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

NCT03116360 | Unknown

• 1 other identifier: 19779
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stress Fracture; Ultrasound Therapy; Musculoskeletal Ultrasound

Outcome Measures

Primary Outcomes (1)

• Non-inferiority comparison of diagnostic ultrasound to x-ray

  Comparison of sensitivity between diagnostic ultrasound and x-ray for acute stress fractures of the lower extremity.

  6 months

Secondary Outcomes (1)

• Comparing ultrasound and x-ray across severity of stress fracture

  6 months

Study Arms (1)

Single Arm

EXPERIMENTAL

All patients will undergo traditional xray screening as well as experimental screening with diagnostic ultrasound. All subjects will undergo confirmatory MRI.

Diagnostic Test: Diagnostic Ultrasound

Interventions

Diagnostic Ultrasound DIAGNOSTIC_TEST

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.

Single Arm

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• age 14 years and up
• suspected acute stress fracture of the lower extremity
• symptoms \< 4 weeks
• x-ray ordered by clinician to which subjects originally present with suspected stress fracture

You may not qualify if:

• age \< 14
• unable to provide consent
• unable to undergo MRI (implantable pacemaker or other device not compatible for MRI)
• previous diagnosis of acute stress fracture in the location of interest
• previous XR or MRI obtained at an outside clinic/facility prior to presentation
• previously implanted hardware (ex. orthopedic screws or plates) at location of interest
• symptoms \> 8 weeks
• depth from skin surface to bone surface that exceeds the capability of ultrasound for visualization
• Pregnant (self-reported)
• Subject is known to all clinicians who would be completing the diagnostic ultrasound component of the study
• Open wound at site of suspected stress fracture

Sponsors & Collaborators

• University of Virginia: lead
• NBA&GE Orthopedics and Sports Medicine Collaboration: collaborator

Related Publications (16)

• Khy V, Wyssa B, Bianchi S. Bilateral stress fracture of the tibia diagnosed by ultrasound. A case report. J Ultrasound. 2012 Jun;15(2):130-4. doi: 10.1016/j.jus.2011.09.002. Epub 2011 Sep 16.

  PMID: 23396635 BACKGROUND

• Nitz AJ, Scoville CR. Use of ultrasound in early detection of stress fractures of the medial tibial plateau. Mil Med. 1980 Dec;145(12):844-6. No abstract available.

  PMID: 6779231 BACKGROUND

• Uri Farkash et al. Ultrasonography as a diagnostic modality of tibial stress fractures. J Musculoskelet Res. 11, 55 (2008).

  BACKGROUND

• Romani WA, Perrin DH, Dussault RG, Ball DW, Kahler DM. Identification of tibial stress fractures using therapeutic continuous ultrasound. J Orthop Sports Phys Ther. 2000 Aug;30(8):444-52. doi: 10.2519/jospt.2000.30.8.444.

  PMID: 10949501 BACKGROUND

• Papalada A, Malliaropoulos N, Tsitas K, Kiritsi O, Padhiar N, Del Buono A, Maffulli N. Ultrasound as a primary evaluation tool of bone stress injuries in elite track and field athletes. Am J Sports Med. 2012 Apr;40(4):915-9. doi: 10.1177/0363546512437334. Epub 2012 Feb 23.

  PMID: 22366519 BACKGROUND

• Boam WD, Miser WF, Yuill SC, Delaplain CB, Gayle EL, MacDonald DC. Comparison of ultrasound examination with bone scintiscan in the diagnosis of stress fractures. J Am Board Fam Pract. 1996 Nov-Dec;9(6):414-7.

  PMID: 8923399 BACKGROUND

• Banal F, Gandjbakhch F, Foltz V, Goldcher A, Etchepare F, Rozenberg S, Koeger AC, Bourgeois P, Fautrel B. Sensitivity and specificity of ultrasonography in early diagnosis of metatarsal bone stress fractures: a pilot study of 37 patients. J Rheumatol. 2009 Aug;36(8):1715-9. doi: 10.3899/jrheum.080657. Epub 2009 Jun 30.

