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NCT05608824
Evaluation of Lower Extremity Athletic Injuries and Response to Treatment Using SWE and MFI
Conditions: Lower Extremity Musculoskeletal Injury, Compartment Syndrome of Leg
Sex: All
Ages: 18 Years – 89 Years
Phase: NA
Enrollment: 80
Sponsor: Oregon Health and Science University
Summary
Primary Objective:Conduct a study of patients being evaluated for lower extremity injuries, including compartment syndrome (CS) injury using shear wave elastography (SWE) measurements of tissue stiffness and microvascular flow imaging (MFI) to determine if a correlation exists with a CS clinical diagnosis.Secondary Objective:To explore changes in SWE and MFI measurements from time of injury through the recovery phase of lower extremity musculoskeletal injuries.Methodology:Eligible subjects with lower extremity injuries, including subjects suspected of having compartment syndrome will undergo SWE and MFI measurements.
Clinical data related to the evaluation of the injury acquired during standard medical care of the injury will be collected from the patients' medical record such as CT or MRI scans, X-rays, physical exams and tests as well as laboratory measurements.
Subjects will undergo serial SWE and MFI imaging throughout their rehabilitation episode of care to assess changes over time, status in rehabilitation and comparison to the contralateral extremity.
Eligibility Criteria
Inclusion Criteria:Subjects age 18 - 89 years;Able to sign an informed consent document;Suspected compartment syndrome or musculoskeletal injury of the lower extremity (i.e.
hamstring injuries and soft tissue injuries involving the ankle).Exclusion Criteria:Prior fasciotomy of same limb;Diagnosis of chronic extremity vascular disease, acute uncorrected compromise of proximal vascular perfusion, hemodialysis grafts of involved and contralateral extremity;Extremity wounds preventing ultrasound imaging.
Source: ClinicalTrials.gov (NCT05608824). StuddyBuddy aggregates publicly available trial information.