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.

Study Overview

• Status: Completed
• Conditions: Compartment Syndrome Traumatic Lower Extremity; Compartment Syndrome Traumatic Upper Extremity
• Intervention / Treatment: Device: MY01 Continuous Compartmental Pressure Monitor

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abdelkrim Temzi; Phone Number: 5145616809; Email: abdel.temzi@my01.io
• Study Contact Backup: Name: Kelly Trask; Phone Number: 902-473-3161; Email: kelly.trask@nshealth.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Foothills Medical Center
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Halifax Infirmary
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre
    • Ottawa, Ontario, Canada, K1Y 4E9
      • Ottawa Civic Hospital
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MY01 Device; Device: MY01 Device Insertion of the MY01 device for up to 24 hours for continuous monitoring of compartment pressure	Device: MY01 Continuous Compartmental Pressure Monitor; The MY01 Continuous Compartmental Pressure Monitor is intended for real-time and continuous measurement of compartmental pressures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical ease with which the MY01 device is able to be inserted into a compartment.	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.	24-48 hours following device insertion.
Ability to monitor in real time the continuous pressure readout from the compartment in remote locations via smartphone.	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.	24-48 hours following device insertion.
The change in intracompartmental pressure.	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.	24-48 hours following device insertion.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events associated with the use of the device.	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."	24-48 hours following device insertion, and again during the final follow-up of the participant approximately two weeks after treatment.
Pain at insertion site.	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].	24-48 hours following device insertion.

Collaborators and Investigators

• Sponsor: MY01 Inc.
• Collaborators: Nova Scotia Health Authority
• Investigators: Principal Investigator: Ross Leighton, MD, Orthopaedic Surgeon, Nova Scotia Health Authority

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2020
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: July 5, 2019
• First Posted (Actual): July 9, 2019

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Acute Compartment Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease; Musculoskeletal Diseases; Muscular Diseases; Syndrome; Compartment Syndromes
• Other Study ID Numbers: MY01-NS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No