Clinical trial NCT05608824: Evaluation of Lower Extremity Athletic Injuries and Response to Treatment Using SWE and MFI
Official title: Evaluation of Lower Extremity Athletic Injuries and Response to Treatment Using Shear Wave Elastography and Micro-vascular Flow Imaging
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lower Extremity Musculoskeletal Injury
Keywords: Ultrasound
Shear wave elastography
Microvascular flow imaging
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: University of Oregon
First posted: 2022-11-08
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: kPa
timeFrame: Within 48 hours
measure: kPa
timeFrame: 5 days post injury (+/- 2 days)
measure: kPa
timeFrame: 6 weeks post injury (+/- 1 week)
measure: kPa
timeFrame: 12 weeks post injury (+/- 1 week)
measure: kPa
timeFrame: 24 weeks post injury (+/- 1 week)
measure: Presence of blood flow
timeFrame: Within 48 hours
measure: Presence of blood flow
timeFrame: 5 days post injury (+/- 2 days)
measure: Presence of blood flow
timeFrame: 6 weeks post injury (+/- 1 week)
measure: Presence of blood flow
timeFrame: 12 weeks post injury (+/- 1 week)
measure: Presence of blood flow
timeFrame: 24 weeks post injury (+/- 1 week)
Secondary outcomes:
Other outcomes:
Locations:
city: Eugene
country: United States
facility: University of Oregon
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Kenton Gregory, MD
role: PRINCIPAL_INVESTIGATOR
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