Lower Extremity Musculoskeletal Injury
Conditions
Keywords
Ultrasound, Shear wave elastography, Microvascular flow imaging
Brief summary
Primary Objective: To explore changes in shear wave elastography (SWE) and microvascular flow imaging (MFI) measurements from time of injury through the recovery phase of lower extremity musculoskeletal injuries to determine if a correlation exists with functional impairment. Secondary Objective: To develop a deep learning AI system for automated region of interest (ROI) determination for measurement of average SWE and MFI. Methodology: Eligible subjects with lower extremity injuries will undergo SWE and MFI measurements and complete the Lower Extremity Functional Scale questionnaire at each study visit. 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.
Interventions
DEVICEShear wave elastography and microvascular flow imaging.
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.
Sponsors
Oregon Health and Science University
University of Oregon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
All SWE and MFI images are evaluated for quality and analyzed by qualified study physicians that are blinded to the clinical data. The analysis includes but is not limited to reading images, identifying the regions of interest, and making measurements. Clinical data will then be reviewed to validate the clinical diagnosis.
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Subjects age 18 - 89 years; * Able to sign an informed consent document; * Suspected MSK injury of the lower extremity (i.e. hamstring injuries and soft tissue injuries involving the ankle).
Exclusion criteria
* Prior fasciotomy of same limb; * Hemodialysis grafts of involved extremity; * Extremity wounds preventing ultrasound imaging.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| kPa | Within 48 hours | Tissue stiffness measured by shear wave elastography |
| Presence of blood flow | Within 48 hours | Measured by microvascular flow imaging |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKenton Gregory, MD
Oregon Health and Science University
Outcome results
None listed