June 9, 2005
FOR IMMEDIATE RELEASE

CONTACT: Tom Rosenberger, APR Communications Department
(513) 569-5260
trosenberger@mayfieldclinic.com

CONTACT: Cindy Starr, MSJ, Communications Department
(513) 584-2214
starrcm@healthall.com

Cincinnati Man Completes Flying Pig Half-Marathon Seven Months after Implantation of Artificial Spinal Disc During Research Trial at University Hospital

CINCINNATI, Ohio – Michael Davis, a 41-year-old executive and one of the first patients of the Mayfield Clinic to receive an artificial disc in his lower back, has come very far very fast in the months since his October surgery at University Hospital. In fact, during Cincinnati ’s 2005 Flying Pig Marathon on May 1, seven months after his operation, he went very, very far – 13.1 miles to be exact – in 1 hour, 49 minutes and 41 seconds.

While Davis has raised a few eyebrows among friends and medical practitioners alike with his rapid return to normal, that wasn’t his primary intention.

“Contrary to popular belief, I’m not trying to push this,” he said. “I was in good shape before the surgery and in decent shape now, and I’m doing what my body says it can do.”

In short, Davis is simply striving to fulfill one of the promises of medical technology by returning to the life he knows and loves following treatment for a painful medical condition. And the life he relishes goes well beyond an athlete’s need to move and a runner’s need to run. “I know that it’s a pretty big accomplishment to run a half-marathon after any kind of back surgery,” he said, “but for people who are thinking about back surgery, this is what they really should know: When I picked up my 5-year-old son with no pain, when I played kickball in our cul-de-sac with my wife and three children, that’s what makes this technology really important. This is as much a family thing for me as anything. This is what it’s really all about.”

Davis is a patient of William Tobler, M.D., a neurosurgeon with the Mayfield Clinic and The Neuroscience Institute at the University of Cincinnati and University Hospital. Dr. Tobler also is Director of Neurosurgery at Christ Hospital.

In October 2004 Dr. Tobler and other neurosurgeons at the Mayfield Clinic and The Neuroscience Institute became the first in Cincinnati to implant an artificial disc in patients suffering from degenerative disc disease of the lower back. Four patients, including Davis, were treated with the FlexiCore artificial disc as part of a clinical trial at University Hospital.

The all-metal artificial disc, manufactured by Stryker Corp. of Kalamazoo, Mich., is designed to relieve severe lower back pain and preserve mobility. In the past such patients would have undergone spinal fusion, a surgical procedure in which two or more vertebrae are fused together to immobilize the spine.

Because the FlexiCore disc is an investigational device, the federal government requires a study of its safety and effectiveness before it can become generally available to the public. The study will continue to follow patients for approximately two more years, or until the sponsor, Stryker, and/or the FDA feels sufficient data has been collected.

The enrollment phase of the FlexiCore trial is complete, and new patients are no longer being accepted. A different disc – the Charite disc – manufactured by DePuy Spine, Inc., a Johnson & Johnson company, was approved in October 2004, however, and is now being implanted in patients at various hospitals around the United States. Dr. Tobler is certified to implant the Charite disc, but reimbursement protocols are still being debated and have not yet been formalized.

Prior to having a disc replacement, Mike Davis tried non-surgical treatment for severe, chronic back pain without success. Physical therapy, chiropractic care, and epidural steroids brought about only temporary relief. His disc disease, he said, was the result of wear and tear over time.

Davis, who is 5-foot-11 and 170 pounds, began resuming regular activities two and a half months following his surgery. On December 11 he ran Cincinnati ’s 5K Jingle Bell run in 28 minutes. Today he runs an average of 25 miles per week and says his flexibility is as good as it ever was. To protect his back he stretches his hamstrings before and after running and does about 250 to 300 crunches (stomach exercises) about five days a week, making sure he keeps his lower back pressed against the floor. At Dr. Tobler’s urging, he also scheduled sessions with a physical therapist. He takes an over-the-counter pain reliever (ibuprofen) only occasionally.

“Since the surgery I’ve been able to do everything I’ve tried to accomplish without pain,” he said. “I must be the poster child for this procedure, because everyone says, ‘I can’t believe this.’ ”

He was pleased with his showing in the Flying Pig half-marathon. “I ran a little slower than normal, but it wasn’t a bad time. I averaged 8:20 a mile.”

Still on his athletic docket: golf and skiing. “I haven’t swung a golf club yet,” he noted. “And I haven’t slalom skied. I will do that eventually. Who knows, maybe the surgery will help my golf game.”

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For more information about the FlexiCore study, or to see a photograph of the artificial disc, go to: http://www.mayfieldclinic.com/CT_FlexiCore.htm. Please note that the study is now CLOSED.

For more information about the Charite disc, go to: www.charitedisc.com.

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The Mayfield Clinic is recognized as one of the nation's leading physician organizations for clinical care, education, and research of the spine and brain. Mayfield, which is affiliated with the UC Department of Neurosurgery, includes 16 neurosurgeons and treats 20,000 patients from 35 states and a dozen countries in a typical year. Mayfield's neurosurgeons are active participants in important clinical trials and have pioneered surgical procedures and instrumentation that have revolutionized the medical art of neurosurgery for brain tumors and neurovascular diseases and disorders.

University Hospital is part of the Health Alliance, an integrated health care delivery system that also includes Christ Hospital, the St. Luke Hospitals, Jewish Hospital, Fort Hamilton Hospital, and the physicians of Alliance Primary Care. To view other Health Alliance news releases, go to www.health-alliance.com/pressroom.

The Neuroscience Institute is a regional center of excellence based at University Hospital and supported by nine neuroscience specialties of the UC College of Medicine. The Institute is dedicated to patient care, research, education, and the development of new medical technologies. To view other Neuroscience Institute news releases, go to www.leadingtheadvance.com/newsflash.nsf/tninews.