Acute Compartment Syndrome Clinical Trial
Official title:
Real-Time Muscle Pressure Measurements in Patients at Risk for Acute Compartment Syndrome: A Prospective Cohort Study With Historical Control
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
Status | Recruiting |
Enrollment | 50 |
Est. completion date | March 31, 2023 |
Est. primary completion date | February 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Hennepin County Medical Center - Orthopaedic Research | Minneapolis | Minnesota |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
McGill University Health Centre/Research Institute of the McGill University Health Centre | Hennepin Healthcare Research Institute, United States Department of Defense, Vanderbilt University Medical Center |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reoperation rate (number of re-operation) | Assess the reoperation rate for all surgically managed acute compartment syndrome patients following the original fasciotomy. | 6 weeks | |
Primary | Number of operative procedures | Number of operative procedures for all surgically managed acute compartment syndrome patients. | 6 weeks | |
Secondary | Comparison of grades of ACS to the historic controls. | Comparison of grades of ACS to the historic controls. | 6 weeks | |
Secondary | Changed proportion of lower ACS outcome grades | changed proportion of lower ACS outcome grades (Grades 1,2 as per grade) | 6 weeks | |
Secondary | Change in time to diagnosis of ACS | 6 weeks | ||
Secondary | Change in short-term visual analog pain scores (VAS) for pain in affected limb | 6 weeks | ||
Secondary | Change in inpatient days | 6 weeks | ||
Secondary | Change in Skin Grafts number | 6 weeks | ||
Secondary | change in Major Myectomy number | 6 weeks | ||
Secondary | change in Anesthesia Time for patients undergoing fasciotomy | 6 weeks | ||
Secondary | Clinician satisfaction survey (percentage) | Clinical ease with which the new compartment pressure monitor was inserted into a muscle compartment, per satisfaction survey. | 6 weeks |
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