Preoperative Magnetic Resonance as an Alternative to Computed Tomography Three-Dimensional Imaging for Characterizing Bone Loss in Shoulder Arthroplasty Candidates With Glenohumeral Osteoarthritis: A Prospective, Blinded, and Controlled Clinical Trial.
Phase: NA
Conditions: Arthritis, Glenohumeral Osteoarthritis
Sponsor: NYU Langone Health

CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center. 
Do not disclose or use except as authorized in writing by the study sponsor (if applicable). 
Preoperative Magnetic Resonance as an Alternative to 
Computed Tomography Three-Dimensional Imaging for 
Characterizing Bone Loss in Shoulder Arthroplasty 
Candidates with Glenohumeral Osteoarthritis 
A prospective, blinded, and controlled clinical-trial. 
Regulatory Sponsor: 
NYU Langone Health 
333 E. 38th Street 
New York, NY 10016 
Funding Sponsor: 
Department of Orthopedic Surgery 
Principal Investigator: 
Joseph D. Zuckerman, MD 
Study Device (Non-
Interventional) 
Magnetic Resonance Imaging 
Co-Investigators: 
Soterios Gyftopoulos, MD 
Young W. Kwon, MD, PhD 
Mohammad M. Samim, MD 
Mandeep S. Virk, MD 
David H. Mai, MD, MPH 
Protocol Number: 
s17-00500 
Initial version:  8.21.2017 
Amended:10.11.2017 
Clinical Research Protocol 
NCT Number:      
 
NCT03379545 

3D MR versus 3D CT in Glenohumeral Osteoarthritis 
 
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Version: 10.11.2017 
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Do not disclose or use except as authorized in writing by the study sponsor (if applicable). 
 
Study Summary 
Title 
Preoperative Magnetic Resonance as an Alternative to Computed 
Tomography Three-Dimensional Imaging for Characterizing Bone Loss in 
Shoulder Arthroplasty Candidates with Glenohumeral Osteoarthritis: 
A prospective, blinded, and controlled clinical trial. 
Short Title 
3D MR versus 3D CT in Glenohumeral Osteoarthritis 
Protocol Number 
S17-00500 
Methodology 
A prospective, unrandomized, single-blinded, self-controlled, and single-armed 
diagnostic radiological evaluation study. 
Study Duration 
12-Months 
Study Center(s) 
Single-Center  
Purpose 
To examine the non-inferiority of three-dimensional (3D) magnetic resonance 
(MR) versus the gold-standard, 3D computed tomography (CT) imaging, in the 
analysis of bone loss in shoulder arthroplasty (SA) candidates with 
glenohumeral osteoarthritis (OA). This study does not assess the safety and 
efficacy of MR imaging for musculoskeletal disorders. 
Number of Subjects 
50 subjects 
Diagnosis and Main 
Inclusion Criteria 
Patients with glenohumeral OA who are candidates for SA based on clinical 
examination with radiographic evidence of significant glenoid wear; males and 
females age 18 and above. 
Study Intervention 
and Planned Use 
3D MR imaging of the shoulder for evaluation of glenoid bone loss. 
Reference 
Intervention 
3D CT imaging of the shoulder for evaluation of glenoid bone loss. 
Statistical 
Methodology 
Paired sample t-test to compare measurements by model and ANOVA to 
assess differences among modalities. 
 
 
 
 
 
 
 
 
 

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Do not disclose or use except as authorized in writing by the study sponsor (if applicable). 
 
I. PURPOSE OF THE STUDY AND BACKGROUND 
 
Purpose 
The purpose of this study is to examine the noninferiority of 3-dimensional (3D) magnetic resonance (MR) 
as an alternative to 3D computed tomography (CT) imaging to characterize glenoid bone loss in shoulder 
arthroplasty (SA) candidates with glenohumeral osteoarthritis and radiographic evidence of severe 
glenoid erosion. MR has been routinely used in musculoskeletal imaging with and without contrast. This 
study employs no non-FDA approved investigational MRI hardware or software. 
  
