Adam Yanke, MD, a sports medicine orthopedic surgeon at Midwest Orthopaedics at Rush talks about a drug that brings cholesterol levels to such a low point they are able to prevent some heart diseases.
Interview conducted by Ivanhoe Broadcast News in November 2019.
Can you explain, what is knee arthritis?
YANKE: Knee arthritis is essentially the loss of cartilage inside of the knee. The easiest way to think about it is like a tire. As you slowly lose rubber on the tire and it wears away you might need to have the tire replaced at some point. That’s how the advancement of arthritis works. When that gets far enough along, the replacement of the tire is essentially a knee replacement.
How can pain associated with knee arthritis affect or limit someone’s life?
YANKE: The way knee arthritis affects people is usually pain and swelling in the joint which can lead to restricted activities. That can also lead to restricted motion. We really start to see their circle of function shrink and we want to offer whatever treatments we can to expand that back out to what they were used to. So, it’s just a matter of whether that’s something like an injection or therapy or surgery depending on the severity.
If I’m looking at an x-ray of somebody with knee arthritis, what will I see?
YANKE: As people develop more and more arthritis on x-ray, you see the space that they normally have for their joint getting smaller and smaller. That’s the lack of cartilage, or the loss of cartilage, as it thins out over time. So, end stage arthritis, the most severe version of it, is when the bones are touching and that would be bone on bone arthritis. The different ways to treat knee pain related to arthritis and one of the most common medications that we use is an anti-inflammatory. Those would be in the category of like Advil, Aleeve, ibuprofen. The issue with those medications is they’re OK for a couple of days or a week or two. But when you take them longterm, they can have significant side effects. We really try to limit that especially if somebody has a condition that’s chronic in nature.
How is Hyaluronic acid used to treat knee pain?
YANKE: Hyaluronic acid is a common injection that’s used for knee arthritis. It’s also called H.A. or a gel injection. Some people refer to it as a rooster comb injection which is one source of it that’s used to lubricate the joint as well as be an anti-inflammatory. It’s an injection that’s been around for a long time and does have some evidence behind it. Recently, insurance companies are starting to remove coverage for that injection because they don’t think the evidence is sufficient any longer. Amniotic products come from patients that are having healthy elective c-sections and they choose to donate these products at the time of the delivery. They’re heavily screened, both the products themselves and the patients, so that we can offer them to patients and companies will procure them separately for use.
Is it injected into the knee?
YANKE: Different amniotic products are available on the market for different uses. There are membranes that can be used for ulcers and the heel or in the cornea. In this setting, we’re looking at a fluid and it’s an injectable. So, we inject it directly into the knee joint itself just like you would a steroid or a gel injection.
How was this study conducted and can you summarize what the results were?
YANKE: We performed a study here at Rush that was a multi-center study looking at the use of amniotic injections for knee arthritis. It was the first study of its kind with that level of evidence and we compared gel injections as well as saline injections. Essentially, what we found was that by six months the only one that still provided significant relief was the amniotic injection as compared to the gel injection and the saline injection. So, those results were very encouraging because it showed that these injections were at least as helpful, if not more helpful, than existing injections that are still considered part of the standard of care.
How did the patients who received the amniotic fluid compare to the other participants who did not?
YANKE: Within the study, patients were randomized to receive a given injection to begin with. That could have been the placebo, the gel injection or the amniotic injection. We saw that patients who had either the gel injection or the saline injection, which was the placebo, over half of those patients continued to have pain at three months and asked to be unblinded to find out what they had. The patients that had the amniotic injection had a significantly lower rate of having pain at three months and looking to have other treatments.
So, Marty is an enrollee in the study? He didn’t know which injection he was going to receive, right?
YANKE: Correct. Part of the idea of blinded studies are to not let patients know what they have in the beginning. Ultimately, they’ll always get to know. It’s their right. But we don’t want to have that influence the outcomes in the survey data that we collect throughout the study.
What is your best guess why it worked better than the other two injections that were found in the study?
YANKE: The amniotic injection is different than other standard injections that exist that are non-biologic injections because it has many different factors that are trying to improve the overall environment within the knee. A steroid injection basically just has the steroid which is like a single molecule that’s trying to act, whereas hyaluronic acid is also a single molecule but it’s slightly more like a biologic because we all have some hyaluronic acid in our knee. The amniotic injection has many different factors, different proteins, as well as hyaluronic acid in it. It’s really trying to take a larger, more global, approach to decreasing the inflammation in the joint and changing that environment moving forward.
