N/A
N=29
3D MR Versus 3D CT for Glenohumeral Arthritis
Arthritis · Glenohumeral Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT03379545 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Glenoid Version — 12.1; 11.4 degrees
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 3-dimensional (3D) magnetic resonance (MR) imaging (Diagnostic_test); 3D computed tomography (CT) imaging (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glenoid Version |
12.1; 11.4 | — |
| PRIMARY Glenoid Inclination |
89.2; 91 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03379545). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.