NCT03540394

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2023

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

3.9 years

First QC Date

May 3, 2018

Last Update Submit

November 10, 2023

Conditions

Compartment Syndromes

Outcome Measures

Primary Outcomes (2)

  • Lower Extremity Function (LEF)

    Function of lower Limb

    1 year

  • Upper Extremity functional Index (UEFI)

    Function of upper limb

    1 year

Secondary Outcomes (1)

  • EQ5D

    1 year

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Victoria Hospital

London, Ontario, N6A4G5, Canada

Location

Related 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.

    PMID: 15455478BACKGROUND

  • 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.

    PMID: 3363458BACKGROUND

MeSH Terms

Conditions

Compartment Syndromes

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopaedic Surgeon

Study Record Dates

First Submitted

May 3, 2018

First Posted

May 30, 2018

Study Start

January 1, 2019

Primary Completion

December 1, 2022

Study Completion

November 10, 2023

Last Updated

November 14, 2023

Record last verified: 2023-11

Locations

CA(1)