Real-Time Muscle Pressure Measurements in Patients at Risk for Acute Compartment Syndrome
NCT ID: NCT04671173
Last Updated: 2022-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
50 participants
INTERVENTIONAL
2022-03-18
2023-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of New Catheter & Pressure Monitor System to Help Prevent Compartment Syndrome From Developing in the Injured Leg
NCT00681616
Micro-EMG: A Novel Multi-electrode System for Intramuscular Imaging
NCT05713474
Comparison of Onset of Neuromuscular Blockade With Electromyographic and Acceleromyographic Monitoring
NCT05120999
Neuromuscular Monitoring in Children (6 Months - 2 Years) With Electromyography and Acceleromyography
NCT06409260
Clinical Evaluation of a Novel Neuromuscular Blockade Monitoring System
NCT04406740
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
2 - Patients treated in the PACS study previously funded by DOD and run by METRC.
3- Trauma Quality Programs Participant Use File (TQP) data.
Another goal is to assess the reoperation rates, for limb salvage or amputation among patients that undergo continuous monitoring of ICP using the MY01 monitor relative to a cohort of historical controls who did not receive continuous monitoring.
Primary Research Outcome
Assess the reoperation rate and number of operative procedures for all surgically managed acute compartment syndrome patients.
Secondary Research Outcomes
There are numerous outcomes that are related to the severity of ACS when it is diagnosed. This study will also assess our ability to identify the following secondary outcomes among a cohort of prospectively enrolled patients relative to a cohort of historical controls.
1. Comparison of grades of ACS to the historic controls.
2. Increased proportion of lower ACS outcome grades (Grades 1,2 as per grade)
3. Reduction in time to diagnosis of ACS
4. Improved short-term visual analog pain scores (VAS) for pain in affected limb
5. Reduction in inpatient days
6. Reduction in Skin Grafts
7. Reduction in Major Myectomy
8. Reduction in Anesthesia Time for patients undergoing fasciotomy
9. Clinical ease with which the new compartment pressure monitor was inserted into a muscle compartment, per satisfaction survey.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
United States Department of Defense
FED
Hennepin Healthcare Research Institute
OTHER
Vanderbilt University Medical Center
OTHER
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
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
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mitchell Bernstein, Dr
Role: PRINCIPAL_INVESTIGATOR
Research Institute of McGill University Health Centre (RI MUHC)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hennepin County Medical Center - Orthopaedic Research
Minneapolis, Minnesota, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Via AG, Oliva F, Spoliti M, Maffulli N. Acute compartment syndrome. Muscles Ligaments Tendons J. 2015 Mar 27;5(1):18-22. eCollection 2015 Jan-Mar.
Shadgan B, Menon M, Sanders D, Berry G, Martin C Jr, Duffy P, Stephen D, O'Brien PJ. Current thinking about acute compartment syndrome of the lower extremity. Can J Surg. 2010 Oct;53(5):329-34.
McQueen MM, Gaston P, Court-Brown CM. Acute compartment syndrome. Who is at risk? J Bone Joint Surg Br. 2000 Mar;82(2):200-3.
Collinge CA, Attum B, Lebus GF, Tornetta P 3rd, Obremskey W, Ahn J, Mirick G, Schmidt A, Spitler C, Coles C, Krause P; Orthopaedic Trauma Association's Evidence-based Quality and Value Committee. Acute Compartment Syndrome: An Expert Survey of Orthopaedic Trauma Association Members. J Orthop Trauma. 2018 May;32(5):e181-e184. doi: 10.1097/BOT.0000000000001128.
Schmidt AH, Bosse MJ, Frey KP, O'Toole RV, Stinner DJ, Scharfstein DO, Zipunnikov V, MacKenzie EJ; METRC. Predicting Acute Compartment Syndrome (PACS): The Role of Continuous Monitoring. J Orthop Trauma. 2017 Apr;31 Suppl 1:S40-S47. doi: 10.1097/BOT.0000000000000796.
Shadgan B, Pereira G, Menon M, Jafari S, Darlene Reid W, O'Brien PJ. Risk factors for acute compartment syndrome of the leg associated with tibial diaphyseal fractures in adults. J Orthop Traumatol. 2015 Sep;16(3):185-92. doi: 10.1007/s10195-014-0330-y. Epub 2014 Dec 28.
McQueen MM, Court-Brown CM. Compartment monitoring in tibial fractures. The pressure threshold for decompression. J Bone Joint Surg Br. 1996 Jan;78(1):99-104.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021-6655
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.