Selected Podcast
Cervical Disc Replacement
Oliver Tannous, MD, discusses the surgical options for treating cervical disc disease and related issues, including the emerging approach of cervical disc replacement. Dr. Tannous also explains the research and FDA approval process surrounding disc replacement, as well as the promising benefits: a more rapid recovery, fewer complications, and a reduced risk of subsequent surgeries to address adjacent segment disease.
Featured Speaker:
Learn more about Oliver Tannous, MD
Oliver Tannous, MD
Oliver Tannous, MD, is an orthopaedic spine surgeon at MedStar Washington Hospital Center.Learn more about Oliver Tannous, MD
Transcription:
Cervical Disc Replacement
Melanie Cole (Host): The standard initial treatment for symptomatic cervical disc disease typically involves physical therapy, medications, and occasional spinal injection procedures. If the symptoms continue and are very bothersome for more than six to twelve weeks, surgical treatment might be considered. My guest today is Dr. Oliver Tannous. He’s an Orthopedic Spine Surgeon and a member of MedStar Orthopedic Institute at MedStar Washington Hospital Center. Welcome to the show, Dr. Tannous. What’s typically been done for cervical disc disease and issues?
Dr. Oliver Tannous (Guest): Hi Melanie, thanks for having me. For one it’s patients who have already failed conservative care. They’ve failed physical therapy, injections, they’ve given it time, they continue to have symptoms in their disc disease. The standard of care for the past 30 years has been a discectomy and a fusion, meaning what you do is you go in, you take out the disc, you take out whatever’s pinching on the nerve, you relieve the pressure off the nerve, and now, instead of the disc being there, there’s a big space. You put a piece of bone and over time, the patient’s natural bone -- at the level above and the level below -- fuses into the bone graft that you put into the patient. It’s called a fusion or an ACF, which stands for an Anterior Cervical Discectomy and Fusion. That, still today in 2017, is the gold standard for cervical degenerative disc disease, but the caveat to that is that there’s new technology now for cervical disc replacement that are showing some really promising results over the past 10 years. There is a movement now towards trying to treat cervical disc disease in some patients with a disc replacement as opposed to a fusion.
Melanie: So tell us about the disc replacement. Who might be a good candidate for this?
Dr. Tannous: People who are the best candidates for a fusion are typically patients who are going to be between the ages of 30 and 60. They can’t have a lot of arthritis -- the problem with arthritis is that it limits motion and it makes things more stiff. If you think about the spine, there are essentially two parts to the spine. There’s the front part, which is in front of the spinal cord. There’s the back part, which are the facet joints, which are behind the spinal cord. When we do a discectomy, it’s the front of the spine -- we’re taking the disc out from the front -- but you have to understand that we’re not going after the facet joints in the back. In patients who have normal looking facet joints, they’re great candidates, in general, for a disc replacement because they’re going to have normal motion in the joints in the back. But if you’re too old, or if you have too much arthritis and the facet joints are too arthritic, typically most surgeons today would do a fusion, as opposed to a disc replacement because you don’t want to increase the range of motion through an arthritic joint, it would cause excess pain.
Melanie: So then speak in the disc replacement about motion preservation and adjacent segment disease and how this changes that.
Dr. Tannous: Absolutely. A little bit about adjacent segment disease, in its simplest definition -- if you think about doing a fusion is you have seven levels in the neck that are moving. When you do a fusion -- if you lock up that level by doing a fusion -- now the motion that would have otherwise been absorbed by that level goes to the level above or the level below so you increase the stress that’s being experienced at the level above or the level below. When patients come in, they have degenerative disks, and typically they’ll have it at multiple levels, but we only go after the one level that’s being symptomatic. When you fuse that, now discs above it or below it that already have some level of degeneration – the process accelerates the degeneration of discs above it or the discs below it. It’s called adjacent segment disease and overall, the rate is about 2.5 to 3% per year of increased degeneration, meaning at ten years, 25% of people who have already had a fusion will need a fusion at the level above it or the level below it because of symptomatic disease at those levels. That’s where the concept of the disc replacement came in. The theory is if you put a disc replacement and maintain the range of motion of the spine, you eliminate that increased stress that gets absorbed at the level above it or the level below it. That’s the concept of adjacent segment disease.
Melanie: And based on this theory, what’s recovery like for patients for cervical disc replacement?
Dr. Tannous: In my experience, patients who have disc replacements recover a lot faster. I don’t put them in a brace. In fact, you don’t want to put patients in a brace after a disc replacement because you want them moving through the implant, you want them to preserve that range of motion of the neck and you don’t want them to get stiff versus when patients have a fusion, you put them in a brace – and most surgeons will put patients in a brace from anywhere from six to twelve weeks -- because you want to lock up that level, you want the spine to fuse. You don’t want to increase the motion to that segment while things are healing. In my experience, the recovery rate for disc replacement’s much quicker. I’ve had patients go back to work within three to four days. After the surgery, they typically leave the hospital the morning after having had the surgery. I’ve seen incredible results with a disc replacement.
