David Flannigan, MD, an Orthopedic Surgeon with expertise in sports medicine, cartilage restoration, and other knee related issues, Professor, Department of Orthopedics at Ohio State University Wexford Medical Center, talks about the treatment options for osteoarthritis of the knee, and the calypso knee system.
Interview conducted by Ivanhoe Broadcast News in January 2019.
Tell me for starters a little bit about osteoarthritis of the knee. We’ve heard of arthritis but for those of us who don’t have a firsthand experience with it can you explain what’s going on for these patients?
Dr. Flannigan: Sure. Osteoarthritis is a condition of the knee joint or other joints where you start getting breakdown of your cartilage, which is that gristle that’s at the end of the bone. As we age, sometimes after trauma or other injuries we can start getting some wearing and tearing of that articular cartilage over time and that’s what arthritis is.
And what does that feel like for the patient?
Dr. Flannigan: Well sometimes when arthritis starts they may not even know that it’s starting. It can be kind of a silent disease early. But as it progresses it will start causing swelling of the knee and pain, especially with physical activities. Then that can cause some different mechanical symptoms at times as well with some crunching or cracking of the knee joints. And then just continually feel an ache throughout the whole day. So that’s kind of the progression of the arthritis and it will get more and more severe as it gets more down the road.
So what are the options for patients prior to having this device? What can you do if you’re starting to get to that point where the pain is unbearable?
Dr. Flannigan: Some of the easy first line treatments are gonna be anti-inflammatories, sometimes physical therapy, we’re going to get their strength back up because as we all get older we get a little bit weaker. So getting some strength up is going to be very beneficial to offload some of the bones and the joints themself. Weight reduction is really important, and then you can go towards any type of injection therapy to the knee. Those can be sometimes as simple as a steroid shot or lubrication shots and different ortho-biologic injections as well. Finally, if people are really becoming symptomatic and those things are not helping and you’re really looking at other options as far as how you can alleviate some pain there’s a surgical option there. The ultimate surgical option, especially for severe arthritis, will be some sort of joint replacement; whether that’s a partial knee replacement or full knee replacement. But there are a lot of patients who have mild to moderate arthritis who have tried some of these other modalities and types of treatments and they just haven’t worked for them. Those are the patients that we’re really looking at how can we help them and buy them some time before the need for a knee replacement. That’s where I think this device is really unique in a kind of fits that little niche as far as those patients.
Before we talk about the clips, why is it important to buy time some time with the knee replacement?
Dr. Flannigan: Well knee replacements are pretty permanent. Once you have it, you’ve actually change the structure of knee by removing bone, removing cartilage, you put metal and plastic in there and there is no going back at that point. We know that in the United States joint replacement surgery has just kind of exponentially grown over the last few years. And the problem with that is if those don’t work, then they’re going through another revision with their knee and a total joint replacement after the fact and that can obviously have a big effect on the patient. So if we can maintain that knee joint and again buy them some time where they are, it will help them enjoy their activities with less pain and delay that. Holding off on that joint replacement for another 10-15 years, I think that can be very beneficial.
Talk to me about this device. Is this a first of its kind?
Dr. Flannigan: In essence this trial is the first of this newer design, but this concept has now been out there for a few years. It started in Europe where they tried some devices that were very similar to this. It then came to the United States and they had the first rendition of this implant a few years ago, of which we were part of that study as well. We had to modify this implant a little bit in that design. Now this is what they hope is going to be the final product. In essence, if you think of your cars shock absorber, that’s what this really is; you’re putting a shock absorber outside the knee joint on the inner portion of the knee so that when they’re walking that shock absorber take some of that load off. So it can help alleviate some of that impact that people will feel with that arthritis, because that device has taken some of that load off. That’s how it really works; the concept is very much like a shock absorber that we see in cars.
Instead of bone on bone you’ve got that piece that’s taking the pressure?
Dr. Flannigan: Yeah, again, this is not inside the knee joints. It’s outside the knee joint. You still have that arthritis that’s inside the knee joint, but as you’re walking this implant is going to take that stress off the joint and allow that to not be as painful when they’re walking.
