MRI Scanning of People With MR Safe Orthopedic Implants That Are Made of Metal

Study Overview
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Brief Summary
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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.

Detailed Description
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The technology comprising Magnetic Resonance (MR) imaging systems and accessories is under continuous development in order to improve the quality of images, speed of acquisition, and usability of MR devices applied to image subjects with metallic orthopedic implants. Collection of in vivo human data throughout the product development and maintenance lifecycle plays an important role in enabling the technology to be investigated, optimized, and validated. This is a pre-market investigation involving commercially available devices, investigational devices, and commercial devices modified with investigational components. The Study will be conducted for three years, over which time a number of endpoints will be collected for various devices under development.

Official Title
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Development of MR Systems, Accessories, and Software for Imaging Subjects With Metallic Orthopedic Implants.

Conditions
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Implants

Participation Criteria
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Eligibility Criteria
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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 implant other than knee or hip implant Presence of tissue expander (breast) Intra-uterine device, diaphragm or pessary Loose dental fillings or dental fillings in the last 30 days Tattoo or permanent make up Breathing problem or motion disorder Claustrophobia or panic attacks Hearing Aid Body piercing jewelry Dentures or partial plates External medical hardware (example: orthopedic braces, orthodontic appliance) Known or past allergic reactions to latex

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| orthopedic implants, no treatment<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Review of real-time and post-acquisition technical assessment will occur. The assessment of images will be made by scientists, engineers and radiology technologists. Validation activities will consist of a comparison of the observed images with the prospective acceptance criteria to determine if each specific test results in a pass or fail. There are no statistical tests and no efficacy endpoints. | Within the first hour after scanning | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ease of use and optimization of the MR device in imaging of subjects with metallic implants will be assessed. | Software programs, data processing software and other types of MR system accessory hardware and software components will be tested and evaluated for how easy and problem-free they are to use and optimize for imaging of subjects with a metallic implant. Once this is established, validation of user requirements and specifications will be performed in accordance with Good Manufacturing Practice (GMP) design control requirements. | Within one hour of scanning | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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implants, knee implants, hip implants, metallic implants