Background & Study Rationale  
There has been over a five-fold growth in incidence of shoulder arthroplasty (SA) for glenohumeral 
osteoarthritis (OA) since 2000 (1) (2) (3) (4). Asymmetric glenoid erosion may occur in glenohumeral OA 
(5). Patient-specific variations in magnitude and retroversion of glenoid bone loss in glenohumeral 
osteoarthritis pose a challenge for orthopaedic surgeons in joint reconstruction (6). Eccentric loading of 
the glenohumeral joint may lead to glenoid loosening which potentially requires revision surgery (7). 
Moreover, posterior glenoid erosion is a risk factor for poorer outcomes in function and pain (8) (9) (10). 
The management of glenoid erosion in shoulder arthroplasty demands individualized surgical techniques 
as well as implants to optimize outcomes and maximize implant longevity. Surgical techniques to address 
glenoid retroversion include eccentric reaming, glenoid bone grafts, augmented glenoid components, total 
shoulder arthroplasty, or specialized implants (7) (11) . The “gold-standard” modality for assessment of 
complex glenoid anatomy to assist with surgical planning is 3D CT imaging (9) (12) (13). However, CT 
imaging exposes patients to radiation. Recently, 3D MR has been developed to characterize glenoid bone 
loss (14). 
 
There is significant variation in glenoid morphology among patients with glenohumeral OA. Prior studies 
have discussed higher distributions of patients with glenoids who had posterior erosion and/or 
retroversion (15-18) . To better guide treatment approaches, Walch et al. described glenoid morphology 
using CT scans in 113 shoulders between 1988 and 1995 (19) . Specifically, the authors developed three 
broad classification types based on humeral head position, glenoid retroversion, and erosion pattern: 
Type A, Type B, and Type C. Types A and B have subgroups based on severity. 
 
Three-dimensional reconstruction of CT images at the glenohumeral joint have reliably assisted surgeons 
with preoperative planning whereas two-dimensional (2-D) radiographs and CT scans may misrepresent 
important anatomical characteristics of the shoulder leading to insufficient evaluation of erosion (12) (13). 
 
To mitigate radiation exposure from 3D CT, 3D MR could serve as an alternative for patients with end-
stage glenohumeral OA indicated for shoulder reconstruction. 
 
Study Design 
Prospective, unrandomized, double blinded, self-controlled clinical trial 
 
Objective 
 
1. The primary objective is to evaluate the noninferiority of 3D MR when compared to 3D CT for 
characterizing bone morphology in patients with glenohumeral osteoarthritis. 
 
Hypothesis 
3D MR imaging provides the same information as 3D CT in characterizing glenoid morphology. 
 
Primary Endpoints 
• 
Differences and/or similarities in glenoid erosion and version measurements between of 3D CT 
and 3D MR. 
 
Outcome Measure Evaluation Criteria 
• 
Degree of concordance/discordance between interpretation from 3D CT and 3D MR 
 
 

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Do not disclose or use except as authorized in writing by the study sponsor (if applicable). 
 
II. CHARACTERISTICS OF THE RESEARCH POPULATION 
 
Number of Subjects 
A total of fifty (50) patients will be enrolled in this study.  
 
Gender of Subjects  
Men and women will be included in this study. 
 
Age of Subjects 
Subjects will be at least 18 years of age. 
 
Racial and Ethnic Origin 
There are no enrollment restrictions based on race or ethnic origin. 
 
Inclusion Criteria 
• 
Males and females ages 18 or more; 
• 
Patients suffering from glenohumeral OA;  
• 
Radiographic evidence of severe glenoid erosion; 
• 
Indication for TSA based on clinical exam; 
• 
Patient is willing and able to review and sign a study informed consent form. 
 
Exclusion Criteria 
• 
Prior arthroplasty at the affected shoulder; 
• 
Patients with inflammatory arthritis; 
• 
Patients with post-capsulorrhaphy arthritis; 
• 
Patients with post-traumatic arthritis; 
• 
Patients with rotator cuff tear arthropathy; 
• 
Patients exhibiting a lack of physical or mental ability to perform or comply with the study 
procedures; 
• 
Patients who are pregnant; 
• 
Patients with implanted medical devices that are contraindicated to exposure up to a 3.0-tesla 
magnetic field. 
 
Vulnerable Subjects 
Vulnerable subjects will not be enrolled. 
 
Subject Withdrawal 
Patients are free to withdraw at any time from the study. 
 
 
 

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Do not disclose or use except as authorized in writing by the study sponsor (if applicable). 
 
III. METHODS AND PROCEDURES 
 
Sample Size Analysis 
Using SAS software, version 9.4 (SAS Institute Inc., Cary, NC, USA) based on paired t-test analysis, for 
alpha = .05 and power = .80, ten pairs are required, at minimum, for the study. 
 
