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

Lower Extremity Musculoskeletal Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05608824
• Other study ID #: 00000608
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Oregon Health and Science University
• Contact: Natalie Pettigrew, DPT
• Phone: 858-342-4191
• Email: terwilln[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Athletic Injuries
• Lower Extremity Musculoskeletal Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	University of Oregon	Eugene	Oregon
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	University of Oregon

Country where clinical trial is conducted

United States, 

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* Note: There are 31 references in all — Click here to view all references

Outcome

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