Optimized MRI of Patients With Hip Arthroplasty

NCT04875884 | Recruiting DMC FDA Device

• 1 other identifier: 20-00971
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hip Arthropathy

Outcome Measures

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.

  Visit 1, Day 0

Secondary Outcomes (2)

• Assessment of the visibility of normal structures

  Visit 1, Day 0

• Assessment of the abnormality detection rate

  Visit 1, Day 0

Study Arms (1)

MRI group

EXPERIMENTAL

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.

Device: Modified MRI

Interventions

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.

MRI group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• Radiological Society of North America: collaborator
• ISS, Inc.: collaborator

Study Sites (1)

NYU Langone Radiology - Center for Biomedical Imaging

New York, New York, 10017, United States

RECRUITING

Study Officials

• Iman Khodarahmi, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iman Khodarahmi, MD

CONTACT

212-263-1379; Iman.Khodarahmi@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 6, 2021
• Study Start: August 11, 2022
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: Upon reasonable request. Requests should be directed to Iman.Khodarahmi@nyulangone.org . To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)