The use of an artificial disc to replace a damaged spinal disc that is generating chronic back pain has been practiced in a number of European countries for many years and is currently in various phases of development and clinical trials in the U.S. The Charité was FDA-approved in October 2004 and the PRODISC-L was approved in August 2006. The Maverick and FlexiCore lumbar discs have completed their randomized enrollments and are currently in Continued Access non-randomized modes. The Kineflex lumbar disc received approval in June 2005 to begin patient recruitment.

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There are a wide variety of new products, procedures and techniques currently in development to enhance spine surgery, and many spine surgeons believe that artificial disc technology holds real promise for significantly improving the standard of care for many patients. Published study data from the Charite trial, as well as interim comparative data from the larger ProDisc investigational study centers demonstrate improved VAS and Oswestry functional scores in arthroplasty patients, and suggest earlier return to work with better lumbar motion as compared to the control fusion group.

Traditionally, spinal fusion surgery (rather than artificial disc surgery) has been the treatment of choice for individuals who have not found pain relief for chronic back pain through nonsurgical treatment (such as physical therapy, medication, manual manipulation, etc), and have remained disabled from their occupation, from their activities of daily living, or simply from enjoying a relatively pain-free day-to-day existence.

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In the United States, over 200,000 spinal fusion surgeries are performed each year. While there have been significant advances in spinal fusion devices and surgical techniques, the procedure does not always work reliably. For example: In a review of 4,454 patients in 78 reports, Bono and Lee found the average fusion rate was 85%, and the average clinical success rate (pain reduction) was 75%. They also found that a successful spinal fusion takes a relatively long time (3-24 months, average 15 months) for healing and recuperation, and causes adverse effects on adjacent levels over time.

Premature degeneration at adjacent levels of the spine (Transition Syndrome) remains one of the more vexing problems facing spinal surgeons when advising relatively young people to consider lumbar fusion surgery.

In the 1990s, physicians and surgeons caring for people with disabling mechanical back pain became increasingly interested in isolating the disc as the source of pain. Advances in diagnostic imaging studies, such as the MRI scan and discography, now allow for a more definitive diagnosis to be made of discogenic pain (pain generated from a spinal disc).

As a result, there have been a number of developments in surgical treatment of this type of chronic back pain—including artificial disc technologies.

The artificial disc offers several theoretical benefits over the spinal fusion for chronic back pain, including:

  • Potentially enhanced clinical success rates (pain reduction)
  • Potential to avoid premature degeneration at adjacent levels of the spine by maintaining normal spinal motion