Comparison of a Novel Weight Bearing Cone-beam Computed Tomography (CT) Scan to Gravity Stress X-ray for Determining Instability of Supination-external Rotation Type Ankle Fractures
Conditions: Supination-external Rotation Ankle Fractures
Sponsor: State University of New York at Buffalo

PROTOCOL TITLE: Comparison of a novel weight bearing cone beam 
computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
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Title: Comparison of a Novel Weight Bearing Cone Beam Computed 
Tomography (CT) Scan to Gravity Stress X-ray for Determining Instability 
of Supination-External Rotation Type Ankle Fractures 
 
NCT02599441 
 
11/11/2015 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL TITLE: Comparison of a novel weight bearing cone beam 
computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
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INSTRUCTIONS: Complete Research Protocol (HRP-503) 
 Depending on the nature of what you are doing, some sections may 
not be applicable to your research.  If so, you must provide the 
reason why the section is not applicable for the response.  For 
example, most behavioral studies would answer all questions in 
section 30 with words to the effect of “drugs and medical devices 
are not used in this study.” 
 When you write a protocol, keep an electronic copy. You will need 
to modify this copy when making changes. 
 Do not remove the italics instructions or headings. 
 If you are pasting information from other documents be sure to use 
the “Merge Formatting” paste option so that the formatting of the 
response boxes is not lost.  If information is presented outside of 
the response boxes, it will not be accepted.  
 If this study involves multiple participant groups who participate 
in different research procedures, consent processes, etc., be 
certain to provide information in each applicable section for each 
participant group and clearly label each participant group within 
a section or subsection.  
 
 
PROTOCOL TITLE: 
Include the full protocol title. 
Response: Comparison of a novel weight bearing cone beam computed 
tomography (CT) scan to gravity stress X-ray for determining instability 
of supination-external rotation type ankle fractures 
 
PRINCIPAL INVESTIGATOR: 
Name 
Department 
Telephone Number 
Email Address 
Response:  
John Marzo, MD 
UBMD Orthopaedics & Sports Medicine 
(716) 829-2982 
jmmarzo@buffalo.edu 
 

PROTOCOL TITLE: Comparison of a novel weight bearing cone beam 
computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
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VERSION NUMBER:  
Include the version number of this protocol. 
Response: 1 
 
DATE:  
Include the date of submission or revision. 
Response:  
 
Grant Applicability: 
Describe whether or not this protocol is funded by a grant or contract and if so, 
what portions of the grant this study covers. 
Response: Carestream Health is providing funding for the research 
procedures involved in the study.  In addition, Carestream is supplying the 
3D CT scanner for this study to be housed in the Department of Radiology 
at the Erie County Medical Center.    
 
 

PROTOCOL TITLE: Comparison of a novel weight bearing cone beam 
computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
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Table of Contents 
1.0 
Objectives ................................................................................................................ 5 
2.0 
Background .............................................................................................................. 5 
3.0 
Inclusion and Exclusion Criteria .............................................................................. 7 
4.0 
Study-Wide Number of Subjects (Multisite/Multicenter Only) .............................. 8 
5.0 
Study-Wide Recruitment Methods (Multisite/Multicenter Only)............................ 8 
6.0 
Multi-Site Research (Multisite/Multicenter Only)................................................... 9 
7.0 
Study Timelines ....................................................................................................... 9 
8.0 
Study Endpoints ..................................................................................................... 10 
9.0 
Procedures Involved............................................................................................... 10 
10.0 Data and Specimen Banking .................................................................................. 12 
11.0 Data Management .................................................................................................. 13 
12.0 Provisions to Monitor the Data and Ensure the Safety of Subjects ....................... 15 
13.0 Withdrawal of Subjects .......................................................................................... 16 
14.0 Risks to Subjects .................................................................................................... 17 
15.0 Potential Benefits to Subjects ................................................................................ 18 
16.0 Vulnerable Populations .......................................................................................... 18 
17.0 Community-Based Participatory Research ............................................................ 19 
18.0 Sharing of Results with Subjects ........................................................................... 19 
19.0 Setting .................................................................................................................... 19 
20.0 Resources Available............................................................................................... 20 
21.0 Prior Approvals ...................................................................................................... 22 
22.0 Recruitment Methods ............................................................................................. 22 
23.0 Local Number of Subjects ..................................................................................... 23 
24.0 Confidentiality ....................................................................................................... 23 
25.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 24 
26.0 Compensation for Research-Related Injury ........................................................... 25 
27.0 Economic Burden to Subjects ................................................................................ 25 
28.0 Consent Process ..................................................................................................... 25 
29.0 Process to Document Consent in Writing .............................................................. 30 
30.0 Drugs or Devices.................................................................................................... 30 
 

PROTOCOL TITLE: Comparison of a novel weight bearing cone beam 
computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
Page 5 of 42 
 
1.0 
Objectives 
1.1 Describe the purpose, specific aims, or objectives. 
Response: The primary objective of this study is to compare measures of 
ankle stability from an investigational weight bearing cone beam 
computed tomography (CT) scanner to the same measures on gravity 
stress X-ray in patients who have supination-external rotation ankle 
fractures.  
The secondary objective is to assess inter-rater reliability of ankle stability 
measures from the investigational cone beam CT scanner and gravity 
stress X-ray between 2 independent radiologists.   
An exploratory objective of this study is to determine if sensitivity of the 
investigational cone beam CT scan can be verified using the gravity stress 
X-ray as the gold standard. 
 
1.2 State the hypotheses to be tested. 
Response: The primary hypothesis is that the mean medial clear space will 
be different for the investigational weight bearing cone beam CT scan 
versus the gravity stress X-ray. 
2.0 
Background 
2.1 Describe the relevant prior experience and gaps in current 
knowledge. 
Response: Supination-external rotation (SER) or Weber B type ankle 
fractures are considered the most common type of ankle fracture1-4.  An 
SER fracture is considered unstable when it is associated with deltoid 
ligament rupture.  Clinical findings of medial tenderness, swelling, and 
ecchymosis were once thought to be reliable for correctly determining the 
stability of SER ankle fractures, but have since proven to be poor 
predictors of deltoid ligament disruption3, 5.  Rupture of the deltoid 
ligament allows lateral talar shift, and can be identified by widening of the 
medial clear space on standard radiographs as well as stress radiographs6, 
7.  
2.2 Describe any relevant preliminary data.  
Response: Many studies have shown that gravity stress radiographs are 
necessary and are currently considered to be the gold standard for 
diagnosis of SER fractures5. Of all the methods that have been used to 
diagnose instability and investigate deltoid ligament integrity (clinical 
examination, weight bearing radiographs, stress radiography, magnetic 
resonance imaging (MRI), arthroscopy, ultrasound), none have been 
shown to be cost-effective, rapid, reliable, and easy to use4.  Gravity stress 

PROTOCOL TITLE: Comparison of a novel weight bearing cone beam 
computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
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radiographs are performed without a uniform method, are known to lack 
sensitivity, and are very user dependent. Therefore, more research is 
needed to determine which method is most accurate and efficient for SER 
fracture diagnosis.  
2.3 Provide the scientific or scholarly background for, rationale for, and 
significance of the research based on the existing literature and how 
will it add to existing knowledge. 
Response: Weight bearing on the extremity is thought to be more 
representative of the normal use of the ankle joint, and CT scan is known 
to deliver excellent bone detail for interpretation of images.  The ability of 
weight bearing cone beam CT scanning to measure medial clear space 
may present a new opportunity to evaluate instability of SER ankle 
fractures.  
2.4 Include complete specific citations/references.  
Response:  
1. Gill JB, Risko T, Raducan V, Grimes JS, Schutt RC, Jr. Comparison of 
manual and gravity stress radiographs for the evaluation of supination-
external rotation fibular fractures. The Journal of bone and joint surgery 
American volume. 2007 May;89(5):994-9. Epub 2007/05/03. 
2. Egol KA, Amirtharajah M, Tejwani NC, Capla EL, Koval KJ. Ankle 
stress test for predicting the need for surgical fixation of isolated fibular 
fractures. The Journal of bone and joint surgery American volume. 2004 
Nov;86-a(11):2393-8. Epub 2004/11/04. 
3. Stufkens SA, van den Bekerom MP, Knupp M, Hintermann B, van Dijk 
CN. The diagnosis and treatment of deltoid ligament lesions in 
supination–external rotation ankle fractures: a review. Strategies in 
Trauma and Limb Reconstruction. 2012;7(2):73-85. 
4. Croft S, Furey A, Stone C, Moores C, Wilson R. Radiographic 
evaluation of the ankle syndesmosis. Canadian journal of surgery Journal 
canadien de chirurgie. 2015 Feb;58(1):58-62. Epub 2015/01/27. 
5. van den Bekerom MP. Diagnosing syndesmotic instability in ankle 
fractures. World journal of orthopedics. 2011 Jul 18;2(7):51-6. Epub 
2012/04/05. 
6. Nielson JH, Gardner MJ, Peterson MG, Sallis JG, Potter HG, Helfet 
DL, et al. Radiographic measurements do not predict syndesmotic injury 
in ankle fractures: an MRI study. Clinical orthopaedics and related 
research. 2005 Jul(436):216-21. Epub 2005/07/05. 
7. Beumer A, van Hemert WL, Niesing R, Entius CA, Ginai AZ, Mulder 
PG, et al. Radiographic measurement of the distal tibiofibular syndesmosis 

