Randomized Controlled Trial of Ultrasound Guidance for Reduction of Pediatric Forearm Fractures
Phase: NA
Conditions: Forearm Fracture, Ultrasound
Sponsor: Montefiore Medical Center

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Randomized Controlled Trial of Ultrasound Guidance for Reduction of 
Pediatric Forearm Fractures 
IRB Protocol 
 
Principal Investigators: 
Joni Rabiner, MD jrabiner@montefiore.org 
Norman Otsuka, MD notsuka@montefiore.org 
Ariella Nadler, MD  anadler@montefiore.org 
Jeffrey Avner, MD jravner@montefiore.org 
 
Statistician 
Dr Yungtai Lo, PhDyungtai.lo@einstein.yu.edu 
 
Research Associate and Study Contact:  
Regina Hanstein, PhD, hanstein@montefiore.org, 718-920-7739 
 
I. 
PURPOSE OF THE STUDY AND BACKGROUND 
 
Ia. Background and Significance 
 
Ultrasound is now widely accepted as a diagnostic tool for use in the emergency 
department, as supported by the American College of Emergency Physicians (ACEP) position 
statement in 2001 (revised in 2008).1 In addition, the American Academy of Pediatrics (AAP) 
policy statement in 2015 (also supported by The Society for Academic Emergency Medicine 
(SAEM), ACEP, and World International Network Focused on Critical Ultrasound 
(WINFOCUS)) now requires point-of-care ultrasound education for PEM fellowship training2. 
Ultrasound is particularly useful in pediatrics as it is rapid, reliable, portable, easy to use, does 
not require the patient to remain motionless and does not use ionizing radiation. 
Ultrasoundhas been shown to have applications in the evaluation and diagnosis of 
pediatric skeletal injuries3,4.There are a number of studies in the literature that support the use of 
ultrasound in fracture diagnosis. Grechenig et al5studied the ability ofultrasound to pick up 
fractures in cadavers with the goal of delineating the minimum fracture size that could be 
detected on ultrasound.  With the use of high resolution ultrasonography (7.5MHz), cortical 
discontinuities greater than or equal to 1 mm were identified on all study subjects.  Fractures 
were studied in both longitudinal and cross-sectional views as the authors noted that fractures 
                                                     
