For the first time in 10 years, people with chronic back pain now have a new option to get them back on their feet.
The FDA recently approved the newest generation of artificial lumbar discs and some patients who’ve gotten the implants say the results are life-changing.
When you see Jorge Padron working out, it’s hard to believe he ever had a back problem.
Padron told Ivanhoe, “When I would walk even a little hard, the pain was just unbearable.”
He had a deteriorated disc. Doctors wanted to fuse his spine, which would have caused stiffness and a lack of mobility.
“I just thought to myself there’s got to be a better solution than fusion,” said Padron.
He went to see Rolando Garcia, MD, an orthopedic spine surgeon at Orthopedic Care Center in Miami, Florida. Dr. Garcia developed the ACTIV-L artificial lumbar disc. The implant is made of chromium endplates that attach to the patient’s vertebrae. The disc is the first to also use polyethylene, or plastic plates, to allow for a better fit.
“We’re talking about a new generation implant that tries to better mimic or reproduce the movement of the spine when it’s normal,” explained Dr. Garcia.
Good candidates for transplant are people with back pain that’s lasted at least several months that does not respond to non-surgical treatment and those who don’t have osteoporosis.
“Generally speaking, the recovery period for this replacement is faster than with traditional fusion,” Dr. Garcia told Ivanhoe.
Most artificial lumbar disc patients spend just one night in the hospital and are fully recovered after six weeks.
“No pain, full range of motion, running, jumping, hand standing, lifting like nothing ever happened,” said Padron.
Dr. Garcia said surgeons place the insert through the front of the spine, and not the back, sparing muscles from being cut and also easing recovery.
Contributors to this news report include: Cyndy McGrath, Supervising Producer; Robbi Peele, Field Producer; Milvionne Chery, Assistant Producer; Tony D’Astoli, Editor; Andrew Smith, Videographer.
BACKGROUND: It is estimated that 70 to 80 percent of people will experience low back pain at some point in their lives. There are many causes of back pain such as injuries and accidents, mechanical problems such as disk breakdown, spasms, tense muscles, and ruptured disks. Back pain may also occur due to some conditions and diseases like scoliosis, arthritis, spinal stenosis, pregnancy, kidney stones, and infections. When you experience numbness or tingling, severe pain that does not improve, or pain after a fall or injury, a doctor should be seen. Acute pain starts quickly and lasts less than 6 weeks, whereas chronic pain lasts for more than three months. Acute pain usually gets better without any treatment besides over the counter medications to ease pain. For chronic pain, more treatment options are available.
(Source: http://www.niams.nih.gov/health_info/back_pain/back_pain_ff.asp)
TREATMENT: Lumbar fusion surgery is the standard treatment for low back pain patients. However, the results of the surgery vary on an individual basis. Some doctors believe that the variation in pain reduction following surgery is because the fusion prevents normal motion of the spine. Artificial disk replacement surgery is an alternative treatment option for low back pain. Artificial disk replacement has been available in Europe for over a decade, while the procedure gained FDA approval for use in the U.S. in 2004. Similar to hip or knee joint replacements, a disk replacement substitutes a mechanical device for an intervertebral disk in the spine. The device restores motion to the spine. Good candidates for disk replacement have back pain caused mostly from one or two intervertebral disks in the spine, no facet joint disease or bony compression on nerves, is not excessively overweight, and has no deformity like scoliosis. The procedure is performed through an incision in the abdomen, allowing the surgeon to access the spine without moving the nerves. There are a number of different disk designs, some of which are still in the experimental stages.
(http://orthoinfo.aaos.org/topic.cfm?topic=a00502)
NEW TECHNOLOGY: The activL Artificial Disc is a lumbar disc replacement device developed by Rolando Garcia, M.D. The artificial disc consists of two endplates made of a mix of metals commonly used in spine surgery and a plastic insert that fits between the two endplates which is designed to move during daily activities. It is designed to allow motion at the treated level of the spine, with a plastic insert which can move from back to front, but not side to side. The design of the device aims to allow motion of the lower back, unlike the results of lumbar fusion surgery, to allow patients to return to their normal lives.
