3D MR Versus 3D CT for Glenohumeral Arthritis

Arthritis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03379545
• Other study ID #: 17-00500
• Status: Completed
• Phase: N/A
• Start date: January 11, 2017
• Est. completion date: June 5, 2020

Study information

• Verified date: March 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 5, 2020
• Est. primary completion date: December 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Glenohumeral Osteoarthritis
• Osteoarthritis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glenoid Version	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.	3 Months
Primary	Glenoid Inclination	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.	3 Months