1 American College of Emergency Physicians Policy Statement.  Emergency Ultrasound 
Guidelines.  Ann Emerg Med. April 2009;53(4):550-70. 
2Marin, JR, Lewiss RE, Point-of-care ultrasonography by pediatric emergency medicine 
physicians. Pediatrics. 2015 April; 135(4):e1113-22 
3Moritz JD, Berthold LD, Soenksen SF, et al.  Ultrasound in diagnosis of fractures in children: 
unnecessary harassment of useful addition to x-ray?  Ultraschall in Med 2008:28:267-274. 
4 Weinberg ER, Tsung JW, Tunik MG.  Accuracy of point-of-care ultrasound for the diagnosis of 
fractures in the pediatric emergency department.  Acad Emerg Med.  2008 May; 15(5):S45. 
5 Grechenig et al. Scope and limitations of ultrasonography in the documentation of fractures-an 
experimental study. Arch Orthop Traum Surg 1998; 117(6-7): 368-71. 
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could potentially escape detection if the transducer is placed parallel to the course of the fracture.  
Fractures were demonstrated as either cortical discontinuities or interruptions in acoustic 
shadows4,5,6. 
Several studies in the pediatric literature have shown that ultrasound can adequately 
identify long bone fractures, determinethe need for reduction of a displaced fracture and assess 
the adequacy of reductionwhen compared to plain films.In a prospective study involving 
pediatric emergency medicine (PEM) physicians by Patel et al6,ultrasound was compared to 
plain films to identify fractures, determine need for reduction and assess adequacy of 
reductionThe study found a 95.5% agreement between ultrasoundand radiography in fracture 
identification, a 92.3% agreement in need for fracture reduction and a 92.3% agreement in 
adequacy of reduction.  
In a case study, Durston and Swartzentruber7 described three cases in which ultrasound 
was helpful in guiding fracture reduction. Chen et al8, in a prospective study, compared 
ultrasound to x-ray for the diagnosis of forearm fractures and used ultrasoundas a real-time 
imaging modality to guide the reduction procedure. They found 97% sensitivity and 100% 
specificity in the diagnosis of forearm fractures with ultrasound compared to plain films andthe 
initial success rate of ultrasound-guided reduction was 92% with two patients requiring repeat 
reduction. Two of 65 fractures were missed, both ulnar styloid fractures in patients who alsohad 
radial metaphysis fractures and therefore the management was not altered because of the missed 
diagnosis. However, this study did not compare ultrasound-guided reduction to blinded reduction 
or reduction with another mode of real-time imaging such as fluoroscopy.  
Of note, children tolerate musculoskeletal ultrasound, even in areas of injury, very well.  
Chien, et al. evaluated the use of ultrasound for the diagnosis of clavicular fractures in children 
and found that the ultrasound examination was not associated with an increase in pain9. While 
not formally studied, both Patel et al7 and Chen et al6 noted that with liberal application of 
ultrasound transmission gel, there was no worsening of pain andpatients did not require 
additional pain medication during the ultrasound exam7.  
One pediatric study, by Dubrovsky et al10,compared the use of ultrasound guided 
reduction to reduction with fluoroscopy to accurately determine successful fracture realignment. 
Study physicians used ultrasound to assess the fracture prior to and after reduction, with the 
option of dynamic visualization during reduction. Fluoroscopic images were obtained after 
ultrasound images. When comparing the treating physician’s interpretation of ultrasound results 
to a blinded orthopedic surgeon’s interpretation of the fluoroscopy results, with a positive test 
indicating an inadequately reduced fracture, the sensitivity was 50%, specificity 89%, negative 
                                                     
6Patel et al, The Utility of bedside ultrasonography in identifying fractures and guiding fracture 
reduction in children, Pediatric Emergency Care, 2009 April; 25(4): 221-2 
7Durston, Swartzentruber, Ultrasound guided reduction of pediatric forearm fractures in the ED, 
Am J Emerg MEd2000 Jan, 18(1): 72-77 
8Chen et al, Diagnosis and guided reduction of forearm fracture in children using bedside 
ultrasound, Peds Emerg Care, 2007 Aug; 23(8) 528-531 
9Chien M et al, Bedside ultrasound in the diagnosis of pediatric clavicle fractures, Pediatr Emerg 
Care 2011 Nov 27(11); 1038-41 
10Dubrovsky et al, Accuracy of ultrasonography for determining successful realignment of 
pediatric forearm fractures, Annals of Emergency Medicine, Ann Emerg Med 2015 Mar; 65(3): 
260-5 
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predictive value was 95.3% and positive predictive value was 28.6%, indicating that ultrasound 
was best at identifying adequately aligned fractures. Additionally, 78% of physicians indicated 
that ultrasound was helpful with the reduction procedure.  
The use of ultrasound for real-time guidance of fracture reduction compared to blind 
reduction has been assessed in the adult literature. In a before-and-after study, Ang et al11, 
compared ultrasound guided reduction to a retrospective control group who underwent blinded 
fracture reduction and showed a decreased rate in the number of repeat reductions. In a similar 
before-and-after study, Chinnock et al12, showed no significant difference in successful reduction 
rates with ultrasound compared to blinded reduction.Brahm J et al13. in an unpublished abstract, 
conducted a randomized, single blinded study of adult patients comparing ultrasound guided 
reduction to standard closed reduction of distal radius fractures and found no difference in the 
adequacy of reduction, time to reduction or number of repeat reductions between the groups.  
It is apparent from these studies that there is a role for ultrasound in guiding fracture 
reduction. Using ultrasound for dynamic visualization instead of fluoroscopy has several 
advantages. Ultrasound provides no ionizing radiation, while fluoroscopy exposes the patient, 
caretaker, and provider to ionizing radiation, requiring shielding forall involved to minimize 
exposure. Fluoroscopy requires the use of a large, cumbersome machine and many emergency 
departments, including our institution, are not equipped with fluoroscopic equipment. We intend 
to build on the studies of Chen et al9,Patel et al, and others, with a randomized controlled trial to 
compare the use of real-timeultrasoundguidance of closedforearm fracture reduction to blinded 
closed forearm fracture reduction in the pediatric emergency department.  
 
