Study Stopped
Large sample size and change in Orthopaedic practice to use of CCPM in conjunction with Clinical Monitoring rendered project less timely.
Continuous Pressure Monitoring In Lower Leg Fractures
Continuous Compartment Pressure Monitoring (Ccpm) Following Tibial Fracture: A Prospective Randomized Trial
1 other identifier
interventional
250
1 country
1
Brief Summary
This study has been designed to allow us to learn more about diagnosing Compartment Syndrome, which is a condition that occurs in approximately 5% of tibial (lower leg) fractures. In Compartment Syndrome, nerves, muscle and blood vessels are affected by swelling within the enclosed spaces (compartments) of the leg. The tissue covering these compartments (called the fascia) is not expandable and is not able to accommodate this swelling, and so the tissues within the compartments become compressed. If the pressure is not relieved it can result in blood flow being blocked to the inside of the compartment (muscle, blood vessels, and nerves) which can lead to permanent injury to the muscle and nerves. Late complications in untreated compartment syndrome include a failure of the injured bone to heal, nerve damage, and contracture (shortening) of muscle, all of which can result in a weak, painful, stiff, and poorly formed limb that is not functioning well, and could result in amputation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2006
CompletedFirst Posted
Study publicly available on registry
August 1, 2006
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedMarch 30, 2010
March 1, 2010
1.5 years
July 28, 2006
March 26, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Outcome measures will be assessed at the time of discharge and at the six and twelve month clinical appointments and will be as follows:
Fasciotomy rate
Secondary Outcomes (1)
Outcome measures will be assessed at the time of discharge and at the six and twelve month clinical appointments and will be as follows:Time from injury to fasciotomy 2) Early local outcomes 3) Late local outcomes
Interventions
See Detailed Description.
Eligibility Criteria
You may qualify if:
- years of age and older, presenting for treatment in 24 hours or less
- Diaphyseal or bicondylar plateau fracture of the tibia
You may not qualify if:
- Patients under 16 years of age
- Patients who present to VGH more than 24 hours after the injury
- Patients who are not mentally competent to give Informed Consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vancouver General Hospital
Vancouver, British Columbia, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
P J O'Brien, MD
University of British Columbia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 28, 2006
First Posted
August 1, 2006
Study Start
September 1, 2008
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
March 30, 2010
Record last verified: 2010-03