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

December 13, 2023 updated by: Kenton W. Gregory, Oregon Health and Science University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Oregon
      • Eugene, Oregon, United States, 97403
        • Recruiting
        • University of Oregon
        • Contact:
        • Principal Investigator:
          • Mike Hahn, PhD
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
        • Principal Investigator:
          • Kenton Gregory, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Musculoskeletal injury
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

University of Oregon

Investigators

  • Principal Investigator: Kenton Gregory, MD, Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

October 20, 2022

First Submitted That Met QC Criteria

November 2, 2022

First Posted (Actual)

November 8, 2022

Study Record Updates

Last Update Posted (Actual)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00000608

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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