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| HealthMonday, August 20, 2007 10:51 AM CDT |
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Disc makes a
world of difference
BLOOMINGTON — When Dave Moravec of Normal ruptured a disc and pinched a nerve in his neck while golfing, all he wanted was pain relief. He got relief. That relief came by participating in a national study of a new artificial cervical disc that makes his experience even more special. “I think it’s kind of cool,” the 45-year-old computer business development manager, husband and father said of participating in the nationwide study of the Prestige Cervical Disc. Because of the five-year study’s success, Prestige recently became the first artificial cervical disc approved by the U.S. Food and Drug Administration for use nationwide. “It’s awesome,” Moravec said. “I’m excited for anyone who’s going to have the procedure. “My life is the better for it.” Central Illinois Neuroscience Foundation (CINF) in Bloomington was among 32 sites across the country selected to participate in the study, called a clinical trial. Twenty of the 541 patients in the study had their surgeries performed by CINF neurosurgeons — Drs. Ann Stroink, Keith Kattner or Emilio Nardone — at BroMenn Regional Medical Center in Normal. Moravec was among the 20 patients. “We expected it (the FDA approval) because we knew it was a good product,” Stroink said. “I knew it was going to be approved after I started to put it in because I saw how well my patients were doing,” said Kattner, who performed most of the Prestige procedures locally, including Moravec’s. The neurosurgeons are optimistic that the new cervical disc procedure will be approved for use soon at BroMenn and at OSF St. Joseph Medical Center in Bloomington. But representatives of each hospital said Prestige — as with any new device and procedure — first must be analyzed and approved by hospital officials. They must determine the procedure’s effectiveness, safety, improvements over the existing procedure, staff training, cost and reimbursement from Medicare and others insurers, said St. Joseph medical director Dr. Paul Pedersen and BroMenn spokesman Eric Alvin. If the procedure is approved soon as expected, Kattner estimated more than 100 patients at BroMenn and St. Joseph would get the artificial cervical disc each year. The three neurosurgeons perform about 1,300 surgeries each year and about 300 of them are cervical disc procedures. Kattner estimated that 35 percent of the 300 would be good candidates for the new artificial cervical disc. The cervical spine in the neck consists of seven bones called vertebrae, which are separated by shock-absorbing intervertebral discs that allow the neck to bend and rotate, according to Medtronic, which makes the Prestige Cervical Disc. Age, genetics, everyday wear and tear and injury may deteriorate the discs. When a deteriorated disc pushes into a nearby nerve root, pain, numbness or weakness may result and radiate down the shoulder and into the arms. This is called degenerative disc disease. The first line of treatment generally includes non-steroidal anti-inflammatory drugs, exercise and physical therapy. When that fails to bring relief, surgery is considered. The traditional treatment is removing a diseased disc from a patient’s neck, replacing it with a disc from a cadaver or a bone from the patient’s own body, then fusing together the two bony vertebrae that had been on either side of the diseased disc, Nardone said. “The success rate of the fusion procedure is high,” Nardone said. But because the procedure involves fusing two or more vertebrae, patients experience some loss of neck mobility, Nardone said. Meanwhile, the discs on either side of the fused vertebrae experience more strain and wear and tear, he said. “In about 5 percent of those patients, we need to do another surgery later above or below” the fused vertebrae, Kattner said. Goals of the artificial cervical disc are to allow for better neck mobility and a reduced risk of future surgeries. The Prestige Cervical Disc replaces the diseased disc. The disc is removed and replaced with two pieces of stainless steel with a ball and groove. This artificial disc is attached to the adjacent vertebrae with bone screws. But a clinical trial needed to take place before the FDA would consider approving the artificial disc. “A lot of centers wanted to be a part of this study because they saw the potential of the first artificial cervical disc of the neck,” Kattner said. The neuroscience foundation, 1015 S. Mercer Ave., was among 32 sites selected because of its experience with clinical trials, because of the number of cervical disc procedures it does and because it has a professional staff that can do accurate data collection, the neurosurgeons said. Participating in the study was voluntary. Not all patients wanted to be considered for something that wasn’t approved by the FDA, Stroink said. To qualify, patients had to have degenerative disc disease that hadn’t responded to non-surgical treatment lasting at least six weeks. Patients also needed to have only one disc affected. Patients with more than one diseased disc or with severe degeneration in the neck because of arthritis would not be good candidates for the new artificial cervical disc, Kattner said. Patients were accepted into the study from October 2002 to August 2004. About half of the patients received the traditional surgery and about half got the artificial cervical disc to allow doctors to compare the results fairly. Who received which procedure was determined randomly. Each patient was monitored for at least two years to make sure there were no complications. “Everyone with this particular (artificial) disc had an excellent outcome,” Kattner said. Patients who had the traditional procedure did well too, he said. Patients with the new disc will be followed for seven years to determine the long-range affects of the surgery. Moravec’s experience Moravec is business development manager with Integrity Technology Solutions, a Bloomington-based company that provides computer networking solutions and data integration for schools and businesses. He and his wife, Donna, have three teenage children and lead an active lifestyle. He was golfing in September 2003 when he took a swing and caught the club in the ground under the tee. He thought he injured his shoulder and it hurt even more the next day. A trip to the emergency department and pain relievers provided no relief. The pain got worse and began extending down his left arm. “It was excruciating,” he recalled. “I couldn’t sleep. Vicodin did nothing.” He wasn’t able to work for most of October 2003. His doctor referred him to Kattner, who concluded that he had a single disc rupture between the fifth and sixth vertebrae. Because of the severity of the pain, because Moravec was losing the feeling in his hand and because Kattner was concerned that Moravec could sustain severe nerve damage, Kattner recommended surgery. He told Moravec that he qualified for the study because of his bone structure and because the injury involved only a single disc. Moravec decided to participate. “Even if I ended up with the bone cadaver procedure, I would still be better off.” Moravec’s name was drawn for the artificial cervical disc. Kattner performed the procedure on Oct. 30, 2003. “It couldn’t have gone any better,” Moravec said. “I was up and around the next day.” He began neck exercises immediately to strengthen his neck and increase his mobility. Two days later, he was discharged from BroMenn and he and his wife hosted a party. Four days later, he was back at work, and, within a week, he felt as good as before his injury. The pain was gone and he has experienced no side effects. Moravec’s follow-up appointments are down to once a year. He has resumed all of his previous activities, including fast-pitch baseball, softball, golf and bike riding. “This was like a new life,” he said. Prestige Cervical DiscSOURCES: Medtronic, makers of the Prestige Cervical Disc.; Drs. Keith Kattner, Emilio Nardone and Ann Stroink E-mail this story | Print this story | Search archives | RSS Show comments |  Hide comments | Hide comments on all stories |
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