Thank you very much. So we're looking at a randomized control trial, large, massive tears treated with maximum repair versus graft reconstruction. Our disclosures. We know that repair has been the gold standard for these large, massive tears. But large, massive re-tear rates are somewhere between 50 and 90% as reported on MRIs. Rapid graft jacket reconstructions of rotator cuff tears have been suggested as a treatment for this. And this was during my fellowship, doing a level four study, looking at 45 patients with at least two-year follow-up, using this graft to bridge the distance between a repaired cuff that could not be fully repaired. We found higher WARC, ASES, and UCLA scores with a safe, high patient satisfaction outcome. We did a systematic review, looking at all data out there. And so far, there's two level three studies and 13 level four studies. And of the two level three studies, they followed up with MRI at one year, showing a biceps tendon improvement with a bridging reconstruction, as well as fascia ladder improvement with bridging reconstruction. To date, there's not been any level one studies. So the purpose of our study was to determine the re-tear rate of rotator cuff reconstruction with acellular human dermal allograft, compared with maximal rotator cuff repair of massive tears of the rotator cuff. This is a prospective randomized control trial. It's a single center, double blinded, both the assessor and the patients were blinded, computer randomized. We used sample size calculated a priori to get a minimal clinical important difference of 15% of a WARC score, and found we need 30 patients, 15 in each group. This is the reports for the interim one-year imaging analysis. So our inclusion criteria was MRI with more than three centimeter to tendon with retraction to the glenoid with minimal glenohumeral osteoarthritis. Of the maximal repair group, that randomized 15 patients in that area, and then if they got randomized to allograft bridging reconstruction, it was after a maximal repair, and then we added the bridging reconstruction. Our outcomes one year was re-tear rate on MRI, and next year hopefully we'll be able to report the two-year patient reported outcomes, including the WARC-MARC scores. So outcome measures, MRI for re-tear, x-rays for rotator cuff arthropathy, as well as acromio-humeral distance. Our baseline demographics show very equal groups between the reconstruction and repair groups. All were the same between age at surgery, BMI, gender, and site of injury. For our results, MRI re-tear at one year of the reconstruction group, the re-tear was two out of the 15 patients, or 13%. Of the repairs, 11 re-tore out of 15, which is 73%, which was statistically significant. Early outcome scores show that both groups had improved patient reported outcomes, but the repair group had significantly more re-tears. In terms of acromio-humeral distance, the reconstruction group seemed to maintain the humeral distance from 6.72 to 6.82 at the end of the one-year x-ray. The repair group decreased, and this was significant. More interestingly, of the partial repair or maximal repair group, 20% or three out of these 15 patients progressed onto severe glenohumeral osteoarthritis, which became unsalvageable for a future bridging reconstruction. This is the first prospective randomized control trial that we know of that compares bridging reconstruction versus maximal repair. The re-tear rate of the repair group was 73%, which is quite similar to others reported for partial repair of these large, massive tears. The reconstruction group had a re-tear rate of 13%, which is consistent with our previous experience. Maximal repair, though, can burn bridges. It's not benign. If we do not appreciate that the progression of osteoarthritis happens after the re-tear, these patients may not be a candidate for reconstruction in future. Strength of the study, this is a level one double-blinded study. We used fellowship-trained orthopedic surgeons performing functional assessments that were blinded. Patients were also blinded to the treatment that they had. MRIs were used to confirm healing, which was read by blinded fellowship-trained MSK radiologists. And assessments of rotator cuff arthropathy on our X-ray were also assessed by blinded assessors with fellowship-trained orthopedic surgeons. Limitations, this is a single center. This is still early results. This is a one-year interim report of imaging analysis. The two-year outcome will be next year. Our two-year outcome is based on a priori sample size calculated for work at two years. So in conclusion, rotator cuff reconstruction with acellular dermal matrix demonstrated lower re-tear rate on MRI, a lower progression rate to glenohumeral osteoarthritis, and potentially an increase in work score. Thank you.

randomized control trial

maximum repair

graft reconstruction

rotator cuff

re-tear rates