(Source: http://www.accessdata.fda.gov/cdrh_docs/pdf12/P120024d.pdf)
FOR MORE INFORMATION ON THIS REPORT, PLEASE CONTACT:
Joanna Palmer
305-674-2589
Joanna.palmer@msmc.com
If this story or any other Ivanhoe story has impacted your life or prompted you or someone you know to seek or change treatments, please let us know by contacting Marjorie Bekaert Thomas at mthomas@ivanhoe.com
Rolando Garcia, M.D., an orthopedic spine surgeon at the Orthopedic Care Center in Miami, Florida talks about a surgery that is allowing patients with chronic back pain to resume an active pain-free lifestyle.
Interview conducted by Ivanhoe Broadcast News in June 2016.
There’s a new procedure tell me what is it called and what exactly is?
Dr. Garcia: The procedure is called a lumbar disc replacement and more specifically we’re talking about a new generation implant that tries to better mimic or reproduce the movement of the spine when it’s normal.
Who is a good candidate for this?
Dr. Garcia: Candidates for lumbar disc replacements are usually younger patients, and by younger patients I mean patients between the ages twenty-one and sixty. They are for patients who have had back pain for an extended period of time. You don’t want to obviously propose surgery in someone who just began experiencing back pain but someone who’s had debilitating back pain for several months – someone who has tried different types of non-operative treatment and they have unfortunately not had adequate response and for patients that typically have one level of disease in the lumbar spine.
The alternative to this procedure would be spinal fusion correct?
Dr. Garcia: Correct. Traditionally with other joints in the body including the hip and the knee, and we’re talking about decades ago, if somebody had debilitating hip pain or they had debilitating knee pain from arthritis or from an infection the traditional method of relieving that pain was to fuse those joints. Now for decades most people don’t even know of anybody that has a hip fusion or a knee fusion since if you had debilitating pain from one of those joints the current standard of treatment is to replace it. The reason for replacement is obvious – you want to maintain function and motion and the truth is that in order to achieve full function you need motion. Even as we speak now and in present day a lot of patients with debilitating back pain from what we call degenerative disc disease are undergoing spinal fusion. For some of them that may be their best alternative. But some of them may benefit from the ability to maintain or even restore mobility at the level of the surgery throughout disc replacement.
What would be a good scenario for someone to have spinal fusion rather that the disc replacement?
Dr. Garcia: If someone is having for example what is called spinal instability, where there is excessive movement between the adjacent vertebras then that patient needs a procedure called stabilization or a fusion. Meaning they need something to control the lack of stability in the spine. This replacement relies on the intrinsic stability of the spine so if you have instability you would not be a good candidate for disc replacement. Other patients that would likely benefit better from a spinal fusion are patients in which the joints in the back of the spine called the fesaid joint are so far degenerated that doing a disc replacement would not be the adequate treatment because you would not relieve that pain. There are also patients that have osteopenia or osteoporosis in which the bones are weak and those patients would not be good candidates for disc replacement since the disc replacement requires a solid foundation of bone in order to stay in place and function the way it should.
Obviously this is a surgical procedure, what kind of recovery period are we talking about?
Dr. Garcia: Generally speaking the recovery period for disc replacement is faster than with traditional fusion particularly posterior fusions. The first thing that makes the recovery much quicker is that we’re not waiting for the bones to fuse together, to bond together. Traditionally if someone has a spinal fusion you want to brace or immobilize or restrict the person from moving so that the fusion or the healing of the bones can take place. With a disc replacement you do not want the bones to fuse together; you actually want to maintain mobility. Therefore there is no bracing period which right there makes the recovery much quicker. In addition most spinal fusions are done by going through the back of the spine and those are usually associated with more postoperative pain because you have to go through the muscle. Then there’s incisional pain that is traditionally greater in a fusion than with a disc replacement. With a disc replacement, we go in through the front which has the advantages of a quicker recovery. Generally speaking patients are able to go home after one night in the hospital. They do not require any type of bracing or immobilization and usually by six weeks they have recovered mostly from the surgery and they can return to pretty much normal activities except for contact sports and things like that which are allowed after the three month period. Another great advantage with a disc replacement is that once the patient is fully healed there is usually no restrictions, no limitations.
What about pain, I’ve heard that with fusions often there’s pain even after the spinal fusion. What about with this procedure?
Dr. Garcia: Obviously not all patients get full pain relief. With lumbar disc replacements we use the analogy of baseball. With a fusion we can most of the time hit triples, certainly doubles and triples in terms of pain relief. But it’s unusual for patients to undergo spinal fusion and for you to hit a home run, meaning the patient gets complete pain relief. With lumbar disc replacement when it’s well done and when the patient is well selected we are able to hit homeruns. We’re able to make them really, really functional and I have many patients with lumbar disc replacements where postoperatively they have absolutely no pain.