PROTOCOL TITLE: Comparison of a novel weight bearing cone beam 
computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
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has limited use. Clinical orthopaedics and related research. 2004 Jun 
(423):227-34. Epub 2004/07/03. 
3.0 
Inclusion and Exclusion Criteria 
3.1 Describe the criteria that define who will be included or excluded in 
your final study sample.  
Inclusion: Subjects will be recruited from the clinical practices of the 
study investigators and will: 
 have an isolated fibula fracture 
 have medial clear space measuring less than 5 mm with clinical 
suspicion of instability and would normally require a gravity stress 
x-ray 
 be willing and able to provide written informed consent 
 be 18 or more years of age 
Exclusion: Subjects will be excluded from study participation if they: 
 are pregnant at the time of screening 
 are prisoners  
 have an open fracture 
 have clinical signs of ankle deformity 
 have had any type of previous ankle trauma or surgery on the 
affected foot 
 have significant osteoarthritis or pre-existing ligamentous 
instability or pain in the affected ankle 
 have an inability to stand in the weight bearing position during the 
CT scan 
3.2 Describe how individuals will be screened for eligibility. 
Response: Patients will be screened (see Eligibility Form Attachment A 
that will be used for screening purposes) and recruited by the research 
team in the Emergency Department or clinical offices of the investigators.  
Patient history will be obtained and physical examination will be 
performed, and standard X-rays will be obtained. When the medial clear 
space is less than 5 mm with clinical suspicion of ankle instability, 
patients are referred for a routine gravity stress X-ray.  
3.3 Indicate specifically whether you will include or exclude each of the 
following special populations: (You may not include members of 
these populations as subjects in your research unless you indicate 
this in your inclusion criteria.) 

PROTOCOL TITLE: Comparison of a novel weight bearing cone beam 
computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
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 
Adults unable to consent 
 
Individuals who are not yet adults (infants, children, teenagers) 
 
Pregnant women 
 
Prisoners 
Response: Adults unable to consent, individuals who are not yet adults, 
pregnant women, and prisoners will be excluded from this study. 
3.4 Indicate whether you will include non-English speaking individuals.  
Provide justification if you will exclude non-English speaking 
individuals.  
(In order to meet one of the primary ethical principles of equitable 
selection of subjects, non-English speaking individuals may not be 
routinely excluded from research.  In cases where the research is of 
therapeutic intent or is designed to investigate areas that would 
necessarily require certain populations who may not speak English, 
the researcher is required to make efforts to recruit and include non-
English speaking individuals.  However, there are studies in which it 
would be reasonable to limit subjects to those who speak English: 
e.g., pilot studies, small unfunded studies with validated instruments 
not available in other languages, numerous questionnaires, and 
some non-therapeutic studies which offer no direct benefit.)  
 
Response: Non-English speaking subjects will be included in this study.  
Based on previous experience, we expect that most if not all of our 
potential study subjects will be English-speaking.  However, if we 
encounter a non-English speaking subject we will find someone who can 
orally translate (i.e., fluently speaks the same language as the subject, such 
as a family member) the study description and consent form to the subject.   
 
 
4.0 
Study-Wide Number of Subjects (Multisite/Multicenter Only) 
4.1 If this is a multicenter study, indicate the total number of subjects to 
be accrued across all sites. 
Response: This is not a multisite/multicenter trial.   
5.0 
Study-Wide Recruitment Methods (Multisite/Multicenter Only) 
If this is a multicenter study and subjects will be recruited by methods not under 
the control of the local site (e.g., call centers, national advertisements) describe 
those methods.  Local recruitment methods are described later in the protocol. 
5.1 Describe when, where, and how potential subjects will be recruited. 

PROTOCOL TITLE: Comparison of a novel weight bearing cone beam 
computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
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Response: Not applicable, this is not a multi-site study. 
5.2 Describe the methods that will be used to identify potential subjects. 
Response: Not applicable, this is not a multi-site study. 
5.3 Describe materials that will be used to recruit subjects. (Attach 
copies of these documents with the application. For advertisements, 
attach the final copy of printed advertisements. When advertisements 
are taped for broadcast, attach the final audio/video tape. You may 
submit the wording of the advertisement prior to taping to preclude 
re-taping because of inappropriate wording, provided the IRB 
reviews the final audio/video tape.) 
Response: Not applicable, this is not a multi-site study. 
6.0 
Multi-Site Research (Multisite/Multicenter Only) 
6.1 If this is a multi-site study where you are the lead investigator, 
describe the processes to ensure communication among sites, such 
as: 
 
All sites have the most current version of the protocol, consent 
document, and HIPAA authorization. 
 
All required approvals have been obtained at each site 
(including approval by the site’s IRB of record). 
 
All modifications have been communicated to sites, and 
approved (including approval by the site’s IRB of record) 
before the modification is implemented. 
 
All engaged participating sites will safeguard data as required 
by local information security policies. 
 
All local site investigators conduct the study appropriately. 
 
All non-compliance with the study protocol or applicable 
requirements will reported in accordance with local policy. 
Response: Not applicable, this is not a multi-site study. 
6.2 Describe the method for communicating to engaged participating 
sites: 
 
Problems. 
 
Interim results. 
 
The closure of a study 
Response: Not applicable, this is not a multi-site study.   
7.0 
Study Timelines 
7.1 Describe the duration of an individual subject’s participation in the 
study. 

PROTOCOL TITLE: Comparison of a novel weight bearing cone beam 
computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
Page 10 of 42 
 
Response: The subject will be enrolled in the study once informed consent 
is obtained.  The study will conclude once they have had a gravity stress 
X-ray as standard of care, and a CBCT scan with the investigational 
weight bearing cone beam scanner. 
7.2 Describe the duration anticipated to enroll all study subjects. 
Response: It is anticipated that it will take 8 months to 1 year (based on 
analysis of the past frequency of patients with the diagnosis of an unstable 
SER fracture and the difficult nature of enrolling study patients) to enroll 
all study subjects. 
7.3 Describe the estimated date for the investigators to complete this 
study (complete primary analyses) 
Response: The estimated date for the investigators to complete the primary 
analysis is the first quarter of 2017. 
8.0 
Study Endpoints 
8.1 Describe the primary and secondary study endpoints. 
Response: The primary endpoint is after enrollment of 20 subjects 
estimated to provide significance by power analysis.   
8.2 Describe any primary or secondary safety endpoints. 
Response: The primary safety endpoint is the presence of any adverse 
event. 
9.0 
Procedures Involved 
9.1 Describe and explain the study design. 
Response:  This study is a cross-sectional study designed to compare 
measures of stability from a gravity stress X-ray to the same measures on 
an investigational cone beam CT scanner. 
9.2 Provide a description of all research procedures being performed 
and when they are performed, including procedures being performed 
to monitor subjects for safety or minimize risks. 
Response: Screening/Enrollment Visit: If a patient presents with a 
potentially unstable SER type ankle fracture the subject’s physician will 
screen them, in the emergency room or physician’s office, to determine if 
they are eligible for the study (see attached Eligibility Form, Attachment 
A).   
The determination of a potentially unstable SER type ankle fracture is 
made via a standard X-ray showing medial clear space less than 5 mm 
with clinical suspicion of instability.  This criteria substantiates the 
potential diagnosis of an unstable SER ankle fracture with need for 

PROTOCOL TITLE: Comparison of a novel weight bearing cone beam 
computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
Page 11 of 42 
 
radiographic evaluation by a gravity stress X-ray. To confirm their 
diagnosis and for surgical treatment planning, patients are sent for a 
gravity stress X-ray as part of their standard of care. 
The study will be explained to eligible subjects, and informed consent to 
participate in the study will be obtained at the time the subject is thought 
to have an unstable SER type ankle fracture (in the emergency room or 
physician’s office).  For females of childbearing age who consent to be in 
the study, a urine pregnancy test will be done in the emergency 
department or physician’s office to confirm that the patient is not 
pregnant.  Pregnant females will be excluded from the study (see attached 
Eligibility Form, Attachment A).   
Study Visit: The subject will undergo a weight bearing CBCT scan of 
their affected ankle with the investigational portable cone beam CT 
scanner.  This will be done at the same time or within 7 days as the gravity 
stress X-ray that is part of the routine clinical work-up for this injury.  The 
scan with the investigational CBCT scanner is estimated to last 
approximately 25 seconds.  The patient will be weight-bearing during the 
scan and can hold on to the built-in handles of the scanner for stability 
during the scan.  The subject will be shielded from radiation to the thyroid 
and genitals with commercially available shields.  The risks involved with 
this study include the risk of additional exposure to radiation delivered by 
the investigational CT scan.  The investigational CBCT scanner exposes 
the patient to approximately 50% less radiation per scan than a 
conventional CT scanner. (Carrino et al 2014)   With the investigational 
CBCT scan, there is the risk of pain caused by the need for weight bearing 
and/or flexion of an injured ankle.   If for any reason the subject 
experiences undue discomfort the study will be stopped and the patient 
will be excluded from the study if the scan cannot be performed.  
The patient will also fill out a visual analogue pain scale after both the 
investigational CT scan and gravity stress X-ray (Attachment D). 
Reference: Carrino, J.A., et al., Dedicated cone-beam CT system for 
extremity imaging. Radiology, 2014. 270(3): p. 816-824. 
 
