An MRI Investigation of Soft Tissues in Total Hip Arthroplasty (MoM MRI)
Per the FDA's post-market surveillance order, the purpose of the study is to contact patients who have received a Biomet metal-on-metal product as their primary total hip arthroplasty device. Patients who have not been revised prior to contact will be asked to submit to a blood draw, clinical exam and MRI.
Adverse Local Tissue Reactions in Total Hip Arthroplasty
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
- Number of symptomatic and asymptomatic Metal-on-Metal and Metal-on-Poly patients (via a proportion) with a soft tissue mass [ Time Frame: patients 3 years post-implantation up to 6 years post implantation ] [ Designated as safety issue: Yes ]Compare the proportion of symptomatic and asymptomatic Metal-on-Metal patients with a soft tissue mass to the proportion of Metal-on-Poly patients with soft tissue masses.
- Metal ion concentrations in whole blood and serum [ Time Frame: 1-10 year post implantation, depending on cohort ] [ Designated as safety issue: Yes ]Determine metal ion concentrations in whole blood and serum and assess whether findings correlate to any other variable such as pain, implant type, time since surgery and presence of ALTR.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Patients who are planned but have not yet received a total hip arthroplasty. No intervention or treatment - blood draw only to be used as a surrogate baseline for metal ion exposure.
Patients receiving a Biomet metal on poly hip implanted between January 1, 2003 and December 31, 2006.
M2a Magnum hip
Patients receiving a Biomet M2a Magnum hip implanted between January 1, 2006 and January 1, 2011.
Patients receiving a Biomet metal on metal M2a38 hip implanted between January 1, 2004 and December 31, 2006.
M2a Ringloc hip
Patients receiving a Biomet M2a Ringloc metal on metal hip implanted between January 1, 2002 and December 31, 2004.
M2a Taperloc hip
Patients receiving a Biomet M2a Taperloc metal on metal hip implanted between January 1, 2002 and December 31, 2003.
|United States, Michigan|
|Flint, Michigan, United States, 48507|
|United States, Ohio|
|Joint Implant Surgeons|
|New Albany, Ohio, United States, 43054|
|United States, Texas|
|Texas Center for Joint Replacement|
|Plano, Texas, United States, 75093|
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84108|