Continuous Compartment Pressure Monitoring in Adolescent Tibia Fractures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Continuous anterior compartment pressure
研究概览
简要总结
The goal of this clinical trial is to learn more about anterior leg compartment pressures in adolescents who have sustained tibia fractures. It will also examine whether measuring anterior compartment pressure helps physicians diagnose acute compartment syndrome (ACS), a rare but dangerous complication that can develop following surgical treatment of a tibia fracture.
The main questions it aims to answer are:
- Are there differences in anterior compartment pressures between healthy patients and patients who develop ACS?
- Does compartment pressure monitoring aid physicians in accurately diagnosing ACS?
Participants will have a continuous pressure monitoring sensor placed in their knee anterior knee compartment during their surgery. This sensor will record pressure data following a patient's surgical treatment for 18+ hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 10 to 21 on the day of surgery
- •Undergoing operative fixation for a fracture of the proximal tibia or tibial shaft
排除标准
- •Preoperative diagnosis of acute compartment syndrome
- •Preexisting neuromuscular or vascular condition affecting the injured extremity
- •MY01 device malfunction
研究组 & 干预措施
MY01
All study participants will have an MY01 medical device inserted to record continuous anterior compartment pressure data.
干预措施: Continuous Compartmental Pressure Monitor (Device)
结局指标
主要结局
Continuous anterior compartment pressure
时间窗: From the placement of the MY01 device sensor to 18 hours postoperatively
The primary outcome will be continuous anterior compartment pressure measurements, recorded in millimeters of mercury (mmHg) by the MY01 device.
次要结局
- Development of acute compartment syndrome(From MY01 device insertion to index hospital discharge, up to 1 week postoperatively)
研究者
Kristin Livington
Principal Investigator
Boston Children's Hospital