- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03540394
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
Conditions
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
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-
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.
Sponsor
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.
General Publications
- Mubarak SJ, Owen CA. Double-incision fasciotomy of the leg for decompression in compartment syndromes. J Bone Joint Surg Am. 1977 Mar;59(2):184-7.
- Vitale GC, Richardson JD, George SM Jr, Miller FB. Fasciotomy for severe, blunt and penetrating trauma of the extremity. Surg Gynecol Obstet. 1988 May;166(5):397-401.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 111865
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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