9.3 Describe procedures performed to lessen the probability or 
magnitude of risks. 
Response: The risks involved in inclusion in the study include the risk of 
additional exposure to radiation from the investigational CT scan.  The 
investigational cone beam CT scanner exposes the patient to 
approximately 50% less radiation per scan than a conventional CT 
scanner. (Carrino et al 2014)  The investigational scanner will be shielded 
per manufacturer specifications (see attachment B).  The subject will be 

PROTOCOL TITLE: Comparison of a novel weight bearing cone beam 
computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
Page 12 of 42 
 
shielded from radiation to the thyroid and genitals with commercially 
available shields.  To address the risk of pain caused by the need for 
weight bearing on the injured ankle, the scans will only last about 25 
seconds.  The subject will be provided with assistance entering and exiting 
the scanner, and the handles attached to the housing of the scanner can be 
held by the subject for balance (but not for substantial unloading of weight 
bearing) on the extremity to prevent falling. 
Reference: Carrino, J.A., et al., Dedicated cone-beam CT system for 
extremity imaging. Radiology, 2014. 270(3): p. 816-824. 
9.4 Describe all drugs and devices used in the research and the purpose 
of their use, and their regulatory approval status. 
Response: This study involves the use of an investigational portable 
weight bearing 3D cone beam CT scanner produced by Carestream 
Health, Inc.  Supporting evidence contends that the prototype is a non-
significant risk device (see Attachment C).   
9.5 Describe the source records that will be used to collect data about 
subjects. (Attach all surveys, scripts, and data collection forms.) 
Response: Data will be collected from the patient’s medical records for 
screening potential research subjects (see attached Eligibility Form, 
Attachment A).  Demographic, X-ray and CT data, and a visual analogue 
pain scale score will be documented by the research coordinator, surgeon 
and radiologist (see attached Data Collection Forms, Attachment D).     
 
9.6 What data will be collected including long-term follow-up. 
Response: Demographic data (age, gender, race, height, weight), data from 
the gravity stress X-rays and CT scans (medial clear space distance, 
superior clear space distance, lateral overlap distance, lateral clear space 
distance, and lateral talar shift) and pain VAS data will be collected 
(Attachment D). The measures will be obtained by two independent 
radiologists.  Additionally, a visual analogue pain score will be obtained 
from the patient after both the investigational CT scan and gravity stress 
X-ray.  The actual amount of weight borne by the patient at the time of the 
CT scan will be measured by a scale embedded in the device. 
9.7 For HUD uses provide a description of the device, a summary of 
how you propose to use the device, including a description of any 
screening procedures, the HUD procedure, and any patient follow-
up visits, tests or procedures. 
Response: Not applicable, this study does not involve a HUD device. 
10.0 Data and Specimen Banking 

PROTOCOL TITLE: Comparison of a novel weight bearing cone beam 
computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
Page 13 of 42 
 
10.1 If data or specimens will be banked for future use, describe where 
the data/specimens will be stored, how long they will be stored, how 
the data/specimens will be accessed, and who will have access to the 
data/specimens. 
Response: The images obtained from the investigational cone beam CT 
scan will be saved for future use.  The images will be de-identified and 
saved in the PACS system at the Erie County Medical Center.  The study 
investigators and Carestream Health, Inc. will have access to these files. 
10.2 List the data to be stored or associated with each specimen. 
Response: The images obtained from the investigational cone beam CT 
scans will be saved for future use.   
10.3 Describe the procedures to release data or specimens, including: the 
process to request a release, approvals required for release, who 
can obtain data or specimens, and the data to be provided with 
specimens. 
Response: Requests for data will be accepted verbally or in writing.  The 
principal investigator will approve all requests for data.  Only the study 
investigators and Carestream Health, Inc. will be granted access to the 
data.  The images will be de-identified before they are released.  
Carestream Health, Inc. will be requesting de-identified images, from the 
study-related cone beam CT scans only, for promotion & marketing 
purposes, and to refine the methodology of the scanner. 
11.0 Data Management 
11.1 Describe the data analysis plan, including any statistical 
procedures. 
Response: To test for a difference in medial clear space between gravity 
stress X-ray and weight bearing cone beam CT, we will use a paired t-test. 
Intraclass correlation coefficients (ICC) and corresponding 95% 
confidence intervals will be computed as a measure of inter-rater 
reliability for the two radiologists who will assess the medial clear space.  
Bland-Altman plots will be used to visually assess agreement. 
We will also conduct receiver operating characteristic (ROC) curve 
analysis and report the area under the curve (AUC) and corresponding 
95% confidence interval.  Using medial clear space >4mm for the gravity 
stress X-ray as the gold standard, we will determine the optimal cut-point 
for the cone beam CT scan. 
11.2 Provide a power analysis. 
Response: Sample size calculation was based on paired t-test.  Estimates 
from the literature suggest the standard deviation of the difference of 

PROTOCOL TITLE: Comparison of a novel weight bearing cone beam 
computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
Page 14 of 42 
 
medial clear space is around 1.5 mm.  For a sample size of 20 patients and 
at the 0.05 significance level, we can obtain 80% power to detect a 
difference of at least 1mm. 
11.3 Describe the steps that will be taken secure the data (e.g., training, 
authorization of access, password protection, encryption, physical 
controls, certificates of confidentiality, and separation of identifiers 
and data) during storage, use, and transmission. 
Response: Data collection will be conducted by trained study personnel 
who have completed IRB training.  Data (i.e., demographics and CT and 
X-ray measures) will be entered into an Excel spreadsheet.  The images 
will be de-identified and saved electronically in the PACS system at Erie 
County Medical Center.  Data will be password protected and subject 
identity will be coded to ensure confidentiality of information.  Patient 
names will not be stored with the images and patient data, instead each 
subject will be assigned an ID number.  A separate password-protected 
spreadsheet will contain subject names and ID numbers to link the two 
together.   The PI will assume primary responsibility for the ongoing 
monitoring of the data and safety of the study.  Consent forms and other 
identifiable information will be stored in locked files separately from the 
study data.  All data will be stored in password protected files in the 
research office at UBMD Orthopaedics Location 2 at ECMC. 
11.4 Describe any procedures that will be used for quality control of 
collected data. 
Response: Data will be entered and verified at 100%.  We will utilize the 
services of the UB Clinical Research Office (CRO) for routine study 
monitoring activity.  The UB CRO monitor will source verify the data, 
including consent process, following first subject enrollment.  Subsequent 
monitoring activities will be arranged with the CRO depending on subject 
enrollment.  The images from the gravity stress X-ray and investigational 
CT scan will be provided to the participating radiologist in a blinded and 
random fashion.  When all subjects have been enrolled and undergone 
their scans, the scans will be presented randomly without any identifying 
information, on two separate occasions for measurement.  The average of 
the two sets of measurements will be used for primary analysis. 
11.5 Describe how data and specimens will be handled study-wide: 
Response: Screening data will be collected on forms by the surgeon, 
research coordinator and other trained study staff.  Demographic data will 
be documented on forms by the research coordinator or assistant. Data 
from the CT scan and X-ray will be documented on forms by the 
radiologist.  The images will be de-identified and saved on the PACS 
system at ECMC.  All data and collections forms (see Attachments A & 
D) will be collected by the research coordinator and stored securely. 

