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NCT Number: NCT04012723

Clinical Trial of a New Device for Real-Time Muscle Pressure Measurements in Patients 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.

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Key information

Conditions

Compartment Syndrome Traumatic Lower Extremity Compartment Syndrome Traumatic Upper Extremity

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foothills Medical Center, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MY01 Continuous Compartmental Pressure Monitor

Device

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

Primary outcomes

  1. Clinical ease with which the MY01 device is able to be inserted into a compartment.

    Time frame: 24-48 hours following device insertion.

    At device insertion, the physician will complete a feedback questionnaire, and routine assessment will be performed in compliance with the standard of care. As part of the feedback questionnaire, the physician will be asked to indicate on a sliding scale "How certain are you that the sensor is in the correction position?" [1 = uncertain] - [5 = very certain].

    The scale, administered part of a Clinical Report Form (CRF) titled 'Physician Survey', measures the physicians subjective level of certainty that the device sensor was inserted correctly within a patients muscle compartment. A record of 5 should be considered a positive scenario, whereas a record of 1 should indicate a negative scenario.

  2. Ability to monitor in real time the continuous pressure readout from the compartment in remote locations via smartphone.

    Time frame: 24-48 hours following device insertion.

    At insertion of device the physician will complete a feedback questionnaire on the device, the participant will be assessed for adverse events, and routine assessment will be performed.

  3. The change in intracompartmental pressure.

    Time frame: 24-48 hours following device insertion.

    Routine assessments will be completed by healthcare personnel as per standard of care (the 6P's [Pain, Paraesthesia, Pallor, Paralysis, Pulselessness, Poikilothermia]), and compared against the pressure readout [mmHG] indicated by MY01's MicroElectroMechanical (MEMS) pressure sensor inserted at the afflicted location.

Secondary outcomes

  1. Adverse events associated with the use of the device.

    Time frame: 24-48 hours following device insertion, and again during the final follow-up of the participant approximately two weeks after treatment.

    The patient will be monitored for adverse events during treatment, and will be reassessed during the final follow-up of the participant at the first return visit to the fracture clinic. An adverse event constitutes "Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal lab findings) in participants, users or other persons, whether or not related to the investigational device."

  2. Pain at insertion site.

    Time frame: 24-48 hours following device insertion.

    Participants will be asked to keep a diary while the device is in situ. The diary will consist of a pain Visual Analog Score (VAS) to be completed each time their vitals are taken, with space to freely comment on the device. VAS will be on a sliding scale where [0=no pain] and [10=pain as bad as it can be].

Sponsors and collaborators

Lead sponsor

MY01 Inc.

Industry

Collaborators

  • Nova Scotia Health Authority

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jul 9, 2019
Registry last updated
Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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