Intervertebral disc arthroplasty

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Intervertebral disc arthroplasty

Intervertebral disc arthroplasty, or artificial disc replacement, is a type of arthroplasty. It is a surgical procedure in which degenerated intervertebral discs in the spinal column are replaced with artificial ones. The procedure is primarily used to treat chronic, severe low back pain and cervical pain resulting from degenerative disc disease.

Before artificial disc replacement, the standard of care for chronic back pain was spinal fusion surgery. This procedure involves fusing two or more vertebrae together to remove motion in those segments of the spine, allowing for pain reduction or elimination due to the resulting decreased movement. Artificial disc procedures were developed with the goal of pain reduction or elimination, while still allowing motion throughout the spine. Another advantage is the prevention of premature breakdown in adjacent levels of the spine, a potential risk in fusion surgeries.

History

Artificial disc surgery is still relatively new in the United States, but has been used in Europe for more than 15 years. In the United States, only three brands of artificial discs have been approved by the FDA for use in the general patient population: the Charite, manufactured by DePuy for use in the lumbar spine; the ProDisc, manufactured by Synthes for use in the lumbar spine; and the Prestige, manufactured by Medtronic for use in the cervical spine. Dr. Rudolf Bertagnoli helped to develop Pro Disc and its surgical technique in Europe and has taught more than 2,500 how to perform the procedure. All are FDA approved for one-level applications after clinical trials showed improvements in motion and pain. Two-level disc replacement surgery is still considered experimental in the United States, but again, has been in use in Europe for many years.

While these three discs have received complete FDA approval, some insurance companies in the United States continue to deny coverage for the surgery, still classifying it as experimental. Interestingly, data shows that artificial disc replacement patients, when compared to spinal fusion patients, have shorter surgeries, less blood loss, shorter hospital stays and are quicker to return to work following surgery.

The first artificial disc approved for use in the United States is the Charite artificial disc. Invented at Charite University Hospital in Berlin in the mid-1980s by the East German scientist, two-times Olympic champion in women's artistic gymnastics Karin Büttner-Janz and Kurt Schellnack, the disc did not receive FDA approval in the United States until October 2004, following an extensive four-year clinical trial.

The first surgeon to perform a Charite artificial disc surgery in the United States was Scott Blumenthal, M.D., a spine surgeon at Texas Back Institute in Plano, Texas. Blumenthal served as principal investigator for the Charite study and works regularly with all discs on the market, giving him the unique position of performing more artificial disc surgeries than any other surgeon in the United States. Blumenthal is also in the process of developing his own artificial disc, culminating all the knowledge he has gleaned from working with the discs currently on the market.

In addition to total disc replacement, some companies are also working toward developing products and methodologies to replace only the inner portion of the disc. Referred to as disc nucleus replacement, these new techniques would allow for posterior insertion and a potentially shorter surgery with fewer complications.

Criticism

Recent concerns have been raised relating to the transparency of research being carried out by investors in Prodisc.

In addition, there are several class-action lawsuits pending against the Charite Artificial Disc, and reports of complications with the Pro Disc Artificial Disc implant when used in certain surgical situations. A grassroots group of concerned spine surgeons calling itself the Association for Ethics in Spine Surgery has formed to raise awareness and help protect uninformed consumers.