Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE December 7, 2017
First Posted Date  ICMJE December 20, 2017
Results First Submitted Date  ICMJE April 3, 2020
Results First Posted Date  ICMJE April 16, 2020
Last Update Posted Date April 16, 2020
Actual Study Start Date  ICMJE January 11, 2017
Actual Primary Completion Date December 21, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 18, 2017)
  • Differences in glenoid erosion and version measurements between of 3D CT and 3D MR [ Time Frame: 3 Months ]
    Using SAS software, version 9.4 (SAS Institute Inc., Cary, NC, USA) Paired sample t-test to compare measurements by model and ANOVA to assess differences among modalities. Patients will have both 3D CT and 3D MR scheduled on the same day. MRI 3D Post-processing: The water-only source images from the Dixon sequence were post-processed using standard subtraction software on a syngo MMWP workstation (VB 3oE, Siemens). The 3D MRI glenoid version is measured by the two observers with the same method used for CT 3D glenoid version measurement following generating a new 2D axial MR images form the 3D MRI model using the three-point method.
  • Similarities in glenoid erosion and version measurements between of 3D CT and 3D MR [ Time Frame: 3 Months ]
    Using SAS software, version 9.4 (SAS Institute Inc., Cary, NC, USA) Paired sample t-test to compare measurements by model and ANOVA to assess differences among modalities. Patients will have both 3D CT and 3D MR scheduled on the same day. MRI 3D Post-processing: The water-only source images from the Dixon sequence were post-processed using standard subtraction software on a syngo MMWP workstation (VB 3oE, Siemens). The 3D MRI glenoid version is measured by the two observers with the same method used for CT 3D glenoid version measurement following generating a new 2D axial MR images form the 3D MRI model using the three-point method.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 3D MR Versus 3D CT for Glenohumeral Arthritis
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Arthritis
  • Glenohumeral Osteoarthritis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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.
Interventions:
  • Diagnostic Test: 3-dimensional (3D) magnetic resonance (MR) imaging
  • Diagnostic Test: 3D computed tomography (CT) imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 3, 2020)
29
Original Estimated Enrollment  ICMJE
 (submitted: December 18, 2017)
100
Estimated Study Completion Date  ICMJE June 5, 2020
Actual Primary Completion Date December 21, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03379545
Other Study ID Numbers  ICMJE 17-00500
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joseph D Zuckerman, MD NYU Langone Health
PRS Account NYU Langone Health
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP