Evaluation of Lower Extremity Athletic Injuries and Response to Treatment Using SWE and MFI

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Lower Extremity Athletic Injuries and Response to Treatment Using Shear Wave Elastography and Micro-vascular Flow Imaging

Conditions
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Lower Extremity Musculoskeletal Injury

Intervention / Treatment
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* Device: Shear wave elastography and microvascular flow imaging.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Musculoskeletal injury<br>Shear wave elastography and microvascular flow imaging. | Device: Shear wave elastography and microvascular flow imaging.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| kPa | Tissue stiffness measured by shear wave elastography | Within 48 hours | 
| kPa | Tissue stiffness measured by shear wave elastography | 5 days post injury (+/- 2 days) | 
| kPa | Tissue stiffness measured by shear wave elastography | 6 weeks post injury (+/- 1 week) | 
| kPa | Tissue stiffness measured by shear wave elastography | 12 weeks post injury (+/- 1 week) | 
| kPa | Tissue stiffness measured by shear wave elastography | 24 weeks post injury (+/- 1 week) | 
| Presence of blood flow | Measured by microvascular flow imaging | Within 48 hours | 
| Presence of blood flow | Measured by microvascular flow imaging | 5 days post injury (+/- 2 days) | 
| Presence of blood flow | Measured by microvascular flow imaging | 6 weeks post injury (+/- 1 week) | 
| Presence of blood flow | Measured by microvascular flow imaging | 12 weeks post injury (+/- 1 week) | 
| Presence of blood flow | Measured by microvascular flow imaging | 24 weeks post injury (+/- 1 week) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasound, Shear wave elastography, Microvascular flow imaging