The Lumbar Artificial Disc:
An Alternative to Spinal Fusion

ON OCTOBER 26, 2004, the Food and Drug Administration (FDA) made artificial discs available in the United States by approving the Charité Artificial Disc, for the treatment of low back pain from degenerative disc disease.

Worldwide experience with the Charité disc, commencing in 1987, now comprises more than 7,500 cases implanted in some 30 countries throughout Europe, Asia, Canada, Australia, Africa, and Latin America. European outcomes data are compelling. Studies reflecting five and ten year follow up periods report good or excellent clinical outcome in 84.8% and 90% of the study populations, respectively.

The Charité artificial disc, comprised of two metallic endplates and an unconstrained polyethylene core, is designed to help align the spine and preserve motion. The free-floating design allows the core to move dynamically within the disc space during normal spinal motion, moving posteriorly in flexion and anteriorly in lumbar extension. This movement, unlike traditional fusion surgery, reduces stresses and motion at adjacent levels that may lead to adjacent level disc disease.

Qualified Candidates

• Single level lumbar degenerative disc disease
• Two level lumbar degenerative disc disease
• Failed conservative treatment
• Positive provocative discography
• Positive MRI findings
• Low back pain as primary complaint

Results from the pivotal study*

The FDA IDE multicenter trial of the Charité artificial disc was performed at 15 centers across the US. Qualified study patients were randomized between fusion (99 patients) and placement of the Charité disc (205 patients). Key findings of the study include:

  • Charité artificial disc was found to be safe and effective for the treatment of degenerative disc disease compared to traditional spinal fusion
  • At 24 months follow-up, over 70% of patients receiving the artificial disc were satisfied with their surgery, compared to only 55% of the fusion control group patients (p=.0011)
  • At 24 months follow-up, nearly 70% of patients receiving the artificial disc would choose the same treatment again, compared to 50% of the fusion control group patients (p=.0062)
  • 57% of patients receiving the artificial disc rated their surgery a success compared to 46% in the fusion control group (p<.001)
  • Patients receiving the artificial disc had a statistically significant lower Oswestry Disability Index score (rating scale to measure function) than the fusion control group at 6 weeks, 3, 6, and12 months
  • Patients receiving the artificial disc had a statistically significant lower VAS pain score than the fusion control group at 6 weeks, 3, 6, and 12 months

Overall, patients receiving the artificial disc regained function faster, had less post-operative pain and indicated a better quality of life than the patients in the fusion control group. Complication rates for both the artificial disc and fusion groups were similar.
*Charité Pivotal USFDA EDE Study, sponsored by DePuy SPine