Can you talk to me a little bit about the surgery? How long does it take and if you can kind of step knee step by step through what you have to do?
Dr. Flannigan: It’s about an hour procedure; we use basically a live x-ray machine. We make an incision on the inside part of the knee, maybe about five to six inches long. We go down through that soft tissue and find that medial collateral ligament, which is one of our main ligaments of the knee that sits right outside our knee joint. This implant then is basically referenced off that media collateral ligament and sits just above it. It’s anchored into the bone both in the femur, which is your thighbone, and in the tibia, which is a kind of shinbone with three different screws. Then that shock absorber is in between those two areas.
Can patients feel the device in their knee if they rub their hand up and down their leg? Are they going to be able to feel where the screws are or where the device is?
Dr. Flannigan: You can sometimes; if you’re very, very thin you may notice a little bit of a fullness in that area. But most of us have some soft tissue in that area that will cover it and you really don’t notice this at all, you can’t really feel it. You’re not going to see it when they’re standing up. It really is hidden underneath all that soft tissue.
What’s recovery like for patients? How long does it take you before they’re up on their feet, before they feel back to normal?
Dr. Flannigan: Yes they are back up on their feet right away. We want them walking on this even right after surgery. They’ll be on crutches until their gait is doing OK, and they’re able to come and get enough motion in therapy. This therapy can take anywhere from four to six months. It is a progression, just like any type of surgery, but most people are pretty back towards their normal activities within about two months and then they just continue to progress as they get stronger.
Do they have any restrictions? Are people able to go walking, jogging, back to work, or do they have to be careful with this with this device?
Dr. Flannigan: The expectation is whatever activities they were doing before surgery, are the activities that we want them to get back to. If they were running beforehand, but with pain, our hope is that they’re going to be running again without pain. If they were walking beforehand with pain, we want them to walk without pain. It’s not necessarily try to become a marathon runner if you weren’t one beforehand, so realistic expectations. We want them to just enjoy the activities that they normally do but without pain.
What phase is this in?
Dr. Flannigan: This is an FDA, in essence it’s a phase three if you want to say but it’s not randomized so it’s really just a trial with the implant. And if it’s successful, we move on. They’ve had again multiple renditions of this trial. So this is this the last step before FDA. The FDA has allowed 10 patients initially in the study. They’re going to review those 10 patients and then it’s going to open up to 80 patients across the country. And then at that point once those 80 patients are done if the data looks great then we anticipate this will be heading to the market in the future.
Can you talk to me a little bit about your patient Chuck?
Dr. Flannigan: Chuck is a great guy. I really wanted a phenomenal patient who really is looking for a different alternative besides a knee replacement. He’s extremely active in what he does now. Even retired, he’s pretty active and he was really looking for those other alternatives. Something else, besides a total joint; something that can keep him walking, doing his auctions, and everything else without really having much discomfort. He’s tried a lot of different treatments beforehand with therapy injections. He’s had previous knee scopes and now it just hurts. So Chuck was really the type of patient that we’re looking for, not really significant arthritis where he needs to have a knee replacement but enough of it where it is impacting his activities of daily living and how can we help him be active and do the things that he enjoys.
Any indication how long the device will last? Is this intended to stay in?
Dr. Flannigan: It can stay in as long as it’s working. In the European studies that they’ve had, they have people well over 10 years at this point with this implant and doing well. Our expectation is that this can be something that can bridge a decade or more beyond. We hope to see how that that pans out over time.
Is there anything I didn’t ask you that you would want people to know?
Dr. Flannigan: About probably who are the ideal patients? The patients that we’re looking at are really those that are kind of the ideal body weight, under 300 pounds, which have a BMI of less than 35. Age is less than 60 and that’s primarily because as we all get older our bones become a little bit weaker and so some of these with screws it may not be the best for people who have weaker bones and they have failed some of these other treatments that we’ve talked about. It’s something that’s continually giving them pain over the long run. And that pain is just on the inside part of the knee when they’re doing activities. This device doesn’t work for significant arthritis in the kneecap area or on the outside part of the knee. It’s currently just designed for arthritis in the inner portion, what we call the medial aspect of our knee.
END OF INTERVIEW
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