Hip ArthropathyNCT04875884
Optimized MRI of Patients With Hip Arthroplasty
A study testing Modified MRI in people with Hip Arthropathy, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hip Arthropathy
- What is being tested?
- Modified MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2022to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Radiology - Center for Biomedical Imaging
New York, New York, 10017
Iman Khodarahmi, MD, 212-263-1379, Iman.Khodarahmi@nyulangone.org
About this study
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.
Read the 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.
- Conditions
- Hip Arthropathy
- Being tested
- Modified MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified MRIDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Modified MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Visit 1, Day 0
Secondary outcomes (2)
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
Measured: Visit 1, Day 0
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.
Measured: Visit 1, Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start11 Aug 2022
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthropathyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Radiological Society of North America, ISS, Inc.
- Responsible party
- Sponsor
- Investigators
- Iman Khodarahmi, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875884
- Sponsor's protocol ID
- 20-00971
- Status last verified
- Mar 2026
- First submitted
- 4 May 2021
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized MRI of Patients With Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT04875884
- Acronym / sponsor ID
- 20-00971
- Conditions
- Hip Arthropathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Radiological Society of North America, ISS, Inc.
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI group | Experimental | Device: Modified MRISubjects 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified MRIA 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. | Device | MRI group |
Primary outcome
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.
2 secondary outcomes
Assessment of the visibility of normal structures
Time frame: Visit 1, Day 0
Assessment of the abnormality detection rate
Time frame: Visit 1, Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Iman Khodarahmi, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified MRI in people with Hip Arthropathy, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iman Khodarahmi, MD (212-263-1379, Iman.Khodarahmi@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the size of the artifact-degraded regions (time frame: Visit 1, Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.