MRI Scanning of People With MR Safe Orthopedic Implants That Are Made of Metal (NCT01570543) | Clinical Trial Compass
WithdrawnNot Applicable
MRI Scanning of People With MR Safe Orthopedic Implants That Are Made of Metal
Stopped: After over a year no subjects were identified
United States0Started 2012-03
Plain-language summary
The purpose of the study is to improve image quality, increase speed of scanning and to see how well certain products test by scanning people who have an orthopedic hip or knee metallic implant.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* At least 18 years of age; and
* Must have an in-place knee or hip orthopedic implant; and
* Must have a metallic orthopedic implant that is labeled as "MR safe" or "MR Conditional" by the implant manufacturer; and
* Must be able to provide sufficient documentation of the implant such that study staff can confirm its compatibility with the specific MR environment per the implant labeling; and
* Must be able to provide written documentation or attestation of the date their orthopedic implant was placed; and
* Must be able to hear and understand English without assistive devices; and
* Must provide written informed consent; and
* Must provide the name and contact information for his/her Physician
Exclusion Criteria:
* Any implant more than 5 years old
* Any implant that is investigational
* Any implant which cannot be verified with a manufacturer's label
* Any implant implanted outside of U.S.A.
* Any implant associated with a recall
* Any history of pathology associated with an in-place orthopedic implant
* History of pain at implant site, in the past 30 days
* Known or suspected complication, defect, or concern regarding an in-place orthopedic implant
* Surgery related to an orthopedic implant within the past 120 days
* Potential for metal to be in body due to a previous injury involving metallic objects
* Pregnancy or late menstrual period
* Any non-orthopedic implant
* Any type of prosthesis (eye, penile, heart valve, etc.)
* Any other type of metal …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Image quality of images that are obtained from scanning subjects who have metallic MR Safe or MR Conditional implants, will be evaluated on a pass/fail basis.