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

Not Applicable

Completed

• Conditions: Compartment Syndrome Traumatic Lower Extremity; Compartment Syndrome Traumatic Upper Extremity
• Interventions: Device: MY01 Continuous Compartmental Pressure Monitor

• Registration Number: NCT04012723
• Lead Sponsor: MY01 Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-03
• Study First Submitted QC: 2019-07-05
• Study First Posted: 2019-07-09
• Study Start: 2020-11-17
• Primary Completion: 2022-11-30
• Study Completion: 2023-03-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MY01 Device	MY01 Continuous Compartmental Pressure Monitor	Device: MY01 Device Insertion of the MY01 device for up to 24 hours for continuous monitoring of compartment pressure

Primary Outcome Measures

Name	Time	Method
Ability to monitor in real time the continuous pressure readout from the compartment in remote locations via smartphone.	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.
The change in intracompartmental pressure.	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.
Clinical ease with which the MY01 device is able to be inserted into a compartment.	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.

Secondary Outcome Measures

Name	Time	Method
Adverse events associated with the use of the device.	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."
Pain at insertion site.	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 \[10=pain as bad as it can be\].

Trial Locations

Locations (5)

Foothills Medical Center; 🇨🇦 Calgary, Alberta, Canada

Halifax Infirmary; 🇨🇦 Halifax, Nova Scotia, Canada

Ottawa Civic Hospital; 🇨🇦 Ottawa, Ontario, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada