Thank you. I'm Brad Bushnell. I'm Chairman of Orthopedics down at the Harbin Clinic about three and a half hours down the road in Georgia. Thanks to my co-authors on this study, also thanks to the AOSSM and Anna leadership for picking Nashville. I got to spend four great years here as an undergrad when this building was literally a dusty parking lot. So it's really cool to see that and to see everybody here in person. So we all know the background of some of the latest in cuff repairs, that biology and biological treatment options are the hot thing. You've heard about this resorbable bio-inductive bovine collagen implant showing promise in cuff repair, specifically for partial thickness tears. I had the honor to be a part of a multi-center group of 19 institutions. That's published some papers about this implant. And recent studies have tried to just look at the efficacy and safety of it. I should point out that Dr. McIntyre, who was lead author on a paper came out two years ago, is an earlier version of this data set. And this paper kind of represents the maturation of that. Our purpose was to evaluate the efficacy and safety of this implant in a larger population with the hypothesis that the findings of the earlier studies would play through, that it is safe and effective. We also wanted to look at the performance of what we're calling an isolated bio-inductive repair, or an IBR, using the implant alone versus a traditional takedown and repair, plus the implant for these partial thickness tears. And then we also looked at various clinical and demographic risk factors. So our inclusion criteria were adults over than 21 with an MRI documented partial thickness tear. We collected these folks between April of 16 and December of 18. The surgical technique, pretty straightforward. Put the scope in, make sure that there's actually a partial thickness tear there. Surgeons graded it as 1, 2, or 3 by the Elman system. And then we used the implant to cover it up. That's what an IBR is. A takedown obviously is completing the repair and then repairing it by a method selected by the surgeon. Our assessments were done pre-op baseline, two weeks post-op, six week post-op, three and six months, and then at one year. We used a lot of different outcome scores of which you are all familiar. We also looked at time for return to work, return to sport, driving, sling, and how long they were in PT. And then one of the big things we looked at was additional surgery, kind of as our safety point. Statistics, we did the mean with standard deviations for each of these scores. We looked at the post-op recovery parameters. If you're in the reviewers' workshop today, you know the importance of MCID because statistics and clinical significance are not always the same thing. We looked specifically at IBR versus takedown and repair. And then we looked at some additional surgical factors with our good friend P less than 0.5 being significant. Now, we started with 272 people. We had about 50 folks that melted to follow up. So we ended up with 227 at one year. If you look at this, the timing was mostly chronic or acute-on-chronic. Most of these tears were high-grade, defined as two or three. Most folks had an acromioplasty and then kind of a smattering of other surgeries as well. And the vast majority of these were done with the IBR. A little bit of a busy slide, but the trend you see here is between baseline, three months, and one year. The pain went down, and all of the PROs went up. And every one of these up is good. All of these were statistically significant at three months, except for the VR12 PCS score. And by a year, they were all statistically significant. And then every one of these met or exceeded the MCID. Now, in our subgroup analysis, the IBR versus the takedown, again, this is for high-grade tears, the IBR had significantly better scores for the ASES, SANE, and WORK compared to takedown and repair at two weeks and at six weeks. So the take-home there is that the IBR does better in the early time frame. However, all this went away at a year. So basically, whether you take it down, repair it, or just put the patch on there, they do better with the patch early, but they equalize late. Prior shoulder surgery did seem to make a difference, that basically there was not much difference at baseline, but the outcomes weren't as good if the patient had prior surgery for a lot of the scores. Biceps, as a Hawkins fellow, I've been a biceps killer since I could walk, but apparently that doesn't matter, that if you left the biceps alone, tenodist it, or tenotomized it, we didn't see any difference. Here's our sling times, PT times, WORK, driving, sport. These compare favorably to some published values. Mean was what you see here, standard deviation obviously varied a little bit by surgeon and patient. This is probably, to me, the most important slide, looking at additional surgery as kind of an adjunct measure of safety. Less than 5% of our cohort had to have additional surgery, and if you look in the breakdown under reasons, eight out of those 11 were basically for inflammation. So either bursitis or stiffness slash capsulitis. Only three did not heal, and then one somehow got dislodged. I don't know the exact story of that one, but I'm sure it was interesting. So essentially, relatively safe with the main complication being inflammation requiring a second surgery. So in conclusion, we have bigger numbers here, further establishing the safety and efficacy. It looks like the IBR over takedown and repair is potentially better early and equal late. No difference with biceps tendon procedures. You get a little bit better results if your patient hasn't had shoulder surgery before. And we actually are in right now a randomized trial looking at IBR versus takedown and repair without supplementation. Thank you for your time.

Dr. Brad Bushnell

Orthopedics

resorbable bio-inductive bovine collagen implant

partial thickness cuff tears

safety and efficacy