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临床试验/NCT00916136
NCT00916136已完成不适用

Evaluation of Skeletal Versus Cutaneous Traction for Diaphyseal Femur Fractures

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2009年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
1
主要终点
Time to Pass Guidewire After Attaining Starting Point

研究概览

简要总结

The purpose of this study is to determine whether there are any differences in skeletal or cutaneous traction for the treatment of femur fractures.

详细描述

Diaphyseal femur fractures are a common occurrence in busy level one trauma centers and even in the age of damage control orthopaedics most of these fractures are fixed definitively within 24 hours. The historical method of temporizing these fractures has been to place a distal femoral or proximal tibial skeletal traction pin. However, in the pediatric population skeletal traction is not utilized due to concern for physeal injury and cutaneous traction has been the gold standard for decades. Reasons for skeletal traction in adults are not well defined and there are no clinical studies showing that skeletal traction provides better outcomes in time of reduction in the operating theater or better pain control than cutaneous traction. With the ever increasing amount of high energy trauma seen by junior residents in the emergency department time constraints have become a large factor in patient care. Long delays for sedation and equipment procurement make stabilizing a diaphyseal femur fracture a time consuming experience. The purpose of this study is to determine whether differences exist between skeletal and cutaneous femoral traction in terms of: 1) time in patient consultation and fracture stabilization; 2) cost and risk to the patient due to lack of conscious sedation; 3) pain scores prior to surgery; 4) time of reduction of the diaphyseal femur fraction during surgical fixation; and 5) pain relief after traction application.

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
否

入选标准

  • •Patient willing to consent
  • •18 years of age or older
  • •Sustained a diaphyseal femur fracture, open or closed
  • •English competent
  • •Isolated fracture on that extremity

排除标准

  • •Pathologic fracture
  • •Sedated patient
  • •Polytrauma to same extremity
  • •Unable or not willing to consent

研究组 & 干预措施

Cutaneous Traction

Active Comparator

Applied by using a strap on boot that attaches to the leg. A rope is attached to the boot. Weight is attached to the rope to use gravity to pull traction. The traction is left in place until patient is taken to surgery for reduction of the femur fracture.

干预措施: Femoral Traction (Procedure)

Skeletal Traction

Active Comparator

A small incision is made on the inside of the knee and a pin is surgically inserted through the bone. Weights are then attached that will pull traction on the broken femur. This traction pin will stay in until patient is taken to surgery for reduction of the femur fracture.

干预措施: Femoral Traction (Procedure)

结局指标

主要结局

Time to Pass Guidewire After Attaining Starting Point

时间窗: while in Emergency Department (ED) up to 24 hours

Time to pass guidewire across reduced fracture once opening reamer is used in OR

Difference in the Two Groups in Regards to Resident Time.

时间窗: while in Emergency Department (ED) up to 24 hours

Time from consult entered to time traction apparatus is applied.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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