Charité Artificial Disc: Single-Level Lumbar Disc Disease

Charité Artificial Disc - Clinical Results Tell the Story: Part 2

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Two Studies
In order to receive FDA approval, the Charité Artificial Disc had to undergo rigorous testing and clinical trials. A clinical trial is a type of research study that uses human volunteers to see if certain medications or treatments are safe and effective. Two such studies looking at the Charité Artificial Disc are discussed below.

The first study was based on a series of 40 patients each receiving the Charité Artificial Disc for single-level lumbar disc disease. Each patient's pain was assessed before the device was implanted. Patients were also seen by a spine surgeon 3 months, 6 months, 12 months, and 24 months after the surgery. Radiographs were taken at each of these visits. The surgeon also took measurements of exactly where the artificial disc was implanted so as to identify the ideal placement of the device and to see how the surgeons experience changed as more surgeries were performed.

charite artificial disc implanted

The study results were promising. Overall, patients reported a significant decrease in pain after the surgery. In addition, improvements were made in the placement of the device. Surgeons were able to determine that the ideal place to implant the artificial disc was in the exact center of the disc space at the midpoint of the pedicles.

As is common in these types of studies, there were some patients who did not have a successful outcome. Several patients needed to have their artificial discs removed because the devices had became displaced. These patients then underwent anterior spinal fusion surgery with posterior instrumentation. Fortunately, there were no complications associated with removing the artificial disc.

The conclusions made by the spine surgeons were that despite a few complications, the Charité Artificial Disc is a highly successful treatment option for patients with single-level lumbar disc disease. They were also pleased to be able to identify the ideal placement site and noted that surgeon experience made a difference in a patient's outcome.

Updated on: 03/24/16
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Charité Artificial Disc versus Anterior Lumbar Interbody Fusion (ALIF)
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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Charité Artificial Disc versus Anterior Lumbar Interbody Fusion (ALIF)

Currently the Charité Artificial Disc is only approved for patients with single-level degenerative disc disease between L4/L5 or L5/S1.
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