PROTOCOL TITLE: Comparison of a novel weight bearing cone beam 
computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
Page 15 of 42 
 
11.6 What information will be included in that data or associated with the 
specimens? 
Response: The following data will be collected: medical history, 
demographics, VAS pain score, and X-ray and investigational cone beam 
CT data (see Attachment D). 
11.7 Where and how data or specimens will be stored? 
Response: Consent forms and source data forms will be stored in locked 
files in the research office at UBMD Orthopaedics Location 2 at ECMC. 
The images will be saved on the PACS system at ECMC.  Electronic data 
will be stored on our department’s secure network drive in password 
protected files.   
11.8 How long the data or specimens will be stored? 
Response: The data will be stored throughout the duration of the study and 
final data analysis.  The data will then be stored for 3 more years after the 
study closing date in accordance with the IRB policies. 
11.9 Who will have access to the data or specimens? 
Response: The study investigators, research coordinator and research 
assistant will have access to the data.  Carestream Health, Inc. will also 
have access to the images upon request and under approval of the principal 
investigator.  Images will be de-identified before sharing with Carestream 
Health, Inc. 
11.10Who is responsible for receipt or transmission of the data or 
specimens? 
Response: The research coordinator or assistant is responsible for 
retrieving and storing the data. 
11.11How data and specimens will be transported? 
Response: The research coordinator or assistant will pick up the study 
forms directly from the consenting and enrolling physicians after 
enrollment on a daily basis. 
12.0 Provisions to Monitor the Data and Ensure the Safety of Subjects 
12.1 Describe the plan to periodically evaluate the data collected 
regarding both harms and benefits to determine whether subjects 
remain safe.   
Response: Adverse events will be reported to the Data Safety Monitoring 
Board (DSMB) within 2 days to review safety of the study. 
12.2 Describe what data are reviewed, including safety data, untoward 
events, and efficacy data. 

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computed tomography (CT) scan to gravity stress X-ray for determining 
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Response: Any adverse events will be reported to the research coordinator 
and reviewed by the DSMB within 2 days of notification of the event.   
12.3 Describe how the safety information will be collected (e.g., with case 
report forms, at study visits, by telephone calls with participants). 
Response: Adverse events will be documented in writing during study 
visits. 
12.4 Describe the frequency of data collection, including when safety 
data collection starts. 
Response: Safety data collection will begin after signed informed consent 
is obtained and continues until all data has been collected from 20 
patients.   
12.5 Describe who will review the data. 
Response: Data collection will be monitored by the University at Buffalo 
Clinical Research Office for appropriate reporting of all adverse events 
and any serious adverse events that may occur during the course of the 
trial.  The PI will have oversight of all of the subject data. 
12.6 Describe the frequency or periodicity of review of cumulative data. 
Response: Given the small sample size and relative low risk of the study 
and procedures, cumulative data will be analyzed when 20 subjects have 
been enrolled. 
12.7 Describe the statistical tests for analyzing the safety data to 
determine whether harm is occurring. 
Response: Adverse events will be reviewed by the DSMB on a case-by-
case basis to determine if harm is occurring. 
12.8 Describe any conditions that trigger an immediate suspension of the 
research. 
Response: This study is low risk and we are not aware of a specific 
condition that would suspend the study.  The DSMB will review all 
adverse events and assist in determining if the study needs to be 
suspended.   
13.0 Withdrawal of Subjects 
13.1 Describe anticipated circumstances under which subjects will be 
withdrawn from the research without their consent. 
Response: If the patient is noncompliant or unable to stand in the weight 
bearing position, they will be withdrawn.  If the subject exhibits any 
discomfort the study will be stopped immediately.   
13.2 Describe any procedures for orderly termination. 

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computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
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Response: Subjects will be withdrawn from the study by the principal 
investigator if they do not complete the investigational CBCT scan.  
Subjects can withdraw from the study at any time, for any reason. 
13.3 Describe procedures that will be followed when subjects withdraw 
from the research, including partial withdrawal from procedures 
with continued data collection. 
Response: If the patient does not complete the investigational cone beam 
CT scan, none of their data will be retained.   
14.0 Risks to Subjects 
14.1 List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the subjects related the subjects’ participation in 
the research. Include as may be useful for the IRB’s consideration, a 
description of the probability, magnitude, duration, and reversibility 
of the risks. Consider physical, psychological, social, legal, and 
economic risks. 
Response: The risks involved in inclusion in the study include the risk of 
additional exposure to radiation from the investigational CBCT scan.  The 
investigational cone beam CT scanner exposes the patient to 
approximately 50% less radiation per scan than a conventional CT 
scanner, the total dose delivered to study subjects will be half that of a 
single conventional CT scan. (Carrino et al 2014)  The investigational 
scanner will be shielded per manufacturer specifications (see Attachment 
B).  The subject will be shielded from radiation to the thyroid and genitals 
with commercially available shields.  To address the risk of pain caused 
by the need for weight bearing and/or flexion of an injured knee, the scan 
will only last about 25 seconds.  The subject will be provided with 
assistance entering and exiting the scanner, and the handles attached to the  
housing of the scanner can be held by the subject for balance (but not for 
substantial unloading of weight bearing) on the extremity to prevent 
falling. 
14.2 If applicable, indicate which procedures may have risks to the 
subjects that are currently unforeseeable. 
Response: There are no unforeseeable risks to report. 
14.3 If applicable, indicate which procedures may have risks to an 
embryo or fetus should the subject be or become pregnant. 
Response: The CBCT scan does involve a low dose of radiation, thus 
women who are currently pregnant will not be included in the study. 
14.4 If applicable, describe risks to others who are not subjects. 

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computed tomography (CT) scan to gravity stress X-ray for determining 
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Response: Technicians who are running the CBCT scanner will be 
properly trained in safety and take the necessary precautions to protect 
themselves from radiation exposure.  There are no risks to family or those 
in close contact with the subject during their participation in the trial (see 
Attachment B). 
15.0 Potential Benefits to Subjects 
15.1 Describe the potential benefits that individual subjects may 
experience from taking part in the research. Include as may be 
useful for the IRB’s consideration, the probability, magnitude, and 
duration of the potential benefits. 
Response: There may be no potential benefits to subjects who enroll in the 
study. 
15.2 Indicate if there is no direct benefit. Do not include benefits to 
society or others. 
Response: There are no direct benefits to subjects who enroll in the study. 
16.0 Vulnerable Populations 
16.1 If the research involves individuals who are vulnerable to coercion 
or undue influence, describe additional safeguards included to 
protect their rights and welfare. 
 
If the research involves pregnant women, review 
“CHECKLIST: Pregnant Women (HRP-412)” to ensure that 
you have provided sufficient information. 
 
If the research involves neonates of uncertain viability or non-
viable neonates, review “CHECKLIST: Neonates (HRP-413)” 
or “HRP-414 – CHECKLIST: Neonates of Uncertain Viability 
(HRP-414)” to ensure that you have provided sufficient 
information. 
 
If the research involves prisoners, review “CHECKLIST: 
Prisoners (HRP-415)” to ensure that you have provided 
sufficient information. 
 
If the research involves persons who have not attained the 
legal age for consent to treatments or procedures involved in 
the research (“children”), review the “CHECKLIST: Children 
(HRP-416)” to ensure that you have provided sufficient 
information. 
 
If the research involves cognitively impaired adults, review 
“CHECKLIST: Cognitively Impaired Adults (HRP-417)” to 
ensure that you have provided sufficient information. 
 
Consider if other specifically targeted populations such as 
students, employees of a specific firm or 

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computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
Page 19 of 42 
 
educationally/economically disadvantaged persons are 
vulnerable to coercion or undue influence.  The checklists 
listed above for other populations should be used as a guide to 
ensure that you have provided sufficient information.  
Response: This research does not involve any of these vulnerable 
populations. 
17.0 Community-Based Participatory Research 
17.1 Describe involvement of the community in the design and conduct of 
the research. 
Response: NA, this is not a community-based study. 
Note: “Community-based Participatory Research” is a collaborative 
approach to research that equitably involves all partners in the 
research process and recognizes the unique strengths that each 
brings. Community-based Participatory Research begins with a 
research topic of importance to the community, has the aim of 
combining knowledge with action and achieving social change to 
improve health outcomes and eliminate health disparities. 
18.0 Sharing of Results with Subjects 
18.1 Describe whether or not results (study results or individual subject 
results, such as results of investigational diagnostic tests, genetic 
tests, or incidental findings) will be shared with subjects or others 
(e.g., the subject’s primary care physicians) and if so, describe how 
it will be shared. 
Response: The study results or individual subject results, such as results of 
investigational diagnostic imaging, will be shared with the study subjects 
if requested verbally or in writing.  The study results may become public 
knowledge if included in a manuscript accepted for publication in peer 
reviewed scientific literature. Any and all identifying features of 
individual images will be de-identified before publication. 
19.0 Setting 
19.1 Describe the sites or locations where your research team will 
conduct the research.  
Response: Research will be conducted at UBMD Orthopaedics & Sports 
Medicine.  The investigational CBCT scanner will be located in the 
SkyView Room of the radiology department at ECMC. 
19.2 Identify where your research team will identify and recruit potential 
subjects. 

