Optimized MRI of Patients With Hip Arthroplasty

NYU Langone Health

Status: Enrolling

Conditions: Hip Arthropathy

Treatments: Device: Modified MRI

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04875884

20-00971

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

MRI group

Experimental group

Description:

Subjects enrolled in this study will undergo both standard and new MRI techniques. The standard MRI is needed for your routine care and as ordered by the referring doctor. The new MRI is performed for research purposes. Participants will be imaged with both methods and the results will be compared.

Treatment:

Device: Modified MRI