Ib. Objectives/Purpose of the study 
 
Our objective is to conduct a prospective randomized trial to assess the utility of using 
real-time ultrasound imaging in the reduction of forearm fractures in the PED. We also plan to 
assess provider satisfaction with using ultrasound for the reduction procedure compared to 
fracture reduction without use of ultrasound.  We hypothesize that the use of ultrasound will 
improve patient outcomes and provider satisfaction. Thus, the primary outcome of the study will 
be:  
1) To compare the number of patients requiring a repeat reduction procedure between the 
experimental group (ultrasound guided fracture reduction) and control group (standard of 
care forearm fracture reduction).  
 
Secondary Outcomes: 
1) To compare provider satisfaction with the reduction procedure between the two groups. 
Specifically, we will ask providers to determine: 
I. 
Providers from experimental group: 
a. Ease of fracture reduction - scale 1-5, (1=easy5=verydifficult)  
                                                     
11Ang et al, Ultrasound-guided reduction of distal radius fractures, Am J of Emerg Med, 2010; 
28, 1002-1008 
12Chinnock et al, Ultrasound-guided reduction of distal radius fractures, J of Emerg Med, 
2011,40 (3) 308-312 
13 Brahm J et al, A Randomized controlled trial of emergency department ultrasound-guided 
reduction of distal radius fractures, Annals of Emerg Med-Abstracts, 2011 Oct; 58(4), 230 
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b. Ease of using ultrasonography on a 5 point scale (1-easy, 5=verydifficult).  
c. Was ultrasound helpful in completing the fracture reduction?  a) yes b) no c) 
uncertain 
II. 
Providers from control group: 
a. Ease of fracture reduction - scale 1-5, (1=easy5=Most difficult)  
b. Do you think real-time imaging would have been helpful for this reduction? 
 
2) To compare the adequacy of reduction between groups by measuring and comparing the 
degree of angulation and displacement on the post reduction x-rays. An orthopedic 
surgeon who is blinded to the patient’s group assignment will read the x-rays. The 
acceptable degree of angulation will be the same in both groups. The acceptable degree 
of angulation based on age is less than 20 degrees’ angulation for patients younger than 
10 years of age and less than 10 degrees’ angulation for patients older than 10 years of 
age14.  
3) To compare the time for the fracture reduction procedure between the experimental and 
control group. 
4) To compare the number of patients requiring operative repair after reduction between the 
experimental and control group. 
5) To compare the post-reduction ultrasound and x-ray interpretation, including 
measurement of degree of angulation and displacement on the ultrasound and x-ray for 
each patient.    
 
Ic. Study Design 
The study will be a prospective randomized, controlled, single blinded study. The study is 
single blinded in that the orthopedic surgeon reading the x-rays and determining the degree of 
angulation and displacement will be blinded to all patient characteristics and the patient’s group 
assignment.  
 
II. CHARACTERISTICS OF THE RESEARCH POPULATION 
 
IIa. Inclusion Criteria 
 
Patients from 0- 21 years of age, male or female, who present to the Pediatric Emergency 
Department (PED) with a confirmed displaced forearm fracture that will require reduction by 
orthopedic surgery in the PEDwill be eligible for inclusion in this study.   
 
IIb. Exclusion criteria 
1) Patients with open fractures. 
2) Patients with neurovascular compromise. 
3) Unstable patients with life-threatening injuries who require ongoing resuscitation. 
 
