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

MY01 Inc.

Status

Completed

Conditions

Acute Compartment Syndrome

Treatments

Device: MY01 - Continuous Compartmental Pressure Monitor

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04016103

MY01 - QC - 01

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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