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

Not Applicable

Active, not recruiting

• Conditions: Lower Extremity Musculoskeletal Injury
• Interventions: Device: Shear wave elastography and microvascular flow imaging.

• Registration Number: NCT05608824
• Lead Sponsor: Oregon Health and Science University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2022-11-02
• Study First Posted: 2022-11-08
• Study Start: 2023-10-01
• Primary Completion: 2025-02-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Musculoskeletal injury	Shear wave elastography and microvascular flow imaging.	Shear wave elastography and microvascular flow imaging.

Primary Outcome Measures

Name	Time	Method
kPa	24 weeks post injury (+/- 1 week)	Tissue stiffness measured by shear wave elastography
Presence of blood flow	24 weeks post injury (+/- 1 week)	Measured by microvascular flow imaging

Trial Locations

Locations (2)

University of Oregon; 🇺🇸 Eugene, Oregon, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States