Dr Sheean : Welcome to the Arthroscopy Association’s Arthroscopy Journal podcast. The views expressed in this podcast do not necessarily represent the views of the Arthroscopy Association or the Arthroscopy Journal. Welcome everybody. I'm Dr. Andrew Sheean from the San Antonio Military Medical Center. Today I'm excited to be talking to Dr. Al Getgood from London, Ontario. Dr. Getgood is an associate professor at the University of Western Ontario and works at the Fowler Kennedy Sport Medicine Clinic. His paper entitled, "No Difference in Functional Outcomes When Lateral Extra-articular Tenodesis is Added to Anterior Cruciate Ligament Reconstruction in young patients: The STABILITY Study", which was recently made available online as article and press.
Dr Sheean: Dr. Getgood welcome to the podcast and thanks for joining me.
Dr Getgood: Thanks very much Andy for having me here.
Dr Andrew Sheean : So to start things off, what would you say to the casual knee arthroscopist or perhaps the shoulder surgeons listening to our talk today, that are saying to themselves right now "Oh great, another ACL study. Don't we already know everything we need to about ACL reconstruction?". What in your mind are the one or two critical knowledge gaps as they pertain to ACL reconstruction in 2020?
Dr Al Getgood: It's a great question and it's not uncommon for that sort of question to come out at various conferences. It's always, "Are you guys still talking about the ACL?". And I think what's really come out probably in the last five years has been the interest in, and the first thing would be appreciating that the ACL injury is not an isolated injury. There's been an awful lot more work along the effect of the meniscus and both medial and lateral in terms of controlling anterior translation as well as rotation. The effect of bony geometry, whether that's lateral femoral condyle architecture, notch width, but also tibial slope. And then of course the concern regarding the collateral structures, so the extra articular structures and whether that's we've known for a long time posterolateral corner as an issue regarding increasing strain on your ACL if you have PLC deficiency. But more this, the issue of the anterolateral complex, the anterolateral ligament, IT band stabilizers as well as more recently the MCL and considering medial rotatory laxity. So there's an awful lot more just what we're thinking along the lines of, not every ACL injury is the same. And certainly it's the idea, the outage of an isolated ACL injury probably doesn't happen.
And I think that the second thing is then when we start looking at studies, is understanding that not every patient's the same and maybe that we can't just take all commerce, we can't just take all case series of patients who have had an ACL injury and then compare one technique versus another. Because over and over and over, we've seen studies have shown there's really very little differences in surgical technique. But when we start breaking down into the younger age group at high risk, critical age group of patients going back to contact pivoting sports their failure rates are that much higher. And that's when we start seeing differences in even a graft type. And that's where the argument of graft type has come back in again. And I think the study that Julian Feller did a number of years ago looking at his failure rates, it really should be commended because it's one of the first papers that came out and showed that this really high failure rate up to 20% and in patients under the age of 18 which is really quite concerning. So I think that's the real differences that we're seeing in more contemporary ACL literature.
Dr Andrew Sheean: Yeah. And the other thing I find myself repeating to the, I guess, to “the haters” for lack of better words, when we're talking about ACL studies and ongoing research efforts is where else in orthopedic surgery would we accept a failure rate of 20% of the surgical intervention? You know what I mean? I mean if we were talking about total hips and total knees or wherever, I mean 20% failure rate's unacceptable. So I think that that data point in itself should be compelling us to continue to ask the tough questions and take on ambitious initiatives such as yours to try to get better at what we're doing.
Dr Al Getgood: Yeah, I think, I mean, I couldn't agree more. We have so much room to improve, particularly when we start looking at our high risk individuals.
Dr Andrew Sheean : So why don't you give us a broad overview of the STABILITY study in terms of what your overarching research question was and how you and the co-investigators tackle it from a methodological standpoint.
Dr Al Getgood: Sure. I mean it really stems from the fact that we recognize and a lot of people that obviously had published a lot of literature showing that there were these high rates of failure in our younger age group. So we wanted to look at was there something that we could do to try and improve our rates of failure in that particular age group and really try to weed out the high risk individuals. And this study through the Genesis of the study came roundabout sort of 2012/13 when there was a lot more talk about the anterolateral ligament, the anterolateral capsule. We've been doing some work on the biomechanics of the ALL on the lateral side and it was clear that this was an area that really deserves a little bit more analysis.
And when we look back at some of the historic literature on the use of lateral tenodesis and ACL reconstruction, it was pretty obvious to me that it had an effect and we published a systematic review in 2015 which showed that the addition of a lateral-plasty reduced rotatory laxity when teamed up with an ACL reconstruction. But there hadn't really been a very strong, adequately powered, methodologically rigorous study that could really show a clear, significant, clinically significant as well as statistically significant difference within a high risk patient population. So that was the genesis of STABILITY. And interestingly, I think everything sort of came about quite nicely in that ISAKOS at the time then had put out a call for an award for a grant application that was centered on a multicenter, multinational study. So really we had all our ducks lined in a row really quite nicely.
So we applied for that grant. And so the premise of the study was that we wanted to be a multicenter randomized clinical trial comparing ACL reconstruction with or without lateral tenodesis and patients that we deemed as being at high risk of reinjury of failure. And so this involved nine centers across Canada, so seven in Canada and two centers in Europe and our inclusion criteria to the patients all under the age of 25. And we chose 25 primarily for an issue of both high risk but also feasibility, we knew we were going to need large numbers. We wanted to try and focus on patients again who had higher risk of reinjury with regards to their presenting examination. So patients going back to contact pivoting sport, patients who had generalized ligament, just laxity, or hyperextension recurvatum and then patients who have high grade rotatory laxity. And the patients have to have at least two of those three criteria to be included in the study. So again, we're trying to weed out the really high risk group because to be able to show a meaningful difference, we really need a high event rate to be able to show a difference. So we randomized patients at the time of surgery to have an ACL reconstruction with the hamstring tendon autograft with or without a lateral tenodesis and then patients were followed for a period of 24 months at your standard intervals. And our primary outcome of choice was what we described as clinical failure. Clinical failure was a composite outcome of both rotatory laxity, so persistent rotatory laxity as well as graft failure. And the reason that we chose that particular composite outcome is that if we were adding an extra procedure on to our standard ACL surgery, although some patients we know may present pocket 12 months or 24 months with a grade one pivot shift, but if we've done an extra procedure to reduce the rotatory laxity, then by definition that procedure has failed. So that's why we called it a clinical failure.
And then we also looked at secondary outcome measures, which is graft failure as well as your standard patient reported outcomes like if we see KOOS activity score, Marx activity score, and then a number of centers did some other functional testing, which is the focus of the paper in arthroscopy. But essentially what we find within the study was that the primary outcome, the addition of the lateral tenodesis to an ACL reconstruction by 24 months had a significant, so both a statistically significant and clinically significant, reduction in clinical failure. So that went from essentially 40% down to 25% and then something, maybe it's a bit easier to get your head around, which is the graft rupture from 11% to 4% so a 66% relative risk reduction in graft rupture. There were really no differences in patient reported outcomes. There was a small difference that was not clinically significant, but three and six months in KOOS score, that was in favor of the ACL only group, all those changes washed by 12 to 24 months.
Dr Andrew Sheean : Why don't you briefly describe for the listeners exactly what the modified Lemaire lateral extra articular tenodesis is and why you chose this tenodesis over other ones that have been described in the past.
Dr Al Getgood: So the modified Lemaire: I mean, there are a quite a large number of extra articular tenodesis procedures that have been described over the years and have been used for decades. The modified Lemaire procedure was a strip of IT band that was harvested approximately just over a centimeter wide and 10 centimeters long and it was basically passed deep to the lateral collateral ligament and passed through a bone tunnel just behind the FCL origin and then passed back underneath the FCL and reattached to itself. We modified it just purely because we didn't feel it was necessary to put it through a bone tunnel. So we just attached it to the lateral flare of the femoral condyle, just posterior and proximal to the origin of the fibular collateral ligament. And you know, you could also call it a modified Macintosh. It's essentially, you know, it's an IT band, it's a strip as opposed to your half of the IT band and I think the important thing is that it's passed deep to the fibular collateral ligament and then it's fixated somewhere between 60 to 70 degrees of flex with neutral tibial rotation, with very little tension applied to the grafts. So biomechanical studies have shown that if you do less than 20 Newtons of tension applied to the graft then you're not going to over constrain the joint in external rotation and you really get that tenodesis effect occurs when you come into extensions, it's up between zero and 30 degrees of flexing where you're controlling the anterolateral subluxation.
The group chose the Lemaire procedure primarily because I actually visited David DeJour back in 2012 before I moved out to Canada and I'd never seen a tenodesis before and David showed me his technique and he was using a modified Lemaire at that time. He was using an interference screw to fix the graft, whereas we used to staple. The reason for using the staple in our study was that it's very simple, it's cheap, it's an easy thing to translate into a number of different healthcare practices. So it wasn't going to be a major ask when trying to translate the results of the study if it was found to be efficacious.
