Accuro XV Ultrasound Imaging System for BoneEnhance and Fracture Detection Algorithms

• Accuro XV Ultrasound Imaging System (Device): The Accuro XV Ultrasound Imaging System is a cart-based ultrasound imaging device designed to acquire volumetric images of bone and soft tissue anatomy of the distal extremities. In this study, participants will undergo additional Accuro XV imaging following standard-of-care imaging for a distal extremity injury. The imaging procedure includes acquisition of multiple views of the injured anatomy using ultrasound technology and advanced image-processing methods to generate three-dimensional representations of bone and soft tissue structures. Images collected during the study will be used to evaluate device feasibility, safety, image quality, and to support the development and testing of future algorithms. Accuro XV imaging results will not be used for clinical decision-making.

Primary outcomes

• Accuro XV Image Quality Assessment [From Accuro XV image acquisition through completion of retrospective image-quality assessment, up to 48 months.]: Retrospective assessment of acquired Accuro XV images for artifacts and other visual imperfections to evaluate image quality and suitability for subsequent analysis and algorithm development.
• Feasibility of Accuro XV Imaging Acquisition [During and immediately after Accuro XV imaging on the day of enrollment.]: Successful acquisition of Accuro XV images of the target distal extremity anatomy according to study procedures; site PIs, AIs, and other Accuro XV users will be queried on how Accuro XV fits into their clinical workflow in terms of usability, maneuverablity, reliability and more. Surveys to be developed.
• Participant Comfort During Imaging [Immediately after Accuro XV imaging on the day of enrollment.]: Participant-reported comfort and pain scores associated with Accuro XV imaging collected through the participant questionnaire. Participants completed a questionnaire assessing pain associated with both standard-of-care imaging and Accuro XV scanning. Specifically, participants were asked to rate their pain (1) before standard-of-care imaging, (2) during standard-of-care imaging, (3) before Accuro XV scans, and (4) during Accuro XV scans. Pain was measured using an 11-point Likert-type scale ranging from 0 ("none") to 10 ("severe"), with higher scores indicating greater pain.

Secondary outcomes

• Likert-Type Scale Participant-reported Imaging Modality Preference [Immediately after Accuro XV imaging on the day of enrollment.]: Participant-reported preference between Accuro XV imaging and standard-of-care imaging modalities. Participants completed a questionnaire assessing satisfaction with both standard-of-care imaging and Accuro XV scanning. Participants were asked to rate their satisfaction with each imaging modality on an 11-point Likert-type scale ranging from 0 ("not satisfied at all") to 10 ("very satisfied"), with higher scores indicating greater satisfaction. In addition, participants were asked to indicate their preferred imaging modality by selecting either Accuro XV, standard-of-care imaging, or no preference.

Sex: All, ages: 5 Years to any

Sites are currently on two different protocol Revisions.

Inclusion Criteria

* Age greater than or equal to 5 years.
* The patient is presenting for distal limb injury of the wrist, forearm, ankle, or lower leg.
* The patient is scheduled to receive an X-ray that includes a view of the ankle, lower leg, wrist, and/or forearm or any patient that received an X-ray accessible by the study team for the studied anatomy in the past 48 hours.
* English and/or Spanish speaking.

Exclusion Criteria

* An open fracture, grossly open wound, or severe angulation of the limb is present.
* Patients for whom the site investigator feels that study participation could prohibit or impair ongoing medical care.
* Known allergy to ultrasound couplants.