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

NCT ID: NCT04012723

Last Updated: 2024-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-17
• Study Completion Date: 2023-03-30

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, 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.

Conditions

Compartment Syndrome Traumatic Lower Extremity; Compartment Syndrome Traumatic Upper Extremity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

MY01 Device

Device: MY01 Device

Insertion of the MY01 device for up to 24 hours for continuous monitoring of compartment pressure

Group Type: EXPERIMENTAL

MY01 Continuous Compartmental Pressure Monitor

Intervention Type: DEVICE

The MY01 Continuous Compartmental Pressure Monitor is intended for real-time and continuous measurement of compartmental pressures.

Interventions

MY01 Continuous Compartmental Pressure Monitor

The MY01 Continuous Compartmental Pressure Monitor is intended for real-time and continuous measurement of compartmental pressures.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nova Scotia Health Authority

OTHER

Sponsor Role: collaborator

MY01 Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ross Leighton, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopaedic Surgeon, Nova Scotia Health Authority

Locations

Foothills Medical Center

Calgary, Alberta, Canada

Halifax Infirmary

Halifax, Nova Scotia, Canada

London Health Sciences Centre

London, Ontario, Canada

Ottawa Civic Hospital

Ottawa, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

MY01-NS-01

Identifier Type: -

Identifier Source: org_study_id