3D MR Versus 3D CT for Glenohumeral Arthritis

NCT03379545 | Completed Results FDA Device

• 1 other identifier: 17-00500
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis; Glenohumeral Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

3D MR and 3D CT Imaging

OTHER

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; Diagnostic Test: 3D computed tomography (CT) imaging

Interventions

3-dimensional (3D) magnetic resonance (MR) imaging DIAGNOSTIC_TEST

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 MR and 3D CT Imaging

3D computed tomography (CT) imaging DIAGNOSTIC_TEST

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.

3D MR and 3D CT Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Arthritis

Interventions

Magnetic Resonance Imaging; Diagnostic Imaging

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Joseph Zuckerman, MD
• Organization: NYU Langone Health

Joseph.Zuckerman@nyulangone.org

212-598-6674

Study Officials

• Joseph D Zuckerman, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 20, 2017
• Study Start: January 11, 2017
• Primary Completion: December 21, 2018
• Study Completion: June 5, 2020
• Last Updated: March 25, 2021
• Results First Posted: April 16, 2020

Record last verified: 2021-03

Locations

US (1)