3D MR Versus 3D CT for Glenohumeral Arthritis

Not Applicable

Completed

• Conditions: Arthritis; Glenohumeral Osteoarthritis

• Registration Number: NCT03379545
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-11
• Study First Submitted: 2017-12-07
• Study First Submitted QC: 2017-12-18
• Study First Posted: 2017-12-20
• Primary Completion: 2018-12-21
• Results First Submitted: 2020-04-03
• Results First Submitted QC: 2020-04-03
• Results First Posted: 2020-04-16
• Study Completion: 2020-06-05
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-03
• Last Update Posted: 2021-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States