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3D MR Versus 3D CT for Glenohumeral Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03379545
Recruitment Status : Active, not recruiting
First Posted : December 20, 2017
Results First Posted : April 16, 2020
Last Update Posted : April 16, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Arthritis Glenohumeral Osteoarthritis Diagnostic Test: 3-dimensional (3D) magnetic resonance (MR) imaging Diagnostic Test: 3D computed tomography (CT) imaging Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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.
Actual Study Start Date : January 11, 2017
Actual Primary Completion Date : December 21, 2018
Estimated Study Completion Date : June 5, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
3D MR and 3D CT Imaging
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
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.




Primary Outcome Measures :
  1. Glenoid Version [ Time Frame: 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.

  2. Glenoid Inclination [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03379545


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Joseph D Zuckerman, MD NYU Langone Health
  Study Documents (Full-Text)

Documents provided by NYU Langone Health:
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03379545    
Other Study ID Numbers: 17-00500
First Posted: December 20, 2017    Key Record Dates
Results First Posted: April 16, 2020
Last Update Posted: April 16, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases