An interventional study of Shear wave elastography and microvascular flow imaging. in Lower Extremity Musculoskeletal Injury, sponsored by Oregon Health and Science University. Completed at 2 sites in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Diagnostic
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.
Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Shear wave elastography and microvascular flow imaging.
Device: Shear 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.
kPa
Tissue stiffness measured by shear wave elastography
Time frame: Within 48 hours
kPa
Tissue stiffness measured by shear wave elastography
Time frame: 5 days post injury (+/- 2 days)
kPa
Tissue stiffness measured by shear wave elastography
Time frame: 6 weeks post injury (+/- 1 week)
kPa
Tissue stiffness measured by shear wave elastography
Time frame: 12 weeks post injury (+/- 1 week)
kPa
Tissue stiffness measured by shear wave elastography
Time frame: 24 weeks post injury (+/- 1 week)
Presence of blood flow
Measured by microvascular flow imaging
Time frame: Within 48 hours
Presence of blood flow
Measured by microvascular flow imaging
Time frame: 5 days post injury (+/- 2 days)
Presence of blood flow
Measured by microvascular flow imaging
Time frame: 6 weeks post injury (+/- 1 week)
Presence of blood flow
Measured by microvascular flow imaging
Time frame: 12 weeks post injury (+/- 1 week)
Presence of blood flow
Measured by microvascular flow imaging
Time frame: 24 weeks post injury (+/- 1 week)
Plan to share: No
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Oregon Health and Science University