Real-Time Muscle Pressure Measurements in Patients at Risk for Acute Compartment Syndrome: A Prospective Cohort Study With Historical Control
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 50
- Locations
- 4
- Primary Endpoint
- Reoperation rate (number of re-operation)
Study Overview
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
Detailed Description
Research Plan
The purpose of this trial is to conduct a pilot study that will inform the design of a trial to evaluate the clinical benefit of MY01, a FDA cleared device that allows continuous monitoring of intracompartmental muscle pressure in patients at risk for developing acute compartment syndrome. The MY01 device is a digitally connected device with a companion mobile app designed to continuously monitor intracompartmental pressure, outputting the results to the mobile app, where clinicians can track the pressure in real time.
There are several goals of this study. Fifty patients with high-energy injuries to the proximal leg and tibial shaft will be prospectively studied and compared to a cohort of historical controls. We want to evaluate the feasibility of collecting data related to the diagnosis of ACS and the measurement of its associated complications. We will also use this data to attempt to assign a modified Boyers grade to a cohort of prospectively enrolled patients and historical controls. Clinical validation of the modified Boyers grade will represent a large step forward in compartment syndrome research, since it will bring an objective assessment of severity to the diagnosis of acute compartment syndrome.
These control patients are to be obtained from several cohorts of patients:
1- Data collected for 3 Retrospective studies on tibial fractures and dislocations resulting in acute compartment syndrome completed in Montreal General Hospital, Vanderbilt University Health Centre and Hennepin Healthcare. The data received from those existing studies will be de-identified.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Frankly contaminated or infected wounds or fractures.
- •Clinical suspicion of acute compartment syndrome requiring urgent fasciotomy at time of presentation to study center.
- •Monitoring could not be initiated within 12 hours of presentation
- •Acute or pre-existing neuropathy in the study limb.
- •Patient is pregnant
- •Patient is a prisoner/incarcerated
Outcomes
Primary Outcomes
Reoperation rate (number of re-operation)
Time Frame: 6 weeks
Assess the reoperation rate for all surgically managed acute compartment syndrome patients following the original fasciotomy.
Number of operative procedures
Time Frame: 6 weeks
Number of operative procedures for all surgically managed acute compartment syndrome patients.
Secondary Outcomes
- Change in inpatient days(6 weeks)
- Change in Skin Grafts number(6 weeks)
- change in Anesthesia Time for patients undergoing fasciotomy(6 weeks)
- Changed proportion of lower ACS outcome grades(6 weeks)
- Change in time to diagnosis of ACS(6 weeks)
- Comparison of grades of ACS to the historic controls.(6 weeks)
- Change in short-term visual analog pain scores (VAS) for pain in affected limb(6 weeks)
- change in Major Myectomy number(6 weeks)
- Clinician satisfaction survey (percentage)(6 weeks)
Investigators
Mitchell Bernstein
Assistant Professor, Departments of Surgery & Pediatric Surgery, McGill University and Head, Pediatric 0Orthopaedic Trauma, Montreal Children's Hospital Orthopaedic Trauma & Limb Deformity Surgery
McGill University Health Centre/Research Institute of the McGill University Health Centre