Feasibility Study on Ceramic Femoral Component

A ceramic femoral knee component used in total knee replacement is designed to avoid the problem of polymer wear, bone resorption, and subsequent implant loosening.

The ceramic component, from Encore Orthopedics, Inc. (Austin, TX, USA; www.encoremed.com), is made from zirconia oxide by Saint Gobain Desmarquest (Evruex, France). The component has geometry similar to the cobalt-chromium alloy femoral component of Encore's Foundation Knee system. This allows it to be used in conjunction with the Foundation tibial and patellar components in treating patients with arthritis of the knee joint. Laboratory walking simulation at the University of Nebraska Medical Center (Lincoln, USA) has shown that the zirconia femur produces 250% less wear debris than traditional metal/polyethylene knee replacement devices.

A feasibility clinical study will involve three investigational sites and 21 implants, as a precursor to a full pivotal study involving 20 surgeons and 300-400 patients. "Laboratory and clinical data would support the position that the ceramic femoral component is an important step in developing a total knee prosthesis that will outlast the patient, regardless of age or activity level of the patient,” said J.D. Webb, vice president, research and development, for Encore Orthopedics.



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