Stress Fracture Clinical Trial
Official title:
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.
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 to enroll. Subjects
will be required to have already undergone the initial step of the traditional diagnostic
algorithm with x-ray of the suspicious region on the day of enrollment. All subjects will
then be scheduled to undergo diagnostic ultrasound at a separate appointment with ultrasound
procedure performed by a blinded clinical physician boarded in Physical Medicine and
Rehabilitation, competent in performing and reading diagnostic ultrasound. All patients will
then undergo a confirmatory MRI of the region of concern. Subject recruitment and data
collection are expected to be completed over a six-month period. A statistician in the
Department of Public Health at the University of Virginia will be performing statistical
analysis. We plan to analyze findings using a McNemar chi-square test to evaluate for
significant differences between the sensitivities of ultrasound and x-ray in diagnosing
acute stress fracture of the lower extremity. All x-ray and MRI obtained for this study will
be read by a Radiologist board certified in Musculoskeletal Radiology.
Diagnostic ultrasound performance: 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.
Statistical Analysis/Power Analysis: Sensitivity and specificity of diagnostic ultrasound
and x-ray were calculated. MRI was used as the gold standard confirmatory test. Positive
predictive value and Negative predictive value were also calculated for comparison. A priori
power analysis determined a sample size of 186 was needed to obtain a power of 80%. The
primary aim will be analyzed using a bootstrap test to compare the x-ray sensitivity to the
ultrasound sensitivity. In order to account for the paired nature of the data, the bootstrap
sampling will be at the subject level and will draw pairs with the x-ray and ultrasound
outcomes associated with individual subjects. A statistician from the University of Virginia
was hired for all statistical calculations.
Subject Recruitment: Subjects presenting to the Sports Medicine clinic with suspected acute
stress fracture of the lower extremity on initial presentation will be offered
participation. Participation includes an additional clinic visit with a separate physician
to perform a diagnostic ultrasound of the area of concern in addition to the standard work
up they would receive for their presenting complaint. Informed consent was obtained at the
time of study enrollment. Subjective will be offered ultrasound evaluation as well as follow
up confirmatory MRI. The cost of follow up MRI is included in the study to prevent selection
bias based on insurance coverage for MRI. The costs associated with the additional clinic
visit for diagnostic ultrasound is also included in the study budget.
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