Recently approved by the FDA and available at Jefferson, the first artificial disc offers relief, mobility, and improved recovery to those with progressive back pain who have not been aided by medication or braces

		Orthopedic Surgery News Archive Featured in the Media JeffNEWS

About three-quarters of all adults suffer from back pain during their lifetime. In fact, back pain is one of the most common reasons adults visit the doctor. For some of these sufferers, back problems are constant and cause significant impairment, keeping them from their daily activities and from doing the things they love.

Traditionally, spinal fusion is used to treat this ailment, but orthopaedic surgeons at Thomas Jefferson University Hospital, Philadelphia, have found that a new FDA-approved artificial disk composed of metal and plastic is proving to be an effective additional choice for patients who might otherwise consider fusion. Jefferson performed its first procedure using the artificial disk in February and is among the first centers in the Philadelphia region to perform this procedure.

The Charite Artificial Disc, made by Johnson & Johnson's DePuy Spine Inc., has been used in Europe for more than 17 years and has been used in treating thousands of patients worldwide with good results. It is currently the only FDA-approved device of its kind.  Treatment with the disk appears to allow for faster recovery than fusion with the potential benefit of still retaining stable motion. Long term studies show about the same amount of pain relief with the artificial disk as with fusion. Total disk replacement with the artificial disk involves removing the deteriorated disk from between the vertebrae and implanting an artificial disk made of metal and plastic.

According to Alexander R. Vaccaro, M.D., co-director of Reconstruction Spine Services at the Rothman Institute at Thomas Jefferson University Hospital, follow up studies from pre-approval testing of the artificial disk produced very favorable results.

“This device allows the spine to move, something you don’t get with fusion. In studies, patients were observed to have motion between zero and 21 degrees while bending forward and backward,” says Dr. Vaccaro, Professor of Orthopaedic Surgery, Jefferson Medical College of Thomas Jefferson University.

Many of the problems of the spine are caused by degenerative disk disease. This condition affects the cartilaginous cushions called intervertebral disks that can be found between the vertebrae (bones) of the back. These disks act as shock absorbers between adjacent vertebrae and also work to hold the spine together. When injured through aging and injury, disks cannot repair themselves, and this wear can lead to degenerative disk disease–and often pain for its sufferers.  The diagnosis of degenerative disk disease can be confirmed by history, X-rays and MRI.

One treatment for degenerative disk disease is surgery–including spinal fusion–to reduce further degeneration and control pain. Spinal fusion involves the "welding" of two or more of the small bones (vertebrae) that make up the spinal column and fusing them together with bone grafts and internal devices such as metal rods. The end product is a solid, stiff area of the affected vertebrae.

With the new procedure, the surgeon chips away the damaged disk, creating room for the new one to be placed, while checking with X-rays to ensure proper alignment. For each patient, the surgeon chooses the specific artificial disk size that will restore their patient’s original disk height and function and match his or her anatomy.

The first patient to receive the disk replacement at Jefferson, David Lodi, was a good example of the type of patient who can benefit from the new device.

Lodi, 42, a postal worker from Audubon, N.J, had a “bad back” and degenerative disk disease for years, but he didn’t know that he essentially had a “time bomb” ready to go off in his aching spine. Lodi’s life was changed when he was stuck by a car crossing a crosswalk in February 2004. After his accident, Lodi’s back pain was suddenly nearly unbearable. “I had trouble walking. I couldn’t sleep. I couldn’t do everyday things without a lot of pain. My whole life was turned upside down,” Lodi says. He found himself constantly making accommodations to his daily routine so as to avoid pain. At work at the U.S. Post Office in Bellmawr, N.J., Lodi was reassigned to light desk duty.

Lodi’s physician prescribed various approaches to treat his pain including medications, braces and epidural steroids (an injected combination of cortisone and a local anesthetic).

When these approaches didn’t cut the pain, Lodi’s doctor suggested that he look into spinal surgery at Jefferson.

While Lodi may have been an appropriate fusion patient, Dr. Vaccaro suggested surgery with the new disk. According to the makers of the Charite Artificial Disk, the disk is an alternative to spinal fusion for patients who have one diseased disk between the L4 and L5 levels or between the L5 and S1levels. Those with degenerative disk disease whose spine has moved less than three mm may receive the disk.

Patients receiving the disk should have at least six months during which pain treatment, such as medication or physical therapy, has failed. Patients who have had some minor lower back surgery may also be a candidate for the disc.

The artificial disk is not appropriate for those who have an infection throughout the body or spine, disk degeneration or instability at more than one spinal level or who have poor bone quality, said Dr. Vaccaro.

In two-year post-op studies by Charite, patients also reported greater pain relief and restored function no worse than patients who had fusion surgery. There is a limited risk of complications with the surgery, including potential injury to the surrounding vessels on insertion and the potential for wear over time because of its nature as an articulation moving device, said Dr. Vaccaro. The rates of complications were about the same between the artificial disc patients and fusion patients.

“We are very excited to be able to offer this technology at Jefferson,” says Dr. Vaccaro. “We’ve had artificial knee and hip replacements for years, and now we have this option for the spine that we expect to be very successful.”