CHARITÉ™ Artificial Disc versus Anterior Lumbar Interbody Fusion (ALIF)

CHARITÉ™ Artificial Disc - Clinical Results Tell the Story: Part 3

John J. Regan, MD
Orthopaedic Surgeon
Beverly Hills, CA
Ms. Mary Claire Walsh
SpineUniverse Staff Writer
In another study, which took place 2 years after the first randomized controlled trial, spine surgeons compared the CHARITÉ™ Artificial Disc to the anterior lumbar interbody fusion (ALIF) procedure. In this study, 304 patients (147 males and 157 females with an average age of 39 years old) with single-level lumbar disc disease were studied. 205 of the patients received the CHARITÉ™ Artificial Disc and 99 patients underwent the ALIF procedure with BAK cages and iliac crest bone graft.

The results of this study showed several similarities and differences between the treatment options (see chart below). Areas in which the procedures were similar included the length of time for the operation and the amount of blood loss. Differences however, were seen in the amount of pain patients still had after 2 years and their satisfaction with the procedure.

Comparisons of CHARITÉ™ Artificial Disc and ALIF Procedure

  CHARITÉ™ ALIF
Operative time 111 minutes 114 minutes
Blood Loss 207 ml 209ml
Length of hospital stay 3.7 days 4.3 days
Pain (at 2 years post-op) Decreased 62.5% Decreased 50%
Satisfaction with procedure 73% said they were satisfied 55% said they were satisfied
Choose procedure again (at 2 years post-op)? 83.2% responded "yes" 64.6% responded "yes"
Complication rate 21.4% 17.2%

The authors of this study concluded that while function and overall health status were similar between both procedures, patients who received the CHARITÉ™ Artificial Disc experienced less pain over time and more patient satisfaction, making this device a safe and effective alternative to fusion for one level lumbar degenerative disc disease.

A Patient's Story
Consider the following story of a real patient: "Jack" is a 38-year-old LA County Sheriff who sustained an on-the-job injury resulting in a herniated disc at L4-5. He underwent a series of conservative care treatment options including physical therapy and epidural injections until finally having a microdiscectomy at L4-5 in December of 2003. He returned to work but soon experienced increasing leg pain. A repeat MRI scan detected a recurrent disc herniation at L4-5. He underwent a repeat discectomy in January 2004 with improvement in his sciatic pain. Following his surgery he began to experience back pain aggravated by prolonged sitting. He was unable to work as a result of increased pain related to wearing his vest and utility belt. Repeat studies did not demonstrate a recurrent disc herniation but showed a 50% collapse of the L4-5 disc space.

In September of 2004 he underwent an artificial disc replacement at L4-5. Within 6 weeks, his back and residual buttock pain were gone. He was able to return to full duty 12 weeks following his surgery and has continued his employment without recurrence of pain.

Is it for me?
Currently, the CHARITÉ™ Artificial Disc is only approved for patients like Jack with single-level degenerative disc disease between L4 and L5 or between L5 and S1. Patients can only be considered for the device if they have not found relief after 6 months of non-surgical treatments such as pain medications, back braces, or physical therapy. It cannot be used on patients with more than one level of degeneration or for patients with osteoporosis. Also, keep in mind that all surgical procedures carry risk and that the use of an artificial disc is no guarantee that patients will be pain-free.

The Future
The FDA approval of the CHARITÉ™ Artificial Disc is a major step forward in the treatment of degenerative disc disease. Despite only being approved for single-level disc disease in the lumbar spine, the CHARITÉ™ Artificial Disc is showing promising results. This device will need continued study to ensure its safety and efficacy over time. In addition, in the next few years, other artificial discs will be approved and increase the body of knowledge and experience of these devices.

If you are interested in finding out if you are a candidate for the CHARITÉ™ Artificial Disc, talk to your spine surgeon. If you would like to locate a spine surgeon in your area, see the "Find a Physician" area of SpineUniverse.

Last Updated: 04/28/2005
Continue Reading: CHARITÉ™ Artificial Disc - Clinical Results Tell the Story
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Editorial Board Comments on SpineUniverse
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Peer Review by Leading Specialists

    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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