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Completed

NCT Number: NCT04016103

MY01 - An Aid for Diagnosing Acute Compartment Syndrome in Real Time

Compartment syndrome can result from extremity trauma. It can also be caused by procedural cases that involve lower or upper extremity surgery. This condition results in muscle death, chronic pain, infection, and possible amputation. Early diagnosis is essential to institute interventions that can avoid complications. Subjective pain of the patient remains the mainstay for diagnosis. A method or device is needed that would improve our accuracy in diagnosing compartment syndrome. Ideally, this would be suited for single and/or continuous pressure read-outs. The aim is to reduce the incidence of missed compartment syndrome and diminish delays that would lead to significant disability.

Despite awareness, delayed diagnosis and treatment occurs in modern orthopaedic practice. As noted in many studies, once a diagnosis has been made, immediate fasciotomy is necessary to provide the best chance for a favourable clinical result. Therefore, there is a need for improved devices in order to obtain an early and reliable diagnosis.

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Key information

Conditions

Acute Compartment Syndrome

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital du Sacré-Coeur de Montreal, Montreal, Quebec, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men or women, aged 18 years of age and older
  • Any tibial, foot, femoral, forearm or fracture that is felt by the surgeon to have a reasonable indication that elevated ICP could occur in the patient
  • Mentally fit to provide informed consent

Exclusion criteria

  • Patients with fractures that are not felt to be at risk of developing compartment syndrome based on serial clinical evaluation
  • Infected wounds; infected fractures
  • Patients who present with ACS requiring urgent surgical fasciotomy
  • Patients who cannot consent to trial
  • Pregnant women

Treatment and study plan

MY01 - Continuous Compartmental Pressure Monitor

Device

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

Primary outcomes

  1. Clinical ease with which the new compartment pressure monitor was inserted into 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 the device functioned adequately?" [0 = not confident] - [10 = very confident].

    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 10 should be considered a very positive scenario, whereas a record of 0 should indicate a very negative scenario.

  2. Ability to monitor in real-time the continuous pressure read-out from the compartment in remote locations such as an I-phone.

    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 in a Yes or No question "Did the MY01 Application remote data display work properly?" [Yes] or [No].

  3. The correlation of continuous pressure read-outs (high, normal or low) with clinical indications for compartment syndrome in each patient.

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

    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. Correlation of clinical compartment syndrome release with data from the continuous pressure monitor read-out.

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

    Should surgical fasciotomy be deemed necessary to release pent up pressure in the patients muscle compartment, the continuous pressure read-outs [mmHG] derived from the device will be compared against the timeframe when the decision to conduct fasciotomy was made.

  2. Short-term outcomes of the patient following continuous pressure monitoring

    Time frame: 24-48 hours following device insertion.

    Survey and tabulation of data from patient clinical findings.

Sponsors and collaborators

Lead sponsor

MY01 Inc.

Industry

Collaborators

  • Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
  • McGill University Health Centre/Research Institute of the McGill University Health Centre

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 11, 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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