Melanie: Tell us about the FDA approval process for it.
Dr. Tannous: So you have to understand, anterior cervical discectomy and fusions -- so ACDF, meaning the anterior fusion -- has been the gold standard for the past 30, 40, 50 years and it still is, today, the gold standard because it is an extremely successful procedure. In spine surgery, it’s arguably the most successful surgery in the spine world. In order for the FDA to approve a disc replacement, you have to at least show that a disc replacement is not inferior to the standard of care, which is cervical discectomies and fusions. In the 2000’s, several companies that started studying this through IDE trials that got approved by the FDA, meaning they allowed them to test these implants for the specific purpose of getting it FDA approved. These were randomized, prospective, multicenter level one studies that were overseen by the FDA. As far as Orthopedics Research is concerned, these are the most meticulous studies in the Orthopedic and the Spine literature because they have to be because they’re being scrutinized by the FDA.
In the 2000s, they studied one-level disc replacement and overall, what they found, is that there was some trend that the disc replacements were superior to fusions with regards to patient outcomes, with regards to pain improvement, with regards to subsequent surgeries for adjacent segment disease. They didn’t find that most of these were statistically significantly greater, but at least what they found was that they were definitely not inferior to fusions. That prompted the FDA in the mid to late 2000’s to approve one-level disc replacement for multiple companies. Again, they couldn’t find a statistically significant increase in adjacent segment surgery between one or the other for one-level.
Now, for two-level disc replacement – and now so far two companies have been approved for it – one this past summer, and one back in 2013 for two-level disc replacements. Both of these show, actually pretty impressive results. For two-level fusion versus a two-level disc replacement, the reoperation rate – meaning you have to go back to the OR because either you didn’t fuse, or now you have another disc that’s degenerative, or you have some complications in the surgery – for two-level disc replacement, the reoperation rate is 16% versus 4% and that’s for one company. For the other company, they found a reoperation rate for two-level fusion of 15% versus 4% for two-level disc replacement and these are statistically significant numbers, so some potentially very promising data and these are five- to seven-year results for both of these companies, with both of these implants.
The rate of adjacent segment disease for one company – sorry from one implant for two-level fusion, the rate of adjacent segment disease was 11% versus only 3% for a disc replacement. And for the other one, it was 12.5% for a fusion, versus 6.5% for a disc replacement. These numbers are very promising. We’re now at the seven-year mark for some of these two-level disc replacement studies and they’re showing very promising results with very low complication rates for these implants. In my opinion, I think for a younger patient who doesn’t have a lot of arthritis in the back or the neck, who doesn’t have a cervical deformity, who doesn’t have any other contraindications, I think a two-level disc replacement might be a better way to go than a two-level fusion.
Melanie: And what are some indications for referral – you just mentioned a few, but continue along that line and wrap it up for us, with your best advice about cervical disc replacement.
Dr. Tannous: What I tell my patients -- and I saw every patient just before every surgery -- is that as a spine surgeon, I’m best at treating arm pain, or leg pain. When the nerve is being pinched and now you have disease in the spine that’s causing pain to travel down your arm or your leg there’s a 90 to 95% chance or more that I can make that pain go away as a surgeon. When patients come in and they say that they have predominantly just neck pain, without the arm symptoms, I don’t have a great surgery for that, unfortunately, because there are so many things that can cause neck pain. So really, I think the best candidates for a cervical disc replacement, or cervical spine surgery in general, are ones who are going to have predominantly arm symptoms because the nerve is being pinched, as opposed to the ones who aren’t as good candidates, or the ones who have predominantly neck symptoms without the nerve symptoms. I tell that to every single one of my patients and I really stress that in the clinic, before the surgery, and I emphasize that right before we go back to the operating room because we have to understand what the goals of the surgery are. We’re relieving arm pain, and not neck pain, in general.
Melanie: And what would you like to tell other physicians, Dr. Tannous, about adopting this procedure and looking at some of those numbers you mentioned?
Dr. Tannous: Well, first and foremost, I want to really stress that as in everything else in spine surgery, the best approach is a conservative approach. I treat 95 plus percent of my patients with the utmost conservative care, meaning we try everything that we can before we talk about surgery because most patients get better without surgery. Now, once they’re surgical candidates and they’ve failed everything else – and again you have to understand that this isn’t technology that is already been to be proven to be far superior. It’s promising, but the standard care today still is a fusion, but there's some very promising data out there to show that disc replacements are going to be the wave of the future. As with everything else, you don't just jump right into it, it’s a discussion with the patient. The patients have to understand the risks, the benefits, the alternatives and try everything possible before talking about going under general anesthesia and having a procedure done.
