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 range18 Years – 85 Years
SexALL
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 …
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.