Charité Artificial Disc versus Anterior Lumbar Interbody Fusion (ALIF)
Charité Artificial Disc - Clinical Results Tell the Story: Part 3
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 CHARITE Artificial Disc and ALIF Procedure
|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"|
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 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.