Optimized MRI of Patients With Hip Arthroplasty
Primary Purpose
Hip Arthropathy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Modified MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Hip Arthropathy
Eligibility Criteria
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
Sites / Locations
- NYU Langone Radiology - Center for Biomedical ImagingRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MRI group
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
Full Information
NCT ID
NCT04875884
First Posted
May 4, 2021
Last Updated
June 27, 2023
Sponsor
NYU Langone Health
Collaborators
Radiological Society of North America, ISS, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04875884
Brief Title
Optimized MRI of Patients With Hip Arthroplasty
Official Title
Optimized MRI of Patients With Hip Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2022 (Actual)
Primary Completion Date
August 30, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Radiological Society of North America, ISS, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Arthropathy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MRI group
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Modified MRI
Intervention Description
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 Outcome Measure Information:
Title
Assessment of the size of the artifact-degraded regions
Description
The area of artifact degraded regions (in pixel^2) in paired images of modified and standard MRIs determined by manual segmentation.
Time Frame
Visit 1, Day 0
Secondary Outcome Measure Information:
Title
Assessment of the visibility of normal structures
Description
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
Time Frame
Visit 1, Day 0
Title
Assessment of the abnormality detection rate
Description
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.
Time Frame
Visit 1, Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iman Khodarahmi, MD
Phone
212-263-1379
Email
Iman.Khodarahmi@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iman Khodarahmi, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Radiology - Center for Biomedical Imaging
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iman Khodarahmi, MD
Phone
212-263-1379
Email
Iman.Khodarahmi@nyulangone.org
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing 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.
IPD Sharing 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.
Learn more about this trial
Optimized MRI of Patients With Hip Arthroplasty
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