You’re describing amniotic injection as part of a category called biologics. What do you mean by that?
YANKE: There are different types of injections that exist now for knee arthritis, and a larger category is called biologic injections. A lot of times this is either taken from the patient themselves, which would be an autograft, or it’s donated from another patient, which would be an allograft. When we look at our own tissue that could be your own fat through a type of suction. It can be your own bone marrow cells. It can be your own blood which is platelet rich plasma. Those are all biologic injections that come from your own tissue. The amniotic injections are biologic, but they come from a donor. You don’t have to harvest any of your own tissue for its use.
Do you think that this should be the standard of care?
YANKE: Part of the issue is as we learn that there’s other treatments that can help patients with pain related osteoarthritis or swelling, it takes a long time for these products to come to the market. Currently, they are available in the marketplace, but they’re not covered by insurance. That’s part of the goal of these studies is that we can get enough momentum to show that they are beneficial and then get insurance coverage for patients so that we can offer this to more patients.
Who’s not suitable for this study?
YANKE: The best candidates to receive amniotic injections or biologic injections in general are patients that are told they have too much arthritis for a simple knee scope to go in and kind of clean things out surgically. They’re also not advanced enough for knee replacement. Patients that are in this middle ground where they don’t have bone on bone arthritis yet, but they still have real arthritis can really benefit the most from biologic injections and amniotic injections.
Tell me about Marty. Did he kind of fit that description? How severe were his symptoms when you met him?
YANKE: Marty was very active and an avid runner and used to come in with a significant amount of swelling in his knee. We would have to pull fluid out of the knee to try to decrease that and manage his symptoms related to his arthritis. That was primarily behind the kneecap. The idea of the injection for him was to decrease swelling and decrease pain so that he could hopefully get his functional envelope back to where it was where he’s running and doing all the things that he used to enjoy. He and I both know that the arthritis is still going to be in the knee. The idea is just to get it to be quiet again. Almost everybody has arthritis in their knee before they realize it. It’s a very slowly developing process. If we can just shut it down systematically, it doesn’t matter if it’s still there structurally. The level of arthritis that Marty had was perfect for the study because he didn’t have bone on bone arthritis and was not ready for a knee replacement, both based on x rays and based on his functional activity. But it was real enough that doing something simpler surgically, like an arthroscopy, to clean things out would likely not be beneficial for him.
How did he do after his injection?
YANKE: I think he did well afterwards. He never came back for me to have to drain his knee again. We never had the fluid come back. He was nice enough to bring a medal in that he won first place in a 5K within his divisions. That was very exciting, and we were very happy about that. We’ve checked in on and off just to make sure things are still going well. But it’s been several years now and it’s still holding up.
Are there going to be any more studies or is this an ongoing study trial?
YANKE: Even though the existing study that we did is finished enrollment, we’re actually trying to come up with even more data behind this and it has the same criteria for enrollment as our original trial because we want to bring enough data to the FDA and insurance companies for eventual approval. So, we are enrolling again in the same trial and will be eventually able to get out more information on the specifics for them.
How would someone go about getting an amniotic suspension graft who doesn’t know you or doesn’t live in Chicago?
YANKE: I think it’s important for patients to advocate for themselves. I think that if you’ve been told that you have knee arthritis and you’ve had a steroid injection, you’ve had gel injections and you’re told that maybe a knee replacement’s right for you or you’re just not quite there yet, ask your doctor if a biologic injection would be appropriate for you and specifically an amniotic product or other products that exist on the market. Hopefully, that physician is educated and understands the space to try to figure out which one would make the most sense based on your specific situation.
This does not have FDA approval yet. But is that your goal?
YANKE: Yes. These amniotic products are currently clinically available and do have FDA oversight, and that is actively changing throughout time. That’s why it’s important for us to stay ahead of this with gathering evidence to try to support the use of them because regulations are only going to become more strict.
Is there anything that I didn’t ask you that people should know?
YANKE: The lack of regeneration is important. I think that one of the most important things for patients to understand is that right now we don’t have a way to do an injection and turn the clock back and take away arthritis. That’s really the most important point. These injections can be a better mousetrap and can just decrease inflammation, hopefully for a longer period, but they’re not going to change how your knees look on x-ray. It’s important for patients to understand they can still feel better even if we don’t make their x-rays look better. So, different injections that exist, whether they’re stem cell injection or biologic injection, the goal is not to grow tissue back, but to quiet down symptoms that they can get back with the things they’d like to do in life.
Interview conducted by Ivanhoe Broadcast News in December 2018.
END OF INTERVIEW
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