The FDA approved a ceramic-on-metal total artificial hip system for patients with osteoarthritis on June 13. Made by Johnson & Johnson's subsidiary DePuy Orthopaedics, the Pinnacle CoMplete Acetablur Hip System is the first to provide a ceramic ball and a metal socket, according to the agency.
Previously approved artificial hip systems include metal-on-polyethylene, ceramic-on-polyethylene, metal-on-metal or ceramic-on-ceramic, according to the agency.
“Orthopedic surgeons and their patients now have an additional option for total hip replacement with the approval of the Pinnacle CoMplete Acetabular Hip System,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.
A condition of the approval requires DePuy to conduct a post-market study, monitoring patients for adverse events and metal ion concentrations in their blood, the FDA said.
A proposed instructions for use document made available on the FDA website stated that the ceramic-on-metal system is believed to produce lower wear debris and last longer than other systems. Additionally, there’s evidence that ceramic wear particles are more biocompatible than metal or polyethylene particles and are, therefore, more tolerable by the human body.
The FDA said its approval was based on a two-year, randomized clinical trial, which 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. In the study, two patients who received the ceramic-on-metal system required a second surgery to replace their new implant, compared with three patients in the control group who required a second surgery.