Moving ahead on back surgery

New clinical trial that forgoes fusion pleases doctors and their patients

Health & Fitness

May 09, 2004|By Karen Nitkin | Karen Nitkin,Special to the Sun

At age 70, Charles Slechta loves dancing with his wife, Viola. And thanks to a new kind of back surgery, the Pikesville resident is again able to do the jitterbug and the polka.

Slechta and more than 40 other area residents have taken part in a Food and Drug Administration clinical trial testing a surgical procedure designed to relieve chronic back and leg pain without the need for a spinal fusion.

With as many as 400,000 Americans a year undergoing spinal fusion surgery, the potential benefit of this relatively new technique, called Dynesys, is significant.

During the past two years, pain in his back and legs made dancing and many other activities impossible for Slechta.

"I started with what seemed like a case of sciatica," he said, "and eventually the pain got bigger and bigger on both sides, shooting down my legs, and then a constant pain down to my ankles."

As his condition worsened, Slechta could barely walk the single block from his parking space to the front door of his Northrop Grumman office building in Fort Meade, where he works in security.

Ordinarily, Slechta would have been a prime candidate for fusion surgery, a procedure that permanently immobilizes the involved vertebrae. Instead, he took part in the Dynesys trial in November.

During the Dynesys procedure, small, flexible spacers are attached to the affected vertebrae. The apparatus, made from flexible polyurethane tubing and nylonlike cord, stabilizes the vertebrae but still allows for some range of motion -- unlike a fusion.

A major change

"We're moving away from rigidly immobilizing the spine to keep it from hurting," says Dr. Reginald Davis, chief of neurosurgery at Greater Baltimore Medical Center, who performed Slechta's operation, along with about 20 others for the clinical trial. Davis believes the Dynesys system represents a new way of thinking about back treatment.

Dr. Paul McAfee, chief of spinal surgery at St. Joseph Medical Center in Towson, the only other surgeon in the area participating in the FDA trial, also has done about 20 of the Dynesys procedures.

"I think it's a good operation," McAfee said. "It's definitely a safe operation." And because it holds the promise of reducing the need for fusion surgeries, McAfee sees the procedure as potentially revolutionizing treatment for back pain. "Patients don't want to have fusions," he said.

Dr. Alan Levine, co-director of the Spine Center at Sinai Hospital in Baltimore, added a note of caution. "In theory, it sounds like a very appealing idea," he said. But it's too early to really know."

The lower back undergoes tremendous stress, Levine said, which could cause the Dynesys device to move or break. He also believes that the device may still allow movement of the disc, which for some patients could result in pain.

"The concept is a very enticing one," he added. "The question is, 'Are we there yet?' "

Though the Dynesys system is new to the United States, it has been available in Europe since 1994. More than 11,000 patients worldwide have had the procedure, according to literature from Zimmer / Spine, the Minnesota-based company that manufactures the device.

The approval process in Europe is not as rigorous as in the United States, Davis said. "It's very easy to come up with an idea and get it implemented" in Europe. "They don't have the FDA, so they're about a decade ahead of us."

Awaiting results

During the two-year trial, 400 patients in 20 medical centers around the nation will be treated with the Dynesys system, which is currently considered an investigational device and can only be used as part of the trial.

The safety and effectiveness of the treatment will be evaluated, and the results will determine if the procedure wins FDA approval.

Based on his outcomes and the number of procedures that have been done in Europe, Mc-Afee said, "I'm sure it will be approved."

Davis has also seen positive results.

"I've been impressed, No. 1, that the technology works and the patients do get better, and No. 2, that it is less invasive and less destructive" than a spinal fusion, he said. "The fusion itself disrupts the normal physiology of the spine."

Mickey Adams, 52, of Cockeysville, had Dynesys surgery in January to relieve pain from a herniated disc.

"It was unbearable pain in my right hip and then extending to my leg," Adams said. "Often my right foot was partially numb."

The surgery changed everything. "It was amazing," he said. "I was able to get out of bed and walk around normally the day after my surgery without any real discomfort at all."

He wore a brace for six weeks, and still feels some discomfort, but he said that's because it can take some time for the damaged sciatic nerve to heal.

"The patients coming up on a year [post-surgery] for the most part seem to be doing well," Davis said. "In my personal series, I've not had any problems with the instrumentation."

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