NYU Langone Radiology - Center for Biomedical Imaging
New York, 10017, United States
Location status: Recruiting
NCT Number: NCT04875884
This is a single-center single-arm clinical trial with a paired design which compares the effectiveness of 3T MRI with (modified) and without (standard) radiofrequency pulse polarization optimization in reducing metal-related artifacts in patients with hip arthroplasty implants.
Interested in participating?
Request Info18 year–99 year
All sexes
Interventional
Not applicable
New York, 10017, United States
Location status: Recruiting
Twenty participants with symptomatic primary total hip arthroplasty will be imaged with both methods. The results of the two methods will be compared in reference to the size of the artifact-degraded regions, visibility of the normal structures and the rate of abnormality detection.Primary Objective: To assess the size of the artifact-degraded regions, defined as regions of the image where underlying anatomic structure are obscured, between modified and standard MRI protocols. Secondary Objectives: (1) To assess the visibility of normal structures between modified and standard MRI protocols. (2) To assess the abnormality detection rate using modified and standard MRI protocols.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A technical modification to the standard MRI which only affects radiofrequency pulse polarization attempting to optimize the image quality. All other factors, including pulse sequence parameters, and patient and coil positioning is similar to that of the standard MRI.
Time frame: Visit 1, Day 0
The area of artifact degraded regions (in pixel^2) in paired images of modified and standard MRIs determined by manual segmentation.
Time frame: Visit 1, Day 0
Visibility of anatomic landmarks (hip flexor, external rotator and abductor tendon attachments, joint capsule and implant-bone interface) on paired images of modified and standard MRIs using a 3-point scale with 1=structure visible without artifacts, 2=structure partly visible because of artifacts and 3=structure not visible because of artifacts
Time frame: Visit 1, Day 0
Presence or absence of abnormality in paired images of modified and standard MRIs. Abnormalities include: bone marrow edema (defined as osseous short-tau inversion recovery (STIR) signal hyperintensity); fractures (linear osseous signal abnormality and osseous STIR signal hyperintensity); osteolysis (interposing linear or geographic signal hyperintensity between the host bone marrow and the implant surface); synovitis (capsular thickening and/or joint fluid with bulging of the capsule); tendinopathy (at least partial-thickness substance loss of the cross-sectional tendon area and/or split); extracapsular collections.
Contact information is provided by the study sponsor or research team.
NYU Langone Health
Other
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