Dr Andrew Sheean : Well, that was a great overview. What role does functional testing play in your day-to-day practice? Are you doing these functional tests that you all described in the paper, that you looked at it in the paper on everybody prior to returning them to sport?
Dr Al Getgood: Yeah, I mean primarily we're using... I would tell say first and foremost our functional testing is occurring in more of our research studies and what we found with this particular paper, and I guess I didn't really go into that, was that with the functional testing there was no real difference in the two different groups of patients. So whether you had an ACL reconstruction or an ACL with the lateral tenodesis, there was no difference in limb symmetry indexes measured on our hop tests, there were actually four hop tests. There were no clinically significant difference in isokinetic strength. There was a small statistical difference in a quadriceps strength at three and six months in terms of peak torque and hamstring quad ratios. But that washed out by 12 and 24 months.
We didn't think the difference was that clinically relevant. But when we looked at the questionnaires on our lower extremity functional scores, they also were a little lower, although wouldn't have really hit that main clinically important difference. But there was a trend that we're seeing in the early functional or in the early recovery phase, the patients were maybe taking a little bit longer to recover in those first three months. And that would maybe go hand-in-hand with the fact that you're doing an extra procedure and that extra procedure is on the lateral side of the knee and you know, putting graft underneath the quadriceps. So I think that all goes hand-in-hand with that. Importantly, so I mean from the point of view of the study, we didn't see significant differences in functional outcomes, whether you did a lateral tenodesis or not. What's probably more interesting is that we didn't find that the results of the functional testing were actually predictive of failure. And we're just in the process of doing it, a multivariate analysis, looking at trying to work out what patients, whether we could actually determine who would be at higher risk of failure than others. And our functional testing in terms of the absolute numbers, or at least sorry the limb symmetry index, are not that predictive of failure. And it could be related to the fact that we're using limb symmetry index because there's ultimately probably some de-functioning of the contralateral side which has been shown in multiple studies before. So it then makes you think what benefit is or are these battery of functional tests to your every day sense of practice. And I think that's still somewhat controversial and that happened obviously some studies that have shown that if you do a battery of tests that may be somewhat more predictive of outcome.
I think where we use functional tests on a more of a daily basis in our clinical practice is to try and slow our athletes down. We know that, Tim Hewett’s work has shown that if you prolong the length of rehabilitation and keep them out of contact, you keep them out of at risk sports so to speak, then your risk of failure reduces. And certainly we see in our failure rates in STABILITY that most of the failures are happening early. And so I think the longer you can keep them out of that at risk activity, then that's for the better. And so I'll often use our functional testing at athletes who are trying to get back maybe sooner than I want them to. And we'll use it as a method to show them where they are, so after nine months and they'll see where that their limb symmetry index is reduced and it'll really show them that they're not ready. And I think sometimes athletes need that and equally gives them a bit of a spur on the open to start working further on the rehab, focusing on specific aspects of the rehab, retest again at the 12 month mark or you know, again testing 12 months and then retesting at 15 months and seeing the difference. And just trying to get them in a better position before they go back to play. Because obviously it doesn't stop them from having a reinjury, all we're really trying to do is mitigate risk.
Dr Andrew Sheean : So how successful have you been at telling a soccer player that at 12 months, he's not ready to go back?
Dr Al Getgood:I mean, it's always a challenging one. I mean, I'm very successful at telling them, that's why they're not there and listen to what I have to say. And ultimately it depends on the athlete that you're working with. If you're working in a college and you have the ability to sign people back in or out then you've got a little bit more control. But I'd say that 90% of my patient population I don't have control of whether they go back or not. So they have to listen to my advice and then they choose whether they listen to my advice. And I'm pretty pragmatic about it, I give them the information and if they seem a bit skeptical we put them through the functional testing. And I would say the majority, when they go through the functional testing, they understand the issues that they're having.
They know that they don't feel right. The kinesiologist is very good. They're hearing it, they're not just hearing it from me. They're hearing it primarily from the kinesiologist and the physiotherapist. And they can look at numbers, but they can also understand that they may be landing but with a stiff leg, they're off balance, you've got a lot of lateral trembling. And they can see that, they do that in front of a mirror and they can really see that. So I think that's sort of, well maybe not positive feedback, but that feedback that they get from those tests, they will often take that on board and then they really want to come back and three months later and show me that actually no, they've improved and they're working hard. So it's just something else that you're going to add to your armamentarium to try and mitigate risk of reinjury in these young people.
Dr Andrew Sheean : I like it. Well, so I'll ask you this question and we'll wrap things up. So based upon the results of your work, what are your current indications for the lateral articular tenodesis in the setting of a primary ACL reconstruction?
