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CHARITÉ? Artificial Disc - Clinical Results Tell the Story

Part 1

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Everybody has back pain at some time. Most cases can be treated with a little rest, pain medications, physical therapy, and exercise. However, for people with chronic pain caused by such conditions and degenerative disc disease, back pain can be severe and debilitating.

Degenerative Disc Disease
Intervertebral discs are the shock absorbers of the body. They are made up of a soft gel-like inner substance called the nucleus pulposus and a tough outer band called the annulus fibrosus. As we age, our discs lose moisture making it harder for them to absorb the stresses placed on the spine during everyday activities. Excessive strain or injury can cause the discs to bulge or rupture, allowing the vertebrae above and below the disc to move closer together and pinch or compress nerve roots in the spine. The result is chronic and sometimes severe pain. For advanced cases of degenerative disc disease, non-surgical treatment methods of pain relief are often not successful. For these patients, surgery may be necessary.

The Limits of Fusion
The most common surgical treatment for patients with degenerative disc disease is fusion with instrumentation. In this procedure, the spine is strengthened and stabilized by fusing vertebrae together using bone graft or a graft substitute. In addition, spinal instrumentation such as rods or screws are often used to hold the spine in place and help facilitate fusion.

Advancements over the years have improved fusion procedures, however its biggest disadvantage is that patients lose a certain amount of mobility and flexibility in their spines. To address this, spine surgeons have spent years looking for a way to restore damaged disc space and retain spinal movement.

Today, their search is over. After 2 years of clinical trials in the United States and 17 years of experience in Europe, the FDA approved the CHARITÉ™ Artificial Disc in October 2004.

CHARITÉ™ Artificial Disc
The CHARITÉ™ Artificial Disc has a sliding core made of medical grade plastic surrounded by 2 endplates made of cobalt chromium alloy. The endplates have rigid "teeth" that secure them to the vertebrae above and below the disc space. The sliding core fits snugly in between these endplates.

charite artificial disc
CHARITÉ™ Artificial Disc
DePuy Spine, Inc.

The biggest advantage to the artificial disc is that once implanted, the spine is still able to retain mobility and flexibility. According to DePuy Spine, worldwide distributors of the CHARITÉ™ Artificial Disc, clinical trial patients were able to move up to 21º while bending forward and backward. Another important advantage to using an artificial disc is there is no longer a need for bone graft. In fusion surgery, bone graft is harvested from the patient's hip. For many patients, this is a major source of post-operative pain.



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Updated on: 02/01/10
Jeffrey C. Wang, MD
With the FDA approval of the artificial lumbar disc, this brings in a new era of a potentially valuable treatment for patients with degenerative lumbar disc disease. As with all new technology we need to look at this in a fair, balanced, and unbiased manner in order to critically evaluate the risks and benefits of the technology, in order to understand the potential risks and potential harm that it may do to our patients. I think that all surgeons hope that this novel treatment gives us a better option for our patients with this pathology. However, I think we need to temper our excitement and enthusiasm with the cold harsh reality that this is a very new and novel procedure and that we certainly need to gather much more information before we can conclusively define the risk and benefits and potential complications of this technology.

I think we all must understand that the excitement generated by the introduction of this new technology, which is being pushed very strongly by the spinal instrumentation companies which stands to profit quite a bit from selling this novel product, have all lead to increase pressure to adopt this technology. As physicians we must do what is proper and appropriate for our patients. Certainly, the early clinical results of the well-controlled studies that were performed in the United States demonstrate very good results with the disc arthroplasty. And certainly, these appear to be at least comparable to patients undergoing fusion surgery. As scientists, we must continue to follow these results in order to completely define the problems that we may encounter and explain fully to our patients that this still remains a novel technology. In addition we must not be narrow-minded and focused only on the spine arthroplasty implants. Rather, we must remember that spinal fusion is a very viable alternative that has well-defined benefits. Currently, comparing all the studies that have been performed, there is no definitive and proven evidence to choosing the arthoplasty over a lumbar fusion. I think that we all hope in the future as we gather more information we may be able to conclusively state that arthroplasty may be superior to fusion.

Until that time, we must certainly keep our minds open to novel technologies and potentially beneficial approaches to treating our patients. And we must also approach this in a stepwise logical manner and continue to gather information. I think this is a very exciting time for spine surgeons with the advent of new technology. We hope this introduces a new era and hopefully better treatment options for our patients.

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