Dr. R. Sean Churchill, Aurora Health Care – St. Luke’s Hospital at Milwaukee, WI, discusses this publication “Clinical and Radiographic Outcomes of the Simpliciti Canal-Sparing Shoulder Arthroplasty System: A Prospective Two-Year Multicenter Study.”
Wright Medical Clinical Summary
To view online: https://journals.lww.com/jbjsjournal/Abstract
R. Sean Churchill, MD, Christopher Chuinard, MD, J. Michael Wiater, MD, Richard Friedman, MD, FRCSC, Michael Freehill, MD, Scott Jacobson, MD, Edwin Spencer Jr., MD, G. Brian Holloway, MD, Jocelyn Wittstein, MD, Tally Lassiter, MD, Matthew Smith, MD, Theodore Blaine, MD, and Gregory P. Nicholson, MD J Bone Joint Surg Am. 2016;98:552-60 SKU: AP-013583
e. Yeah, I'm Robert Sean Churchill, and I practice it to Milwaukee, and I'm a shoulder specialist focused on his shoulder reconstruction surgery. I did my shoulder reconstruction Fellowship at University of Washington under Dr Madison's direction. Um, today we're gonna talk about the i d. Study for the stem lis. Uh, shoulder implant. Uh, this is a pivotal study that we worked with with the FDA. And one of the strengths of this study of among many is there was a multi center center study, so we had 100 57 patients and we had 14 centers and 16 physicians working on it. And it was a great study. It was very regimented. So patients, um, we saw preoperative Lee, obviously. Then we saw him. Two weeks, six weeks, three months, six months, one year and two year and each one of these, um, junctures. The patients went through a battery of tests and and discussions. Pain scores, um, range of motion strength scores on once they're past six weeks, the S. E s score the constant score, the SST score. Uh, these were all calculated for patients on every step of the way. And one of the things that make this study so strong is that every single section at every single stop patients underwent this battery of tests, and if they were even missing one data point, they were considered a fallout. And we had a 95% completion of every single data point for all spots along the first two years. So it was really a good, well rounded study, multi center study as I spoke. So you've got a lot of different surgeons. It's not just one surgeons, um, ability to get good results, that we had a battery of surgeons who are working with us. So it was, uh, that was very, um very well designed then, uh, probably the strongest point for most people is the independent radiological examination. So there were three independent musculoskeletal trained radiologists who are not involved, really with any of the manufacturer knowledge of the implement instruments and the implants. So they looked the implants afterwards and the X rays and they looked for signs of seating, signs of migration, signs of tilt signs of Lucent lines. Um, and what they found was none of those occurred. So no seeding adjustments? No, um, until no subsidence um, no Lucent line information and obviously no loose implants. So all these were then reviewed and then reviewed again, and they were all in agreement with this. So this study is pretty much unlike almost any study you see out there as far as the size and the in depth analysis that was performed and the 95% return rate. So it really was the springboard and allowing us to then have the FDA approved our product and and utilize this stem lis implant for everyday use. And I tell you, the stainless implant has revolutionized how how I performed shoulder surgery. Now during the FDA study, when I was looking at it, I really thought that maybe 50% of my patients would be good candidates for this. And then after the study was completed and I specifically reviewed all the images myself to look at them because I was interested in this 157 patients and I realized that it really was that good, uh, becoming stable and really having good bone in growth. I started realizing that maybe 75% of my patients would be good candidates for stimulus. Well, in the past 4.5 years, I've fully converted over to 100% of my patients being stimulus. So, uh, there have only been, ah, couple of instances where I got into the operating room and decided to convert to a stem. And usually those were patients who had other other problems. They've had cancer chemotherapy, agent chemotherapeutic agents. They had had excessive radiation to that area, their body due to a cancer or other reason. But pretty much everyone now in my practice receives a stimulus implant, and I'm over 99% of my usage is now stimulus. So without the knowledge of this FDA trial and the study as strong as it was and is Robustas, it was, there's no way I would be comfortable having moved it that moved to the complete stimulus replacement.