NCT01570543

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2012

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 4, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

October 1, 2013

Status Verified

October 1, 2012

Enrollment Period

1.5 years

First QC Date

March 13, 2012

Last Update Submit

September 27, 2013

Conditions

Implants

Keywords

implantsknee implantship implantsmetallic implants

Outcome Measures

Primary Outcomes (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.

    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 Outcomes (1)

  • The ease of use and optimization of the MR device in imaging of subjects with metallic implants will be assessed.

    Within one hour of scanning

Study Arms (1)

orthopedic implants, no treatment

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community sample from Waukesha, Wisconsin area.

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GE Healthcare

Waukesha, Wisconsin, 53188, United States

Location

Related Publications (19)

  • 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

    BACKGROUND

  • 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.

    PMID: 15342757BACKGROUND

  • 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.

    PMID: 21862766BACKGROUND

  • 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.

    PMID: 14711959BACKGROUND

  • Sofka CM, Potter HG. MR imaging of joint arthroplasty. Semin Musculoskelet Radiol. 2002 Mar;6(1):79-85. doi: 10.1055/s-2002-23166.

    PMID: 11917273BACKGROUND

  • 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.

    PMID: 9798849BACKGROUND

  • 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.

    PMID: 10616816BACKGROUND

  • 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.

    PMID: 22499278BACKGROUND

  • 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.

    PMID: 19165901BACKGROUND

  • 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.

    PMID: 20981709BACKGROUND

  • 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.

    PMID: 20882607BACKGROUND

  • 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.

    PMID: 16846767BACKGROUND

  • 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.

    PMID: 16056041BACKGROUND

  • 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.

    PMID: 16022981BACKGROUND

  • 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.

    PMID: 21435495BACKGROUND

  • Hayter CL, Potter HG, Padgett DE, Perino G, Nestor BJ. MRI assessment of wear-induced synovitis. ISMRM Annual Conference, paper presentation. Montreal; 2011.

    BACKGROUND

  • 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.

    PMID: 20458645BACKGROUND

  • 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.

    PMID: 18591590BACKGROUND

  • 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.

    PMID: 18068790BACKGROUND

Study Officials

  • Troy Lewein

    American Registry of Radiologic Technologists

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2012

First Posted

April 4, 2012

Study Start

March 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

October 1, 2013

Record last verified: 2012-10

Locations

US(1)