Status:
UNKNOWN
Real-Time Muscle Pressure Measurements in Patients at Risk for Acute Compartment Syndrome
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
United States Department of Defense
Hennepin Healthcare Research Institute
Conditions:
Acute Compartment Syndrome
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this trial is to conduct a pilot study that will aid in the design of an evaluation of the clinical benefit of MY01, an FDA cleared device, that allows continuous monitoring of intracom...
Detailed Description
Research Plan The purpose of this trial is to conduct a pilot study that will inform the design of a trial to evaluate the clinical benefit of MY01, a FDA cleared device that allows continuous monito...
Eligibility Criteria
Inclusion
- Direct admission to hospital from scene of injury, or if transferred, admitted no more than 12 hours from injury
- High-energy fracture of the tibial plateau (bicondylar or medial fracture - dislocation)
- High energy displaced tibial diaphysis (highly comminuted or segmental fracture, or proximal third of tibia (e.g. GSW to the proximal fibula)) that is felt by the surgeon to have a likelihood of elevated ICP and risk of ACS.
Exclusion
- Frankly contaminated or infected wounds or fractures.
- Clinical suspicion of acute compartment syndrome requiring urgent fasciotomy at time of presentation to study center.
- Monitoring could not be initiated within 12 hours of presentation
- Acute or pre-existing neuropathy in the study limb.
- Patient is pregnant
- Patient is a prisoner/incarcerated
Key Trial Info
Start Date :
March 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04671173
Start Date
March 18 2022
End Date
March 31 2023
Last Update
April 12 2022
Active Locations (2)
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1
Hennepin County Medical Center - Orthopaedic Research
Minneapolis, Minnesota, United States, 55414
2
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232