IIc. Vulnerable subjects: 
 
The population of interest in this study includes patients < 18 years old (i.e. vulnerable 
subjects).  All efforts will be made to protect these children during this study.  As mentioned 
before, ultrasound emits no radiation and is a painless procedure; therefore, this study presents 
                                                     
14Daruwalla, JS, 1979; Textbook: Rockwood and Wilkins' Fractures in Children 
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no risk to these patients.  If the patient expresses any discomfort from the ultrasound 
examination, the procedure will be immediately discontinued and the patient will be removed 
from the study.  The purpose of investigating ultrasound guidance for fracture reduction in this 
vulnerable population was mentioned in the background section. 
 
IId. Number of Subjects 
From a retrospective chart review sampling of displaced forearm fractures requiring 
reduction from June 1 to August 31, 2015 at CHAM, there were 20 displaced forearm fractures 
that underwent a closed reduction procedure in the Pediatric Emergency Department. 5 of the 20 
displaced forearm fractures (25%) were inadequately reduced and required repeat reduction 
and/or operative management. Based on a recent study by Wellsh et al, only 6% of patients 
required repeat fracture reduction when US guidance was used. 
In order to observe such a difference with 80% power, the sample size calculation would require 
a minimum of 56 patients in each group (standard of care vs US-guided reduction) with alpha set 
at P= 0.05. 
Statistical significance will be assessed using mean, percentages, frequency distributions, 
and p-value. The significance will be set at 0.05. The test statistic used will be the Chi-square 
test. Confidence intervals will also be obtained.After the primary analysis of the group 
differences, logistic or normal regression will be used to determine factors related to these 
outcomes. The significance will be set at 0.05.The statistical approaches will be further 
developed with the assistance of the statistician in the orthopaedic surgery department following 
data collection and study approval. 
 
