Trial Outcomes & Findings for 3D MR Versus 3D CT for Glenohumeral Arthritis (NCT NCT03379545)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

3 Months

Results posted on

2021-03-25

Participant Flow

Participant milestones

Participant milestones
Measure	Shoulder Arthroplasty (SA) 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 Study STARTED	29
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Shoulder Arthroplasty (SA) n=29 Participants 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.
Age, Continuous	68 years n=29 Participants
Sex: Female, Male Female	10 Participants n=29 Participants
Sex: Female, Male Male	19 Participants n=29 Participants
Region of Enrollment United States	29 participants n=29 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Shoulder Arthroplasty (SA) n=29 Participants 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.
Glenoid Version 3D-MR Scan	12.1 degrees Standard Deviation 8.7
Glenoid Version 3D-CT Scan	11.4 degrees Standard Deviation 7.4

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Shoulder Arthroplasty (SA) n=29 Participants 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.
Glenoid Inclination 3D-MR Scan	89.2 degrees Standard Deviation 7.2
Glenoid Inclination 3D-CT Scan	91 degrees Standard Deviation 8.1

Adverse Events

Shoulder Arthroplasty (SA)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joseph Zuckerman, MD

NYU Langone Health

Phone: 212-598-6674

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place