Clinical Trial of a New Device for Real-Time Muscle Pressure Measurements in Patients at Risk for Acute Compartment Syndrome

Clinical Trial of a New Device for Real-Time Muscle Pressure Measurements in Patients With an Upper or Lower Extremity Fracture at Risk for Acute Compartment Syndrome

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, chronic pain, infection, and possible amputation. Early diagnosis is essential to institute interventions to avoid complications. Unfortunately, the subjective pain of the patient remains the mainstay for diagnosis. A method or device is needed that would improve the investigator's ability to diagnose this potentially devastating condition. The purpose of this trial is to evaluate the safety and functionality of MY01, an investigational device that allows continuous monitoring of intracompartmental muscle pressure in patients at risk for developing acute compartment syndrome. This is a single centre, non-randomized, non-controlled, unblinded, prospective trial of the MY01 device. A cohort of 25 participants will be prospectively enrolled to document the performance of the device.

Inclusion Criteria:

• 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 Criteria:

• 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.