NCT05608824

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lower Extremity Musculoskeletal Injury

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-02-28
• Completion: 2025-09-30
• First posted: 2022-11-08
• Last updated: 2026-04-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study