Back to results3D MR Versus 3D CT for Glenohumeral Arthritis
Primary Purpose
Arthritis, Glenohumeral Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3-dimensional (3D) magnetic resonance (MR) imaging
3D computed tomography (CT) imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Arthritis
Eligibility 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.
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
3D MR and 3D CT Imaging
Arm Description
All shoulder arthroplasty candidates with glenohumeral osteoarthritis will be receiving both 3D computed tomography (CT) and 3D non-contrast magnetic resonance (MR) imaging.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03379545
Brief Title
3D MR Versus 3D CT for Glenohumeral Arthritis
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 11, 2017 (Actual)
Primary Completion Date
December 21, 2018 (Actual)
Study Completion Date
June 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Glenohumeral Osteoarthritis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3D MR and 3D CT Imaging
Arm Type
Other
Arm Description
All shoulder arthroplasty candidates with glenohumeral osteoarthritis will be receiving both 3D computed tomography (CT) and 3D non-contrast magnetic resonance (MR) imaging.
Intervention Type
Diagnostic Test
Intervention Name(s)
3-dimensional (3D) magnetic resonance (MR) imaging
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
3D computed tomography (CT) imaging
Intervention Description
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 Measure Information:
Title
Glenoid Version
Description
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.
Time Frame
3 Months
Title
Glenoid Inclination
Description
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.
Time Frame
3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph D Zuckerman, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
3D MR Versus 3D CT for Glenohumeral Arthritis
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