Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04875884

Optimized MRI of Patients With Hip Arthroplasty

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Radiology - Center for Biomedical Imaging

New York, 10017, United States

Location status: Recruiting

Location contact

Iman Khodarahmi, MD

CONTACT

[email protected]

212-263-1379

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified MRI

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.

Primary outcomes

  1. Assessment of the size of the artifact-degraded regions

    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.

Secondary outcomes

  1. Assessment of the visibility of normal structures

    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

  2. Assessment of the abnormality detection rate

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Iman Khodarahmi, MD

CONTACT

[email protected]

212-263-1379

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • ISS, Inc.
  • Radiological Society of North America

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
May 6, 2021
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.