FDA Approved Alternative To Spinal Fusion Surgery
Total disc replacement, approved by The U.S. Food and Drug Administration (FDA) in October 2004 is a procedure that treats severe low back pain by replacing a damaged or worn out spinal disc with an artificial one. While artificial replacements are commonly used in hips and knees, this is the first FDA approval of such a device for spinal discs.
Currently, there are only 15 spine centers throughout the U.S. who offer disc replacement with artificial discs.
"These artificial discs have the potential to revolutionize spine surgery," said Darryl Antonacci, MD, an attending Orthopaedic Surgeon at Lenox Hill Hospital. "Until now, spine surgery relieved pain by limiting motion. Now, for the first time, we can relieve pain and preserve motion."
The discs are made of two metallic endplates and a movable high-density plastic center that, once implanted, is designed to help align the spine and preserve its ability to move. Spinal discs maintain the position of the spine and allow for the flexibility to bend and twist.
Lumbar spinal fusion surgery, a common surgical treatment for low back pain or degenerative disc disease, is often effective in reducing pain, but limits range of motion and may transfer extra stress to discs above and below the fusion site. More than 200,000 of these procedures are performed each year in the U.S.
In clinical trials comparing artificial disc replacement to spinal fusion surgery, the artificial disc patients maintained flexibility, experienced improvements in pain and function, left the hospital sooner and were more satisfied with the procedure. Complication rates for both groups of patients were similar.
"Artificial disc patients are able to return to work and normal activity sooner than spinal fusion patients. Typically artificial disc patients can return to work in 12 weeks or less, which is far better than the spinal fusion patients who usually are not able to go back to work for about six months," said Dr. Antonacci.
About 65 million Americans suffer from low back pain every year, according to the American Association of Neurological Surgeons (AANS). Americans spend about $50 billion each year on low back pain, the most common cause of job-related disability and lost work days.
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