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

NCT ID: NCT04016103

Last Updated: 2024-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-17
• Study Completion Date: 2023-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

MY01 Device

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

Group Type: EXPERIMENTAL

MY01 - Continuous Compartmental Pressure Monitor

Intervention Type: DEVICE

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

Interventions

MY01 - Continuous Compartmental Pressure Monitor

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: collaborator

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

OTHER

Sponsor Role: collaborator

MY01 Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mitchell Bernstein, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Montreal General Hospital

Montreal, Quebec, Canada

Hôpital du Sacré-Coeur de Montreal

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

MY01 - QC - 01

Identifier Type: -

Identifier Source: org_study_id