Kineflex artificial disc.

The Department of Neurological Surgery at the University of Pittsburgh has been selected to be one of twenty sites for an Food and Drug Administration study of a new device seen as an alternative to cervical fusion for the treatment of certain types of chronic neck pain as well as arm pain.

Safety data has been acquired based on hundreds of patients in South Africa implanted with the Kineflex|C™ Spinal System. The FDA has granted an investigational device exemption (IDE) approval to conduct a pivotal study utilizing this new disc, with study patients to be randomized equally to the disc or to anterior cervical disc fusion (ACDF) surgery. There are currently no cervical artificial discs approved by the FDA in the United States.

Peter C. Gerszten, MD, and William C. Welch, MD, are evaluating the Kineflex|C artificial disc for the treatment of arm pain and neck pain caused by degenerative disc disease (DDD). The neurosurgeons will be comparing the Kineflex|C to the more standard cervical discectomy and fusion in a randomized clinical trial. The goal of the artificial disc is to preserve motion, while minimizing or eliminating pain. The preservation of motion at the diseased segment, as opposed to fusion, is believed to prevent further degeneration of adjacent disc levels.

The Kineflex|C artificial disc is a three-component modular system, manufactured by SpinalMotion of Sunnyvale, CA. The endplates and mobile core are of cobalt-chrome-molybdenum (as used in hip and knee implants), and the bone-contact surfaces of the endplates are coated with a plasma spray of titanium (for bone on-growth).

If you are interested in further information about requirements for patients’ participation in the study, please contact Dr. Gerszten.