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computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
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Response: Subjects will be recruited & consented after undergoing an 
orthopaedic consultation at the ECMC Emergency Department or in the 
offices of the physicians of UBMD Orthopedics and Sports Medicine at 
ECMC or the Northtowns office (4949 Harlem Rd., Amherst, NY 14226). 
19.3 Identify where research procedures will be performed. 
Response: Subjects will be recruited & consented at ECMC Emergency 
Department or in the offices of the physicians of UBMD Orthopedics and 
Sports Medicine at ECMC or the Northtowns office (4949 Harlem Rd., 
Amherst, NY 14226).  The investigational CBCT scan will be done in the 
SkyView room of the radiology department at ECMC. 
19.4 Describe the composition and involvement of any community 
advisory board. 
Response: NA, there will be no community advisory board involved in 
this study. 
19.5 For research conducted outside of the organization and its affiliates 
describe: 
 Site-specific regulations or customs affecting the research for 
research outside the organization. 
 Local scientific and ethical review structure outside the 
organization. 
Response: NA, research will not be conducted outside of the organization. 
20.0 Resources Available 
20.1 Describe the qualifications (e.g., training, experience, oversight) of 
you and your staff as required to perform their role. When 
applicable describe their knowledge of the local study sites, culture, 
and society. Provide enough information to convince the IRB that 
you have qualified staff for the proposed research. Note- If you 
specify a person by name, a change to that person will require prior 
approval by the IRB. If you specify people by role (e.g., coordinator, 
research assistant, co-investigator, or pharmacist), a change to that 
person will not usually require prior approval by the IRB, provided 
that person meets the qualifications described to fulfill their roles. 
Response: John Marzo, MD is the principal investigator and Associate 
Professor of Clinical Orthopedics, SUNY University at Buffalo, and has 
extensive experience in clinical research.  Christopher Ritter, MD, 
Christopher Mutty, MD, and Mark Anders, MD are all faculty members of 
UBMD Orthopaedics & Sports Medicine and very active traumatologists 
experienced in treating SER fractures. They are all active in clinical 
research of orthopaedic trauma. Collaborating investigators, Michael 

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computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
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Manka currently serves as the Chief of Emergency Medicine at Erie 
County Medical Center, and Jon Marshall, MD and Keyur Shah, MD are 
both Board Certified in Radiology.  Several orthopaedic residents at 
UBMD Orthopaedics and Sports Medicine will assist with obtaining 
informed consent and all have extensive experience in patient interaction 
(Matthew Binkley, MD, Matthew Brown, MD, Timothy Bryan, MD, 
Samir Nayyar, MD, Christopher Urband, MD, Richard Ahn, MD, Rishi 
Dave, MD, Paul Phillips, MD, Andrew Baron, MD, Alexander Boiwka, 
MD, Kathleen Boyle, MD, Tyler Miller, MD, and Nicholas Valente, MD).  
Melissa Kluczynski has a MS in Epidemiology and has been a Clinical 
Research Associate at UBMD Orthopaedics & Sports Medicine for several 
years.  She is productive and experienced in orthopaedic research and 
clinical trials.  Laura Ryan, MPH and Kathleen Lafferty are Research 
Assistants at UBMD Orthopaedics & Sports Medicine and are very 
experienced in assisting with orthopaedic research studies.  All of the 
above investigators have integral knowledge of the local study sites, 
culture, and society. All personnel mentioned have CITI and GCP 
training. 
Describe other resources available to conduct the research: For example, 
as appropriate: 
20.2 Justify the feasibility of recruiting the required number of suitable 
subjects within the agreed recruitment period. For example, how 
many potential subjects do you have access to? What percentage of 
those potential subjects do you need to recruit? 
Response: In the past year, approximately 50-60 patients with potentially 
unstable SER type ankle fractures were treated by the study investigators.  
Based on our sample size calculation, we need to enroll 20 patients.  Thus 
we should have a sufficient pool of subjects to recruit from. 
20.3 Describe the time that you will devote to conducting and completing 
the research. 
Response: We estimate that it will take about 8 months to 1 year to enroll 
all subjects, and about 6 months after that to complete the analysis and a 
manuscript. 
20.4 Describe your facilities. 
Response: Erie County Medical Center is a hospital with 550 licensed 
beds located in Buffalo, New York and is a member of the Great Lakes 
Health System. The hospital is affiliated with the University at Buffalo. 
The hospital is equipped with the latest information technology, including 
an electronic medical record system. 

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computed tomography (CT) scan to gravity stress X-ray for determining 
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20.5 Describe the availability of medical or psychological resources that 
subjects might need as a result of an anticipated consequences of the 
human research. 
Response: The radiology technician will periodically evaluate acquisition 
of the first CBCT scan to ensure maximum patient comfort and safety. 
Modifications will be made as appropriate and may include cushions, 
padding, external supports, or other changes when they add patient 
comfort or safety. Subjects will be withdrawn from the study if they 
cannot complete the investigational CBCT scan. Subjects can withdraw 
from the study at any time, for any reason.  No other medical or 
psychological issues are expected to occur as a result of this study. 
20.6 Describe your process to ensure that all persons assisting with the 
research are adequately informed about the protocol, the research 
procedures, and their duties and functions. 
Response: Each of the persons assisting with the research has been 
involved in designing the study, and writing of this proposal.  The 
investigative team will meet periodically to discuss the protocol, modify 
the research procedures as necessary, and review the results.  All study 
personnel will be involved in preparing a manuscript based on the results 
of the study. 
21.0 Prior Approvals 
21.1 Describe any approvals that will be obtained prior to commencing 
the research. (E.g., school, external site. funding agency, laboratory, 
radiation safety, or biosafety approval.) 
Response: Prior to commencing the research, a basic research agreement 
will be executed between The Research Foundation for the State 
University of New York (“Institution”) on behalf of the University at 
Buffalo (“University”) with a business address of 402 Crofts Hall, 
University at Buffalo, Buffalo, New York 14260-7016 and Carestream 
Health, Inc. (funding agency), a Delaware Corporation with its principal 
office located at 150 Verona Street, Rochester, New York 14608. 
Additionally, research approval will be obtained from ECMC’s Clinical 
Research Department.  
22.0 Recruitment Methods 
22.1 Describe when, where, and how potential subjects will be recruited. 
Response: Subjects will be recruited after presenting to the ECMC 
emergency department or the physician’s office with a potentially unstable 
SER type ankle fracture as clinically diagnosed by a consulting 
orthopaedic physician. The study will be explained to subjects who are 

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computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
Page 23 of 42 
 
deemed to be eligible for this study.  Consent will be obtained from 
subjects who agree to participate.   
22.2 Describe the source of subjects. 
Response: Subjects will be patients who present to the emergency 
department at ECMC or to the physician’s office with a potentially 
unstable SER type ankle fracture who are receiving medical care from one 
of the study investigators. 
22.3 Describe the methods that will be used to identify potential subjects. 
Response: Subjects will be screened by one of the consulting orthopedic 
physicians (included as study personnel) during their visit.  Each subject’s 
medical record will be reviewed to determine if the subject is eligible.  
The Eligibility Checklist (see Attachment A) will be completed for each 
patient who is screened. 
22.4 Describe materials that will be used to recruit subjects. (Attach 
copies of these documents with the application. For advertisements, 
attach the final copy of printed advertisements. When advertisements 
are taped for broadcast, attach the final audio/video tape. You may 
submit the wording of the advertisement prior to taping to preclude 
re-taping because of inappropriate wording, provided the IRB 
reviews the final audio/video tape.) 
Response: NA, there are no recruitment materials.   
22.5 Describe the amount and timing of any payments to subjects. 
Response: NA, subjects will not be compensated for their participation in 
this study. 
23.0 Local Number of Subjects 
23.1 Indicate the total number of subjects to be accrued locally. 
Response: A total of 20 patients will be enrolled locally. 
23.2 If applicable, distinguish between the number of subjects who are 
expected to be enrolled and screened, and the number of subjects 
needed to complete the research procedures (i.e., numbers of 
subjects excluding screen failures.) 
Response: Based on last year’s records, approximately 50-60 patients were 
diagnosed with SER fractures by the study investigators.  Thus, at most we 
expect to screen 60 patients and exclude 20-30% due to ineligibility or 
lack of interest in participating.  Our sample size analysis indicated that 
we need to enroll 20 patients that will complete the study procedures.  
24.0 Confidentiality 

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instability of supination-external rotation type ankle fractures 
 
 
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Describe the local procedures for maintenance of confidentiality. 
24.1 Where and how data or specimens will be stored locally? 
Response: All study participants will be assigned an ID number to protect 
their anonymity and confidentiality.  De-identified data will be stored in 
password protected files in the research office at UBMD Orthopaedics 
Location 2 at ECMC until publication, followed by storage on disks in 
locked files in the same room.  The consent forms and source data forms 
will be stored in locked files in the same office mentioned above.   
24.2 How long the data or specimens will be stored locally? 
Response: The data will be stored throughout the duration of the study 
(approximately 1.5 years), and for three years after the study closes in 
accordance with IRB regulations. 
24.3 Who will have access to the data or specimens locally? 
Response: The study investigators, research coordinator and assistant will 
have access to the data. 
24.4 Who is responsible for receipt or transmission of the data or 
specimens locally? 
Response: The research coordinator and assistant are responsible for 
retrieving and storing the consent forms and source data forms. 
24.5 How data and specimens will be transported locally? 
Response: The research coordinator or assistant will pick up study forms 
directly from the study physicians and data collectors at ECMC. 
25.0 Provisions to Protect the Privacy Interests of Subjects 
25.1 Describe the steps that will be taken to protect subjects’ privacy 
interests. “Privacy interest” refers to a person’s desire to place 
limits on whom they interact or whom they provide personal 
information. 
Response: The consent form that subjects will sign, includes a HIPAA 
authorization which all study personnel will uphold.  All subjects will be 
assigned an ID number for the study to protect their privacy and only 
study personnel will have access to the data. 
25.2 Describe what steps you will take to make the subjects feel at ease 
with the research situation in terms of the questions being asked and 
the procedures being performed. “At ease” does not refer to 
physical discomfort, but the sense of intrusiveness a subject might 
experience in response to questions, examinations, and procedures. 
Response: Subjects are not going to be asked any sensitive questions.  The 
only procedure that the subject will undergo for this study is an 

