Optimized MRI of Patients With Hip Arthroplasty

Hip Arthropathy Clinical Trial

Official title:

Optimized MRI of Patients With Hip Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04875884
• Other study ID #: 20-00971
• Status: Recruiting
• Phase: N/A
• Start date: August 11, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: May 2024
• Source: NYU Langone Health
• Contact: Iman Khodarahmi, MD
• Phone: 212-263-1379
• Email: Iman.Khodarahmi[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: December 30, 2025
• Est. primary completion date: August 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Arthropathy
• Joint Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	NYU Langone Radiology - Center for Biomedical Imaging	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
NYU Langone Health	ISS, Inc., Radiological Society of North America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Assessment of the visibility of normal structures	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	Visit 1, Day 0
Secondary	Assessment of the abnormality detection rate	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.	Visit 1, Day 0