The Food and Drug Administration recently approved an artificial disc for back surgery, and shortly after, a Cottonwood Hospital surgeon implanted one in a patient.

While the disc, developed by CHARITE, is the first to receive FDA approval, it's by no means unique. There are several more right behind it in the pipeline, expected to get approval in the next couple of years, with still more likely to follow. And it's not the first time such a disc has been used in a Utah operating room. Others have been implanted in Utahns at various hospitals as part of the clinical testing required to get FDA approval.

But the arrival of artificial discs on the market marks a very significant point in the often-slow evolution of back surgery.

Artificial discs will be especially helpful to patients who in the past were told to live with their pain as long as possible, said Dr. Junius "Judd" Clawson, a spine surgeon at the Intermountain Spine Institute at Cottonwood, who led the team implanting the high-tech artificial disc in Cynthia Johnsen two weeks ago. Before coming to Utah, Clawson implanted artificial discs as part of clinical trials while working in Texas, so he was very familiar with them, he said.

Johnsen, 26, was injured in a car accident four years ago. Since then, she's been unable to sit for long periods at work and was equally miserable if she had to stand for more than a few minutes, leaving her with few pain-free options. She eventually exhausted all the benefits of more conservative nonsurgical treatment and had to decide on either a spinal fusion or an artificial disc.

Spine surgeons typically try to avoid back surgeries in young patients. Those in their 20s, 30s and 40s are encouraged to put off having their spine fused as long as possible because fusion locks the impaired vertebrae to those on either side so they are supported but inflexible. Removing the motion typically removes the pain, but it brings with it less-desirable effects as well.

It's also common for adjacent sections of spine to take up some of the function that has been lost, so they get overworked and degenerate, leading to more pain in other places.

"When someone is in his 20s, you don't want to start down that road (of fusion), so you have to live with it" in part to avoid or delay the adjacent wear-and-tear, Clawson said. "We think we can do these (artificial discs) and not have those consequences."

The artificial disc resembles a high-tech sandwich cookie, with movable high-density plastic centered between two metal endplates.

The advantages are apparent, Clawson said, including earlier return to work, less rehab time, less pain initially following surgery. There were no significant differences in complications. By three months, studies show the discs are roughly equivalent to a fusion in terms of pain control.

Part of that reduced pain is increased ability to move around earlier. "With most conditions, the more you restrict motion, you tend to have more pain," he said.

Johnsen was released from the hospital the weekend after surgery.

The artificial disc is not for everyone, Clawson said. He estimated that fewer than 10 percent of patients are actually candidates for the procedure. It is ideal for younger patients, 18-55, who have a localized disc injury. It's approved by the FDA for single-disc replacement, although some surgeons are using it for two or three. It is not an option for people who have soft bones.

Long-term complications of the disc aren't known. Will it wear out? Can it spit out the plastic core? Clawson asks. "Once you have a solid fusion, you never need to worry about the hardware. You worry about the next level up or down as an issue. With the artificial disc you may still have to operate on that level. You may have to do a fusion" in the future. It's too early to have that down-the-road data.

If the implant is placed well, Clawson said, "you're not going to have problems."

There are so many advantages and the clinical trial work was so promising that Clawson is among doctors who believe the discs can provide great relief for some people. "I have two in a friend of mine, and he's doing fabulous. But there are fusions that have zero pain and are doing fantastic, too."

The instruments used for the implant are a little bulkier than those used for fusions, he said. And the artificial disc surgery must be much more meticulous. "Where you place the device and how you size it is critical. It's a matter of being kind of a perfectionist and making sure you do it right. It's more challenging," he said.

Typically, two surgeons work together. A vascular surgeon goes through an abdominal incision toward the spine, delicately moving blood vessels and organs aside. Then the spine surgeon uses special tools to remove the damaged disc and make space for implantation of the artificial disc between two vertebrae.

Back pain is a huge problem for 65 million Americans, who spend about $50 billion each year on low-back pain, the most common job-related disability and leading cause of lost workdays. More than 12 million people reportedly suffer degenerative disc disease.


E-mail: lois@desnews.com