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

NCT04016103 | Completed

• 1 other identifier: MY01 - QC - 01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Acute Compartment Syndrome

Keywords

Acute Compartment Syndrome

Outcome Measures

Primary Outcomes (3)

• Clinical ease with which the new compartment pressure monitor was inserted into 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 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.

  24-48 hours following device insertion

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

  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 \[No\].

  24-48 hours following device insertion

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

  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, and again during the final follow-up of the participant approximately two weeks after treatment

Secondary Outcomes (2)

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

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

• Short-term outcomes of the patient following continuous pressure monitoring

  24-48 hours following device insertion.

Study Arms (1)

MY01 Device

EXPERIMENTAL

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

Device: MY01 - Continuous Compartmental Pressure Monitor

Interventions

MY01 - Continuous Compartmental Pressure Monitor DEVICE

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

MY01 Device

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MY01 Inc.: lead
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator
• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: collaborator

Study Sites (2)

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Hôpital du Sacré-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

Study Officials

• Mitchell Bernstein, MD

  Staff Surgeon, Orthopaedic Trauma & Limb Deformity, Montreal General Hospital | Assistant Professor Department of Surgery and Pediatric Surgery McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: July 11, 2019
• Study Start: July 17, 2020
• Primary Completion: February 1, 2023
• Study Completion: June 30, 2023
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)