By Susan Shinn
LANDIS ó This spring, Gail Fisher could no longer bear the constant pain in her left leg, caused by degenerated discs pressing on her sciatic nerve.
“I had never stopped going,” says Fisher, 66, who lives in Landis. “It just hurt.”
She decided to talk to her orthopedic surgeon about spinal fusion.
“Wait a minute,” he said. “I might have something better.”
Her physician, Dr. Vinay Deshmukh, and his partner, Dr. Dom Coric, of Carolinas Neurosurgery and Spine Associates, were enrolling patients to participate in a research study. The study involved the use of the Impliant TOPS System, an artificial disc.
Says Fisher’s husband David, who taught auto mechanics at Rowan-Cabarrus Community College, “I’m really amazed at the engineering.”
As a participant in the study, Fisher would receive either fusion surgery or implant surgery ó the procedure is randomized.
Either surgery would have given Fisher the relief she was seeking from the pain.
But Coric, the study’s principal investigator and chief of neurosurgery at Carolinas Medical Center, believes the new surgery is a better option.
With fusion, the adjoining vertebrae receive the stress that the fused one handled.
The new device spreads out the stresses and allows preservation of range of motion.
Additionally, patients recover sooner and are able to resume normal activities more quickly.
“This device is the same at one week as it is at 10 years as far as maximum stability,” Coric says.
There’s about a one-month recovery process for the soft tissue to heal, versus a six-month to one-year recovery for fusion patients.
Fisher is pleased with the amount of movement she still has.
“I’ve got front and back movement and sideways movement,” she says, demonstrating. “You’ve got almost the same amount of motion as before the surgery.”
More importantly for her, she says, “When I woke up, I had no pain in my leg.”
One of the first questions Fisher asked was whether insurance would pay for the surgery.
However, insurance does not cover investigative surgeries.
But, Coric says, the hospital has received a grant from the manufacturer to pay all costs for surgeries.
Fisher had already had one back surgery several years ago, in which the bones of her vertebrae were shaved to allow more room for the nerves. Then the vertebrae shifted, necessitating the second surgery.
As a participant in the surgery, Fisher will receive follow-up appointments for two years.
“I’ve got friends who have had spinal fusions and I think about how fortunate I am,” Fisher says. “At that point, I wanted to get rid of the pain. I didn’t mind sacrificing movement.”
The pain was beginning to affect her daily activities. She couldn’t vacuum or go grocery shopping. She and her husband, David, had cut back on their traveling.
Since surgery, they’ve been to Tennessee.
“I rode 51/2 hours and I got along fine,” Fisher says. “It was great.”
She’s still not able to lift more than 10 pounds ó which is hard.
Her husband pitches in.
“We laugh and say David cooks well with plastic.”
Friends have brought in meals.
“And a lot of prayers from our church and other churches,” David Fisher adds.
Coric hopes to enroll 20 patients in the study this year; some 400 patients are sought nationwide.
With two years of enrollment and two years of follow-up care, the investigational device exemption program ó IDE ó takes about five years, and $20 million to $30 million, to bring a product of this nature to market.
“It’s a long deal,” Coric says.
He says he sees no reason why the device should not receive FDA approval.
“We’re a big center and we’ve been involved in three different artificial disc studies,” he says. “I pick what I think is going to be beneficial to patients.”
The device now undergoing investigative surgery, is says, is used to relieve back and leg pain.
In Fisher’s case, he says, her worn-out joints were the precipitating problems.
The new system, he says, is “cutting edge,” he says, while the fusion surgery, which has been done for 50 years, is tried and true.
“Nerve pain is a very intractable type of pain,” he says.
All of his patients thus far have done well with the surgery, he says.
“I can’t say enough good things about it,” Fisher says.
It’s gotten her back into the kitchen ó much to her husband’s delight.
“I love to bake,” Fisher says. “I couldn’t stand that long. I couldn’t stand still if my back was hurting.”
Fisher was able to go back to work part-time at Rowan-Cabarrus Community College.
She says the hardest thing is not being able to pick up her granddaughter, Anna Gobble, although the 7-year-old thinks she’s getting a little too old for that anyway. Fisher’s grandson, Evan Gobble, is 13.
“Anna had to pick up a lot of things for me,” she says, giving Anna a hug. “She did a good job of it. She’s MaMaw’s helper.”
Contact Susan Shinn at 704-797-4289 or firstname.lastname@example.org.
By Susan Shinn