Melanie: Thank you, so much, Dr. Tannous, for being with us today. You’re listening to “Medical Intel” with MedStar Washington Hospital Center and for more information, you can go to MedStarWashington.org, that’s MedStarWashington.org. This is Melanie Cole. Thanks, so much, for listening.
Cervical Disc Replacement
Melanie Cole (Host): The standard initial treatment for symptomatic cervical disc disease typically involves physical therapy, medications, and occasional spinal injection procedures. If the symptoms continue and are very bothersome for more than six to twelve weeks, surgical treatment might be considered. My guest today is Dr. Oliver Tannous. He’s an Orthopedic Spine Surgeon and a member of MedStar Orthopedic Institute at MedStar Washington Hospital Center. Welcome to the show, Dr. Tannous. What’s typically been done for cervical disc disease and issues?
Dr. Oliver Tannous (Guest): Hi Melanie, thanks for having me. For one it’s patients who have already failed conservative care. They’ve failed physical therapy, injections, they’ve given it time, they continue to have symptoms in their disc disease. The standard of care for the past 30 years has been a discectomy and a fusion, meaning what you do is you go in, you take out the disc, you take out whatever’s pinching on the nerve, you relieve the pressure off the nerve, and now, instead of the disc being there, there’s a big space. You put a piece of bone and over time, the patient’s natural bone -- at the level above and the level below -- fuses into the bone graft that you put into the patient. It’s called a fusion or an ACF, which stands for an Anterior Cervical Discectomy and Fusion. That, still today in 2017, is the gold standard for cervical degenerative disc disease, but the caveat to that is that there’s new technology now for cervical disc replacement that are showing some really promising results over the past 10 years. There is a movement now towards trying to treat cervical disc disease in some patients with a disc replacement as opposed to a fusion.
Melanie: So tell us about the disc replacement. Who might be a good candidate for this?
Dr. Tannous: People who are the best candidates for a fusion are typically patients who are going to be between the ages of 30 and 60. They can’t have a lot of arthritis -- the problem with arthritis is that it limits motion and it makes things more stiff. If you think about the spine, there are essentially two parts to the spine. There’s the front part, which is in front of the spinal cord. There’s the back part, which are the facet joints, which are behind the spinal cord. When we do a discectomy, it’s the front of the spine -- we’re taking the disc out from the front -- but you have to understand that we’re not going after the facet joints in the back. In patients who have normal looking facet joints, they’re great candidates, in general, for a disc replacement because they’re going to have normal motion in the joints in the back. But if you’re too old, or if you have too much arthritis and the facet joints are too arthritic, typically most surgeons today would do a fusion, as opposed to a disc replacement because you don’t want to increase the range of motion through an arthritic joint, it would cause excess pain.
Melanie: So then speak in the disc replacement about motion preservation and adjacent segment disease and how this changes that.
Dr. Tannous: Absolutely. A little bit about adjacent segment disease, in its simplest definition -- if you think about doing a fusion is you have seven levels in the neck that are moving. When you do a fusion -- if you lock up that level by doing a fusion -- now the motion that would have otherwise been absorbed by that level goes to the level above or the level below so you increase the stress that’s being experienced at the level above or the level below. When patients come in, they have degenerative disks, and typically they’ll have it at multiple levels, but we only go after the one level that’s being symptomatic. When you fuse that, now discs above it or below it that already have some level of degeneration – the process accelerates the degeneration of discs above it or the discs below it. It’s called adjacent segment disease and overall, the rate is about 2.5 to 3% per year of increased degeneration, meaning at ten years, 25% of people who have already had a fusion will need a fusion at the level above it or the level below it because of symptomatic disease at those levels. That’s where the concept of the disc replacement came in. The theory is if you put a disc replacement and maintain the range of motion of the spine, you eliminate that increased stress that gets absorbed at the level above it or the level below it. That’s the concept of adjacent segment disease.
Melanie: And based on this theory, what’s recovery like for patients for cervical disc replacement?
Dr. Tannous: In my experience, patients who have disc replacements recover a lot faster. I don’t put them in a brace. In fact, you don’t want to put patients in a brace after a disc replacement because you want them moving through the implant, you want them to preserve that range of motion of the neck and you don’t want them to get stiff versus when patients have a fusion, you put them in a brace – and most surgeons will put patients in a brace from anywhere from six to twelve weeks -- because you want to lock up that level, you want the spine to fuse. You don’t want to increase the motion to that segment while things are healing. In my experience, the recovery rate for disc replacement’s much quicker. I’ve had patients go back to work within three to four days. After the surgery, they typically leave the hospital the morning after having had the surgery. I’ve seen incredible results with a disc replacement.
Melanie: Tell us about the FDA approval process for it.
