Optimized MRI of Patients With Hip Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Modified MRI.
- Who it may be relevant to
- Registry conditions: Hip Arthropathy. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Device Modified MRI
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.
Primary outcome measures
- Assessment of the size of the artifact-degraded regions [Time frame: Visit 1, Day 0]
Secondary outcome measures (2)
- Assessment of the visibility of normal structures [Time frame: Visit 1, Day 0]
- Assessment of the abnormality detection rate [Time frame: Visit 1, Day 0]
Eligibility criteria
Inclusion criteria
- 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
- No contraindication to MRI: defined as claustrophobia or presence of other MRI-incompatible devices
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- NYU Langone Radiology - Center for Biomedical Imaging — New York
Identifiers
NCT: NCT04875884 · 20-00971