3D MR Versus 3D CT for Glenohumeral Arthritis

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT03379545
• Collaborator: (none)
• Enrollment: 31
• Location: 1
• Arm: 1
• Actual Duration (Months): 40.8
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

This study aims to assess the efficacy of three-dimensional magnetic resonance (MR) compared to three-dimensional computed tomography (CT) imaging. This proposed study is a prospective, unrandomized, single-blinded, self-controlled, and single-armed diagnostic radiological evaluation study.

Condition or Disease	Intervention/Treatment	Phase
Arthritis; Glenohumeral Osteoarthritis	Diagnostic Test: 3-dimensional (3D) magnetic resonance (MR) imaging; Diagnostic Test: 3D computed tomography (CT) imaging	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official 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.
• Actual Study Start Date: Jan 11, 2017
• Actual Primary Completion Date: Dec 21, 2018
• Actual Study Completion Date: Jun 5, 2020

Arms and Interventions

Arm

Intervention/Treatment

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

Diagnostic Test: 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.; Diagnostic Test: 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.

Outcome Measures

Primary Outcome Measures

1. Glenoid Version [3 Months]

   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.

2. Glenoid Inclination [3 Months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients suffering from glenohumeral OA;

• Radiographic evidence of severe glenoid erosion;

• Indication for TSA based on clinical exam;

• Patient is willing to participate by complying with pre-operative visit requirements;

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Joseph D Zuckerman, MD, NYU Langone Health

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 11, 2017

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03379545
• Other Study ID Numbers: 17-00500
• First Posted: Dec 20, 2017
• Last Update Posted: Mar 25, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Arthritis; Osteoarthritis

Study Results

Participant Flow

Arm/Group Title	Shoulder Arthroplasty (SA)
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

Baseline Characteristics

Arm/Group Title	Shoulder Arthroplasty (SA)
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 Participants	29
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	68
Sex: Female, Male (Count of Participants)
Female	10 34.5%
Male	19 65.5%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	29 100%

Outcome Measures

1. Primary Outcome

Title	Glenoid Version
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Shoulder Arthroplasty (SA)
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.
Measure Participants	29
3D-MR Scan	12.1 (8.7)
3D-CT Scan	11.4 (7.4)

2. Primary Outcome

Title	Glenoid Inclination
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	3D MR and 3D CT Imaging
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.
Measure Participants	29
3D-MR Scan	89.2 (7.2)
3D-CT Scan	91 (8.1)

Adverse Events

Time Frame	6 months
Arm/Group Title	Shoulder Arthroplasty (SA)
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 (%)	# Events
Total	0/29 (0%)
Serious Adverse Events
	Shoulder Arthroplasty (SA)
	Affected / at Risk (%)	# Events
Total	0/29 (0%)
Other (Not Including Serious) Adverse Events
	Shoulder Arthroplasty (SA)
	Affected / at Risk (%)	# Events
Total	0/29 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.