Arthritis, Glenohumeral Osteoarthritis
Conditions
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.
Interventions
DIAGNOSTIC_TEST3-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_TEST3D 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.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Shoulder Arthroplasty (SA) 3D computed tomography (CT) and 3D non-contrast magnetic resonance (MR)
3-dimensional (3D) magnetic resonance (MR): 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. | 29 |
| Total | 29 |
Baseline characteristics
| Characteristic | Shoulder Arthroplasty (SA) | — |
|---|---|---|
| Age, Continuous | 68 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 29 participants | — |
| Sex: Female, Male Female | 10 Participants | — |
| Sex: Female, Male Male | 19 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 29 |
| other Total, other adverse events | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
Primary
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.
Time frame: 3 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Shoulder Arthroplasty (SA) | Glenoid Inclination | 3D-MR Scan | 89.2 degrees | Standard Deviation 7.2 |
| Shoulder Arthroplasty (SA) | Glenoid Inclination | 3D-CT Scan | 91 degrees | Standard Deviation 8.1 |
Primary
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.
Time frame: 3 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Shoulder Arthroplasty (SA) | Glenoid Version | 3D-MR Scan | 12.1 degrees | Standard Deviation 8.7 |
| Shoulder Arthroplasty (SA) | Glenoid Version | 3D-CT Scan | 11.4 degrees | Standard Deviation 7.4 |