Optimized MRI of Patients With Hip Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-11

Study Completion Date

2027-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hip Arthropathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MRI group

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.

Group Type EXPERIMENTAL

Modified MRI

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No