ImplantsMRINCT01570543
MRI Scanning of People With MR Safe Orthopedic Implants That Are Made of Metal
An observational study of Implants, run by GE Healthcare at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Implants
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community sample from Waukesha, Wisconsin area.
Who may be able to join
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Implants
- Keywords
- implants, knee implants, hip implants, metallic implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| orthopedic implants, no treatment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: Within one hour of scanning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2013
- Study completionSep 2013
Why it stopped: After over a year no subjects were identified
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for ImplantsStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Troy Lewein, Principal investigator, American Registry of Radiologic Technologists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570543
- Sponsor's protocol ID
- 114-2011-GES-0029
- Acronym
- MRI
- Status last verified
- Oct 2012
- First submitted
- 13 Mar 2012
- Last updated
- 1 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15342757Hayter 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.
PubMed 21862766Cook 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.
PubMed 14711959Sofka CM, Potter HG. MR imaging of joint arthroplasty. Semin Musculoskelet Radiol. 2002 Mar;6(1):79-85. doi: 10.1055/s-2002-23166.
PubMed 11917273Suh 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.
PubMed 9798849Henk 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.
PubMed 10616816Hayter 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.
PubMed 22499278Koch 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.
PubMed 19165901Koch 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.
PubMed 20981709Koch 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.
PubMed 20882607Potter 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.
PubMed 16846767Walde 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.
PubMed 16056041Weiland 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.
PubMed 16022981Hayter 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.
PubMed 21435495
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of MR Systems, Accessories, and Software for Imaging Subjects With Metallic Orthopedic Implants.
- ClinicalTrials.gov ID
- NCT01570543
- Acronym / sponsor ID
- MRI / 114-2011-GES-0029
- Conditions
- Implants
- Keywords
- implants, knee implants, hip implants, metallic implants
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: After over a year no subjects were identified
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 4 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| orthopedic implants, no treatment | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample from Waukesha, Wisconsin area.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2013.
- BackgroundNyenhuis, 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: PubMed 15342757Potter 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.
- Background: PubMed 21862766Hayter 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.
- Background: PubMed 14711959Cook 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.
- Background: PubMed 11917273Sofka CM, Potter HG. MR imaging of joint arthroplasty. Semin Musculoskelet Radiol. 2002 Mar;6(1):79-85. doi: 10.1055/s-2002-23166.
- Background: PubMed 9798849Suh 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.
- Background: PubMed 10616816Henk 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.
- Background: PubMed 22499278Hayter 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.
- Background: PubMed 19165901Koch 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.
- Background: PubMed 20981709Koch 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.
- Background: PubMed 20882607Koch 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.
- Background: PubMed 16846767Potter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Troy Lewein principal investigator
American Registry of Radiologic Technologists
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Implants, run by GE Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01570543, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2013.