Natural History of Anterior Compartment Pressures of the Thigh Following Femur
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 主要终点
- Compartment pressures
研究概览
简要总结
This study is to determine the natural history of compartment pressures in the anterior thigh secondary to a fracture of the femoral shaft.
详细描述
Compartment syndrome is a painful condition where increased tissue pressure in a restricted area compromises circulation and endangers the tissue within that area possibly leading to surgery, amputation, major loss of function and in rare cases, death. Compartment syndrome of the thigh can be particularly devastating because of the size of the muscle and large amount of blood flow to the area, however it is one of the more rare and therefore least understood of all compartment syndromes. The purpose of this study is to determine the natural history of pressures of the anterior compartment of the thigh following femur fracture, which could help elucidate the diagnostic and treatment algorithms for thigh compartment syndrome. This small project is designed to be a non-randomized, investigational prospective trail to be conducted at the General Division of Charleston Area Medical Center. The target population consists of males and non-pregnant females age 18 and over who have suffered a mid-shaft femur fracture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •femur fracture
- •age 18 and older
排除标准
- •patients who are not candidates for surgical repair of femur fracture
- •patients not expected to survive more than 1 week
研究组 & 干预措施
Needle Insertion into Femur
Data gathering with monitoring of pressures in the thigh via via needle in femur.
干预措施: Pressure monitoring device (Device)
Needle Insertion into Femur
Data gathering with monitoring of pressures in the thigh via via needle in femur.
干预措施: Compartmental fracture pressure monitoring (Device)
Needle Insertion into Femur
Data gathering with monitoring of pressures in the thigh via via needle in femur.
干预措施: This small project is designed to be a non-randomized, investigational prospective trial of compartment pressures in the thigh following femoral fracture (Device)
结局指标
主要结局
Compartment pressures
时间窗: Pre-operative to 50 hours post operation
次要结局
未报告次要终点
研究者
Michael Whitler, BS
IRB Admin
CAMC Health System