  PMID: 19567620 BACKGROUND

• Battaglia PJ, Kaeser MA, Kettner NW. Diagnosis and serial sonography of a proximal fifth metatarsal stress fracture. J Chiropr Med. 2013 Sep;12(3):196-200. doi: 10.1016/j.jcm.2013.10.002.

  PMID: 24396321 BACKGROUND

• Wright AA, Hegedus EJ, Lenchik L, Kuhn KJ, Santiago L, Smoliga JM. Diagnostic Accuracy of Various Imaging Modalities for Suspected Lower Extremity Stress Fractures: A Systematic Review With Evidence-Based Recommendations for Clinical Practice. Am J Sports Med. 2016 Jan;44(1):255-63. doi: 10.1177/0363546515574066. Epub 2015 Mar 24.

  PMID: 25805712 BACKGROUND

• Starkey C. Injuries and illnesses in the national basketball association: a 10-year perspective. J Athl Train. 2000 Apr;35(2):161-7.

  PMID: 16558626 BACKGROUND

• Taylor PM, Gordon G, Lowe MK: Basketball injuries. In: Subotnik SI (ed): Sports Medicine of the Lower Extremity (2nd edition), Ch. 31, W.B. Saunders Co., Philadelphia, 1999, p. 695.

  BACKGROUND

• Bennell KL, Malcolm SA, Thomas SA, Wark JD, Brukner PD. The incidence and distribution of stress fractures in competitive track and field athletes. A twelve-month prospective study. Am J Sports Med. 1996 Mar-Apr;24(2):211-7. doi: 10.1177/036354659602400217.

  PMID: 8775123 BACKGROUND

• Brudvig TJ, Gudger TD, Obermeyer L. Stress fractures in 295 trainees: a one-year study of incidence as related to age, sex, and race. Mil Med. 1983 Aug;148(8):666-7. No abstract available.

  PMID: 6415522 BACKGROUND

• Strowbridge NF. Musculoskeletal injuries in female soldiers: analysis of cause and type of injury. J R Army Med Corps. 2002 Sep;148(3):256-8. doi: 10.1136/jramc-148-03-06.

  PMID: 12469426 BACKGROUND

• Liong SY, Whitehouse RW. Lower extremity and pelvic stress fractures in athletes. Br J Radiol. 2012 Aug;85(1016):1148-56. doi: 10.1259/bjr/78510315.

  PMID: 22815414 BACKGROUND

• Moran DS, Evans RK, Hadad E. Imaging of lower extremity stress fracture injuries. Sports Med. 2008;38(4):345-56. doi: 10.2165/00007256-200838040-00005.

  PMID: 18348592 BACKGROUND

MeSH Terms

Conditions

Fractures, Stress

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Nicholas E Anastasio, MD

CONTACT

(434) 243-5600; nea5j@hscmail.mcc.virginia.edu

David Hryvniak, DO

CONTACT

(434) 243-5600; DJH3F@hscmail.mcc.virginia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Subjects will be required to have already undergone the initial step of the traditional diagnostic algorithm with x-ray of the suspicious region. All subjects will then be scheduled to undergo diagnostic ultrasound at a separate appointment with ultrasound procedure performed by a blinded clinical physician. All patients will then undergo a confirmatory MRI of the region of concern. A statistician in the Department of Public Health at the University of Virginia will be performing statistical analysis. 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.
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Subjects suspected to have an acute stress fracture of the lower extremity will be recruited. Subjects will be required to have already undergone the initial step of the traditional diagnostic algorithm with x-ray as part of clinical care of the suspicious region on the day of enrollment. A physical exam and vital signs will be obtained as part of standard clinical care. All subjects will then be scheduled to undergo diagnostic ultrasound for research purposes 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 subjects will then undergo a confirmatory MRI without contrast of the region of concern. The MRI may be ordered as part of clinical care or for research if not required for clinical purposes. MRI screening per standard processes will be done by the MRI staff.

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 17, 2017
• Study Start: August 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: May 1, 2018
• Last Updated: April 17, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share