Hi, I'm Pat Smith from Columbia, Missouri, and the following is a summary of the role of suture tape augmentation for ACL reconstruction. Here are my pertinent disclosures. So I'd offer to you, we do have a clinical problem, even in 2024, relative to the increased risk of ACL autograft-free tears in our younger patients. Look at these published studies. Manarette showed a 30% hamstring failure rate, males under the age of 18. Kate Webster published the same thing, 28% hamstring failure rate, males under the age of 18. Cruz published 17% failure rate BTB, 26% hamstring failure rate, ages less than or equal to 19. Even the MOON group showed 7% BTB failure, 13% hamstring failure in age 17 year olds, and again in this younger age group. So I'd offer to you a potential clinical solution is adding suture tape augmentation for the ACL construct as you see here in this picture. My sole rationale for doing so is to protect my ACL grafts from re-tear. I don't put the tape in so my patients run faster, jump higher, come back to sport quicker. I'd like to be an ACL surgeon that had no graft re-tears, and I can tell you adding suture tape has definitely helped me get closer to that goal as I'll show you later on in this presentation based on some recent clinical data that I've published. I would like to emphasize first and foremost, this is not an artificial ligament. This is polyethylene suture we're using. It's been used in cuff repair for years with no issues. It's the same material used for surgeons for graft preparation and even meniscal suturing in the knee joint with no problem. This is not like an LED or a Lars ligament. Those are devices that have a history of adverse joint reactions. So I'd like to share with you in this PowerPoint is some scientific evidence to support suture tape augmentation, beginning with translational, then biomechanical, and then clinical published studies. Translationally, it was important to show that it was safe to use. So I went to the canine model. This was published six years ago in the journal Knee Surgery. Canine is a good model for the human ACL. It's a double-boned structure. So I put the tape across an intact ACL in six dogs. Then I wanted to look at the worst-case scenario, so I cut the tape in three of the dogs. They were filed for six months before sacrifice, which represents a two-year file for a human. You can see in these pictures, we saw no articular cartilage changes and no synovitis, even with cut tapes. So this confirmed that the safety was there in the translational model, and we published this, what I would term a human safety study earlier this year at OJSM. These were 25 patients of mine. They had a quad-tenon autograft with suture tape augmentation, young group, less than 20 years old. They had MRIs, which showed an intact graft. An independent radiologist reviewed the MRIs for the ACL-PCL ratio, or APR, as well as what is called the MOCS joint score for inflammation. And what he found was that with the augmented group, those 25 patients, their APRs and MOCS scores were exactly the same as what had been published in the literature for non-augmented ACL grafts. So again, further confidence of the safety of use of tape in the knee joint in this human safety study. The key is the biomechanics. As you see here, the tape is passed independent from the graft. So here's our femoral fixation button. The tape is passed through the button. The graft represented by the shoelace is through the loop. So you can see it's totally independent. It's fixed independently. So now this avoids the risk of any stress shielding on the graft. The tape becomes load-sharing. It functions as a dynamic safety belt to reduce the elongation, and it's simple to use. I always fix the tape in full hyperextension on the tibia, then the tibia is fixed second. So this is the first biomechanical study we published six years ago. Here's our study construct. Here's our Instron machine. Here's our porcine tibia. Here's our graft. Here's our tape. We deliberately put the tape in our biomechanical testing in a millimeter lax, but in full extension it tightens and it loosens inflection. So we looked at an eight millimeter hamstring graft. It's a relatively weak graft. This is the force displacement curve. Here in gray is where it says ACL. This is a cone of the normal hysteresis curve for the ACL based on the literature. In our testing model, we went to 250 newton load for 1,000 cycles first, and then up to 400 newtons, which is a very high rehab load, higher than most people study their grafts at in 1,000 cycles. What we found, without the augmentation, we had significant displacement as you see here on the right, but adding the augmentation put this relatively small graft in the right zone protecting it with less displacement. So this study showed us that lower loads are on the graft until it starts to displace, and that's when the tape kicks in at higher loads to reduce the load on the graft and hopefully protect it. This is a second very important study to reference though, also proving that these tape augmentations are load sharing and not stress shielding. What we did here is we used optical tracking to find out when did the tape go from the slack to the tight status. So here we looked at a seven millimeter graft, small graft on the left versus a diameter on the right. Load on the graft is red, load on the tape is blue. What you find here is that the initial load is on the graft, but at 200 newtons that's when the tape starts to kick in, and as the load goes up to 400 newtons, there is load sharing, 30% on the tape only, 70% on the graft, which is what you want. You want the majority of load on the graft so it revascularizes and remodels. Now on the larger nine millimeter graft, what happened is the tape did not kick in to 300 newtons, which makes sense because this is a stronger graft with a larger diameter. So here was an 80-20 ratio, again, the majority of load on the graft, only 20% on the tape. So what's happening is the load increases to prevent elongation at these higher loads, that's when the tape kicks in by increasing the construct stiffness to protect the graft from stretching and failure. So for my fixation, it's done through a button that I applied to my suspension device on the tibia. It has two holes. I'll show you in a video in a second. Fixed with my anchor, always in full hyperextension, and after fixation of the tapes on the tibia, then the graft is fixated. I cycle the knee and re-tension both on the femoral tibial side, but the tape is already fixed again in full hyperextension. So here's a video showing that. Here's our small tibial incision. You can see the blue tapes. For suture augmentation, the white sutures represent the suspension fixation device. First thing I need to do is apply my small button to the suspension fixation device to complete it. Here it is here. So there's two slots on each side. So the two white sutures on one side, two white sutures on the other. This completes the suspension fixation device. Again, this button conveniently has two small holes. So now I'm going to pass each end of the tape through one of the respective holes, as you see here. The knee is kept in hyperextension with a bump underneath the heel at all times. Then what I do is I just use the white shortening strands of the suspension device to bring the tibial button down to the tibia, but I'm not yet tightening the tibia to the graft. So I've already passed in the femur and tightened the femoral side, but the tibial side is not tightened yet. I take my slack out of my tapes. The button's on the tibia, not tight though. Then about a centimeter or so distal of the button, I drill a small hole. This is tapped as this bone is very hard. Then I'm going to fixate the two tapes with this anchor, again, done with the knee fully hyperextended and the graft not yet tightened on the tibial side. So you can see here, passing the two tapes through the anchor. It's very important to make sure the tapes do not cross those white shortening strands, which I'll show you here in just a second. Full hyperextension, the tapes are fixed with the anchor. You can see that the two white sutures are between the tapes. Otherwise you wouldn't be able to tighten them. So now I tighten the graft in full hyperextension with the handles. Next thing I do is I'm going to cycle the knee intraoperatively. I work with fellows in residence and I tell them they can do whatever they want. They can put a pivot shift on the knee at this point, Lockman, anterior drawers you'll see and really cycle the knee because if there's any creep in the construct, it will be eliminated by re-tensioning both on the femoral and tibial side, a big advantage of the all-in-side technique, which I prefer. Again, the tapes have already been fixed, hyperextension. I re-tension my femoral end of the graft to eliminate any laxity that might be present from cycling. Same thing on the tibia, so I get optimal stability of my graft. Again, the tape was fixed first. The last thing to see load is the graft. You will always see that the suture tape is going to be lax at 90 degrees of flexion. Ludifrate showed this, that the normal pattern is lengthening of the ACL from 90 degrees of full extension by three millimeters as seen in this graft. This is what you'll see intraoperatively. Here's my final construct. Here's a tape. I put my probe underneath the tape at 90 degrees. There's always that laxity. The tape is tight in extension. That's where I believe primarily ACL injuries happen toward full extension. That's where I want the tape to be protective. What is in the literature? This was a scoping review published two years ago. Looked at 22 studies. There were no adverse reactions using suture tape, which is important. We showed that in our translational, then in our human safety study that referenced earlier. This scoping review did show increased stability with the ACL graft by augmentation, but felt more powered clinical studies were necessary. What has been published clinically with use of tape? This was the first study published by Argentar in 2019 in arthroscopy. This is a retrospective study, 30 with tape, 30 without. Pre-injury group close to 30, which is important when you start looking at retear rates. This was a combination of both allograft hamstring and allograft hamstrings. Now, in this particular study, it's very important to note that the tape was not passed independently like I do. In any event, this study's conclusion was the tape augmented constructs actually had improved PROs, less pain, with a higher percentage of an early return to pre-injury level compared to the non-augmented group that they were almost even better, which is something I haven't shown. The pre-tear rate was almost 7% for both groups, so again, tape was not passed independent. This was the second study published out of the Mayo Clinic in 2021. This was a match cohort study, 36 reconstructed patients that had suture tape augmentation that was independent. The way I do it, 72 without, no difference in complications or graft failure return to sport. Again, this was a hamstring group. The suture tape patients did have higher technic scores though. This was an important study that was published two years ago as well. This is a very young group, about 15 years old, so this is the highest risk group for re-tears. 40 with tape, 40 without. The re-tear rate was only 5% with tape versus 18% without, almost, but not quite statistically significant. They also had higher technic levels post-operatively, no difference in other PROs. This study was published last year and looked at 97 patients with hamstring grafts and BTB, again, older group at 35. Somewhat smaller grafts, mean diameter hamstring 7, BTB 8.3, again, these are all augmented with suture tape. They had six-month follow-up for everyone, but some had to have their PROMs corrected greater than two years that were not necessarily in the clinic, but they did have a mean five-year follow-up. All the PROMs did improve post-operatively, though it was a decrease in technic level, which is not uncommon when you follow ACL patients longer out. They go from surgery as they tend to be less active. They just had one failure in the BTB group, but actually no failures in the hamstring group, which is pretty impressive, but again, this was an older age group. This was the first study of mine published last year, looking at 100 patients that had suture augmentation versus 100 controls, young group, age less than 20. These were active patients. Pre-operative marks activity level is 13.4 out of 16, so they're active. What we found in this particular study, I had an 8% graft re-tear rate without tape and only 1% with tape in this 100 control batch study, so again, the advantage of suture tape to lessen the risk of graft re-tear. We looked at another study published last year in General Knee Surgery, 252 patients that we followed with suture tape. These were multiple grafts, still pretty young, 23.6, follow-up greater than three years. Some of these were full follow-ups, but many of them were followed up in the clinic. We only had two re-tears, less than 1%, 0.8 graft failure rate, and only one of those patients had a revision, so again, very favorable, less re-tear rate with suture tape augmentation. Then we broke it down and looked at the peterotendent grafts of mine, 114 patients, 52 with tape, 62 control without, young group, less than 19 years old, follow-up greater than five years. No tears in the suture tape group, five without, and that was statistically significant, greater than 85% return to full capacity to support that led to the initial injury. So with BTB, we were very successful, no re-tears up to five years. This is published earlier this year in Arthroscopy, looking at my quad tendon group, 60 patients, they were all high school inclusion athletes, young group, mean age 16.8, follow-up greater than three years. No graft failures in this group, 90% return to the sport that they were injured in. The six that didn't were because they graduated from high school and did not play competitive sport again. However, my hamstring group is not quite as good. Here are my hamstrings, 104 patients, 36 augmented with tape, 68 controls, mean age 22, again young group, our follow-up was greater than four years. Interestingly, two years, our revision rate was only 3% with tape, which is good, versus 12% with control, was the control group without tape, although that was not statistically significant. Greater than four years though, look what happened. My suture tape group was still pretty good, 5.6% re-tear, but without tape, I had a 24% re-tear rate, which takes you to those numbers that I quoted at the start of this PowerPoint. Young patients with hamstring grafts, high rate of re-tear, I had at 24%. Now it was much better with tape, only 5.6%, which was statistically significant, but again, the hamstrings did not do near as well as the quad tendon and BTB with my published studies. So in conclusion, I would emphasize that based on the evidence, suture tape augmentation is safe. This is not an artificial ligament. The critical thing is the passage of the suture tape independent from the graft itself, both in terms of position on the suspensory fixation device and fixation, so now it becomes load sharing. There's no stress shielding of the graft. This concept of the seatbelt for protection of the graft at the higher loads to minimize risk of graft re-tear, and that has been borne out with recent published clinical studies as I've shown you. Thank you very much.

suture tape augmentation

ACL reconstruction

graft re-tear rates

biomechanical data

clinical efficacy