Methods and Procedures  
 
Visit 1 -- Recruitment and Enrollment: 
The study will employ convenience sampling of surgical candidates with glenohumeral osteoarthritis from 
the practice of the primary investigator, who is the treating surgeon. Immediately following his or her 
clinical visit with the primary investigator, each patient who is a candidate for shoulder arthroplasty will 
receive information on the study, including benefits and harms of participating in the study from the co-
investigator at primary investigator’s clinical office (NYU Langone Orthopedic Center). Written consent will 
be obtained from subjects based upon their medical condition (as determined by their physician). The 
consent process will take place during an office visit at which time the investigator has determined 
subject’s voluntary participation has been upheld. Subjects will be informed about the study and the 
intended purpose. They will be given the opportunity to ask questions and receive thorough explanations. 
They will be made aware of the possible risks and anticipated benefits. They will also be informed of 
alternative procedures. Subjects will then be given another opportunity to ask questions and agree or 
disagree to consent. Potential subjects may enroll by providing informed consent with the co-investigator. 
The study will not exclude potential participants based on sex, race, and/or ethnicity. Subsequently, the 
study co-investigator will determine subject eligibility to participate in the study by obtaining information on 
potential contraindications of MR imaging, such as having prior history of injury involving metal or metallic 
particles as well as presence of medical implants, such as cardiac pacemakers.  
 
This recruitment and enrollment visit should take no more than thirty (30) minutes. 
 
 
Visit 2 -- Preoperative Imaging: 
Subjects will have both 3D CT and 3D non-contrast MR scheduled on the same day. The CT scan, which 
is standard of care, will be scheduled at NYU Langone Orthopedic Hospital followed by the MR, the 
investigational procedure, at NYU Langone Orthopedic Center. Before imaging, the subjects will be 
screened for potential contraindications to each imaging modality in accordance with institutional standard 
of care routine procedures.  The standard of care CT imaging will take no more than 30 minutes while the 
investigational MR imaging will take no more than 60 minutes in duration. Each enrolled subject will 
receive a standard of care CT scan along with an investigational MRI scan of the shoulder girdle while 
supine. Each enrolled subject’s CT imaging is not dependent on receiving prior MR imaging; he/she will 
not experience delays in receiving standard of care CT imaging as a result of study participation. 
 
The CT protocol consists of 3-mm axial images of the glenoid reconstructed into 1-mm sagittal and 
coronal 2D reconstructions using the following parameters: 120 kV, 280 mA, and pitch of 0.9. The CT 
data were also used to produce a 3D reconstruction of each glenoid. 
 
The 2D glenoid version is measured by 2 musculoskeletal-trained radiologists on 2 occasions, at a 
minimum of 2 weeks apart, with the observers blinded to each other’s results. The 2 observers meet 
before obtaining data to review the appropriate technique for measuring glenoid version. The 2D glenoid 
version is determined using the method of Friedman et al (17)  with the mid glenoid cut being determined 
by dividing the total number of axial cuts through the glenoid by 2 (20). 
 
The 2D CT images are imported in Vitrea software. The 3D volume rendering model will be produced. 
The 3D glenoid version is measured by the same 2 observers on 2 occasions, at a minimum of 2 weeks 
apart, with the observers blinded to each other’s results. Three points which were previously validated 
were first interactively placed on the Mimics 3D model by the observer: the inferior tip of the scapula 
body, the center of the glenoid surface, and the medial pole of the scapula, as described by Kwon et al. 
(12)  As described in detail below, these points were used to define the transverse scapular plane, based 

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on which a new 2D CT image is generated. Each observer then manually selected the anterior and 
posterior aspect of the glenoid on this 3D-corrected image, and version was determined according to the 
Friedman et al. (17) The new CT image along the transverse scapular plane is generated according to the 
following procedure. The true coronal scapular plane passed through the 3 points. The scapular axis was 
defined as the line passing through the center of the glenoid and the medial pole of the scapula. The 
transverse scapular plane was perpendicular to the coronal scapular plane and passed through the 
scapular axis. A new CT image along the transverse scapular plane is generated from the original CT 
data set using the Vitrea workstation.  
 
MRI is performed using 3T scanners with a dedicated 16-channel shoulder array coils. The MRI 
sequences include 3-mm slice thickness and 0.5-mm gap width with a field of view of 14 or 15 cm. There 
were 6 diagnostic sequences with axial, coronal, and sagittal proton density weighting as well as coronal 
T2 with frequency selective fat suppression and sagittal T1 images. The protocol also included an axial 
3D dual echo-time T1-weighted FLASH sequence with Dixon-based water–fat separation with the 
following parameters: TR 10, TE 2.45/3.7, field of view of 200 mm, acquired voxel size 1.0×1.0×1.4 mm, 
reconstructed voxel size 1.0×1.0×1.0 mm, flip angle 9 deg, matrix 192×192, bandwidth of 400 Hz/pixel, 
number of partitions=120 and a slice thickness of 1mm.  
 
MRI 3D Post-processing: The water-only source images from the Dixon sequence were post-processed 
using standard subtraction software on a syngo MMWP workstation (VB 3oE, Siemens). The lowest mean 
signal intensity (water min) from multiple ROIs placed on the soft tissues surrounding the osseous 
structures was used as a constant to calculate a subtraction image where the pixel values are subtracted 
from this constant (water_min – SI (i) with negative values being set to zero). This resulted in images 
with increased signal in the osseous structures, surrounded by signal poor/void soft tissue structures. 
These subtracted Dixon images then underwent manual segmentation, generating 3D reconstructions of 
each shoulder (Tera Recon software (4.4.5.36.2068)).  
 
The 3D MRI glenoid version is measured by the two observers with the same method used for CT 3D 
glenoid version measurement following generating a new 2D axial MR images form the 3D MRI model 
using the three-point method as described above.  
 
Data Analysis  
 
Using SAS software, version 9.4 (SAS Institute Inc., Cary, NC, USA) Paired sample t-test to compare 
measurements by model and ANOVA to assess differences among modalities. 
 
DATA SAFETY MONITORING PLAN (DSMP) 
 
I. 
Study Monitoring 
The co-investigator, Soterios Gyftopoulos, MD will be the data safety monitor for this project.  
After a three (3) months follow-up period, Dr. Gyftopoulos will review the data for SAE’s, protocol 
deviations and other issues. If it is determined that certain events occur above an expected rate 
(i.e. increased shoulder pain), then enrollment will be stopped. 
 
II. Types of Data 
Under this DSMP, the following data/events will be captured and documented: 
• 
Radiologic images; 
• 
Diagnostic radiology interpretations; 
• 
Reportable and/or adverse events; and 
• 
Protocol Deviations. 
 
III. Responsibilities and roles for gathering, evaluating and monitoring the data:  
Principal Investigator 

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After six months following study initiation, the PI will meet with any co-investigators and the 
Research Coordinator to discuss the current findings and analysis. During these meetings, the PI 
will also be responsible for verifying data accuracy, and compliance with the study protocol. 
 
Research Coordinator 
The Research Coordinator will be responsible for providing data management support to the PI 
by collecting and documenting the required study data. This information will be documented in a 
secure Microsoft Excel spreadsheet with appropriate headings to distinguish the various types of 
data/events. The Research Coordinator will meet with the PI and any co-investigators to discuss 
the current findings/analysis, concerns/issues (unanticipated problems and adverse events), and 
the overall study in general.   
 
IV. Reporting Adverse Events and Unanticipated Problems to the Monitoring Entity 
All reportable events will be sent to the IRB in accordance with the timeframes specified by NYU 
SoM reporting guidelines. The Principal Investigator will have the responsibility of completing and 
submitting a Reportable New Information (RNI) form to the IRB through Research Navigator.   
V. Assessments 
After 6 months and 1 year following study initiation, the Principal Investigator, Co-Investigator(s) 
and Research Coordinator will review and assess the data and/or events captured under the 
DSMP. 
VI. Criteria for Action 
Should there be an event or series of events that occur that increases the risks to the 
participants, the “following steps” will be taken: 
1. An investigation into the event will be conducted; 
2. If required, a Reportable New Information (RNI) form will be submitted to the IRB; 
3. All primary study staff (PI, Co-I, Research Coordinator) will be notified; 
4. After a review, 
a. The protocol may be modified; 
b. The study may be suspended; or 
c. A decision may be made to close out the study 
 
VII. Procedures for Communicating – dissemination of safety information 
Outcomes of monitoring reviews will be communicated to the IRB through a yearly summary that 
will include a narrative on all adverse and reportable events (previously reported or not, serious or 
not), as well as any proposed changes to the protocol and/or study analysis. 
 
Data Storage and Confidentiality 
All patient health information will be de-identified and assigned a code. Information linking participants’ 
names, medical record numbers or other PHI will be stored in securely on NYU Langone Health’s digital 
server via RedCap. Participant medical information will be stored electronically within a password 
protected database available only to the principal investigator, co-investigators, and research staff as 
necessary for data analysis. The names, medical record numbers, and other PHI of the study participants 
will be deleted from their stored medical information and replaced with a linkage code. Access to 
participant medical information contained within this project will be restricted to approved study personnel. 
 
