Stress FractureNCT03116360
Comparison of Ultrasound and X-ray as Screening Tests for Diagnosis of Lower Extremity Stress Fracture.
A study testing Diagnostic Ultrasound in people with Stress Fracture and Ultrasound Therapy, run by University of Virginia.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Stress Fracture, Ultrasound Therapy, Musculoskeletal Ultrasound
- What is being tested?
- Diagnostic Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Aug 2017to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
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.
- Being tested
- Diagnostic Ultrasound
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic UltrasoundDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | All patients will undergo traditional xray screening as well as experimental screening with diagnostic ultrasound. All subjects will undergo confirmatory MRI. Receives: Diagnostic Test: Diagnostic Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Comparing ultrasound and x-ray across severity of stress fracture
Comparison of sensitivity and accuracy of diagnostic ultrasound and x-ray stratified across MRI grading of acute stress fracture of the lower extremity.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study startAug 2017 (estimated)
- Primary completionFeb 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Stress FractureStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- NBA&GE Orthopedics and Sports Medicine Collaboration
- Responsible party
- Principal investigator, David Hryvniak, MD, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116360
- Sponsor's protocol ID
- 19779
- Status last verified
- Apr 2017
- First submitted
- 7 Apr 2017
- Last updated
- 17 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23396635Nitz 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.
PubMed 6779231Uri Farkash et al. Ultrasonography as a diagnostic modality of tibial stress fractures. J Musculoskelet Res. 11, 55 (2008).
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.
PubMed 10949501Papalada 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.
PubMed 22366519Boam 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.
PubMed 8923399Banal 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.
PubMed 19567620Battaglia 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.
PubMed 24396321Wright 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.
PubMed 25805712Starkey C. Injuries and illnesses in the national basketball association: a 10-year perspective. J Athl Train. 2000 Apr;35(2):161-7.
PubMed 16558626Taylor 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.
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.
PubMed 8775123Brudvig 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.
PubMed 6415522Strowbridge 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.
PubMed 12469426Liong 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.
PubMed 22815414
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound and X-ray as Screening Tests for Diagnosis of Lower Extremity Stress Fracture
- ClinicalTrials.gov ID
- NCT03116360
- Acronym / sponsor ID
- 19779
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- NBA&GE Orthopedics and Sports Medicine Collaboration
- Study start
- Aug 2017 (estimated)
- Primary completion
- Feb 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 17 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Diagnostic Test: Diagnostic UltrasoundAll patients will undergo traditional xray screening as well as experimental screening with diagnostic ultrasound. All subjects will undergo confirmatory MRI. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic UltrasoundThe 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. | Diagnostic test | Single Arm |
Primary outcome
Non-inferiority comparison of diagnostic ultrasound to x-ray
Time frame: 6 months
Comparison of sensitivity between diagnostic ultrasound and x-ray for acute stress fractures of the lower extremity.
1 secondary outcome
Comparing ultrasound and x-ray across severity of stress fracture
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
- Background: PubMed 23396635Khy 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.
- Background: PubMed 6779231Nitz 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.
- BackgroundUri Farkash et al. Ultrasonography as a diagnostic modality of tibial stress fractures. J Musculoskelet Res. 11, 55 (2008).
- Background: PubMed 10949501Romani 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.
- Background: PubMed 22366519Papalada 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.
- Background: PubMed 8923399Boam 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.
- Background: PubMed 19567620Banal 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.
- Background: PubMed 24396321Battaglia 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.
- Background: PubMed 25805712Wright 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.
- Background: PubMed 16558626Starkey C. Injuries and illnesses in the national basketball association: a 10-year perspective. J Athl Train. 2000 Apr;35(2):161-7.
- BackgroundTaylor 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: PubMed 8775123Bennell 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic Ultrasound in people with Stress Fracture and Ultrasound Therapy, run by University of Virginia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicholas E Anastasio, MD ((434) 243-5600, nea5j@hscmail.mcc.virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferiority comparison of diagnostic ultrasound to x-ray (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03116360, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2017.