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First Artificial Disc for Treatment of Low Back Pain Approved by FDA
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If you suffer from low back pain, you're far from being alone. About 65 million Americans suffer from low back pain each year, according to the American Association of Neurological Surgeons (AANS). This pain is typically caused from at least one damaged or deteriorating lumbar disc. A normal lumbar disc acts as a cushion between the bones in the spinal column. A disc is said to be herniated or prolapsed when the soft inner core pushes through the weakened or ruptured outer layer. When it touches a nerve, the result is immediate, excruciating pain. Discs can be damaged as a result of a major injury or from performing everyday activities, such as lifting heavy objects incorrectly or reaching down or up repeatedly. However, there are cases when a disc swells, tears or degenerates without any apparent cause.
To help remedy their lower back pain, 200,000 Americans undergo lumbar spinal fusion surgery each year. Conventional spinal fusion surgery removes the damaged disc and using bone grafts, metal screws and/or cages immobilizes that area of the spine. This typically results in pain relief, but limits the patient's range of motion and possibly transfers extra stress to discs that are above and below the fusion site.
A New Disc Replacement Surgery Offers Pain Relief and Motion
A new alternative to spinal fusion, called the Charité Artificial Disc, was approved by the Food and Drug Administration in October, 2004. Made by Johnson & Johnson's DePuy Spine Inc., the Charité Artificial Disc replaces damaged or worn-out spinal discs with artificial ones, allowing the spine to bend and twist. This is the first FDA approval of an artificial replacement for spinal discs. Artificial joints are commonly used in hips and knees. The Charité Artificial Disc consists of two metallic endplates and a movable, high-density plastic center. The design simultaneously aligns the spine and allows it to move.
Recovery Time of Artificial Disc Replacement Surpasses Traditional Spinal Fusion
According to Paul Nottingham, M.D., the first orthopedic surgeon on staff at John Muir Health to perform the artificial disc surgery, "The Charité Artificial Disc can provide greater mobility, less stress on surrounding vertebrae and a faster recovery." While spinal fusion surgery patients can take up to six months to recover, patients given the Charité Artificial Disc were able to return to work and normal activity much sooner — in 12 weeks or less. Additionally, patients who got the replacement disc maintained flexibility, left the hospital sooner, and were more satisfied with their procedure than were spinal fusion patients. In the Charité clinical trials, complication rates for disc replacement surgery were similar to those seen in spinal fusion surgery.
John Muir to Provide Artificial Disc Replacement Training
John Muir Medical Center, Walnut Creek Campus is one of only two centers in the Bay Area to be designated as one of 50 regional training centers throughout the country to provide extensive training of the new procedure.
During the surgery, a general surgeon makes an incision in the abdomen and moves internal organs and blood vessels out of the way. A spine surgeon then uses special tools to remove the damaged disc and to implant the artificial disc. The entire procedure takes one to two hours, and the average hospital stay is about four days.
Though approved after a two-year U.S. clinical trial, total disc replacement with the Charité Artificial Disc began in Europe over 17 years ago, treating thousands of patients worldwide with positive results.
Recognizing Disc Problems
"The Charité Artificial Disc is a very valuable device for certain patients," says Dr. Nottingham. It is recommended only for people who have no success with less drastic methods, including physical therapy and pain medication. It is approved for adults up to the age of 60 who have a single degenerative disc in one of the two lowest lumbar discs and have never had a fusion operation.
See your doctor if you think you may have a disc problem. Typical symptoms of a disc or discs in the lumbar region that could be damaged include:
- Sharp pain in the back, sometimes going down the back of one or both legs, immediately upon or shortly after exertion or injury.
- Inability to bend or straighten your back, accompanied by severe pain.
- Gradual development of neck or lower-back pain, possibly intense on arising or when sneezing or coughing.
- Numbness or tingling in an arm or leg, and possibly a progressive loss of strength in one or both legs.
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