Not long ago, 9-year-old Javier Hruza would have had to face the risks of surgery half a dozen times to adjust the implanted metal rods straightening out his severely curved spine.
But the Shoreview boy had growing-spine rods implanted in January. The procedure allows him to take advantage of a new technology approved by the Food and Drug Administration last September called the MAGEC Spinal Bracing System to treat severe early onset scoliosis.
The device lets doctors adjust the rods in an office visit, using magnets rather than surgical tools.
"It lasted 45 seconds. I said, 'That's it?' I thought he was just warming it up or something," Javier's mother, Elee Hruza, said after Dr. Tenner Guillaume pressed a remote control the size of a power tool against her son's back to advance the magnetically driven mechanism in the growing rods. "I wasn't sure whether it would be uncomfortable, but it doesn't appear to be at all."
Guillaume is one of the pediatric spine surgeons at Gillette Children's Specialty Healthcare in St. Paul who recently began implanting the magnetically controlled growing rods in kids' backs. They are used instead of the traditional rods that require surgery every six months for three years to adjust their length.
"With traditional growing rods, we usually tell families when we initiate that treatment that there is about a 100 percent risk of a complication during their treatment at some point," Guillaume said. "The hope is that we can get rid of a lot of things like wound infection that are associated with those return trips to the operating room."
About 300 children in the United States have had the magnetically controlled rods implanted, including 10 at Gillette Children's Specialty Healthcare, by far the most in the region. A spokesman with Ellipse Technologies, the Orange County, Calif.-based maker of the MAGEC rods, said the Mayo Clinic and the University of Minnesota have each treated one patient with the magnetic rods, as well.
As with most implantable devices for kids, doctors hope never to use them at all. Physicians would much rather treat a severely curving spine like Javier's with custom braces, casts or even traction before resorting to surgical implants. "These are reserved for these very complicated patients," Guillaume said.
Javier Hruza had a quickly worsening 85-degree curve in his spine from neuromuscular scoliosis, which was caused by his spastic quadriplegic cerebral palsy. Such a severe curve can make breathing difficult, especially if the spine is twisting and deforming ribs, as Javier's was. Left untreated, curves of 100 degrees or more can lead to secondary problems that are associated with high mortality.
Patients with curves that severe typically have spinal deformities early in life, but kids can be treated while their bones are still growing. In skeletally mature patients, a common solution for spinal deformities that can't be corrected with other means is to do a spinal-fusion operation with bone screws and other devices that permanently fuse vertebrae together.
But that won't work for younger kids like Javier, because spinal fusions can prevent their thoraxes from growing enough to support adequate adult lung capacity.
"The literature does not support routine definitive fusion of thoracic spinal deformity at an early age in children with scoliosis," Texas-based researcher and orthopedic surgeon Dr. Lori Karol wrote in a 2010 article in the journal Clinical Orthopaedics and Related Research. "Thoracic growth after early surgery is an average of 50 percent of that seen in children with scoliosis who do not have early surgery."
Growing-spine rods work by hooking around the ribs and the pelvic rim, underneath the skin, to create tension that corrects deformities without touching the vertebrae.
As a child's spine grows naturally, the rods must be expanded to accommodate the new length and take the slack out of the system — hence the need for regular adjustments. The hope with magnetically controlled rods is that they will allow for more frequent adjustments, which could improve outcomes in several ways besides just avoiding surgical risks.
"If you have the spine in a certain position for a period of time, we do see some evidence of auto-fusion, or things getting really stiff or sticking together," Guillaume said. "So if we can do it more frequently, the thought is that not only can we control the deformity, but we may also be able to gain greater growth of the spine. And we may even get better control of the deformity over time."
New rods cost more
Of course, the new technology costs more than traditional growing rods.
A spokesman for Ellipse said the company doesn't reveal its prices, and he's not privy to information about whether Medicaid or commercial insurers cover it. But he noted that the larger price should be balanced against the savings from avoiding future surgeries and hospitalizations.
"The results are cost-effective when you use this technology, even at its higher initial price tag," said Neil Beals, Ellipse marketing vice president. "To eliminate a half-dozen surgeries or more for an individual patient provides tremendous savings."
Javier's rods were covered under Minnesota's Medical Assistance insurance program for children with disabilities, Elee Hruza said.
"For him, this has given him extra mobility," she said. "If you could have seen the level of discomfort, and just how unhappy he was just a year ago, it was really hard to watch. He was so uncomfortable. I knew this was going to help, but I didn't expect that it would help this much. He is so much happier."