MRI Scanning of People With MR Safe Orthopedic Implants That Are Made of Metal
NCT ID: NCT01570543
Last Updated: 2013-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2012-03-31
2013-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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orthopedic implants, no treatment
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
85 Years
ALL
Yes
Sponsors
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GE Healthcare
INDUSTRY
Responsible Party
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Principal Investigators
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Troy Lewein
Role: PRINCIPAL_INVESTIGATOR
American Registry of Radiologic Technologists
Locations
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GE Healthcare
Waukesha, Wisconsin, United States
Countries
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References
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Nyenhuis, J. A., Kildishev, A. V., Athey, T. W., Bourland, J. D., Foster, K. S., Graber, G. P., "Heating Near Implanted Medical Devices by the MRI RF-magnetic Field," IEEE Trans. Magn., Vol 35, 1999, pp. 4133-4135
Potter HG, Nestor BJ, Sofka CM, Ho ST, Peters LE, Salvati EA. Magnetic resonance imaging after total hip arthroplasty: evaluation of periprosthetic soft tissue. J Bone Joint Surg Am. 2004 Sep;86(9):1947-54. doi: 10.2106/00004623-200409000-00013.
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. 2011 Sep;197(3):W405-11. doi: 10.2214/AJR.11.6659.
Cook SM, Pellicci PM, Potter HG. Use of magnetic resonance imaging in the diagnosis of an occult fracture of the femoral component after total hip arthroplasty. A case report. J Bone Joint Surg Am. 2004 Jan;86(1):149-53. doi: 10.2106/00004623-200401000-00024. No abstract available.
Sofka CM, Potter HG. MR imaging of joint arthroplasty. Semin Musculoskelet Radiol. 2002 Mar;6(1):79-85. doi: 10.1055/s-2002-23166.
Suh JS, Jeong EK, Shin KH, Cho JH, Na JB, Kim DH, Han CD. Minimizing artifacts caused by metallic implants at MR imaging: experimental and clinical studies. AJR Am J Roentgenol. 1998 Nov;171(5):1207-13. doi: 10.2214/ajr.171.5.9798849.
Henk CB, Brodner W, Grampp S, Breitenseher M, Thurnher M, Mostbeck GH, Imhof H. The postoperative spine. Top Magn Reson Imaging. 1999 Aug;10(4):247-64. doi: 10.1097/00002142-199908000-00006.
Hayter CL, Koff MF, Potter HG. Magnetic resonance imaging of the postoperative hip. J Magn Reson Imaging. 2012 May;35(5):1013-25. doi: 10.1002/jmri.23523.
Koch KM, Lorbiecki JE, Hinks RS, King KF. A multispectral three-dimensional acquisition technique for imaging near metal implants. Magn Reson Med. 2009 Feb;61(2):381-90. doi: 10.1002/mrm.21856.
Koch KM, Brau AC, Chen W, Gold GE, Hargreaves BA, Koff M, McKinnon GC, Potter HG, King KF. Imaging near metal with a MAVRIC-SEMAC hybrid. Magn Reson Med. 2011 Jan;65(1):71-82. doi: 10.1002/mrm.22523.
Koch KM, Hargreaves BA, Pauly KB, Chen W, Gold GE, King KF. Magnetic resonance imaging near metal implants. J Magn Reson Imaging. 2010 Oct;32(4):773-87. doi: 10.1002/jmri.22313.
Potter HG, Foo LF. Magnetic resonance imaging of joint arthroplasty. Orthop Clin North Am. 2006 Jul;37(3):361-73, vi-vii. doi: 10.1016/j.ocl.2006.03.003.
Walde TA, Weiland DE, Leung SB, Kitamura N, Sychterz CJ, Engh CA Jr, Claus AM, Potter HG, Engh CA Sr. Comparison of CT, MRI, and radiographs in assessing pelvic osteolysis: a cadaveric study. Clin Orthop Relat Res. 2005 Aug;(437):138-44. doi: 10.1097/01.blo.0000164028.14504.46.
Weiland DE, Walde TA, Leung SB, Sychterz CJ, Ho S, Engh CA, Potter HG. Magnetic resonance imaging in the evaluation of periprosthetic acetabular osteolysis: a cadaveric study. J Orthop Res. 2005 Jul;23(4):713-9. doi: 10.1016/j.orthres.2005.02.007. Epub 2005 Apr 12.
Hayter CL, Potter HG, Su EP. Imaging of metal-on-metal hip resurfacing. Orthop Clin North Am. 2011 Apr;42(2):195-205, viii. doi: 10.1016/j.ocl.2010.12.006.
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. 2010 Sep;468(9):2321-7. doi: 10.1007/s11999-010-1372-y.
Pandit H, Glyn-Jones S, McLardy-Smith P, Gundle R, Whitwell D, Gibbons CL, Ostlere S, Athanasou N, Gill HS, Murray DW. Pseudotumours associated with metal-on-metal hip resurfacings. J Bone Joint Surg Br. 2008 Jul;90(7):847-51. doi: 10.1302/0301-620X.90B7.20213.
Toms AP, Marshall TJ, Cahir J, Darrah C, Nolan J, Donell ST, Barker T, Tucker JK. MRI of early symptomatic metal-on-metal total hip arthroplasty: a retrospective review of radiological findings in 20 hips. Clin Radiol. 2008 Jan;63(1):49-58. doi: 10.1016/j.crad.2007.07.012. Epub 2007 Oct 24.
Other Identifiers
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114-2011-GES-0029
Identifier Type: -
Identifier Source: org_study_id