"In European clinical trials, the implant alleviated disc-related lower back pain while maintaining spine mobility and eliminated the need for fusion of the lower spine," said David S. Bradford, MD, UCSF professor of orthopedic surgery and lead investigator of the UCSF study.
UCSF Medical Center is one of 13 centers currently evaluating Prosdisc, which replaces discs damaged by degeneration, bulging, herniation, or thinning. The objective of the randomized clinical trial, which will enroll approximately 510 patients over four years, is to compare the safety and effectiveness of the Prodisc implant to spinal fusion surgery. In fusion, the mainstay of surgical treatment for low back pain caused by degenerative disc disease (DDD), surgeons use rods and screws attached to the bones of the spine to hold them until the bones heal together.
While fusion of the lumbar spine has increased at the highest rate of any spinal procedure in the last ten years, advisability for patients, techniques and results remain controversial and unclear, according to Bradford. The ability of the bone to heal or fuse varies. In addition, spinal fusion at one or more levels can cause stiffness and decreased motion in the spine and more stress to be transferred to adjacent levels of the spine. Consequently, not all patients have a successful outcome, he said.
"Most important, fusion is not targeted toward restoration of normal structure and function," said Bradford. "This prospective, randomized study will tell us is if the Prodisc can eliminate back pain by preserving or restoring moti
Contact: Maureen McInaney
University of California - San Francisco