Recruiting

Observational Study

Sponsor:

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

Code:

NCT04671173

Conditions

Acute Compartment Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Measurement of the Intra-Compartmental Pressure with the MY01 device

Study Details

Brief summary:

The purpose of this trial is to conduct a pilot study that will aid in the design of an evaluation of the clinical benefit of MY01, an FDA cleared device, that allows continuous monitoring of intracompartmental muscle pressure in patients at risk for developing acute compartment syndrome. MY01 has previously been successfully tested on animal and Human cadaver Acute Compartment Syndrome models within the RI MUHC through Department of Defense research Grant (Combat Casualty Care Research Program (CCCRP). This trial is supported by the same grant, as the next phase of the overall project.

This is a multi-center, non-randomized, historically controlled, prospective trial of the MY01 device. A cohort of 50 participants will be prospectively enrolled with two weeks follow up to document clinical benefit of the device. Results from this study will be used to inform the design of a larger study designed to demonstrate the clinical benefit of the MY01 device in the early diagnosis of ACS.

The role of each organisation within the trial are detailed below:

  • Research Institute of McGill University Health Centre (RI MUHC): study coordination and data analysis (no recruitment activity will take place in the MUHC).
  • Hennepin Healthcare: participants recruitment
  • Vanderbilt University Medical Centre: participants recruitment

Conditions

Acute Compartment Syndrome

Study ID

NCT04671173

Start date

Mar 18, 2022

Status verified date

Apr, 2022

Completion date

Mar 31, 2023

Anticipated

Primary completion date

Feb 15, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Direct admission to hospital from scene of injury, or if transferred, admitted no more than 12 hours from injury
  • High-energy fracture of the tibial plateau (bicondylar or medial fracture - dislocation)
  • High energy displaced tibial diaphysis (highly comminuted or segmental fracture, or proximal third of tibia (e.g. GSW to the proximal fibula)) that is felt by the surgeon to have a likelihood of elevated ICP and risk of ACS.

Exclusion Criteria:

1. Frankly contaminated or infected wounds or fractures.
2. Clinical suspicion of acute compartment syndrome requiring urgent fasciotomy at time of presentation to study center.
3. Monitoring could not be initiated within 12 hours of presentation
4. Acute or pre-existing neuropathy in the study limb.
5. Patient is pregnant
6. Patient is a prisoner/incarcerated

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Experimental arm (only one arm)

Only one arm, the participants will all received the device to measure Intra-compartmental pressure after consenting to study participation.

Interventions

Measurement of the Intra-Compartmental Pressure with the MY01 device

All Participants will be monitored for clinical signs of symptoms of ACS, including the 7 Ps at a minimum of every 4-6 hours.

The Intra-Compartmental Pressure of the anterior compartment of the leg will be monitored with the MY01 device. The device should be inserted five centimeters (5 cm) from the fracture, if possible, in the muscle belly. The affected limb will then be splinted in a standard U-slab with no pressure on the monitored device.

Primary outcome measure

  • Reoperation rate (number of re-operation) [ Time Frame: 6 weeks ]
  • Number of operative procedures [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Anne Mathiot

5149341934anne.mathiot@muhc.mcgill.ca

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Karen M Trochez

615-936-0347karen.m.trochez@vumc.org

Principal Investigator:

William T Obremskey, MD

More Information

Sponsor

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

Last update posted

Apr 12, 2022

Last verified

Apr, 2022

Keywords

  • Acute compartment syndrome, minimally invasive, sensor, intracompartmental muscle pressure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2022-04-12.