The U.S. FDA has approved the first artificial disc (search) for the treatment of severe low back pain, the device's manufacturer reports.
The Charité Artificial Disc (search), from Johnson & Johnson's DePuy Spine Inc., replaces damaged or worn-out spinal discs (search). Currently, the most common surgical treatment for severe back pain caused by disc damage is spinal fusion (search). Every year, 200,000 Americans undergo this procedure.
Spine surgery often — but not always — relieves back pain. However, spinal fusion surgery removes the damaged disc. It uses bone grafts and metal screws and/or cages to immobilize that area of the spine.
The Charité disc, however, actually replaces the disc with an artificial one. This lets the spine bend and twist, notes Scott Blumenthal, MD, an orthopaedic spine surgeon at the Texas Back Institute in Plano. Blumenthal led a clinical trial of the artificial disc.
"The Charité Artificial Disc has the potential to revolutionize spine surgery," Blumenthal says in a DePuy Spine Inc. news release. "Until now, spine surgery relieved pain by limiting motion. Now, for the first time, we can relieve pain and preserve motion."
The Charité device consists of two metallic endplates and a movable, high-density plastic center, which replaces the damaged disc. It's designed both to align the spine and to allow the spine to move.
Artificial Disc Replacement Beats Spinal Fusion in Recovery Time
In the Charité clinical trials, complication rates for disc replacement surgery were similar to those seen in spinal fusion surgery. Complications of disc replacement include unresolved pain, allergic reactions, and bladder problems.
But patients who got the replacement disc maintained flexibility, left the hospital sooner, and were more satisfied with their procedure than were spinal fusion patients.
Disc replacement patients returned to work and normal activity sooner than spinal fusion patients, says John Regan, MD, a spine surgeon at Cedars Sinai Hospital in Los Angeles. Regan took part in the Charité clinical trial.
"At our center, Charité Artificial Disc patients returned to work in 12 weeks or less, which was far better than the spinal fusion patients who were not able to go back to work for about six months," Regan says in the DePuy news release.
Artificial Disc Replacement a New Trick for Spine Docs
Disc replacement surgery requires two surgeons. 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.
At present, 15 U.S. spine centers offer disc replacement surgery. Surgeons need special training to lean the technique. This means that patients who want the disc replacement will have to wait for several weeks or months while doctors in their area complete the training. DePuy says it is sponsoring such training.
Disc Replacement Not for Everyone
Disc replacement is not an option for every patient with severe back pain. DePuy urges patients to ask their doctors whether artificial disc replacement is appropriate for them.
SOURCE: News release, DePuy Spine Inc., Raynham, Mass.