At a glance
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Cardiac Assessment of Patients With Hip Implants
In Brief
An observational study evaluating Exposure to metal debris for Cardiomyopathy and Cardiac Failure. Completed, enrolled 90 participants across 2 sites.
Detailed Summary
PRIMARY OBJECTIVE To establish the effect of metal ion release from metal hip implants on cardiac function STUDY OUTCOME MEASURES To assess the effect of metal ions from hip implants on cardiac function as measured by Cardiac Magnetic Resonance Imaging (CMR) and Echocardiogram. This involves the surrogate detection of cobalt ion deposition within cardiac tissues and assessment of ejection fraction and tissue characterization (with and without contrast). STUDY IMPACT With 60,000 patients having a metal on metal (MOM) hip implant in the United Kingdom (UK), and over a million worldwide, there is need to clarify this important question, which is the source of significant concern amongst patients and surgeons alike. Also, this problem is not unique to MOM hips since all hip implants contain metal and as seen in various case reports high blood cobalt levels have arisen after catastrophic failure (e.g. fracture of a ceramic bearing surface) leading to abnormal wear of the implant and release of metal ions into the body. In the UK, over 80,000 hip implants are inserted annually.
Study Details
Timeline
Interventions
The 3 groups are defined by the patients exposure to metal debris from a hip implant. This is either elevated metal ions in those with poorly functioning metal on metal hip implants, or low metal ion levels in those with well functioning metal hip implants, and a second control group of patients with non melt bearing hip implants.