FDA approves new alternative to spinal fusion
Nathan Snyder prior to receiving the Total Posterior Spine (TOPS) facet joint replacement system
After receiving the TOPS System, Nathan Snyder, pictured with his family, said he is "better than my old self."
Dr. Donald Whiting
Nathan Snyder competes in the Tough Mudder Run and Obstacle Race.
The TOPS system is a mechanical implant device that replaces the bony and soft tissues removed during spinal decompression surgery. The goal is to maintain stability and preserve the motion of the spine.
Nathan Snyder was used to striving to be first. As a runner, he would compete in strenuous races like the Tough Mudder event, trying to come in first. But on a trip to Hawaii a few years ago, back pain stopped the South Hills native in his tracks.
“I was on a family vacation to Hawaii and my 16-year-old daughter asked me to go on a jog with her and I could not make it,” Snyder recalls. “I’m a fit guy. I couldn’t go on the run, so I decided at that moment I would come back home and get an MRI and see what was wrong.”
An appointment with Allegheny Health Network (AHN) neurosurgeon Dr. Don Whiting led Snyder to being first in a different way.
“I got my MRI and Dr. Whiting immediately said, ‘Hey, you’re going to be a candidate for this new device that we’re studying,'” said Snyder, then 44 year and father of two. He became the first patient enrolled in a study to receive the new TOPS System in early 2018.
“No one wants to confront their own mortality at that age,” Snyder said. “Having surgery at all was anxiety-inducing, and the trial was a difficult hurdle to get over because you are not guaranteed to get the device in the trial. It’s a lottery system.”
With the alternative being possible spinal fusion surgery, Snyder enrolled and received the TOPS device as part of a phase three trial conducted at 30 hospitals across the U.S. to determine if it was more effective than fusion in patients with moderate to severe lumbar spinal stenosis, degenerative spondylolisthesis, and related spinal conditions. The studies proved successful enough that the U.S. Food and Drug Administration recently approved Premia Spine’s Total Posterior Spine (TOPS) facet joint replacement system.
The system is a mechanical implant device that replaces the bony and soft tissues removed during spinal decompression surgery. The goal is to maintain stability and preserve the motion of the spine – something that doesn’t happen with spinal fusion.
Whiting, who has an office in Washington, explained it as a joint replacement for the spine. “Fusion is where you put screws and rods in and you get two vertebrae to grow into one, which stops the motion of that vertebrae,” Whiting said. “The trouble with a fusion is it puts more stress on the level above and below that still move, and a lot of times will cause them to wear down more quickly.” He said down the road, that can necessitate more fusion at another level. The new approach is to just replace that joint in the same way doctors replace a knee or hip joint.
“In this case, we’re removing the joints, or part of the joints, but leaving the disc in place and then putting this artificial facade joint that connects to the vertebrae through the screws just like a fusion,” Whiting said. “Now you can maintain the motion with this joint by putting an artificial joint in between which then allows you to have motion instead of a fusion, which is no motion.” The result is less wear and tear on the level above and below, and that’s what’s the revolutionary part of the device.
This isn’t the first time that approach has been tested. Whiting has been part of clinical trials of two similar devices over the past 16 years. TOPs is the first such device to be FDA approved. “Different studies have come out and the previous joints didn’t make it out of the trial phase,” Whiting said. “This study started in 2017 and there have been 300 patients enrolled. They got approval in June.”
Whiting said the procedure actually returns some motion to the vertebrae. “It’s not actually normal 20-year-old motion, but it’s pretty normal mid-life motion in your spine where you wouldn’t have had it if you’d done the fusion,” he said. The FDA approved the device for patients ages 35 to 85 for moderate to severe lumbar spinal stenosis, degenerative spondylolisthesis, and related spinal conditions.
Six months after Snyder received the TOPS System, he said he felt like a new man. Nearly five years later, Snyder is back to living an active lifestyle, even participating in the Tough Mudder Run and Obstacle Race with his daughter.
“I was back to feeling 100% at about six months and at 12 months I felt better than I had in 15 years,” Snyder said. “I am better than my old self. Until my back was fixed by the surgery, I had no idea how much pain I had suffered through over the years.”
Snyder said he’s careful and consistent with exercise and maintenance for his back, but he’s thrilled with the outcome. “I feel better today than I did when I was 35 years old,” he said. “Now that this procedure is FDA approved, I think it’s fantastic. If my experience is any indication, it’s providing people the opportunity to have their life back.”