andomized clinical trial, ceramic, Ceramic on metal hip, Clinical trial, DePuy, FDA, FDA approval, Food & Drug Administration, Hip Replacement, metal, metal components, Orthopedic surgery, Pinnacle CoMplete Acetabular Hip System, polyethylene liner, second surgery, surgery, Total Hip Replacement
First Ceramic-on-Metal Total Hip Replacement System Approved
Previous total hip replacement systems cleared or approved by the FDA have used different combinations of metal, ceramic, and polyethylene (a form of plastic). The Pinnacle CoMplete Acetabular Hip System (DePuy Orthopaedics Inc) is the first to combine a ceramic ball and a metal socket.
“Orthopedic surgeons and their patients now have an additional option for total hip replacement,” Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said today in a news release.
Yesterday’s approval was based on a 2-year, randomized clinical trial that found no clinical difference between 194 patients who received the new ceramic-on-metal system and 196 patients in a control group who received a metal-on-metal hip implant. Two patients who received the ceramic-on-metal system required a second surgery to replace their new implant compared with 3 patients who required a second surgery in the control group.
As a condition of approval, the manufacturer will conduct a postmarketing study, monitoring patients receiving the new system for adverse events and metal ion concentrations in their blood.
Technorati Tags: arthritis, Articulating Joints, Baby Boomers, ceramic, Elderly Patients, hip implant, hip prosthesis, Hip recall, Hip Replacement, Hip Revision, joint disease, joint replacement, MoM hips, orthopaedic implants, polyethylene wear debris, polymeric, ceramic-on-metal hip, FDA, FDA Appproval, Clinical Trials, second surgery, metal ion concentrations
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