Dr. Tannous: So you have to understand, anterior cervical discectomy and fusions -- so ACDF, meaning the anterior fusion -- has been the gold standard for the past 30, 40, 50 years and it still is, today, the gold standard because it is an extremely successful procedure. In spine surgery, it’s arguably the most successful surgery in the spine world. In order for the FDA to approve a disc replacement, you have to at least show that a disc replacement is not inferior to the standard of care, which is cervical discectomies and fusions. In the 2000’s, several companies that started studying this through IDE trials that got approved by the FDA, meaning they allowed them to test these implants for the specific purpose of getting it FDA approved. These were randomized, prospective, multicenter level one studies that were overseen by the FDA. As far as Orthopedics Research is concerned, these are the most meticulous studies in the Orthopedic and the Spine literature because they have to be because they’re being scrutinized by the FDA.
In the 2000s, they studied one-level disc replacement and overall, what they found, is that there was some trend that the disc replacements were superior to fusions with regards to patient outcomes, with regards to pain improvement, with regards to subsequent surgeries for adjacent segment disease. They didn’t find that most of these were statistically significantly greater, but at least what they found was that they were definitely not inferior to fusions. That prompted the FDA in the mid to late 2000’s to approve one-level disc replacement for multiple companies. Again, they couldn’t find a statistically significant increase in adjacent segment surgery between one or the other for one-level.
Now, for two-level disc replacement – and now so far two companies have been approved for it – one this past summer, and one back in 2013 for two-level disc replacements. Both of these show, actually pretty impressive results. For two-level fusion versus a two-level disc replacement, the reoperation rate – meaning you have to go back to the OR because either you didn’t fuse, or now you have another disc that’s degenerative, or you have some complications in the surgery – for two-level disc replacement, the reoperation rate is 16% versus 4% and that’s for one company. For the other company, they found a reoperation rate for two-level fusion of 15% versus 4% for two-level disc replacement and these are statistically significant numbers, so some potentially very promising data and these are five- to seven-year results for both of these companies, with both of these implants.
The rate of adjacent segment disease for one company – sorry from one implant for two-level fusion, the rate of adjacent segment disease was 11% versus only 3% for a disc replacement. And for the other one, it was 12.5% for a fusion, versus 6.5% for a disc replacement. These numbers are very promising. We’re now at the seven-year mark for some of these two-level disc replacement studies and they’re showing very promising results with very low complication rates for these implants. In my opinion, I think for a younger patient who doesn’t have a lot of arthritis in the back or the neck, who doesn’t have a cervical deformity, who doesn’t have any other contraindications, I think a two-level disc replacement might be a better way to go than a two-level fusion.
Melanie: And what are some indications for referral – you just mentioned a few, but continue along that line and wrap it up for us, with your best advice about cervical disc replacement.
Dr. Tannous: What I tell my patients -- and I saw every patient just before every surgery -- is that as a spine surgeon, I’m best at treating arm pain, or leg pain. When the nerve is being pinched and now you have disease in the spine that’s causing pain to travel down your arm or your leg there’s a 90 to 95% chance or more that I can make that pain go away as a surgeon. When patients come in and they say that they have predominantly just neck pain, without the arm symptoms, I don’t have a great surgery for that, unfortunately, because there are so many things that can cause neck pain. So really, I think the best candidates for a cervical disc replacement, or cervical spine surgery in general, are ones who are going to have predominantly arm symptoms because the nerve is being pinched, as opposed to the ones who aren’t as good candidates, or the ones who have predominantly neck symptoms without the nerve symptoms. I tell that to every single one of my patients and I really stress that in the clinic, before the surgery, and I emphasize that right before we go back to the operating room because we have to understand what the goals of the surgery are. We’re relieving arm pain, and not neck pain, in general.
Melanie: And what would you like to tell other physicians, Dr. Tannous, about adopting this procedure and looking at some of those numbers you mentioned?
Dr. Tannous: Well, first and foremost, I want to really stress that as in everything else in spine surgery, the best approach is a conservative approach. I treat 95 plus percent of my patients with the utmost conservative care, meaning we try everything that we can before we talk about surgery because most patients get better without surgery. Now, once they’re surgical candidates and they’ve failed everything else – and again you have to understand that this isn’t technology that is already been to be proven to be far superior. It’s promising, but the standard care today still is a fusion, but there's some very promising data out there to show that disc replacements are going to be the wave of the future. As with everything else, you don't just jump right into it, it’s a discussion with the patient. The patients have to understand the risks, the benefits, the alternatives and try everything possible before talking about going under general anesthesia and having a procedure done.
Melanie: Thank you, so much, Dr. Tannous, for being with us today. You’re listening to “Medical Intel” with MedStar Washington Hospital Center and for more information, you can go to MedStarWashington.org, that’s MedStarWashington.org. This is Melanie Cole. Thanks, so much, for listening.