Media Contact: Sandra VanE-mail: [email protected]Telephone: 1.800.396.1002Please do not include this telephone number or e-mail in your story. They are provided for media use only.
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LOS ANGELES (June 6, 2001) -- If there is one back-surgery patient who can put a new, experimental artificial disc to the test, his name is Karl Nusch, and there is a good chance he's walking, biking or swimming somewhere near his Redondo Beach home.
Nusch, 41, who loves to compete in triathlons, jumped at the chance to have a prosthetic disc placed between two vertebrae in his low back. The hour and a half operation took place on March 23 at Cedars-Sinai Medical Center's Institute for Spinal Disorders, one of 10 centers nationwide participating in a study of 300 patients.
While patients who undergo fusion surgery need to restrict their motion for up to a year, those who receive artificial discs are encouraged to be mobile right away, according to Nusch's surgeons. Robert S. Bray, Jr., M.D., is director of the Institute, and John J. Regan, M.D., is the Institute's director of research and education.
"In Karl's situation, we actually have to slow him down," said Dr. Regan. Nusch was up and walking in the hospital halls the day after surgery, and he persuaded Drs. Bray and Regan that he was ready to go home the day after that. Although he took medication for pain the first week after surgery, he said most of the discomfort was in the incision area, not where the prosthesis was positioned in his back.
"I did the exercises they told me to do, and two weeks later I was in the pool, swimming," he said. His goal is to again become as physically active as possible, although he realizes that competing in another Ironman triathlon -- 2.4-mile swim, 112-mile bike ride, and 26.2-mile run -- may not be possible. Over the years, he has completed triathlons of various distances, from the shortest to the longest.
Nusch first became aware of his back problem two years ago, just weeks before Ironman Canada. "I started feeling some soreness, pain in my lower back, especially when I was running. I disregarded it and put it down as part of the training," he said. "About two weeks before the race, it got pretty bad, to the point that I had to go to my doctor and get checked out. I started feeling sciatic pain," which occurs when the sciatic nerve in the low back is pinched, causing pain in a hip or leg.
The physician urged him to take two weeks off from training, go into the race cautiously, and if the pain came back during the competition, to quit.
"To be told this after six months of training, I thought are you insane? Race day came and everything went very well," Nusch recalled. "For four days after the race, I felt fine except for my legs being sore. But then I started feeling that pain coming back." He went back to the doctor, who ordered an MRI that showed significant degeneration of the lowest three discs.
A natural, healthy disc is a complex structure between the bones of the spine. The nucleus, sandwiched in the center of the disc, contains fluid that serves as a cushion. Layered collagen fibers of the adjacent annulus provide strength. When the components of a healthy disc work together, they give the back both stability and flexibility. But when a disc deteriorates or gets damaged, the cushion can deflate, bulge or leak, and the collagen loses its elasticity. Pain is often intense, especially when nerves get caught in the degenerative process.
To relieve the pain and strengthen the spine, surgeons sometimes remove the disc or place a bone graft in the spine to fuse two bones together and stop the grinding, crunching action in between.
"Fusion is a very good operation for many people, and it helps them quite a bit in terms of getting out of pain. But one of the concerns we have with fusion is that long-term some people come back with problems at the next disc, either above or below. If something is going to move and one disc is not moving, it's going to increase the motion and stress on the discs next to it," said Dr. Regan.
Since Nusch's diagnosis, he tried a variety of conservative methods to combat the pain while continuing to compete as much as possible. With physical therapy, weight training, and medication, he was able to bike and swim but the pounding action of running was too painful. By the summer of 2000, even sitting at work or in a car for a length of time caused nearly unbearable sciatic pain. When he heard about the artificial disc study, he researched the subject and knew he'd prefer this option to fusion.
Whenever possible, surgeons performing either a fusion or this new operation approach through the abdomen rather than the back. By entering through an incision below Nusch's navel, Drs. Bray and Regan spared the all-important muscles of the back. At about an hour and a half, the operation is shorter than fusion surgery because it does not require bone grafting.
The artificial disc is being implanted at Cedars-Sinai as part of an approved multi-center research trial. Although the first five patients at each center participating in the study are certain to receive the artificial disc, the others are randomized. For every two patients who receive the prosthesis, one has a fusion.
"Part of the reason that this study is being done is to look at the impact of the adjacent discs, related to fusion versus artificial disc," according to Dr. Regan, who was a principal at the Texas Back Institute before joining Cedars-Sinai's program earlier this year. As director of research and education, he now oversees a team of specialists at the largest multidisciplinary spine center in the western United States.
Distributed in the United States by a company called Link America, this type of prosthetic disc already has a good track record in Europe. The Food and Drug Administration will use the results of this study -- which will follow patients' progress over two years -- in deciding whether to approve the device for ongoing use in the United States. It may prove a viable alternative to disc fusion surgery, especially for young, active patients such as Nusch, who will admit that the notion of competing in triathlons still lurks somewhere in his head.
Dr. Regan suggests less intense activity. "I think he will be able to get back to about 100 percent but we don't want him to get back to too much of the long-distance running," he said. "The artificial disc is a prosthesis, after all, and we would have some concern about wearing it out. But the major benefit of this procedure is that because there is still motion at the disc, there is no added stress on the other discs."
Nusch's early recuperation included back exercises, stationary biking and swimming. "I'm not doing any running. I'm not going to jeopardize anything," he said. "I think they were realistic. They don't want me doing a lot of running. It's probably that I'll be doing shorter distances."
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For media information and interviews, please contact Sandra Van via e-mail at [email protected] or by calling 1-800-396-1002. Please do not publish this contact information in your story. It is for media use only. Thank you.
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