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 Rochester and Lead Investigator of the MOTION trial. “Cartiva SCI may offer a less invasive, motion preserving solution to the traditional joint fusion. We are excited to complete enrollment of the trial, and over the next 24 months we will be further evaluating the data for submission to the FDA.”
“Although pain is often eliminated, a fusion does not allow patients to maintain motion in the joint and requires approximately six weeks to recover in a cast,” added Mark Glazebrook, M.D., assistant professor of Othopaedics Surgery at Queen Elizabeth Sciences Centre in Nova Scotia, Canada and investigator in the MOTION trial. “Additionally, in a fusion procedure, the remaining cartilage and adjacent bone are removed in order to fuse the two bones that form the joint. Cartiva SCI has been designed to offer a minimally invasive alternative that preserves more bone and allows patients to maintain motion and return to normal activity much sooner.”
Dr. Glazebrook told OTW,
The clinical experience to date has been encouraging, but we have to wait for the results and ultimate outcome of the trial. It is my hope that the trial will show that Cartiva SCI provides an advanced, less-invasive technology to reduce pain and increase mobility in patients with osteoarthritis of the great toe.