3D MR Versus 3D CT for Glenohumeral Arthritis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03379545
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

NYU Langone Health
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Joseph D Zuckerman, MD
Principal Investigator Affiliation NYU Langone Health
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Arthritis, Glenohumeral Osteoarthritis
Arms & Interventions

Arms

Other: Shoulder Arthroplasty (SA)

3D computed tomography (CT) and 3D non-contrast magnetic resonance (MR)

Interventions

Diagnostic Test: - 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.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

New York University School of Medicine, New York, New York

Status

Recruiting

Address

New York University School of Medicine

New York, New York, 10016

Site Contact

Ariel Aponte

[email protected]

212-460-0176