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3D MR Versus 3D CT for Glenohumeral Arthritis

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ClinicalTrials.gov Identifier: NCT03379545
Recruitment Status : Active, not recruiting
First Posted : December 20, 2017
Results First Posted : April 16, 2020
Last Update Posted : April 16, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Arthritis
Glenohumeral Osteoarthritis
Interventions Diagnostic Test: 3-dimensional (3D) magnetic resonance (MR) imaging
Diagnostic Test: 3D computed tomography (CT) imaging
Enrollment 29
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Shoulder Arthroplasty (SA)
Hide Arm/Group Description

3D computed tomography (CT) and 3D non-contrast magnetic resonance (MR)

3-dimensional (3D) magnetic resonance (MR): 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.

3D computed tomography (CT) imaging: 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.

Period Title: Overall Study
Started 29
Completed 29
Not Completed 0
Arm/Group Title Shoulder Arthroplasty (SA)
Hide Arm/Group Description

3D computed tomography (CT) and 3D non-contrast magnetic resonance (MR)

3-dimensional (3D) magnetic resonance (MR): 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.

3D computed tomography (CT) imaging: 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.

Overall Number of Baseline Participants 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 29 participants
68
(47 to 89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Female
10
  34.5%
Male
19
  65.5%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants
29
1.Primary Outcome
Title Glenoid Version
Hide Description All scans from 3D CT and 3D MR imaging were reviewed carefully for the presence of any morphological changes. For the determination of glenoid version, a line was drawn between the anterior and posterior margins of the glenoid. The transverse axis of the scapula was determined by a line drawn from the midpoint of the genoid fossa to the medial end of the image of the scapula; a line drawn perpendicular to this was defined as a line of neutral version. The angle between the line of neutral version and the line connecting the anterior and posterior margins of the glenoid was measured and recorded as the Glenoid Version.
Time Frame 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Shoulder Arthroplasty (SA)
Hide Arm/Group Description:

3D computed tomography (CT) and 3D non-contrast magnetic resonance (MR)

3-dimensional (3D) magnetic resonance (MR): 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.

3D computed tomography (CT) imaging: 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.

Overall Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: degrees
3D-MR Scan 12.1  (8.7)
3D-CT Scan 11.4  (7.4)
2.Primary Outcome
Title Glenoid Inclination
Hide Description The 3D MRI glenoid inclination is measured by the two observers with the same method used for CT 3D glenoid inclination measurement following generating a new 2D axial MR images form the 3D MRI model using the three-point method. A line on the supraspinatus fossa and 3 points are drawn: Point S represents the inferior border of the glenoid, point R represents the intersection of the supraspinatus fossa line with the glenoid surface, and point A represents the vertex of the right triangle created by the line of the supraspinatus fossa and a perpendicular line passing through point S; this line (RS) is the hypotenuse of the right triangle. The inclination corresponds to the area in which the glenoid component of RSA is implanted.
Time Frame 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 3D MR and 3D CT Imaging
Hide Arm/Group Description:

All shoulder arthroplasty candidates with glenohumeral osteoarthritis will be receiving both 3D computed tomography (CT) and 3D non-contrast magnetic resonance (MR) imaging.

3-dimensional (3D) magnetic resonance (MR) imaging: 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.

3D computed tomography (CT) imaging: 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.

Overall Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: degrees
3D-MR Scan 89.2  (7.2)
3D-CT Scan 91  (8.1)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Shoulder Arthroplasty (SA)
Hide Arm/Group Description

3D computed tomography (CT) and 3D non-contrast magnetic resonance (MR)

3-dimensional (3D) magnetic resonance (MR): 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.

3D computed tomography (CT) imaging: 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.

All-Cause Mortality
Shoulder Arthroplasty (SA)
Affected / at Risk (%)
Total   0/29 (0.00%) 
Hide Serious Adverse Events
Shoulder Arthroplasty (SA)
Affected / at Risk (%)
Total   0/29 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Shoulder Arthroplasty (SA)
Affected / at Risk (%)
Total   0/29 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Joseph Zuckerman, MD
Organization: NYU Langone Health
Phone: 212-598-6674
EMail: Joseph.Zuckerman@nyulangone.org
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03379545    
Other Study ID Numbers: 17-00500
First Submitted: December 7, 2017
First Posted: December 20, 2017
Results First Submitted: April 3, 2020
Results First Posted: April 16, 2020
Last Update Posted: April 16, 2020