Dr Al Getgood: So primarily, it's probably changed my graft choice as a first off in the younger patient, going back to contact pivoted sports. So where I was doing a lot more hamstring tendon autografts when I first started my practice, I switched over to doing an awful lot more patellar tendon, and some instances, quadriceps tendon in the younger patients going back to contact pivoting sport. Even in those patients though where I'm seeing patients with increased tibial slope, a high grade rotatory laxity particularly chronic ACL injuries, and generalized ligamentous laxity, that's where I'll add in lateral tenodesis. I do a lateral tenodesis and in 95% plus of my revision ACL, not that there's clearly another issue going on that needs to be addressed such as a posterolateral corner, that's pretty rare for me to do both lateral tenodesis plus posterolateral corner because you're kind of fighting against yourself. But that would be my main indications.
And I think the question that we always get asked is well the reason that you released studies is because of the hamstring graft. I think maybe that's a little bit unfair. And I think one thing is important to recognize is that you can still get a great result of an ACL reconstruction with a hamstring tendon autograft. I think you just need to be a little bit more selective of who you use it on. And I think for your average athlete, 25 plus, a hamstring graft is still a great option. But when you're getting into the more high demand and the MOON Study and the MOON Group have shown this, the high demand athlete, then maybe a BTB might be a better option in those select patients.
And so I certainly don't claim we need to throw out the hamstring graft at all. And then it comes down to, well can you get the same results with the BTB and not have to do a lateral tenodesis. And we really don't know the answer to that question. We're just about to start a new study along with the University of Pittsburgh's co-investigators with a, it's another multicenter study we're calling STABILITY II, which is both NIH as well as CIHR funded. And that'll be looking at patellar tendon versus quadriceps tendon, with or without a lateral tenodesis. And I still think there's going to be, my hypothesis would be that there's still going to be a certain patient selecting whereby the addition of a lateral tenodesis, no matter what graft you use, will be of benefit.
It remains to be seen whether or not the addition over lateral tenodesis to hamstring graft, which really only gives us a 4% failure rate, whether we can make that any better. And so then would be a lot of other functional indices and donor side issues that we can then start looking at as to what is going to be the optimum technique and graft choice for these individuals.
Dr Andrew Sheean : And you mentioned it when you were describing the technique itself and you talked specifically about the importance of taking a number of steps to avoid over constraining, making sure the tibia is held in neutral rotation, that you're not putting on undue tension on the grafting. I think one of the really important things, I think is coming out of your work is that even though patients may have some issues in the immediate postoperative period up until about three months, they may have some more pain. It seems like there doesn't really seem to be a downside at two years to doing a tenodesis, is that a fair characterization?
Dr Al Getgood: I think we're certainly not seeing a downside at two years. There's always going to be a concern that people will always bring up the risk of osteoarthritis later down the track. And of course we can't answer that question at this point in time. What we can do is we can look at historic literature where tenodesis has been used for decades and the majority of systematic reviews on this particular subject has shown that there isn't an increased risk of post traumatic away with addition of a lateral tenodesis and that meniscus deficiency seems to be driving that more than the addition of a lateral tenodesis. On the biomechanical studies as well, albeit show that there's a small degree of over constraint when doing a majority of anterolateral procedures, it's probably not clinically relevant.
Dr Al Getgood: So, I don't want to at any stage say that there's definitely not going to be any downsides down the track. We know what we know based on the data that we've collected so far, but we're also pretty comforted the fact that we've got a lot of other historic literature to go by. And so I think there's an awful lot more information to get out of this. I don't think every single patient needs to have a lateral tenodesis, I think that's for sure. I think it's important that we get to a point where we can be a little bit more selective, whether that's being selective on graft choice, being selective on adding lateral tenodesis depending on patient's presenting characteristics, depending on their choice choices sport. I hope we'd get to that point. And I think as time goes on, I think as surgeons we probably need to get away from being a BTB surgeon or a hamstring tendon surgeon, is that actually we need to be more selective of what we do and try to be a little bit more selective on those particular patients to try and optimize our outcomes.
Dr Andrew Sheean : Well, tremendous talk today Dr Getgood. I appreciate you taking time out of your busy schedule. Dr. Getgood's paper entitled "No Difference in Functional Outcomes When Lateral Extra-articular Tenodesis is Added to ACL Reconstruction in young patients: The Stability Study" was recently published online, his article and press and can currently be accessed at www.arthroscopyjournal.org. Thank you all for joining us and have a good evening.