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

NCT05608824 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-04-07

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of Oregon

    collaborator OTHER

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Kenton Gregory, MD · Oregon Health and Science University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2025-02-28
Completion
2025-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05608824 on ClinicalTrials.gov