An MRI Investigation of Soft Tissues in Total Hip Arthroplasty (MoM_MRI)
|ClinicalTrials.gov Identifier: NCT01750606|
Recruitment Status : Active, not recruiting
First Posted : December 17, 2012
Last Update Posted : August 5, 2016
|Condition or disease|
|Tissue Reaction Elevated Blood Ion Levels|
This study has been designed to estimate the prevalence of soft tissue changes following primary THA surgery in patients having received one of five Biomet implant types; a MOP primary THA, an M2a 38, M2a Taper, M2a Ringloc and M2a Magnum MOM primary THA device in 308-436 total patients at four centers.
The primary objective of the study is to estimate the prevalence of soft tissue changes in unbiased MoM and MoP samples. Secondary objectives are to evaluate whether the occurrence of soft tissue changes is related to any of several potential covariates including patient and implant characteristics and time in situ.
|Study Type :||Observational|
|Estimated Enrollment :||436 participants|
|Official Title:||An MRI Investigation of Soft Tissues in Total Hip Arthroplasty|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2017|
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.
- 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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750606
|United States, Michigan|
|Flint, Michigan, United States, 48507|
|United States, Ohio|
|Joint Implant Surgeons|
|New Albany, Ohio, United States, 43054|
|United States, South Carolina|
|Columbia, South Carolina, United States, 29201|
|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|
|Study Director:||Russell Schenck, Ph.D.||Zimmer Biomet|