 

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Do not disclose or use except as authorized in writing by the study sponsor (if applicable). 
 
IV. RISK/BENEFIT ASSESSMENT 
 
The following are risks and discomforts that patients may experience during their participation in this 
research study.  
 
Exposure to Magnetic Field  
is an increased risk of burns from devices that conduct electrical energy. These devices can include 
metallic objects, pulse oximeters, EKG leads, or skin tattoos. These devices can be either in or on the 
patient in order for a skin burn to occur. The FDA has found that 70% of all reported injuries from MRIs 
were burns to the skin. To reduce this risk, all patients who are scanned in this study must complete 
thorough screening to ensure that no conductive materials are present in or on the patient’s body.  
Additionally, the power limits of the magnet will be adjusted as necessary. 
 
Another possible risk is that a metal object could be pulled into the scanner and hit the patient. The 
patient could be physically injured as a result. To reduce this risk, everyone near the magnet will remove 
all metal from their clothing or pockets when in the scanning environment.  The door to the scan room will 
remain closed during the exam.  
 
There are no known risks or adverse effects resulting directly from exposure to MRI.  However, subjects 
who have a pacemaker or metal objects in their body such as shrapnel or metal in the eye should not 
have the scan performed. 
 
Exposure to Magnetic Resonance Scanner 
The magnetic resonance scanner may exacerbate a fear of closed spaces, expose patients to loud 
noises 
 
Loss of Confidentiality 
While every effort will be made to keep participant information confidential, there is the potential risk of 
loss of confidentiality. In order to minimize this risk, any information that can identify a subject will be 
removed and replaced with a unique study ID that only the study coordinator/investigators will know. 
 
Psychological Risks 
When completing the radiologic imaging, patients may find testing conditions unpleasant, such as space 
constrictions in medical imaging devices. 
 
Protection Against Risks  
The Principal Investigator is responsible for the collection, management and retention of research data 
and all study related regulatory files. The Principal Investigator shall adopt an orderly system of data 
organization, which includes a complete regulatory binder that dates the records being retained. The PI 
will be responsible for communicating all study methods and systems to all research personnel, and for 
their compliance with the study protocol and all NYU and Federal regulations. Patient PHI, such as MRNs 
can only be used within NYULMC’s administrative records, thus ensuring minimal research risks and 
protecting patient identity from public utilization. As the owner of the research data, the medical center will 
assert its rights with respect to research data in order to assure compliance with regulatory and 
contractual requirements. 
 
Potential Benefits to the Subjects  
Study participants will not directly benefit from this study. 
 
 

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V. INVESTIGATOR’S QUALIFICATIONS AND EXPERIENCE 
 
The CV, human subjects’ tutorial completion report, and medical license (if applicable) are available for all 
investigators who are participating in this study. All research personnel have medical research experience 
and are qualified to participate in this quality study. Most importantly, staff have been properly educated 
and certified with CITI training to conduct research in a matter that will maintain full patient confidentiality.  
 
 
 

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Do not disclose or use except as authorized in writing by the study sponsor (if applicable). 
 
VI. SUBJECT IDENTIFICATION, RECRUITMENT AND CONSENT/ASSENT 
 
Subject Capacity 
All subjects enrolled in this study will have capacity to provide informed consent. 
 
Debriefing Procedures 
No information will be withheld from the subject. 
 
Consent Forms 
Informed consent will be obtained from all subjects and documented with a signed, written consent form 
using the NYU SoM’s English standard consent form. 
 
Documentation of Consent 
In addition to following the consent process, it is understood by the study staff that retrieving informed 
consent is an ongoing process that continues after the actual informed consent has been signed. There is 
a “Documentation of Consent” checklist that will be used as additional documentation. This form will serve 
as secondary proof that the informed consent process has been executed.   
 
Costs to the Subject 
Subjects will not incur any additional financial costs as a participant in this study beyond those normally 
associated with this type of condition. The 3D CT imaging is billed to the patient/patient’s insurance 
provider, hospital insurance, or third-party payer as per standard of care. The investigational 3D MR 
imaging is provided to enrolled participants at no cost – the patient/patient’s insurance provider, hospital 
insurance, or third-party payer is not responsible for the cost of the investigational MR imaging. 
 
Payment for Participation  
No payments/reimbursements will be provided to subjects for their participation in this study. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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CONFIDENTIAL 
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VII. References 
 
 
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2. Kim SH, Wise BL, Zhang Y, Szabo RM. Increasing Incidence of Shoulder Arthroplasty in the United 
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