III. METHODS AND PROCEDURES 
 
IIIa. Methods and Procedures 
 
This will be a prospective randomized, controlled, single blinded study that will take 
place at the Children’s Hospital at Montefiore (CHAM) in the Pediatric Emergency Department 
(PED).  Patients who present to the PED, are confirmed to havea forearm fracture requiring 
closed reduction in the PED and meet the inclusion/exclusion criteria will be eligible for the 
study. The decision to perform a closed reduction procedure in the PED will be made by the 
consulting orthopedic surgeon who will perform the procedure. All eligible patients’ pain will be 
reassessed and managed as necessary as per standard of careThe eligible patient or 
parent/guardian will be approached by the treating physician or consulting orthopedic resident 
for written consent. Written assent will be obtained from minors older than 7 years of age (see 
below for consent timeline/process).After enrollment into the study, patients will be randomized 
to either the experimental group (ultrasound guided fracture reduction) or control group 
(standard of care forearm fracture reduction without real-time imaging). Allocation of patients to 
intervention and control arms will be accomplished by a computer-generated permuted block 
randomization scheme.An individual in the Department of Orthopaedic Surgery,who is not part 
of the study team will perform block randomization and will provide the study team with sealed 
envelopes for treatment prior to the enrollment of any patients in the study. These envelopes will 
be part of the study package, which include study questionnaires.We will choose blocks of 20 
patients in order to reduce or eliminate experimental error contributed by inexperience using the 
US-guidance at the beginning of the study. 
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Consulting orthopedic residents will be trained to perform musculoskeletal sonography 
for this study (see below for standardized training of study physicians in ultrasound) and will be 
considered study-trained physicians.  All patients will undergo procedural sedation and/or pain 
management for closed reduction as per standard of care in the PED. The medication used for 
sedation and/or pain will be determined by the treating PEM physician. Study patients that are 
randomized to the ultrasound guided group will undergo a point-of-care ultrasound, performed 
by a study trained physician using a Sonosite Edge ultrasound machine with an L38 linear 10-5 
MHz transducer probe.  
Prior to the reduction procedure in patients randomized to the experimental group, 
ultrasound images of the fracture site will be obtained and the maximum degree of displacement 
will be measured. The ultrasound technique involves placing ultrasound gel over the fracture site 
and then placing the ultrasound probe in contact with the gel but not with the underlying skin.  
Both longitudinal and transverse views of the injured area will be obtained. Fractures are 
identified as an irregularity or interruption of the cortex of the bone.The degree of displacement 
is measured by drawing two intersecting lines along the edge of the cortex at the fracture site, 
generating an angle. Displacement measurements are then made by calculating the distance from 
the normal cortex to the fractured edge of the cortex.  
The trained physician will then perform real-time ultrasound imaging as neededduring 
the closed reduction procedure. Real-time ultrasound imaging includes both longitudinal and 
transverse views of the fracture site, repeated as often as necessary until the best alignment can 
be obtained. Once the orthopedic resident determines that he/she has obtained optimal alignment 
and prior to casting, a post-reduction ultrasound image will be obtained and the angle of 
displacement will again be measured. All ultrasounds performed prior to and after the reduction 
will be recorded, and the images obtained will include video clips of the ultrasound as well as a 
saved still picture of the best image of the suspected fracture site.The study-trained physician 
who performed the ultrasound will then record his/her findings on the data collection form 
immediately after the procedure and prior to reviewing plain radiographs.  
While it has been our experience that the majority of reduction procedures performed in 
the PED are done without the use of any real time imaging, some orthopedic surgery residents 
employ the use of the c-arm (fluoroscopy) and/or a portable x-ray machine during the reduction 
procedure. At his/her discretion, the orthopedic resident may use either of these modalities in 
both the ultrasound and control group as per standard of care in the PED. The use of these 
modalities will be recorded.  
After the reduction procedure in the ultrasound group and prior to reviewing the post 
reduction x-ray, the orthopedic residentwill complete a brief questionnaire with the following 
questions.  
For the experimental group: 
a. Rate the ease of fracture reduction from 1-5, (1=easy 5=Verydifficult)  
b. Was ultrasound helpful in completing the fracture reduction?  a) yes b) no c) 
uncertain  
c. Rate the ease of using ultrasonography on a 5 point scale (1- easy, 5=verydifficult).  
 
 
The control group will undergo fracture reduction without ultrasound guidance as per the 
current standard of care in the PED. After the reduction procedure in the control group, the 
orthopedic resident will complete a brief questionnaire with the following questions: 
For the control group: 
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a. Rate the ease of fracture reduction from 1-5, (1=easy 5=very difficult)  
b. Do you think real-time imaging would have been helpful for this reduction? 
 
 
After the reduction andcasting is completed, patients in both groups will undergo a post-
reduction x-ray. Based on the degree of displacement on the x-ray, the orthopedic surgeon will 
determine whether the patient needs a repeat reduction, as per routine standard of care.If a repeat 
reduction is required, the treating physician can choose to use ultrasound at his/her 
disgression.The angle of displacement will be measured on the post-reduction x-ray by an 
orthopedic surgeon. Additionally, the angle of displacement measured on the post-reduction 
ultrasound will be measured and compared to the angle of displacement on the post-reduction x-
ray. An expert sonographer will review cases where the ultrasound and x-ray results do not 
correlate.  
 
IIIb. Data Collection / Monitoring 
The primary endpoint of the study is comparing the percentage of patients with an 
adequate degree of angulation on post-reduction x-rays between the experimental group and the 
control group. X-rays will be performed based on the PED routine standard of care. 
Demographic data recorded by the study trained physician will include the patient’s name, age, 
medical record number, date of birth, date of visit, and ultrasound experience of the study-trained 
physician performing the ultrasound.  The patient identifiers are necessary for patient tracking to 
match ultrasound findings with X-ray final readingsand for clinical follow up.Type of sedation 
used, length of procedure and any ultrasound data will be collected and recorded by study trained 
physicians.  Radiographic readings will be collected by the investigators.  
 
