Long Term Outcomes of Pediatric Compartment Syndrome

November 10, 2023 updated by: Abdelrahman Lawendy, Lawson Health Research Institute
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.

Study Overview

Status

Completed

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • London, Ontario, Canada, N6A4G5
        • Victoria Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to CHWO between 2007 and 2017 who underwent a fasciotomy for compartment syndrome of either an upper or lower extremity

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lower Extremity Function (LEF)
Time Frame: 1 year
Function of lower Limb
1 year
Upper Extremity functional Index (UEFI)
Time Frame: 1 year
Function of upper limb
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EQ5D
Time Frame: 1 year
Overall generic health status
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

November 10, 2023

Study Registration Dates

First Submitted

May 3, 2018

First Submitted That Met QC Criteria

May 28, 2018

First Posted (Actual)

May 30, 2018

Study Record Updates

Last Update Posted (Actual)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 10, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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