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| Name | Class |
|---|---|
| University of Oregon | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Musculoskeletal injury | Experimental | Shear wave elastography and microvascular flow imaging. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shear wave elastography and microvascular flow imaging. | Device | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenton Gregory, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oregon | Eugene | Oregon | 97403 | United States | ||
| Oregon Health & Science University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20370999 | Background | Belmont PJ, Schoenfeld AJ, Goodman G. Epidemiology of combat wounds in Operation Iraqi Freedom and Operation Enduring Freedom: orthopaedic burden of disease. J Surg Orthop Adv. 2010 Spring;19(1):2-7. | |
| 18376168 | Background | Kelly JF, Ritenour AE, McLaughlin DF, Bagg KA, Apodaca AN, Mallak CT, Pearse L, Lawnick MM, Champion HR, Wade CE, Holcomb JB. Injury severity and causes of death from Operation Iraqi Freedom and Operation Enduring Freedom: 2003-2004 versus 2006. J Trauma. 2008 Feb;64(2 Suppl):S21-6; discussion S26-7. doi: 10.1097/TA.0b013e318160b9fb. |
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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.
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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) |
| Portland |
| Oregon |
| 97239 |
| United States |
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