Abbott today announced that it has started enrolling patients in a new U.S. clinical study to evaluate the potential benefits of its Wallis Mechanical Normalization System, a new spinal implant technology for the treatment of mild to moderate degenerative disc disease designed to stabilize the spine and reduce pain while preserving range of motion.
The first study of its kind in the United States, this multi-center, randomized trial will compare degenerative disc disease patients who receive the Wallis implant to those who are treated using conservative, non-surgical methods of back pain management. The first surgical procedures to implant the Wallis device took place last week in Eugene, Ore. and Baltimore, Md.
"A very large number of adults in their 20's to 60's suffer from lower back pain, but their degenerative disc disease hasn't yet progressed to the point they require spinal fusion surgery," said Paul McAfee, M.D., of Orthopaedic Associates in Towson, Md.
Dr. McAfee is lead investigator on the trial and one of the first physicians to perform the procedure in the United States. "This study should provide valuable answers to help assess the role that dynamic stabilization devices could play in treating patients' pain," McAfee said.
The Wallis system has been in use in Europe for more than 15 years. It was developed by physicians in France and first used to treat degenerative disc disease in the 1980's. Since then, it has been used in thousands of patients outside the United States.
Americans spend at least $50 billion each year on low back pain, according to the National Institutes of Health. Back pain is the most common cause of disability in the United States and a leading contributor to missed workdays. While most instances of low back pain go away on their own, others may be associated with chronic conditions, including disc degeneration. Currently, physicians rely on a variety of non-surgical techniques to treat milder forms of degenerative disc disease, while advanced cases of disc degeneration are treated with spinal fusion, effectively immobilizing sections of the spine, or total disc replacement.
As the spine's spongy discs or "shock absorbers" deteriorate, parts of the framework of the spine can make contact with each other, causing lower back pain. With the Wallis system, a spacer is inserted between the vertebrae, held into place with stabilizing bands that are wrapped around the bones on the back of the vertebrae.