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computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
Page 25 of 42 
 
investigational cone beam CT scan.  If the patient feels uncomfortable for 
any reason, either emotionally or physically, the study will be stopped.  
The imaging technicians are trained in making the patient feel at ease 
during the procedure.   
25.3 Indicate how the research team is permitted to access any sources of 
information about the subjects. 
Response: The research team has access to the subjects’ medical records 
via our electronic medical record system.  The research coordinator will 
manage all study data and the research team will be given access to the 
data as necessary.  Carestream Health will not have access to the subject’s 
medical records. 
 
26.0 Compensation for Research-Related Injury 
26.1 If the research involves more than Minimal Risk to subjects, describe 
the available compensation in the event of research related injury. 
Response: It is unlikely that a patient will become ill or injured from this 
study.  However, if the patient is injured as a direct result of their 
participation the patient will be responsible for paying for their own 
medical care. 
 
26.2 Provide a copy of contract language, if any, relevant to 
compensation for research-related injury. 
Response: The contract stipulates the following: “Carestream will 
reimburse Institution for direct, reasonable and necessary medical 
expenses incurred by Institution for the treatment of any adverse 
experiences by, illness of, or bodily injury to a Protocol subject that is 
caused by treatment of the Protocol subject in accordance with the 
Protocol.  Carestream will not be responsible for paying medical expenses 
associated with treatment of the normal progression of the subject’s 
disease, nor for injuries resulting from interventions that the subject would 
have incurred had they not participated in the Protocol.”  
27.0 Economic Burden to Subjects 
27.1 Describe any costs that subjects may be responsible for because of 
participation in the research. 
Response: The patient will be responsible for providing their own 
transportation to and from ECMC for the investigational CT scans.  
 
28.0 Consent Process 

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computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
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28.1 Indicate whether you will be obtaining consent 
Response: Consent will be obtained from all subjects who agree to 
participate in this study. 
28.2 Describe where  the consent process take place 
Response: Subjects will be consented in the ECMC emergency department 
or physician’s offices. 
28.3 Describe any waiting period available between informing the 
prospective subject and obtaining the consent. 
Response: Subjects will be consented when they are initially diagnosed 
with a potentially unstable SER type ankle fracture and before they are 
sent for their gravity stress x-ray and investigational cone beam CT scan. 
 
28.4 Describe any process to ensure ongoing consent. 
Response: Subjects will be consented once at the beginning of the study.  
There is only one study visit so ongoing consent is not necessary.   
 
28.5 Describe whether you will be following “SOP: Informed Consent 
Process for Research (HRP-090).” If not, describe: 
 
The role of the individuals listed in the application as being 
involved in the consent process. 
 
The time that will be devoted to the consent discussion. 
 
Steps that will be taken to minimize the possibility of coercion 
or undue influence. 
 
Steps that will be taken to ensure the subjects’ understanding. 
Response: Yes, HRP-090 will be followed when consenting. 
 
Non-English Speaking Subjects  
28.6 Indicate what language(s) other than English are likely to be 
spoken/understood by your prospective study population or their 
legally authorized representatives. 
Response: Spanish is the most likely non-English language that we might 
encounter in this study population.  Non-English speakers will be included 
in this study.  Information for non-English speakers will be provided in 
oral form with the use of an interpreter. 
 

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computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
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28.7 If subjects who do not speak English will be enrolled, describe the 
process to ensure that the oral and written information provided to 
those subjects will be in that language. Indicate the language that 
will be used by those obtaining consent. 
Response: Based on previous experience, we expect that most if not all of 
our potential study subjects will speak English.  However, if we encounter 
a non-English speaking subject we will find someone who can orally 
translate (i.e., fluently speaks the same language as the subject, such as a 
family member) the study description and consent form to the subject. 
 
Waiver or Alteration of Consent Process (consent will not be obtained, 
required information will not be disclosed, or the research involves 
deception) 
28.8 Review the “CHECKLIST: Waiver or Alteration of Consent Process 
(HRP-410)” to ensure you have provided sufficient information for 
the IRB to make these determinations. Provide any additional 
information necessary here: 
Response: Not applicable, consent will not be waived for this study. 
 
28.9 If the research involves a waiver the consent process for planned 
emergency research, please review the “CHECKLIST: Waiver of 
Consent for Emergency Research (HRP-419)” to ensure you have 
provided sufficient information for the IRB to make these 
determinations. Provide any additional information necessary here: 
Response: Not applicable, this study does not involve Emergency 
Research. 
 
Subjects who are not yet adults (infants, children, teenagers) 
28.10Describe the criteria that will be used to determine whether a 
prospective subject has not attained the legal age for consent to 
treatments or procedures involved in the research under the 
applicable law of the jurisdiction in which the research will be 
conducted. (E.g., individuals under the age of 18 years.) For 
research conducted in NY state, review “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013)” to be aware 
of which individuals in the state meet the definition of “children.” 
Response: Not applicable, this study does not include subjects under 18 
years of age. 
 

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computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
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28.11For research conducted outside of NY state, provide information that 
describes which persons have not attained the legal age for consent 
to treatments or procedures involved the research, under the 
applicable law of the jurisdiction in which research will be 
conducted. One method of obtaining this information is to have a 
legal counsel or authority review your protocol along the definition 
of “children” in “SOP: Legally Authorized Representatives, 
Children, and Guardians (HRP-013).” 
Response: Not applicable, this study will not be conducted outside of 
NYS. 
 
28.12Describe whether parental permission will be obtained from: 
 
Both parents unless one parent is deceased, unknown, 
incompetent, or not reasonably available, or when only one 
parent has legal responsibility for the care and custody of the 
child. 
 
One parent even if the other parent is alive, known, competent, 
reasonably available, and shares legal responsibility for the 
care and custody of the child. 
Response: Not applicable, this study does not include subjects under 18 
years of age. 
 
28.13Describe whether permission will be obtained from individuals other 
than parents, and if so, who will be allowed to provide permission. 
Describe the process used to determine these individuals’ authority 
to consent to each child’s general medical care. 
Response: Not applicable, this study does not include subjects under 18 
years of age. 
 
28.14Indicate whether assent will be obtained from all, some, or none of 
the children. If assent will be obtained from some children, indicate 
which children will be required to assent. 
Response: Not applicable, this study does not include subjects under 18 
years of age. 
 
28.15When assent of children is obtained describe whether and how it will 
be documented. 

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computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
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Response: Not applicable, this study does not include subjects under 18 
years of age. 
 
Cognitively Impaired Adults 
28.16Describe the process to determine whether an individual is capable 
of consent. The IRB sometimes allows the person obtaining assent to 
document assent on the consent document and does not 
automatically require assent documents to be used. 
Response: Not applicable, cognitively impaired adults will not be included 
in this study. 
 
Adults Unable to Consent 
When a person is not capable of consent due to cognitive impairment, a 
legally authorized representative should be used to provide consent and, 
where possible, assent of the individual should also be solicited. 
28.17List the individuals from whom permission will be obtained in order 
of priority. (e.g., durable power of attorney for health care, court 
appointed guardian for health care decisions, spouse, and adult 
child.)  For research conducted in NY state, review “SOP: Legally 
Authorized Representatives, Children, and Guardians (HRP-013)” 
to be aware of which individuals in the state meet the definition of 
“legally authorized representative.”  The list in the consent template 
signature section corresponds to the priority list for NYS.   
Response: Not applicable, cognitively impaired adults will not be included 
in this study. 
 
28.18For research conducted outside of NY state, provide information that 
describes which individuals are authorized under applicable law to 
consent on behalf of a prospective subject to their participation in 
the procedure(s) involved in this research. One method of obtaining 
this information is to have a legal counsel or authority review your 
protocol along the definition of “legally authorized representative” 
in “SOP: Legally Authorized Representatives, Children, and 
Guardians (HRP-013).” 
Response: Not applicable, this study does not involve research outside of 
NYS. 
 
