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

NCT03116360 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2017-04-17

No results posted yet for this study

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.

Conditions

  • Stress Fracture
  • Ultrasound Therapy
  • Musculoskeletal Ultrasound

Interventions

DIAGNOSTIC_TEST

Diagnostic Ultrasound

The physician performing the ultrasound will be blinded to the results of the x-ray and MRI. The physician performing the ultrasound will be informed of the bone in question (ex. Tibia) and will be able to perform a focused history and exam. The bone in which acute stress fracture is suspected will then be scanned throughout its length in two orthogonal views. The criteria for diagnosing acute stress fracture on ultrasound include displaying 2 out of 3 of the following: hypoechoic periosteal elevation of cortical bone, visible cortical disruption, hyperemia surrounding the periosteal lesion on power Doppler. The ultrasound physician will then be asked to make a determination whether the ultrasound study is positive for acute stress fracture or negative/indeterminate.

Sponsors & Collaborators

  • NBA&GE Orthopedics and Sports Medicine Collaboration

    collaborator UNKNOWN

  • University of Virginia

    lead OTHER

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-31
Primary Completion
2018-02-28
Completion
2018-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03116360 on ClinicalTrials.gov