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临床试验/NCT02672696
NCT02672696Unknown不适用

Interest of Navigation for the Treatment of Pertrochanteric Fractures With the Gamma 3 Nail

Hôpital du Valais2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Tip-Apex distance

研究概览

简要总结

The aim of the study is to compare Tip-Apex Distance values in two groups of patients after intramedullary nailing of proximal femur. The first group of patients is operated with the help of a 3D reconstruction device connected to the standard fluoroscopy allowing the surgeon to visualize directly the exact position of the tip of the trans-cervical screw while the second group (which is the reference-group) is operated with the help of fluoroscopy alone.

详细描述

The main orthopedic complication after fixation of a proximal femoral fracture with a cephalo-medullary nail is the cut-out of the cephalic screw from femoral head resulting in a protrusion of this screw in the coxo-femoral joint, mostly during the first 6 months after the operation. In most cases, the surgeon has to remove the primary implant and perform a total hip arthroplasty to his patient, therefore rising the morbidity and social costs linked to the treatment of the initial fracture.

Baumgartner showed the importance of the position of the cephalic screw for predicting failure of the implant and proposed a new measurement to evaluate this position, the tip-apex distance which is the sum of the distance from the tip of the cephalic screw to the apex of the femoral head on an anteroposterior radiograph and this distance on a lateral radiograph, after controlling for magnification. He showed a lower TAD was associated with a lower risk of cut-out.

The aim of this study is to evaluate the help of a 3D reconstruction software linked to the standard fluoroscopy in achieving the lowest TAD and therefore minimizing the cut-out rate.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients with a proximal femoral fracture eligible for intramedullary nailing with a Gamma 3 Nail

排除标准

  • 未提供

结局指标

主要结局

Tip-Apex distance

时间窗: 6 months

Change of the value of the tip-apex distance at each follow-up control (6 weeks, 3 and 6 months) compared to the post-op value

次要结局

  • Cut-out of the cephalic screw(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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