Clinical trial NCT04012723: Clinical Trial of a New Device for Real-Time Muscle Pressure Measurements in Patients at Risk for Acute Compartment Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Compartment Syndrome Traumatic Lower Extremity
Compartment Syndrome Traumatic Upper Extremity
Keywords: Acute Compartment Syndrome
Lead sponsor: MY01 Inc.
Sponsor class: INDUSTRY
Collaborators: name: Nova Scotia Health Authority
First posted: 2019-07-09
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical ease with which the MY01 device is able to be inserted into a compartment.
timeFrame: 24-48 hours following device insertion.
measure: Ability to monitor in real time the continuous pressure readout from the compartment in remote locations via smartphone.
timeFrame: 24-48 hours following device insertion.
measure: The change in intracompartmental pressure.
timeFrame: 24-48 hours following device insertion.
Secondary outcomes:
measure: Adverse events associated with the use of the device.
timeFrame: 24-48 hours following device insertion, and again during the final follow-up of the participant approximately two weeks after treatment.
measure: Pain at insertion site.
timeFrame: 24-48 hours following device insertion.
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Center
state: Alberta
city: Halifax
country: Canada
facility: Halifax Infirmary
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Civic Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Orthopaedic Surgeon, Nova Scotia Health Authority
name: Ross Leighton, MD
role: PRINCIPAL_INVESTIGATOR
References: