Name: GraftLink® Technique Research and Outcomes
Uploaded: 2017-03-13T00:00:00Z
Channel: Arthrex
Description: Patrick A. Smith, MD (Naples, FL), discusses the latest research and clinical outcomes of the GraftLink® technique.

<p>Patrick A. Smith, MD (Naples, FL), discusses the latest research and clinical outcomes of the GraftLink® technique.</p>

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VPT1-00821-EN | A | GraftLink® Technique Research and Outcomes

Patrick A. Smith

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GraftLink® Technique Research and Outcomes

Can I talk about the biology to support the all-inside suspensory fixation? And we'll go through the couple published studies on GraftLink that are out there with two year follow up, and share with you some results of a randomized controlled trial that I'm doing. So the All-inside technique, we know it's a quadruple soft tissue graft hamstring. Commonly you can use allograft or quad. The key is a suspensory TightRope fixation on both sides. I've been doing all-inside surgery since 2006, and always felt to me that on the tibial side, if we had that socket, we would get blood and and good growth factor accumulation on the graft to get better healing. I called it the potted plant. So the question was how could we test and see if this was true? So we went to the animal lab, the University of Missouri. There's a vet school there. And Jimmy Cook helped me with this. And we designed this model looking at suspensory versus screw fixation. The dog is a good model because of the double bundle ACL. It's similar to human. The problem is the increased tibial slope of over 30 degrees tends to lead to failure in complete reconstructions. So I had a lot of lot of double bundle experience in humans. So we translated this to the canine. We called it our hybrid double bundle. What we did is we cut the amp bundle in the dog, but left the peel bundle intact and preserved. The joint replaced the bundle with a graft. We studied this model because we had to prove that that reconstructed Am bundle actually saw load, and we proved that that was published in J.R. in 2015. So then we went to our study group for the suspension versus screw. We had 12 dogs, six and six. We mounted them clinically. They were sacrificed at 12 weeks with arthroscopy at that time. Then we did biomechanical testing and most importantly, the histology. So here's what it looks like. This is an interference screw case. You can see on the left side the implantation the native PL is intact. We reconstructed the Am at 12 weeks. You can see it sacrificed. The Am bundle has healed nicely. This is a suspensory all-inside case. Same thing. Native PL is intact. We replaced only the am. You can see at 12 weeks we've got good healing. So it looks like this schematically with the x rays with the all-inside on the right side. Tied biomechanical testing. What we did then is we wanted to just test the graphs. We actually cut the native PL. So all we're going to test is the Am on the reconstructed side versus the normal limb, which was a complete ACL. And what we found is this that you can see in this graph here the control of the normal size in the darker green, the suspensory all-inside groups in the yellow and the light green is the screw group we had higher suspensory was higher for suspensory than screw. None of the suspensory has failed. One of the screws failed and we were and we were stiffer also. So we were pretty happy that our suspensory graft alone at three months had almost 50% strength of the intact control. So the key was the histology. And there were two pathologists looked at this blinded and what they graded the healing of graft to bone and found that it was statistically significantly better for the all-inside suspensory group versus the screw group, both on the femur and tibia. Here's a couple pictures. Go back to your basic science days. On the left you can see the screw in place the shadow of the of the absorbable screw with a bit of graft on the right. With the suspensory, you see more graft in the socket as you'd expect. This is the key, the histology on the tunnel side, the fulls with the screw. All you basically saw was fibrous tissue to bone. No cross-linking at all. But on the on the all-inside suspensory group, what we saw was graft turning into cartilage to calcified cartilage to bone. So that's four zone integration. And that's normally how your ligaments attach in the body. We saw it only in the all-inside group and we saw it on the femur and tibia. Then we looked at a little closer. If you look at this one on the left at the aperture of the screw, you can see the shadow of the screw. There's not much graft there. You look at the aperture on the all-inside, you can see quite a bit of tissue. So we broke this down and looked at this closer. At the aperture, Scott Rodeo published that there was more motion with suspensory fixation. At the aperture. We found exactly the opposite. We were statistically significantly better for the all-inside group at the aperture 0.05 in the middle of the tunnel, and only the base was the same. So we actually saw better healing, which to us means there's minimize motion with the all-inside suspensory technique. So what's in the literature with the All-inside published so far? First day they did what Jim Liebowitz and Randy Schwartzberg, we were just interested in pain. When we started doing this many years ago, we noticed our patients were much less painful. It was similar to the repair group. So we studied this in Allografts. This was a randomized controlled study, 148 patients greater than two year follow up 81%. What we found is statistically significant less pain with the all-inside group versus the full tunnel group. The second study that was really important for the GraftLink is what I would call the GraftLink precursor study that the three of us did. And what we did here is we wanted to compare a precursor of the GraftLink, which was button button fixation. We used a RetroButton on the femur, and we actually just tied sutures on the tibia to a button. That was going to be our suspensory group versus aperture screw on the femur, RetroScrew on the tibia. So we compared aperture fixation to suspensory in this group. This was level two because when we had 74% follow up at two years, Here's what we found. No difference in KTS. Number one, our outcome measures were the same. Our icdc was really good for suspensory and it was a little bit better than aperture. We had no tunnel widening which was very encouraging. So what's been published? Sure is published last year. Two year follow up. This was a GraftLink study. 79 patients. Again, there are outcome measures, all improved from baseline K-2 1,001.7 different. Did have a bit of a high rerupture rate at 13%. The average graph diameter here was just under eight. Adrian's group from from England published this this past year. 108 GraftLink patients for your follow up outcome measures were great side to side. Kt 2.4 Rerupture at 6.5. The graph diameter was a bit over eight. So this is the study that I'm just getting ready to complete. It's a randomized controlled trial looking at patellar tendon the so-called gold standard versus GraftLink MIT. Although I do internal bracing, none of these were internally braced, 64 patients. I wanted to get the toughest crowd I could. So these are all under 25. These were all injured in sport. We have MRIs at a year on everybody. And every patient has completed SOS, which we're happy about. We have 100% compliance in this study group for this study. Here's our sutured construct. Again. There's no internal brace on this. This is just a quadruple TRIM-IT 32 and 32. I lost two at one year. So I have 62 out of 64 followed for one year. I have 48 complete follow up at two years. We just have a few more to go. Average age of my group is 18. So young young population in this group I have had two GraftLink failures. I've had no BTB failures, but I've had two of the BTB patients tear the other side in the two year period. So if you look at our icdc objective, the GraftLink I have 26 A and one C grading and BTB 22 A so far. Side to side. Exactly the same at point five. I'm pretty happy about the outcome of the GraftLink stability equal to BTB. Here's a representative MRI. You can see kind of the potted plant on the left the GraftLink versus the screw in place with the BTB. So just putting it together, looking at the works. That's the two that were published last year kind of side to side. My average graft diameter for my GraftLink group was 8.8. Rerupture rate is 6.67, which I think compares extremely well since these were average age of 18. And we've heard, you know, the risk of rerupture in that age group is up to 30% in some recent published studies. So the graft links have held up well. The CT's are very good. And again, I had a very young study population here in terms of the data looking at it. Sf 12 that we studied were statistically better than baseline for both BTB and GraftLink. Graftlink is in the yellow here. Btb is in white. Graftlink just about exactly the same when you look at Icd's subjective GraftLink tends to be a little bit better, but there's no statistical difference there. We looked at that in the 48 that we have. Same thing with coups. A little bit better with GraftLink, but not statistically significant. Both are, of course better than baseline. Mark's activity score is interesting. Pre-op. Exactly the same at 15. Post-op a year. We have 13 and 13, so it's not back to 15. So I think a lot of us that take care of these high level athletes know that at a year they're really not back 100%. So we'll see where the final mark's is at two years. Hopefully we'll see some improvement there. So what also is interested in is SOS. Again, all my patients have collected, and I don't think anybody has done any validation of SOS yet to in-house data. So what we're doing in this study is all the patients are back in my office at two years. They get an x ray, they fill out all their paperwork. So what I did here is we correlated what they filled out on the computer versus what I found in house trying to validate SOS. And here's the SF 12 physical. So you can see SOS in this slide is yellow in house collection data is white basically the same. No, no statistical difference. We looked at that same thing pretty much exactly the same. So what? We got off online match what I found in the office quality of life with ques about the same thing and the market activity pretty much the same. So this is exciting for me so that this cohort of patients, hopefully when they're three, five, ten, 15 years out, I'm going to go back with them on SOS. Because if it correlates as it has here, that should allow me to get that data and publish it and not necessarily have them come back to the office. So I think the validation of SOS is part of my data here would be very important. So in conclusion, the basic science supports better GraftBolt integration with a suspensory all-inside construct, especially in relation to screw fixation. The published clinical studies so far have showed excellent patient outcome scores. Good CT 1000 numbers. It's a randomized controlled trial that I'm completing with versus BTB in young athletes. Average of age 18 looks very good so far for GraftLink comparable to BTB.

GraftLink® Technique Research and Outcomes

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