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Ed Yeates ReportingThe clinical trials have ended and the FDA likes what it sees. So now, what patients have waited for for a long time is ready for general use. Ed Yeates takes a look at the new implantable artificial disk for the spine.
Ever since a car accident injured her spine, Cynthia Johnsen has suffered severe pain and loss of mobility in her lower back. But that was until last week. At Cottonwood Hospital's Spine Institute, surgeons implanted a new high tech artificial disk, the first one now approved for the U.S. market.
Cynthia Johnsen: “I’ll be able to golf. I’ll be able to hold my baby niece. I’ll be able to have children myself, which was a big concern with me, just the weight of a child on your back. I won’t have any restrictions. I’ll be normal.”
It would appear the artificial disk is nothing more than a couple of pieces of metal with perhaps some plastic in between. But it's really a very sophisticated joint. Even though larger than a natural disk, it moves smoothly and cushions the bone.
Judd Clawson, M.D./Spine Surgeon: “The plastic in the laboratory will last 60, maybe 80 years, if you simulate human movement. This will give you just about as much mobility as your normal disk.”
But Dr. Judd Clawson remains cautious. He says the Spine Institute plans to carefully select patients even though the FDA has approved the disk for widespread use.
Dr. Clawson: “Most of the people who are good candidates for this are people who are very young, who are patients we in general do not want to fuse because of the long-term implications.”
That's why Cynthia Johnsen got one. Though the car accident left her disabled, she had no complications from chronic diseases of the spine and at only 26-years of age fusion would NOT have been a good option.
Data collected from clinical trials at the University of Utah showed the implants could substantially benefit this group of patients. Trials also showed the disk rarely failed, and when it did, it was because the device was positioned incorrectly.
