Vertebroplasty is a surgical procedure recently introduced into the United States used to treat osteoporotic vertebral compression fractures where bone cement with a radiopaque agent is injected into a vertebral body to provide mechanical stability or restore vertebral body height. While the procedure currently is not very common in the United States, with approximately 400,000-700,000 individuals suffering from osteoporotic spine fractures annually, its usage is predicted to increase dramatically over the next five years. A similar procedure to vertebroplasty is also being performed to treat vertebral compression fractures. This procedure, kyphoplasty, also is an off-label procedure with no clinical trials having been conducted. OPC could possibly serve as an alternative to randomized or concurrent controlled study designs and shorten evaluation time for standardized devices.
Initial data is favorable.
Manipulation and Homologous Use in Spine and Other Orthopaedic Reconstruction and Repair. The goal of the meeting was to gather information about human bone allograft in relation to FDA's proposed tissue rules. Web Education Workshop Efforts continue on developing a web-based educational tool that would allow physicians to review key information about medical devices. Such a system could serve as a physician's desk reference for surgeons. Custom Devices Device Forum members discussed issues related to improving device product development.