50 years of research and development makes ADR not just an option, it’s a remedy.
It’s hard to overlook the fantastic scientific and technological developments we have witnessed in the last 50 to 60 years. Especially for anyone born on THIS side of the 1950s. I’m not just talking about men to the moon, cell phones, and the Internet. We’re talking about fundamental changes at nearly every point in American life: from the way we live and work, and the way we receive medical care.
There’s not a procedure or process that’s been left untouched by new technologies, methodologies, and procedures. We even record body vitals differently. Remember the glass thermometers when we were kids? It took a nurse a whole three minutes to get your body temperature. These days they know nearly everything about your vitals in 60 seconds. We’ve also made incredible advancements in diagnostic equipment. We don’t just have X-rays and treadmills, we have scanners (CT, MRI, and EBT), mammograms, and optical tomographies (to measure the thickness of the eyewall). We estimate calcium deposits in the heart and perform total virtual colonoscopies. Surgeons use advanced optical microscopic tools to achieve surgeries that were unthinkable only 10-15 years ago.
About 50 years ago, surgeons in Europe came up with an idea to replace herniated discs in the spine with artificial ones. They worked on the concept, methodology, and the technology, and today – here in the U.S.—neurosurgeons like me, have performed hundreds of artificial disc replacement surgeries.
That’s why I say artificial disc replacement surgery, also known as “ADR,” is not a “new procedure.” It is not experimental nor theoretical. I’ll admit it is “newer” than spinal fusion, but that’s comparing inches on the scale of miles. Artificial discs and the medical methodology that goes with it represents about 40 years of medical research and development. Spinal fusion was developed nearly 100 years ago.
Artificial disc replacement was approved by the FDA in 2005 for lumbar applications; 2007 for cervical. Ongoing clinical studies have verified that it offers a significant improvement in outcomes compared with fusion. In fact, all current studies show better patient outcomes in every way: regarding the reduction of pain complaint, neurological function, and fewer revision surgeries.
I was the lead author of one such study published last year in the Journal of Neurosurgery: Spine. My colleagues and I worked for seven years on the study, which was an FDA approved “level I clinical device trial” and publicly recorded (see: NCT00637156). We tracked 397 randomly selected patients from 30 medical facilities in the U.S. who recently had anterior cervical discectomy and fusion (ACDF) and compared their outcomes with patients who had a two-level cervical ADR surgery using a popular artificial disc called the Prestige LP.
Among the disc replacement patients, we saw an overall success rate of 81.4% compared with the fusion patients where the success rate dropped to 69.4%. To tighten this even further and give an even clearer picture of what happened, the “overall success rate” was determined by four results criteria: (1) neck disability index score improvement greater than 15 pts; (2) maintenance or improvement in neurologic status; (3) no serious adverse event caused by the implant or surgical procedure; and (4) no additional surgery such as supplemental fixation, revision, et cetera.
I expected better results from ADR, but I was pretty amazed that there was such a gap between the two procedures. In the parlance of research, this is what you call “statistical superiority.” Our seven-year study followed several other studies that were also favorable to artificial disc replacement.
We are making head-to-head comparisons with real patients using currently settled medical technologies, methodologies, and procedures. That’s why I can say absolutely and authoritatively – artificial disc replacement surgery is NOT experimental. It’s settled medicine and should be treated as such by the entire medical community, healthcare insurance companies, and by the news media reporting on issues about health.
I’ll go one step further and say that this rumor about ADR, the suggestion that the procedure is not ready for general patient use, is not only clinically incorrect, but it is also doing patients all over the country a terrible disservice. And here I speak, not as a surgeon, but as a patient.
I have artificial discs in both my cervical (neck) and lumbar (lower back) spine. I also have one cervical fusion. I cringe thinking about what my life would be like had I been forced to take spinal fusions instead of artificial discs. I think about the significant changes in my daily activities; the likelihood that I would have had to end my practice as a surgeon. I’m very active. I like to swim. I enjoy my workouts. All of that would have been significantly curtailed. I imagine that could be living pain-free, but that’s where I am now—with artificial discs and as much of my full range of spinal motion as my body can handle.
The difference is spinal fusion’s approach. It’s designed to stop back and neck pain resulting from degenerative discs and other spinal disorders. But it accomplishes this critical task by stopping motion of the affected vertebral level or segments. Artificial disc replacement also stops the pain, but it does so by mimicking the form and function of the original discs: restoring the gap between vertebrae, so bones and herniated disc material isn’t pressing down on nerves and preserving natural movement of the spine. In this way, artificial disc replacement surpasses spinal fusion as a remedy for spinal disorders.
I see patients every day, who remind me of myself several years ago: stooped and hindered by excruciating, nearly debilitating pain. When I meet them for the first time, I think of myself—after my first fusion—and I know they want better answers. Their goal is what I want: not only to get better and put the pain behind them, but they also want to keep their lives the way they are now.
That’s why I’m taking a bolder step and using artificial discs in an off-label procedure to reverse spinal fusions. I call it “restorative motion surgery” – regaining freedom of movement from the brute force of spinal fusion. It takes the prescription of “getting better” one step further: it helps my patients become greater than better.