Well, I guess my talk was going to be on a polycarbonate urethane implant and three-year results from a randomized controlled trial that was combined with a single-arm study. 176 patients in the treatment arm, 66 in the control arm. Control arm was a real-world kind of scenario where they did bracing, injection therapies, and the standard care, we would treat patients in that 35 to 60 age range that didn't want to have the osteotomy or any type of compartment replacement, unit compartmental or total knee arthroplasty procedure. The polyurethane implant reduces the load in that postmeniscectomized knee, and we do a standard arthroscopy, look at the patient, evaluate the medial compartment only, available for the medial compartment only, and then through a mini arthrotomy of about three centimeters with a little anterior interval release, we're allowed to put this implant in place with a little valgus load. It decreases that posterior irritation of the bone that we typically have in the postmenisctomized knee, and patients that could be enrolled were patients that had grade two or three lesions in that 35 to 60 age range, 50% of the patients were greater than 50 years of age, for example. But if you had a grade four lesion that was on the periphery that articulated with the edge of the implant, then you were not enrolled in the state, so that's one of the key exclusion criteria. Other exclusion criteria, for example, were valgus or varus deformities of greater than five degrees, or significant involvement of the telephorema or allowed compartments. What we demonstrated was that at that two to three year interval, and the study's continuing on out to 60 months, but at the two to three year interval, continuing improvements in the treatment arm relative to the control arm. The FDA required that we had a 20 point improvement on KUS sub-skills, particularly overall score and pain score. And when we looked at the results, we were able to demonstrate that by six months, the patients in the treatment arm, the new surface arm of the study, had a greater than 20 point improvement, and actually, particularly in the quality of life and sports scores, those got up to 30 point improvements from baseline, and those results were maintained out to three years. The control arm, by contrast, only improved by about 10 points, which is really the standard of care for these studies, so it really did pretty well, but at two years, as typically is in my patient population, at that time, they started to deteriorate. Interestingly, when we had some exchanges, and we had 33% of the patients have exchanges at 36 months, so it was a total of 57 patients out of the 176 implanted, that we found that when we re-exchanged them, and 80% of the patients chose to have a re-exchange, interestingly as well, that we found, once again, the cartilage was looking pretty good, the joint looked pretty good, and the patients had the similar response. At six months, they jumped up 20 points past their baseline score, back to where they were before, and so over a six month period of time, patients were really able to bounce back pretty quickly. We did some second look arthroscopies, and when we looked back inside, demonstrated that they had a really well-formed cartilage surface there, no significant deterioration in that cartilage surface on the tibia or the femur, and by contrast, the control arm, 56% of the patients had an extension of those lesions. You could have a grade four lesion in the study, if it was centrally located, an eight millimeters or so in diameter, so small ones were allowed. Those extended significantly in the control arm of the study, but did not extend in the treatment arm of the study. And then MRIs, we did some repeat MRIs, and demonstrated decreased bone marrow lesions, well-maintained joint space radiographically, and once again, maintained cartilage. So studies showed that basically, the implant worked really well, exchanges did not deteriorate with time, and people chose to have the exchanges. If there was a failure in the study, it would be a complete removal of the device with no re-implantation, that was in 15% of the patients, averaged about 19.5 months from surgery. Control arm, they would fail the study if they had any type of surgical intervention, even an arthroscopy, and they failed it about nine months after surgery. So significant difference there when they required removal from the study as well. Thank you.

polycarbonate urethane implant

randomized controlled trial

postmeniscectomized knee

mini arthrotomy

implant effectiveness