Orthopedic surgeons and their patients now have several options to choose from after the U.S. Food and Drug Administration (FDA) approved last June the first ceramic-on-metal total hip replacement system for patients suffering from osteoarthritis.

The Pinnacle CoMplete Acetabular Hip System by the DePuy Orthopaedics is the first to combine a ceramic ball with a metal socket. Previous total hip replacement systems approved for use by the FDA have utilized various combinations of metal, ceramic and polyethylene (a type of plastic).

The FDA’s approval is based on a two-year, randomized clinical trial which found no clinical difference between 194 patients implanted with the new ceramic-on-metal system and 196 patients in a control group who were implanted with a metal-on-metal hip replacement device.

The agency, however, requires DePuy Orthopaedics to conduct a post-market study in order to monitor patients implanted with the Pinnacle CoMplete system to determine whether or not they experience any side effects, particularly raised metal ion concentration in their blood.

Perhaps owing to the fact that Depuy has initiated a hip replacement recall of its previous systems such as its metal-on-metal Pinnacle system and ASR system after posing problems to its recipients.

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