"The only approved method today to help cervical disc disease patients is to clear away the troublesome bone spurs and disc material and fuse the cervical vertebrae together," said Nockels. "This permanent fusion of bone eliminates normal movement between the fused vertebrae. It also may put added stress on the vertebrae above and below the fusion."
Loyola is one of 20 centers nationwide evaluating the device under a U.S. Food and Drug Administration protocol.
"Although anecdotal, several disc recipients in the clinical trial have been involved in serious motor vehicle accidents," said Nockels. "One was a front-end crash; another occurred 10 weeks after the disc surgery. Some patients were subject to air bag deployment.
"In spite of this, follow-up X-rays of these patients show continued normal function and no device-related problems," Nockels reported. If the new device is proven effective and approved by the FDA, it will eliminate the need for transplanted human bone, which is required with spinal fusion. It will allow motion of the neck, and may reduce the likelihood of degeneration in adjacent discs.
Co-authors of the study are Dr. Vincent C. Traynelis, University of Iowa Hospitals, Iowa City, Iowa; Dr. Regis W. Haid Jr., Emory University School of Medicine, Atlanta; Dr. Thomas A. Zdeblick, University of Wisconsin, Madison, Wisc.; and Craig M. Squires, Medtronic Sofamor Danek, Memphis, Tenn.