Study Results
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View full resultsBasic Information
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COMPLETED
NA
31 participants
INTERVENTIONAL
2017-01-11
2020-06-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Joseph D Zuckerman, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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New York University School of Medicine
New York, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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17-00500
Identifier Type: -
Identifier Source: org_study_id
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