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FDA Approval For Ceramic-on-Metal Hip Replacement Systems On Back Of Clinical Trails
The United States Food and Drug Administration (FDA) has just approved the world's first ceramic-on-metal hip replacement system on June 14, 2011. The ceramic ball combined with a metal hip socket to simulate natural movement is the first of its kind, and the clinical tests made by its manufacturers have shown that the ceramic-on-metal systems are as stable as its predecessors.
The new ceramic-on-metal hip replacement system has been named ThePinnacle CoMplete Acetabular Hip System and is currently being manufactured by DePuy Orthopaedics Inc. DePuy has been doing clinical tests on the Pinnacle CoMplete for the past two years to make sure that there are no adverse side effects on its new hip replacement systems on its recipients.
The trial was conducted on a control group of 196 patients who were given the traditional metal-on-metal hip replacement systems and an experimental group of 194 patients who were given the new ceramic-on-metal hip replacement systems. The results of the test were positive for DePuy as the number of people who need a second surgery where nearly identical between the control and experimental group. In the control group 3 people needed a second surgery while only 2 people needed a second surgery in the experimental group.
The results were the base of the FDA approval of the Pinnacle CoMplete, the FDA also gave DePuy the condition that they conduct post-market studies and monitor the patients receiving the new system for adverse events and metal ion concentrations in their blood. Christy Foreman, director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health released this statement about the Pinnacle CoMplete; "Orthopedic surgeons and their patients now have an additional option for total hip replacement."
Will the numerous recipients injured by the older version of metal-on-metal hip replacement systems cause it to fade away and become replaced with the newer ceramic-on-metal hip replacement; only time can tell. Those injured have begun to even call for a DePuy Pinnacle Recall. For more information and possible a free consultation feel free to visit a DePuy Pinnacle lawyer as soon as possible.
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