IIIc. Data Storage and Privacy 
 
The principal- and co-investigators will manage the data generated and oversee quality 
control measures for the study in order to ensure the confidentiality of data at all times, as 
mandated under HIPAA.  
 
All data collected during the study will be treated as confidential information by all 
involved staff.  Patient identifier information will be located on only one form that will be 
destroyed upon completion of the study, after data is cleaned, analyzed and published.  Patients 
will be assigned a study number to protect confidentiality, which will be used on all other data 
sheets to ensure that patient identifier information is located on only one protected form. 
 
Data forms will be kept in a secure locked file in a locked office. The data sheet 
containing patient identifier information that will allow follow-up and act as a key to the unique 
study identifier number will be separated from the clinical data forms and stored in a separate 
locked cabinet.  HIPAA-sensitive Personal Health Information (PHI) will not be reused or 
disclosed to any other person or entity, except as required by regulation and law or for authorized 
oversight of the research project. 
 
All patient data stored on the ultrasound machine will be saved under their study patient 
number without patient identifiers. 
 
 
IIId. Study Equipment 
The study intervention will be the use of bedside ultrasound to guide reduction of forearm 
fracture reduction. A Sonosite Edge ultrasound machine with an L38 linear transducer probe 10-
5 MHz will be used for point-of-care ultrasound.   
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IIIe. Standardized Training of Physicians in Ultrasound 
 
Prior to beginning this study, all participating consultingorthopedic residents and PEM 
attendings and fellowswill participate in a one-hour training session which will teach the basics 
of how to use ultrasound to diagnose fractures.  PEM physicians and ortho residents have a 
foundation in emergency ultrasound, and the training session will build upon this background 
knowledge and teach the specific skills necessary for musculoskeletal ultrasonography of the 
forearm. In addition, this session will standardize the method in which bedside ultrasound will be 
performed by participating physicians.  The training session at CHAM will be taught by study 
investigators.The session will begin with a formal PowerPoint presentation, complete with 
ultrasound images and videos of fractures, which will be followed by a practical session where 
participants will perform ultrasound of intact and simulated fractured bones to visualize both 
normal and fractured cortex.  There will be a post-training assessment conducted by study 
investigatorsto ensure that all co-investigators are adequately trained to enroll patients.  In 
previous studies, ED physicians with minimal training were able to successfully perform 
ultrasound studies throughout the course of each study7,11,12. We will also provide a teaching 
manual for reference complete with images and instructions. 
 
IV. RISK/BENEFIT ASSESSMENT 
 
IVa. Potential Risks and Benefits 
 
There are no known risks to ultrasound, with no reports of adverse events in over 50 
years of clinical use.  The use of ultrasound is painless by avoiding contact of the ultrasound 
probe with the injured body part and solely maintaining contact with the ultrasound gel.  The 
ability of patients to tolerate ultrasound of injured areas, without pain, is well documented in the 
literature.Patel et al6 reported that “it was our observation that the bedside ultrasound 
examination did not exacerbate pain.”In a study of ultrasound-assisted diagnosis of pediatric 
ankle fractures, Simanovsky reported similar findings: “All the patients were cooperative and 
tolerated the procedure well”.15 
 
During the process of data collection, patient identifiers will be collected (name, age, 
medical record number, birth date, date of visit).  As mentioned previously, this identifying 
information is necessary for x-ray follow-up and will be located on only one form.  This form 
with identifying information will be kept in a locked file cabinet in a locked office.  All other 
data sheets and saved data will be organized by an assigned patient number. 
 
IVb. Protection against risk 
 
In the unlikely event that a patient is unable to tolerate the ultrasound procedure, the 
ultrasound will be discontinued immediately and the patient will be removed from the study.  
There are no infectious risks from the use of ultrasound in this study; open fractures are 
excluded, and the US machine will be cleaned per routine procedure after each use. 
 
