Real-Time Muscle Pressure Measurements in Patients at Risk for Acute Compartment Syndrome

NCT04671173 | Unknown FDA Device

• 1 other identifier: 2021-6655
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Reoperation rate (number of re-operation)

  Assess the reoperation rate for all surgically managed acute compartment syndrome patients following the original fasciotomy.

  6 weeks

• Number of operative procedures

  Number of operative procedures for all surgically managed acute compartment syndrome patients.

  6 weeks

Secondary Outcomes (9)

• Comparison of grades of ACS to the historic controls.

  6 weeks

• Changed proportion of lower ACS outcome grades

  6 weeks

• Change in time to diagnosis of ACS

  6 weeks

• Change in short-term visual analog pain scores (VAS) for pain in affected limb

  6 weeks

• Change in inpatient days

  6 weeks

Study Arms (1)

Experimental arm (only one arm)

EXPERIMENTAL

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

Device: Measurement of the Intra-Compartmental Pressure with the MY01 device

Interventions

Measurement of the Intra-Compartmental Pressure with the MY01 device 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.

Experimental arm (only one arm)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• United States Department of Defense: collaborator
• Hennepin Healthcare Research Institute: collaborator
• Vanderbilt University Medical Center: collaborator

Study Sites (2)

Hennepin County Medical Center - Orthopaedic Research

Minneapolis, Minnesota, 55414, United States

NOT YET RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Related Publications (7)

• 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.

  PMID: 25878982 BACKGROUND

• 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.

  PMID: 20858378 BACKGROUND

• 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.

  PMID: 10755426 BACKGROUND

• 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.

  PMID: 29432322 BACKGROUND

• 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.

  PMID: 28323801 BACKGROUND

• 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.

  PMID: 25543232 BACKGROUND

• 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.

  PMID: 8898137 BACKGROUND

Study Officials

• Mitchell Bernstein, Dr

  Research Institute of McGill University Health Centre (RI MUHC)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Mathiot

CONTACT

5149341934; anne.mathiot@muhc.mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Departments of Surgery & Pediatric Surgery, McGill University and Head, Pediatric 0Orthopaedic Trauma, Montreal Children's Hospital Orthopaedic Trauma & Limb Deformity Surgery

Model Details: multi-center, non-randomized, historically controlled, prospective pilot trial of the MY01 device.

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 17, 2020
• Study Start: March 18, 2022
• Primary Completion: February 15, 2023
• Study Completion: March 31, 2023
• Last Updated: April 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)