Based on many retrospective studies that have been published, it seems that artificial discs seem to show fair to good results. Yet, like any spine surgery, there are always reports of complications associated with subsidence, wear, adjacent disc degeneration, migration and facet joint degeneration. Posterior fusion has been the gold standard for many years and with the advent of the artificial disc spine surgeons and Wall Street started seeking the new new thing. Much of the hype back then was that "in theory" the procedure was to have advantages over fusion, minimizing the potential for ADD since fusion eliminates motion and causes overloading on the adjacent discs. Yet, some estimated that ADD would occur 10 years down the road. Some investigators even found no evidence that long-term disc results were any better than fusion.
Back then the race was on. Bring on the marketing studies and financial forecasts! Should we be the first? Would it be better to be second? Many strategies abounded. TSB remembers hearing some oracles of the industry claim that 65-75% of fusion patients will be candidates for an artificial disc. Back in 2003 or 2004 one of the major investment banks even put out an analysis on the potential payback. In retrospect, $5,000 per level was an entertaining forecast. But who are we to laugh at Wall Street? They always get it right, don't they? Artificial Disc replacement was going to create a major paradigm shift. Once DePuy acquired Charite, " V-III" sold ProDisc to Synthes, Stryker in its haste acquired Tom Errico's SpineCore device, while Medtronic feverishly labored on Marverick. The industry didn't even have a two year retrospective follow-up in the US market and companies were touting their devices as first gen, second gen, third gen without any rhyme or reason. At that time, the industry hadn't answered the question whether a device should be constrained, semi-constrained or unconstrained. Should it be metal on poly? Poly on Poly? Metal-on Metal? PEEK?
If the Charite is to be remembered as having attained legendary status because it opened the door to motion preservation, it was quite an expensive door opening. If the device was approved by the FDA in 2004, and to date there have been 5,000 implantations, (assuming this is US data) on average DePuy and its surgeons are averaging an estimated 833 procedures per year. Would our readers consider this to be a windfall? Considering that statistically people over 60 have more back problems than younger people, what were we expecting when CMS issued non-coverage decisions for all lumbar disc devices for patients over 60?
So this week "the Dude" and Walter stood over the cliffs of LaJolla and eulogized the old boy, opening the coffee can with the remnants of Charite and throwing it into the wind. May it RIP. TSB wants to know what our readers think?