just heard, but only dealing with the full thickness rotator cuff tears, I'd like to thank the program committee for selecting our publication and also for my co-authors. My disclosures are in the app and I am a consultant for the company that makes this implant. So rotator cuff is familiar to all of us and it's an age-related degenerative phenomenon and a lot of it's asymptomatic and we've really approached rotator cuff disease as a mechanical entity since Codman, so for a hundred years, but really we're realizing more and more that this is a biologic process also and that to get these things to heal that we need to help them somehow, especially the larger ones. So if you look at the literature with large or massive tears, the re-tear rate, the recurrence rate is significant. Now, are these really re-tears or are these just failure to heals? I think it's the latter. I think it's that we don't get these things to heal and that the next 10 years, 15 years of orthopedics are going to be figuring out how to get these things to heal, not just getting them mechanically back to the footprint. So in that regard, there's been a slew of interest in ways to enhance healing with bursal tissue, with platelet-rich plasma, with BMAC, and then with grafting. And this is one of those graft options. This is a purified, highly porous Xenograft made from bovine Achilles tendon. We published this in 2019 in the Arthroscopy Journal. This is the early results of the rebuild registry, 83 patients at one-year follow-up. We had statistically significant improvement in all of our patient-reported outcomes except for VR-12, a mental component. So we were pretty satisfied that it was safe and effective for both partial thickness and full thickness tears. This is just the full thickness portion of that registry. So this is the continuation of that registry, one year but with more patients. It's 17 centers, IRB approved, 210 patients completely enrolled, 192 were available for follow-up for 91% at one year. They had to be able to read and speak English. They had preoperative demographics. Then they had the patient-reported outcomes collected at 2, 6, 12, 26, and 52 weeks. The use of the implant and the repair technique were left to the surgeon preference. Now this is certainly a confounding factor here, but this was just a level four study running forward, checking the safety and efficacy of the implant. These are the demographics, 57 years of age is the average, more men than women, almost 18% of these patients are representative revision surgeries, and you can see the tear sizes here on the right, mostly mid and large rotator cuff tears. Concomitant pathologies and procedures are listed here. This is pretty consistent with the literature. And these are our results. We sustained statistically significant improvement in all the patient-reported outcomes except for VR-12 mental component. And the results pretty much held up from the first published report we had from the first 83 patients to these patients, they were all similar except for the ASES score was actually a little better for this final group of patients. We conducted an ad hoc analysis of small and medium versus large and massive tears because we were trying to get at the value of the implant perhaps in maybe helping large and massive rotator cuff tears heal, and what we found was there was no statistically significant difference in any of the outcome scores except for the SANE score preoperatively, where the large and massive had a worse preop score, as you might imagine. These are the complications, there were 20 for 9.5%. Most of these were revision surgeries, and you can see here on the left that most of the revisions involved failure of the rotator cuff to heal, and they were revised. The weaknesses of our study are certainly a level four selection by study. The indication for the implant was at the preference of the surgeon, and so we really have no imaging studies to assess the graphs postoperatively here, although that work has been done previously by Schlegel et al. The strengths are it's a large cohort with a large follow-up, and it's a widespread geographic application across the United States. It proves safe in a large cohort with statistically significant improvement at 6 and 12 months, but there's no comparison group here, so we really can't say much about the inherent value of the implant yet, and that will be subject to further high-level studies which are going on now. So we've had improvement at one year, and the PROs did not seem to vary by implant size, and we think that that's someplace to go and investigate to see if for those massive and large tears that this may have some value. Thank you very much.

graft option

full thickness rotator cuff tears

patient-reported outcomes

tear sizes

cohort study