28.19Describe the process for assent of the subjects. Indicate whether: 

PROTOCOL TITLE: Comparison of a novel weight bearing cone beam 
computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
Page 30 of 42 
 
 
Assent will be required of all, some, or none of the subjects. If 
some, indicated, which subjects will be required to assent and 
which will not. 
 
If assent will not be obtained from some or all subjects, an 
explanation of why not. 
 
Describe whether assent of the subjects will be documented 
and the process to document assent. The IRB allows the person 
obtaining assent to document assent on the consent document 
and does not routinely require assent documents and does not 
routinely require subjects to sign assent documents. 
Response: Consent will be obtained from all adult subjects over 18 years-
old, this study does not include subjects under 18 years of age. 
 
28.20For HUD uses provide a description of how the patient will be 
informed of the potential risks and benefits of the HUD and any 
procedures associated with its use. 
Response: Not applicable, this is not a HUD study. 
 
29.0 Process to Document Consent in Writing 
 
If your research presents no more than minimal risk of harm to subjects and 
involves no procedures for which written documentation of consent is normally 
required outside of the research context, the IRB will generally waive the 
requirement to obtain written documentation of consent. 
(If you will document consent in writing, attach a consent document. If you will 
obtain consent, but not document consent in writing, attach a consent script. 
Review “CHECKLIST: Waiver of Written Documentation of Consent (HRP-411)” 
to ensure that you have provided sufficient information. You may use 
“TEMPLATE CONSENT DOCUMENT (HRP-502)”to create the consent 
document or script.) 
29.1 Describe whether you will be following “SOP: Written 
Documentation of Consent (HRP-091).” If not, describe whether and 
how consent of the subject will be obtained including whether or not 
it will be documented in writing. 
Response: HRP-091 will be followed when consenting subjects. 
 
30.0 Drugs or Devices 

PROTOCOL TITLE: Comparison of a novel weight bearing cone beam 
computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
Page 31 of 42 
 
30.1 If the research involves drugs or device, describe your plans to store, 
handle, and administer those drugs or devices so that they will be 
used only on subjects and be used only by authorized investigators. 
Response: The CBCT scanner will be stored in a locked room at ECMC 
and only trained study staff will have access to it.  A trained technician 
will operate the CBCT scanner.  The CBCT scanner will only be used for 
study procedures approved by the UB IRB. 
 
If the drug is investigational (has an IND) or the device has an IDE or a 
claim of abbreviated IDE (non-significant risk device), include the 
following information: 
30.2 Identify the holder of the IND/IDE/Abbreviated IDE. 
Response: The investigational cone beam CT scanner is being provided by 
Carestream Health, Inc.  This device poses non-significant risk (see 
Attachment B). 
 
30.3 Explain procedures followed to comply with FDA sponsor 
requirements for the following: 
 
Applicable to: 
FDA Regulation 
IND Studies 
IDE studies 
Abbreviated 
IDE studies 
21 CFR 11 
X 
X 
 
21 CFR 54 
X 
X 
 
21 CFR 210 
X 
 
 
21 CFR 211 
X 
 
 
21 CFR 312 
X 
 
 
21 CFR 812 
 
X 
X 
21 CFR 820 
 
X 
 
Response: Not applicable, this is not an FDA study. 
 
 
 

PROTOCOL TITLE: Comparison of a novel weight bearing cone beam 
computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
Page 32 of 42 
 
 
Attachment A. Eligibility Form 
SER Ankle Fracture Instability STUDY 
ELIGIBILITY QUESTIONS 
TODAY’S DATE: ____________________________________ 
 
 
 
PATIENT’S NAME: _________________________________   
 
 
Please answer the following questions for ALL patients diagnosed with a suspected 
unstable supination-external rotation type ankle fracture requiring a gravity stress 
X-ray.  Please refer to the Inclusion Criteria column to determine if the patient is 
eligible. 
Question 
Answer 
Inclusion Criteria 
1.) Does the patient have a 
diagnosis of a potentially 
unstable SER type (Weber B) 
ankle fracture? 
 
YES / NO 
The patient’s X-ray must show 
medial clear space less than 5 mm 
with clinical suspicion of 
instability  
 
2.) Is the patient able to provide 
written informed consent?  
 
 
YES / NO 
Patients must be able to provide 
written informed consent. 
3.) Is the currently imprisoned?  
 
YES / NO 
Patients must not be in prison. 
4.) How old is the patient? 
Age = ___________ 
Patients must be at least 18 
years-old. 
 
5.) Did the patient have an open 
fracture? 
 
YES / NO 
Patients must NOT have an open 
fracture. 
 
6.) Does the patient have clinical 
signs of ankle deformity? 
 
 
YES / NO 
Patient must NOT have clinical 
signs of ankle deformity. 
7.) Did the patient have any type 
of previous ankle trauma or 
surgery on the affected ankle? 
 
YES / NO 
Patient must NOT have had any 
type of previous ankle trauma or 
surgery on the affected ankle. 
8.) Does the patient have 
significant osteoarthritis or pre-
existing ligamentous instability 
or pain in the affected ankle? 
 
YES / NO 
Patient must NOT have significant 
osteoarthritis or pre-existing 
ligamentous instability or pain in 
the affected ankle. 

PROTOCOL TITLE: Comparison of a novel weight bearing cone beam 
computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
Page 33 of 42 
 
 
 
 
 
10.) Is the patient pregnant? 
 
Patient Verbal Response: YES / NO 
 
Urine pregnancy test result (for 
females who consent ONLY): 
Positive / Negative  
 
The patient must NOT be 
pregnant.  Females who consent 
to participate MUST have a 
negative urine pregnancy test.  
 
11.) Can the patient stand in the 
weight bearing position? 
YES / NO 
The patient MUST be able to 
stand in the weight bearing 
position for the cone beam CT 
scan. 
IS PATIENT ELIGIBLE FOR THE STUDY?          YES / NO 
 
DID THE PATIENT CHOOSE TO ENROLL IN THE STUDY?          YES / NO 
 
NOTES: 
 
 

PROTOCOL TITLE: Comparison of a novel weight bearing cone beam 
computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
Page 34 of 42 
 
 
Attachment B: Installation instructions 
 
CBCT 3D Extremity Imaging System 
 
 
          
 
 
                                                       
 
 
 

PROTOCOL TITLE: Comparison of a novel weight bearing cone beam 
computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
Page 35 of 42 
 
WARNING: 
The system should always be located a minimum distance of 7 feet from 
the center of the bore to the closest wall. 
 
Carestream scatter plot results show that at distances of 6 feet or 
greater from the center of the bore, the yearly exposure based on 1,000 
exams would be <50 millirem.  Correspondingly, 6,000 exams per year 
would be <300 millirem. 
 
WARNING: 
Operator should stand at least 6 feet away from the center of the bore 
during the entire exposure duration.  It is recommended that the Main 
Operator Console be positioned in the following orientation to 
accomplish this: 
                            
 
              
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
WARNING: 
Operator Location 
Closest Wall 
Center of Bore 
Main Operator Console 
Top View of System 
7 Feet 

PROTOCOL TITLE: Comparison of a novel weight bearing cone beam 
computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
Page 36 of 42 
 
The system is designed to attenuate most beam and scattered radiation 
in an effort to reduce shielding requirements for the operator.  Lead 
lined walls generally will not be necessary, however because shielding 
regulatory requirements vary for a variety of factors and by region - A 
room evaluation should be done by a qualified medical physicist.   
Similar to Dental CBCT systems, small office environments can typically 
be accommodated without significant modification to existing 
structures or workflow.  
 
Allowable annual NYS Operator dose < 500 millirem 
Maximum annual scans = 1,000 
Operator outside a 6 foot radius from isocenter will be < 50 millirem/year 
Conclusion: System can be operated at the maximum use case 
                      and be < 10% of the NYS allowable worker limit 
                      without requiring additional operator shielding. 
Allowable annual Public Space dose < 100 millirem 
Maximum annual scans = 1,000 
Dose absorption by double layer drywall = 50% 
Maximum dose/year inside wall is 200 millirem 
Conclusion: System can be installed adjacent to a fully occupied 
                      public space separated by double drywall and  
 
        stay below the allowable public limit 
                      without requiring additional room shielding 
                      if a 3 foot minimum distance from isocenter is maintained. 
 
 

PROTOCOL TITLE: Comparison of a novel weight bearing cone beam 
computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
Page 37 of 42 
 
Attachment C: Statement of Non-significant risk 
 
Carestream Health cone beam 3D CT scan 
Justification for assessment of non-significant risk device 
 
This assessment is drawn from FDA guidance documents, and from studies performed at Johns Hopkins University, where the 
prototype cone beam 3D CT scanning device was determine to be non-significant risk device. (IRB No. 00034417)  The device used 
in this study is an upgraded version (3rd generation) of the previous cone beam 3D CT scanner, with improved software for data 
acquisition and image processing.  There have also been changes to the physical configuration of the device, designed to improve 
patient set-up. 
 
