Musculoskeletal Ultrasound clinical trials

Comparison of Ultrasound and X-ray as Screening Tests for Diagnosis of Lower Extremity Stress Fracture.

Hypothesis: Diagnostic ultrasound is an appropriate screening test for acute stress fracture in the lower extremity and is superior to x-ray. Primary Aims: To determine if diagnostic ultrasound is an appropriate screening test with high sensitivity and at least moderate specificity for the identification of acute stress fractures of the lower extremity. Methods: In this double-blind, prospective clinical study, subjects (age 14 years and up) suspected to have an acute stress fracture of the lower extremity will be recruited from the Sports Medicine clinic at the University of Virginia Health System in the Department of Physical Medicine & Rehabilitation. Subjects will undergo the traditional diagnostic algorithm including screening x-ray as part of standard care. Subjects will then undergo a confirmatory MRI of the region of concern if the initial x-ray was negative as part of standard care. Any subject who does not require an MRI for clinical purposes (initial X-ray was positive) will have one completed for research purposes. All subjects will also undergo diagnostic ultrasound performed by a separate, blinded physician competent in diagnostic ultrasound for research purposes. A statistician in the Department of Public Health at the University of Virginia will be performing statistical analysis during data analysis. Findings will be analyzed using a McNemar chi-square test to evaluate for significant differences between the sensitivities of ultrasound and x-ray.