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

September 27, 2013 updated by: GE Healthcare

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

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.

Study Overview

Status

Withdrawn

Conditions

Detailed Description

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Waukesha, Wisconsin, United States, 53188
        • GE Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community sample from Waukesha, Wisconsin area.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
orthopedic implants, no treatment

What is the study measuring?

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.
Time Frame: Within the first hour after scanning
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.
Time Frame: Within one hour of scanning
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GE Healthcare

Investigators

  • Principal Investigator: Troy Lewein, American Registry of Radiologic Technologists

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

March 13, 2012

First Submitted That Met QC Criteria

April 3, 2012

First Posted (Estimate)

April 4, 2012

Study Record Updates

Last Update Posted (Estimate)

October 1, 2013

Last Update Submitted That Met QC Criteria

September 27, 2013

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 114-2011-GES-0029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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