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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief Summary:

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.

Detailed Summary:

Primary aims: To determine if diagnostic ultrasound is an appropriate screening test (high sensitivity and at least moderate specificity) and non-inferior to x-ray for diagnosis of acute stress fracture of the lower extremity.

Secondary Aims: To determine what grade(s) of acute stress fracture that x-ray and ultrasound are capable of detecting reliably and accurately.

Population: Subjects will be recruited from the Sports Medicine clinic at the University of Virginia Health System in the Department of Physical Medicine and Rehabilitation. Subjects will have suspected acute stress fracture of the lower extremity and will be age 14 years and older. Anatomic locations included in this study are as follows: all bones of the foot and ankle, tibia, fibula, and femoral shaft. Patients with suspected stress fracture of the femoral neck will be excluded due to the difficulty of appropriate ultrasound evaluation secondary to depth as well as the potential for significant morbidity if not diagnosed properly. We estimate that the Sports Medicine clinic diagnoses approximately 12 acute stress fractures per month per physician amongst the three physician's clinics involved in this study. Therefore, our anticipated number of subjects over a 6 month period will be at least 216 patients.

Design: In this double-blind , prospective clinical study, subjects suspected to have an acute stress fracture of the lower extremity will be recruited from Sports Medicine Clinic (conducted by two physicians boarded in Physical Medicine and Rehabilitation and one physician board in Family Medicine and all boarded in Sports Medicine). When patients present to one of three physicians in Sports Medicine Clinic with a suspected acute stress fracture of the lower extremity, they will be offered the opportunity
Sponsor: University of Virginia

Current Primary Outcome: Non-inferiority comparison of diagnostic ultrasound to x-ray [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Comparing ultrasound and x-ray across severity of stress fracture [ Time Frame: 6 months ]

Original Secondary Outcome: Same as current

Information By: University of Virginia

Dates:
Date Received: April 7, 2017
Date Started: August 2017
Date Completion: May 2018
Last Updated: April 11, 2017
Last Verified: April 2017