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临床试验/NCT03540394
NCT03540394已完成不适用

Long Term Outcomes of Pediatric Compartment Syndrome

Lawson Health Research Institute1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Upper Extremity functional Index (UEFI)

研究概览

简要总结

The goal of this study is to review the etiology, diagnostic criteria, complications and outcome of acute pediatric compartment syndrome identified at The Children's Hospital of Western Ontario (CHWO) . Follow up with patients treated for compartment syndrome by fasciotomy will assist in determining the long term effects of compartment syndrome and surgical procedures on the patient quality of life and return to level of function of the affected limb.

详细描述

Acute compartment syndrome (ACS) is caused by elevated pressure within a closed osseofascial compartment, leading to microvascular compromise and cell death. Without urgent decompression of the compartment, significant functional impairment and loss of limb may result. Compartment syndrome can be difficult to diagnose as there are a wide variety of causes, clinical manifestations, and no reliable objective test. The diagnosis in a pediatric population is further complicated when the patient has a decreased ability to communicate verbally, and/or is non-compliant with physical examination. CS pathophysiology indicates that such an increase in compartmental pressure leads to the loss of microvascular perfusion (ischemia), restricting oxygen and nutrient delivery to vital tissues, ultimately causing the permanent functional and physical loss of the limb. The basic principle of fasciotomy is the full and adequate decompression of the compartment of interest and is performed secondary to compartment syndrome. This can be achieved via a single or double incision approach with both methods appearing to be equally effective in reducing intercompartment pressure (ICP). Subsequent skin closure and/or coverage is performed only when all muscle groups are deemed viable. However, there are a number of coverage techniques described without a clear systematic approach based on objective outcomes. Currently, the only available treatment consists of restoration of blood flow by releasing the pressure by slicing open the skin and connective tissue overlying the muscle in a procedure called fasciotomy. This crude method may result in long-term muscle weakness and disfigurement, and does not treat the ischemic damage already caused by the trauma. Pressure release can be achieved via a single or double incision approach with both methods appearing to be equally effective in reducing ICP. Subsequent skin closure and/or coverage is performed only when all muscle groups are deemed viable. However, there are a number of coverage techniques described without a clear systematic approach based on objective outcomes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • skeletally immature patients (i.e under 18 years of age) admitted to Childrens Hospital of Western Ontario (CHWO) between January 2007 and 2017
  • diagnosed compartment syndrome development
  • required surgical intervention in the form of a fasciotomy for compartment syndrome of either the upper or lower extremity

排除标准

  • 18 years of age or greater
  • no development of diagnosed compartment syndrome

结局指标

主要结局

Upper Extremity functional Index (UEFI)

时间窗: 1 year

Function of upper limb

Lower Extremity Function (LEF)

时间窗: 1 year

Function of lower Limb

次要结局

  • EQ5D(1 year)

研究者

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

Abdelrahman Lawendy

Orthopaedic Surgeon

Lawson Health Research Institute

研究点 (1)

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