Description of device:  The scanner is a diagnostic x-ray system intended to produce cross sectional images of the extremities of the 
body by computer reconstruction of x-ray transmission acquired at different angles. The prototype cone beam CT scanner is 
specifically designed for imaging of human extremities such as the shoulders, elbows, wrists, hands, knees, and ankles.  The scanner 
has the following unique capabilities and characteristics: 
- 
The unit is portable 
- 
The ability to acquire images with the joints under weight bearing status 
- 
The ability to acquire images of joints in various degrees of motion 
- 
Lower radiation dose exposure 
- 
No radiation shielding necessary 
- 
Produces higher quality resolution of 3D images 
- 
Allows measurement of surface area of contact in the joint 
 
The scanner, because of some of the above capabilities, has potential usefulness in a hospital department, an office, or operating room 
setting.  The intended use with respect to this document is to perform clinical research that demonstrates effectiveness of the device 
for diagnostic use in orthopedic surgery and radiology. 
 
Risk to Human Subjects:  The main risk to the subjects of study is due the use of ionizing radiation during the imaging 
procedure.  The estimated dosage that will be received by the study participants is ~ 0.14 mSv.  This dose is comparable to 
or less than the typical dose delivered during a conventional diagnostic CT scan – 0.16 mSv as reported by Biswas et al. 
(Radiation exposure from musculoskeletal computerized tomographic scans. JBJS A (91): 1882-1889, 2009)  Radiation 
dose at less than 1 mSv is orders of magnitude less than that associated with possible long term health risks, even by the 
most conservative estimates. (Brenner and Hall. Computed tomography – an increasing source of radiation exposure.  
NEJM 375(22): 2277, 2007)  This statement is also consistent with position statement of the American Association of 
Physicists in Medicine(AAPM), which states: “risks of medical imaging at effective doses below 50 mSv for single 
procedures or 100 mSv for multiple procedures over short periods are too low to be detectable and may be nonexistent.” 
The prototype of the scanner to be used in this study was previously reported by Carrino et al (Dedicated cone-beam CT 
system for extremity imaging. Radiology  270(3): 816-824, 2014) to deliver absolute dose of 9.0 mGy, compared to 39.7 
mGy for the same scan on a conventional CT scanner.  As further outlined by Biswas; these levels of radiation dose are 
approximately equal to the dose of two PA chest radiographs, or two transatlantic flights on a commercial airplane, and are 
“essentially neglible/trivial…” within the context of patient risk associated with radiation exposure.  In most patients, it 
would be expected that the diagnositic information yielded by the CT scan would supersede any concern about excessive 
radiation exposure.   
It is therefore contended that the dose levels associated with the proposed protocol will present negligible risk to the health, 
safety, or welfare of the study participants. 
 
Risk Determination:  Guidance for determination of significant(SR) or non-significant risk(NSR) risk can be found in part 
812.3(m) of the CFR Title 21 and in the FDA document Information sheet guidance for IRBs, clinical investigators, and 
sponsors.   
The FDA definition of a significant risk device is that the device: 
• Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;  
 
Assessment:  The scanner is not intended as an implant 
 
• Is purported or represented to be for use supporting or sustaining human life and presents a potential for serious risk to the health, 
safety, or welfare of a subject;  
 
Assessment:  The scanner is not for use in supporting or sustaining human life… 
 
• Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of 
human health and presents a potential for serious risk to the health, safety, or welfare of a subject;  
 
Assessment:  In this study, the scanner is not for use in diagnosing, curing, mitigating, or treating disease.  Enrolled 
subjects will undergo the normal physician encounter and diagnositic testing associated with their clinical condition.  The imaging 

PROTOCOL TITLE: Comparison of a novel weight bearing cone beam 
computed tomography (CT) scan to gravity stress X-ray for determining 
instability of supination-external rotation type ankle fractures 
 
 
Page 38 of 42 
 
procedure for this study will be taken in addition to the normal diagnostic testing(conventional CT scan).  The scan results will not 
influence patient treatment or clinical management decisions before the diagnosis is established by the medically established standards 
of history, physical examination, and imaging studies. 
 
• Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.  
 
Assessment:  With regard to the use of ionizing radiation, the primary potential risk to be considered is the induction of 
cancer, which is a function of many factors – most notably the level of radiation dose and the age of the patient at the time of 
exposure.  The study only includes subjects 16 years or older.  As noted above, the radiation dose associated with the scanner is ~0.14 
mSv, which is comparable to or less than that of conventional diagnostic CT of the extremities.  As noted by Biswas; these levels of 
radiation dose are “essentially neglible/trivial…” within the context of patient risk associated with radiation exposure.  Radiation dose 
at less than ~1 mSv is orders of magnitude lower than the dose believed to be associated with health risk, even by the most 
conservative of estimates.  Together, these factors suggest an insignificant risk to study participants associated with radiation 
exposure. 
 
According to the FDA document Information sheet guidance for IRBs, clinical investigators, and sponsors: “an NSR devise study is 
one that does not meet the definition for an SR device study.” As outlined in the items above, the proposed study device does not 
meet the definition of a significant risk device study, and is therefore NSR. 
 
Additional Supporting Information: We note the following examples as precedent support for the use of an xray producing system 
in an NSR device study: 
 
The determination of NSR at Johns Hopkins University for study of the prototype scanner to be used in this study (IRB No. 
00034417) 
 
The FDA document Information sheet guidance for IRBs, clinical investigators, and sponsors specifically uses digital 
mammography as an example of an NSR device 
 
The University of Pennsylvania Center for Advanced Computed Tomography Imaging Services, under their Human 
Policies and Procedures, allows CT device protocols to be classified as either NSR or SR.  
(see http:www.uphs.upenn.edu/radiology/research/labs/cactis/policies/human-studies.html) 
 
The Form 10-K/A SEC filing for a cone beam volumetric scanner with intended use in orthopedic imaging and image-
guided procedures identifies the system as a class II NSR device which subsequently gained 510(k) clearance. (O-arm, Imaging 3, 
Burbank, CA) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL TITLE: Comparison of a novel weight bearing cone beam computed tomography 
(CT) scan to gravity stress X-ray for determining instability of supination-external rotation type 
ankle fractures 
 
 
Page 39 of 42 
 
Attachment D: Data Form 
 
SER Ankle Fracture Instability STUDY: DEMOGRAPHIC DATA COLLECTION FORM 
 
STUDY ID#: ___________________  
 
 
 
TODAY’S DATE: __________________________ 
 
AGE: _______________ 
 
GENDER (check one): ____________ Male 
 
 
 
     ____________ Female 
RACE: ________________ 
 
HEIGHT: __________________ 
 
WEIGHT: ___________________ 
 
PATIENT’S DOCTOR: ___________________________   
 
AFFECTED SIDE: ____________ Right 
                                   ____________ Left 
 
COURSE OF TREATMENT: ____________________________________ 
 
 
 
 
 
 

PROTOCOL TITLE: Comparison of a novel weight bearing cone beam computed tomography 
(CT) scan to gravity stress X-ray for determining instability of supination-external rotation type 
ankle fractures 
 
 
Page 40 of 42 
 
SER Ankle Fracture Instability STUDY: CT DATA COLLECTION FORM 
 
STUDY ID #:  ________________ 
 
DATE OF CT SCAN: _____________________ 
RADIOLOGIST: ______________________________ 
 
RESULTS OF CT SCAN: 
 
Date of Measurement: ________________________ 
Medial Clear Space Distance: ___________________________________ 
 
Superior Clear Space Distance: _________________________________ 
 
 
Lateral Overlap Distance: ________________________________________ 
 
 
Lateral Clear Space Distance: __________________________ 
 
Lateral Talar Shift: _____________________________ 
 
Total Weight Bearing: ___________________ 
 
Percent Weight Bearing: ___________________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL TITLE: Comparison of a novel weight bearing cone beam computed tomography 
(CT) scan to gravity stress X-ray for determining instability of supination-external rotation type 
ankle fractures 
 
 
Page 41 of 42 
 
 
 
 
 
SER Ankle Fracture Instability STUDY: X-RAY DATA COLLECTION FORM 
 
STUDY ID #:  ________________ 
 
DATE OF X-RAY: _____________________ 
RADIOLOGIST: _______________________ 
 
RESULTS OF X-RAY: 
 
Date of Measurement: ________________________ 
Medial Clear Space Distance: ___________________________________  
 
Superior Clear Space Distance: _________________________________ 
 
 
Lateral Overlap Distance: ________________________________________ 
 
 
Lateral Clear Space Distance: ___________________________ 
 
Lateral Talar Shift: _____________________________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL TITLE: Comparison of a novel weight bearing cone beam computed tomography 
(CT) scan to gravity stress X-ray for determining instability of supination-external rotation type 
ankle fractures 
 
 
Page 42 of 42 
 
Visual Analogue Scale 
 
On a scale of 0 to 10, where 0 equals no pain and 10 equals extreme pain, please circle the number 
that best represents how much ankle pain you experienced during the scan. 
 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10