT01509859
NCT01509859Unknown4 期

Prospective Randomized Trial Comparing the Weight Bearing After Fixation of Proximal Femur Fractures With Two Different Proximal Intramedullary Devices

Rabin Medical Center2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年12月最近更新:
适应症

试验速览

阶段
4 期
入组人数
100
试验地点
2

研究概览

简要总结

The purpose of the study is to Compare the stability of the fracture and pain after surgery by measuring the stride length and weight bearing on the operated leg. This study will compare these parameters between two different proximal femur nails used for fixing hip fractures.

详细描述

Fractures of the proximal femur and hip are relatively common injuries in adults.

According to the Evans and the AO Classification systems, the fracture can be described as stable after reduction or not according to the direction of the fracture lines and the comminution of the medial cortex or the lateral wall of the proximal femur.

Biomechanically, nails allow for stable anatomical fixation of more comminuted fractures without shortening the abductor moment arm or changing the proximal femoral anatomy. These devices provide fracture stability by virtue of allowing the lateral aspect of the head and neck to come to rest against the nail in the medullary canal.

For fractures with comminuted medial cortex or involvement of the lateral cortex (AO 2.2 - AO 3.3) it is advisable to fixate with a more stable fixation device such as intramedullary proximal femur nail Several intramedullary devices are currently in use for the treatment of the intertrochanteric fractures. In our institution, for the unstable fracture we use either one of the intramedullary devices manufactured by Synthes (Proximal femoral nail - anti-rotation = PFNA) or by Smith&Nephew (Trochanteric Antegrade Nail = InterTan).

Each of these nails allow compression over the Nail\Blade with the intramedullary stability.

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)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • pertrochanteric fracture ao 2.2 and above
  • ambulatory patient, without support prior to the fall
  • minor trauma mechanism
  • without other injuries
  • operated 3 days from the injury

排除标准

  • s/p hip or knee arthroplasty
  • known osteoarthritis

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

yona kosashvili

senior surgeon, joint arthroplasty unit, orthopedic department

Rabin Medical Center

研究点 (2)

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