I spoke to one of your patients and he told me he had no pain. He could run and jump and do everything he could before he had the back problem. Is that really possible?
Dr. Garcia: Absolutely. If a patient undergoes the lumbar disc replacement once they have completed their healing and if they have no residual symptoms then I tell them that they have no limitations. They can ride a rollercoaster, they can sky dive and in fact I have many patients that surprise me by coming back and telling me some things that they’re doing that I was not expecting them to be able to even try.
What’s it like for you when you hear stories like that, when a patient comes back and says I was able to do this. What is that like for you?
Dr. Garcia: Well I think it’s phenomenal! I think most doctors, most physicians, go into medicine because they want to heal, they want to make people better. It is extremely rewarding to be able to be in a profession where I can try my best to make the patient’s life better. When you have the gratification of allowing someone to be able to return to play with their kids, to spend time with their spouse, to travel, to enjoy the things that they want to do and to give them back their quality of life, that is really a tremendous gift.
You are co-developer of this replacement disc correct?
Dr. Garcia: That is correct. I performed my first lumbar disc replacement surgery in the year 2000. I was the first one in the state of Florida, the fourth one in the United States. Given my experience with lumbar disc replacement I had the opportunity to be the co-developer of this new generation implant the ACTIV-L. We performed our first ACTIV-L patient in the United States in 2007. I had the privilege of doing or being the first one to do it. We’ve thankfully been able to help a lot of patient with the procedure.
What is unique about this particular disc, the ACTIV-L disc?
Dr. Garcia: That’s an excellent question. One of the main features that differentiates the ACTIV-L from older generation implants is that the polyethylene, the plastic insert is able to move forward and backwards to mimic or to reproduce the movement that we see with the natural disc. In older generation implants in order for movement to occur the upper plate of the implant would have to translate. By doing so that can put a lot of forces on the posterior joints or the faceid joints which can result in degeneration of the faceids you know after the surgery. There are other advancements such as the coating of the implant, the fact that for example it has multiple sizes. As we speak there are only two lumbar disc replacements that are FDA approved, the ACTIV-L being one of them. The other implant for example has only two sizes whereas the ACTIV-L has four. Just like shirts it’s small, medium and large and extra-large. It is also an anatomic plate, in other words the implant is shaped the way the vertebras are shaped. You don’t have to perform what is called bony resection or reshaping of the bone to try to put the implant in to position. It also has obviously newer instrumentation or newer ways to put it in since the other implant that is available in the United States was FDA approved in 2006, the ACTIV-L was approved in 2015 so there’s a lot of technology obviously that we’re able to put in to our implant that is so much newer.
Is there anything I didn’t ask you that you want to say?
Dr. Garcia: Yes. I’d like to mention the keys to our success for lumbar disc replacement. I think that the key to a successful lumbar disc replacement is the right patient and the right surgeon. You want to pick the patient that is a good candidate for a disc replacement. Disc replacement is not for every patient and disc replacement is not for every surgeon. If you have someone who is a good candidate and you have a surgeon that is experienced then the chances of having a successful outcome is excellent.
What’s the best way to make sure you’ve got the right surgeon?
Dr. Garcia: Well I always tell my family, my friends and my patients to get multiple opinions. Not to be afraid of asking if you are having a procedure like this done and your surgeon is on the early stages of attempting the procedure he may be okay but that is something that you need to know. If it is someone who has been doing it for fifteen years and they’ve done hundreds of them then at least you can make that decision with that knowledge in mind. One of the biggest challenges as I talk about disc replacement in the United States and abroad is that some doctors, some surgeons, some patients, some insurance people are sometimes indicating that disc replacement is either experimental or investigational and I want to make it clear that is neither one of those. Disc replacement has been around in some form for over thirty years and I have personally been involved with disc replacement for over fifteen years. The technology with this new implant is new but the idea of disc replacement is certainly not investigational or experimental and it’s here to stay.
If its FDA approved doesn’t that mean that it’s beyond the experimental stage?
Dr. Garcia: Absolutely and as you probably know the FDA process is quite rigorous. For example, for the approval of the ACTIV-L we had to run a study from 2007 until 2015 with over three hundred patients and we had to follow them closely. This is something that has been rigorously evaluated in order to be available.
