NCT03379545

3D MR Versus 3D CT for Glenohumeral Arthritis

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthritis
• Glenohumeral Osteoarthritis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-01-11
• Primary completion: 2018-12-21
• Completion: 2020-06-05
• First posted: 2017-12-20
• Last updated: 2021-03-25
• Results posted: 2020-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study