Optimized MRI of Patients With Hip Arthroplasty
ConditionHip Arthropathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged ≥ 18 with unilateral symptomatic (e.g. pain) total hip arthroplasty
Referred for MRI examination at the discretion of the treating physician
Provision of signed and dated informed consent form
No metal hardware in the body including contralateral hip arthroplasty
Disqualifiers
History of revision hip arthroplasty
Pregnancy (self-reported, or self-suspected)
Hip arthroplasty surgery within one year of enrollment
Clinical indication to administer intravenous contrast material during MRI
Trial design
Design model
Single group
Treatments tested in this trial
Modified MRI
DeviceA 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.
Treatment groups
22 Participants
are divided into 1 treatment groupGroup A: MRI groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Assessment of the size of the artifact-degraded regions
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 0Secondary outcomes
1
Assessment of the visibility of normal structures
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 02
Assessment of the abnormality detection rate
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.
Time frame
Visit 1, Day 0Sponsors and contacts
Click on the lead sponsor to view all of their trials.
NYU Langone Health
Lead sponsor
Radiological Society of North America
Collaborator
ISS, Inc.
Collaborator
Source ClinicalTrials.gov