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

NCT05608824 | Active Not Recruiting

• 1 other identifier: 00000608
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Ultrasound; Shear wave elastography; Microvascular flow imaging

Outcome Measures

Primary Outcomes (10)

• 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

  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)

Study Arms (1)

Musculoskeletal injury

EXPERIMENTAL

Shear wave elastography and microvascular flow imaging.

Device: Shear wave elastography and microvascular flow imaging.

Interventions

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.

Musculoskeletal injury

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Prior fasciotomy of same limb;
• Hemodialysis grafts of involved extremity;
• Extremity wounds preventing ultrasound imaging.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• University of Oregon: collaborator

Study Sites (2)

University of Oregon

Eugene, Oregon, 97403, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

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Study Officials

• Kenton Gregory, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: November 8, 2022
• Study Start: October 1, 2023
• Primary Completion: February 28, 2025
• Study Completion: August 31, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)