Most people don't enjoy spring cleaning. Barbara Mulvihill does. For seven months, she lived with severe pain in her back and shooting down her leg.
"People would look at me and say, 'Barb, you can just see the pain in your face,' and I'd say, 'I know. I hurt,'" Mulvihill says.
She had spinal stenosis, a common arthritic condition in the spine. Dr. Antonio Castellvi says typically, he would do a fusion surgery- putting two rods in her back. But there's a new option called the TFAS device.
"It reproduces normal to near normal motion as compared to some of the other devices we are seeing out there," says Antonio Castellvi, M.D., an orthopedic spine surgeon with Florida Orthopedic Institute in Tampa, Fla.
The TFAS device allows more movement, compared to a rigid spinal fusion surgery.
"We are able to stabilize the spine... eliminate the pain that comes from the facet joints and still allow motion," Dr. Castellvi says.
Dr. Castellvi has performed 15 TFAS surgeries. Only 150 have been done worldwide. Results have been excellent.
"We know how it works. We know why it works. What we don't know with certainty is will it be functioning and doing very well ten years from now or 15 years from now," Dr. Castellvi says.
Mulvihill says the implant allowed her to get back to life without pain.
"I was just so glad I thought, 'Woo -- I can move. I can walk. It doesn't hurt me,'" Mulvihill says.
And that means she can also get back to her favorite hobby, gardening.
The TFAS device is still in clinical trial and is not FDA approved. The study will compare the results of patients who get the TFAS to those that have the standard fusion surgery.
FOR MORE INFORMATION, PLEASE CONTACT:
Will Darnall
University Community Hospital
wdarnall@mail.uch.org
Phone: (813) 615-7395
Patrick O'Connor
Sr. Marketing Manager
Archus Orthopedics Inc.
Phone: (425) 284-3683
Relieving Chronic Back and Leg Pain - In-depth Doctor's Interview Antonio Castellvi, M.D., an orthopaedic spine surgeon, explains how a new procedure is alleviating back pain without limiting movement
How is the world of spine surgery changing right now?
Dr. Castellvi: Spine surgery is at a point in history that it is the probably the most exciting point that has occurred this century. We are transitioning from a period of time where we have done nothing but fusions to try to take away low back pain to actually being able to preserve motion in the spine. And because of that, there has been just a pother of devices that have been developed and are being developed at this time to try to preserve motion in the lumbar spine and to restore motion in the lumbar spine.
How does the TFAS work?
Dr. Castellvi: The TFAS is called a facet replacement device. It consists of two stems that tie into some ball and socket type articulation that articulates with a cuff that sits underneath. So you are actually able to roll it and it rolls within that device. Its rather a complicated design and I'm really simplifying it but it actually has a increased gradient of friction and it reproduces normal or near normal motion as compared to some of the other devices that we are seeing out there. So it's very exciting and very progressive.
Is it being studied?
Dr. Castellvi: Yes. It's an investigational device, it is experimental and it's very important that my patients know that they are participating in a FDA approved study.
What have the results been like so far?
Dr. Castellvi: The results have been excellent. They really have. We have done very, very well. Functional outcomes have been absolutely phenomenal. We are able to stabilize spines, eliminate the pain that comes from the facet joints and still allow motion.
What's the pain like before and after the surgery?
Dr. Castellvi: The pains that patients had before are both back pain and leg pain that radiates into both legs.
After the surgery, is that being relieved?
Dr. Castellvi: That is being relieved.
How quick is the recovery?
Dr. Castellvi: The relief is almost immediate. They are out of bed the next morning; we have them start physical therapy and walking the next morning. Once the device is put in, the cement hardens within 15 minutes, so once the cement is hard it's just a question of letting the wound heal.
Are there any side effects or downsides that you have seen?
Dr. Castellvi: There are some downsides with everything, it is a device or an implant that requires complete excision and removal of facets, so it has a lot of bones removed to try to get those nerves free. That makes reconstruction a little bit more difficult if you have to, but it's still something that we do on a regular basis. We routinely do facetectomies and do a fusion. So the device doesn't work for whatever reason, whether the cement loosens or the stem loosens inside the cement or it doesn't take away pain, it can be converted to a fusion.
How long does it last?
Dr. Castellvi: Hopefully, forever.
So it's a permanent solution?
Dr. Castellvi: Yes, its forever. The idea is that this is a permanent solution to the problem, not a temporary solution. What we don't know is how long it will last. So that is what truly makes it experimental. We know how it works, we know why it works, what we don't know with certainty is that it will be functioning and doing well ten years from now, 15 years from now.
Would you consider this a medical breakthrough?
Dr. Castellvi: It's just such a radical change from what we have done from past. We have tried to address these problems in the past with fusion. We no longer have to eliminate motion. If you take away the motion, the motion is distributed over the discs, the loads are all there, once you take away one of these discs, the loads in motion are still there so its shifted to the other levels. And what we are seeing is that in some studies up to 80 percent of the patients in about 5 to10 years will have the level above the fusion fall apart. So it seems like we keep chasing our tails, going up and up and up. With this device, hopefully, we will be able to prevent the adjacent level degeneration by allowing it to continue to share the loads in the motion that are applied to the spine.
But we won't know that until you see it 5, 10, 15 years from now?
Dr. Castellvi: It will take us 10 years to have class 1 evidence that it, in fact, prevents adjacent level degeneration.
There are lots of types of back pain, so who specifically is this for?
Dr. Castellvi: This device specific is used in patients with spinal stenosis and severe facet arthritis.
How old are most of those patients?
Dr. Castellvi: Forty, fifty, sixty, seventy.
You have done 15 trials?
Dr. Castellvi: Yes.
And 150 across the country?
Dr. Castellvi: 150 have been done across the country and across the world.
Why is movement so important in what you're doing?
Dr. Castellvi: Twenty years ago, 25 years ago, we were doing hip fusions; no one today would consider having a hip fusion. We were doing knee fusions 25 years ago; no one today would have a knee fusion. We would do a total hip arthroplasty or total knee arthroplasty. What makes you think that the spine is any different and that we are better off eliminating all motion?
It sounds like the spine is catching up with new technology.
Dr. Castellvi: The spine is catching up. That is what truly makes this an exciting time.
