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

This study has been withdrawn prior to enrollment.
(After over a year no subjects were identified)
Sponsor:
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01570543
First received: March 13, 2012
Last updated: September 27, 2013
Last verified: October 2012
  Purpose

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.


Condition
Implants

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Development of MR Systems, Accessories, and Software for Imaging Subjects With Metallic Orthopedic Implants.

Resource links provided by NLM:


Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 0
Study Start Date: March 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
orthopedic implants, no treatment

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Community sample from Waukesha, Wisconsin area.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01570543

Locations
United States, Wisconsin
GE Healthcare
Waukesha, Wisconsin, United States, 53188
Sponsors and Collaborators
GE Healthcare
Investigators
Principal Investigator: Troy Lewein American Registry of Radiologic Technologists
  More Information

Publications:
Hayter CL, Koff MF, Shah P, Koch KM, Miller TT, Potter HG. MRI After Arthroplasty: Comparison of MAVRIC and Conventional Fast Spin-Echo Techniques. AJR Am J Roentgenol. Sep 2011;197(3):W405-411.
Hayter CL, Koff MF, Potter HG. Magnetic resonance imaging of the postoperative hip. J Magn Reson Imaging 2011
Koch KM, Brau AC, Chen W, et al. Imaging near metal with a MAVRIC-SEMAC hybrid. Magn Reson Med. Jan 2011;65(1):71-82.
Hayter CL, Potter HG, Padgett DE, Perino G, Nestor BJ. MRI assessment of wear-induced synovitis. ISMRM Annual Conference, paper presentation. Montreal; 2011.
Campbell P, Ebramzadeh E, Nelson S, Takamura K, De Smet K, Amstutz HC. Histological features of pseudotumor-like tissues from metal-on-metal hips. Clin Orthop Relat Res. Sep 2010;468(9):2321-2327.

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01570543     History of Changes
Other Study ID Numbers: 114-2011-GES-0029
Study First Received: March 13, 2012
Last Updated: September 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by GE Healthcare:
implants
knee implants
hip implants
metallic implants

ClinicalTrials.gov processed this record on July 20, 2014