Status:
COMPLETED
Clinical Trial of a New Device for Real-Time Muscle Pressure Measurements in Patients at Risk for Acute Compartment Syndrome
Lead Sponsor:
MY01 Inc.
Collaborating Sponsors:
Nova Scotia Health Authority
Conditions:
Compartment Syndrome Traumatic Lower Extremity
Compartment Syndrome Traumatic Upper Extremity
Eligibility:
All Genders
16-65 years
Phase:
NA
Brief Summary
Compartment syndrome remains a very serious complication of lower extremity trauma and/or procedural cases that involved lower or upper extremity surgery. This condition results in muscle death, chron...
Eligibility Criteria
Inclusion
- Adults age 16-65.
- Fracture of the tibia, foot, forearm, femur, or humerus that is felt by the surgeon to have a reasonable indication that elevated intracompartmental pressure could occur in the patient.
- Planned admission to hospital (to enable monitoring of compartment pressures)
- Provision of informed consent to participate.
Exclusion
- Frankly contaminated or infected wounds or fractures.
- Clinical suspicion of acute compartment syndrome requiring urgent fasciotomy at time of presentation to study center.
- Current or pre-existing neuropathy in the study limb.
- Pregnant women.
Key Trial Info
Start Date :
November 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04012723
Start Date
November 17 2020
End Date
March 30 2023
Last Update
February 21 2024
Active Locations (5)
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1
Foothills Medical Center
Calgary, Alberta, Canada, T2N 2T9
2
Halifax Infirmary
Halifax, Nova Scotia, Canada, B3H 1V7
3
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
4
Ottawa Civic Hospital
Ottawa, Ontario, Canada, K1Y 4E9