Cartiva: On the Way to PMA (Orthopedics This Week)
http://www.carticept.com/cartiva.html
Cartiva, Inc. has just completed enrollment in the MOTION trial, an international, multi-center study of its Cartiva Synthetic Cartilage Implant (SCI). The results of the MOTION trial, which has enrolled 233 patients at 12 sites in Canada and the UK, are intended to establish the basis for a Premarket Approval Application (PMA) to the FDA.
The MOTION study, the largest prospective clinical trial for osteoarthritis (OA) of the first metatarsophalangeal (MTP) joint, was designed to determine the safety and efficacy of Cartiva SCI in comparison to joint fusion for reducing the pain associated with OA of the MTP joint in the great toe. The primary endpoint for the study is a composite evaluation of three study outcomes—pain, function and safety.
“As aging baby boomers continue to remain active, there is a need for less invasive treatments that preserve motion and minimize bone loss,” said Judith F. Baumhauer, M.D., in the June 21, 2012 news release. Dr. Baumhauer is associate chair of Academic Affairs and professor, Division of Foot and Ankle Surgery, Department of Orthopaedics at the University of...