The risk of patient confidentiality being violated in this study is minimal due to the 
numerous safeguards that have been implemented (see section IVa). 
                                                     
15 Simanovsky et al. Sonographic detection of radiographically occult fractures in paediatric 
ankle injuries. Pediatr Radiol 2005; 35(11):1062-5. 
 
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V. INVESTIGATOR QUALIFICATIONS AND EXPERIENCE – see attached CV 
 
VI.SUBJECT IDENTIFICATION, RECRUITMENT AND CONSENT/ASSENT 
 
VIa. Consent and Procedure Timeline / Process  
The PEM attending, fellow or orthopedic resident caring for the patient will determine if 
the patient is eligible for inclusion in this study.  If the patient is eligible and does not meet any 
of the exclusion criteria, the patient will be asked to participate (see written consent and child 
assent documents).  The patient will be randomized to one arm of the study only after obtaining 
written consent from the patient > 18 years of age or the parent/guardian of a minor and assent if 
the child is > 7 years. 
The experimental group will have an ultrasound performed prior to, duringand after 
forearm fracture reduction. The ultrasound procedure involves placing ultrasound gel over the 
fracture site.  The ultrasound probe is then placed in contact with the gel but not with the 
underlying skin.  Images of the bony cortex are obtained in both longitudinal and transverse 
orientations and recorded on the ultrasound hard drive.  After completion of the post-reduction 
ultrasound, the ultrasound gel will be removed, and the patient will undergo routine 
casting/splinting andpost-reduction x-ray as per thePediatric ED standard of care. The control 
groupwill undergo the standard of care fracture reduction with post-procedure x-ray images.  
While it is possible that the procedure with ultrasound will take longer than standard of 
care closed reduction, it is also possible that the procedure time will be the same or shorter. In 
the abstract by Brahm et al13, they found no difference in time for fracture reduction between the 
two groups. Based on prior studies, we do not anticipate that patients participating in this study 
will incur significant delays in routine care based on their participation.  
The alternative treatment for patients/parents who do not want to participate in this study 
will be fracture reduction without ultrasound.  
 
VIb. Subject Identification/Recruitment/Consent 
 
Potential subjects will be recruited by PEM attendings, PEM fellows and orthopedic 
residents who have participated in the formal ultrasound fracture diagnosis training session.  
Subjects will be recruited solely on the basis of inclusion and exclusion criteria.  The 
consent/assent will be obtained and then documented by the study trained physician who is 
performing the ultrasound.  
 
VIc. Subject Capacity 
 
The only subjects in this minimal risk study that may meet criteria for limited capacity 
would be children.  We have put several safeguards in place to provide full protection to this 
group: consent provided by a parent/guardian, assent provided by a child over seven years, and 
an assent script in which the study is described in basic language appropriate to a seven year old 
child.  
 
VId. Subject Comprehension 
 
We will provide consent documents to guarantee a standardized delivery of information 
when obtaining consent.  By using basic language that is easy to understand for a seven year old 
child, we will maximize the patients’ comprehension of the study. 
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VIe. Consent Forms / Documentation of Consent 
 
Please see attached consent and assent forms.  We will seek IRB approval of a translated 
consent/assent form in Spanish after IRB approval of the English consent/assent forms. 
 
VIf. Costs and Compensation to Subjects 
There will be no costs or compensation to subjects taking part in this study. 
 
VIg. Potential Conflict of Interest and Funding 
 
There will be no funding for this study. No funds will accrue to any of the investigators. 
No funding is sought or exists from commercial sources, and no relationship exists or is sought 
with any commercial company.  
 
VII. Data Safety Monitoring 
 
The PI and study coordinator will monitor data and safety, with emphasis on data 
integrity and patient safety concerns including: review of adverse events, recommendations 
concerning continuation or conclusion of the study, protection of the confidentiality of the trial 
data and the results of monitoring, review of data and study quality. Any adverse events, 
unanticipated problems, and protocol deviations will be reported to the IRB. 
 
 
 
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