Long Term Outcomes of Pediatric Compartment Syndrome

Compartment Syndromes Clinical Trial

Official title:

Long Term Outcomes of Pediatric Compartment Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03540394
• Other study ID #: 111865
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: November 10, 2023

Study information

• Verified date: November 2023
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 10, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Compartment Syndromes
• Syndrome

Locations

Country	Name	City	State
Canada	Victoria Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower Extremity Function (LEF)	Function of lower Limb	1 year
Primary	Upper Extremity functional Index (UEFI)	Function of upper limb	1 year
Secondary	EQ5D	Overall generic health status	1 year