I am talking about a new concept in meniscus repair today. I do have some disclosures. The biggest disclosure is I was an investigator on the trial that I'm presenting. We all know that arthroscopies have gone up tremendously and that particularly partial meniscectomies are very, very prevalent and particularly in the middle-aged group of patients. We also know that a lot of these meniscectomies really do not lead to complete pain control. And if you look very carefully at treatment options for meniscus injuries, there is a treatment gap. If you look at meniscus repairs, they're mostly done in young patients. If you look at meniscus transplants, it's also younger patients. If you then go further down the lines, meniscectomies are more prevalent in the middle to, you know, higher middle age, and then unis and total knee arthroplasties are typically more in the sixth and seventh decade. And there is a phase in between where the indications for repair and transplants go way down, but the overall numbers of meniscectomies are not up. And this is also the same type of patient that in the 50s really doesn't have great outcomes with potential arthroplasties, and they may have failed nonoperative management. So about in 2005, there were efforts ongoing to develop a new meniscus implant that is able to bridge that gap. And this is basically based upon previously known concepts such as the unispacer, the I-forma, which by the way, all have failed. And so this time they did that differently and did not use a metallic implant, but used a polyurethane-based implant. This is a brand new type of polymer, which is a polycarbonate urethane implant that is reinforced with ultra-high molecular weight polyethylene fibers in the circumferential aspect of the implant. However, it is a concept of a spacer. The biomechanical studies initially were very good. So if you look at the normal meniscus and the post-meniscectomy, the typical post-traumedia wear in medial meniscectomies, and with the implantation of the new surface device, that was pretty much restored back to normal. So the early biomechanical testing was very promising. The early first in human applications, which started in 2008, also basically helped to nail down the actual surgical technique, which really is mostly an arthroscopically assisted technique. So in the initial arthroscopy is utilized in order to basically prepare the meniscus, which basically requires a meniscus rim of about a millimeter to maximum two millimeters along the periphery of the meniscus. That has to continue to be intact. And then through a mini-arthrotomy of about two centimeters, you can slide that implant in and basically position it into place. And you see it basically sits right in here essentially as a non-fixed movable implant that acts as a meniscus spacer. And you see here on the MRI, it conforms very well, both in the sagittal as well as in the coronal plane. The VENUS study consisted of 10 sites performed by 14 surgeons. It is a randomized clinical trial study design, a one-to-one randomization, 61 subjects in the investigational group and 66 in a control group. Multiple time points for assessment, both clinically as well as patient reported outcomes and MRI assessments, all the way down to the 36-month visit, which is the data that I will be presenting today. The inclusion criteria include the fact that these patients have had to have a previous meniscectomy. They've had to have a pain score that is 75 or less on the COOS. They need that intact meniscal rim that I mentioned between the ages of 30 and 75. And then obviously they have to be willing and understanding to do this study. The exclusion criteria is higher level articular cartilage wear, various valgus deformity over five degrees, more complex ligament instability or patellofemoral degeneration. The cutoff for the BMI was at 32. The definition of success was based on the COOS, a difference of 20 points on the COOS and 20 points for pain and overall. And that was basically for the nonoperative group and no additional knee surgery required. The success for the new surface treatment group was the same in terms of pain and COOS and no implants dislocation or fracturing or implant removals. The baseline demographics for both groups were identical and you see here every single one of these had previous meniscectomies, but some of them had two or even three or more meniscectomies. These are the results. So overall you see there's a significant improvement here in blue over the control group and red on the COOS overall. The pain score for the COOS is also a significant improvement and this is showing the change from the baseline. So this is a change of close to 30 points from the initial baseline. The patients had less symptoms. They had better ADLs. They had higher activity scores and a better quality of life. So in conclusion here, the new surface group maintained similar COOS improvements at three years compared to the two year time point. So this is a relatively flat line versus you see the control group, the nonoperative treatment group declined significantly after two years while it also improved initially with standard treatment options. One other thing that we noticed is, and this is a case example, this is a case that got a new surface implantation and the implant actually fractured. And so that's actually my case. I took that implant out and then I was very surprised when I started taking it out and I looked at the articular surface, the articular surface was essentially normal. And we saw that also on MRI and further follow up looking at that, this could be confirmed statistically that the implant protected the articular cartilage. So in conclusion, the 68% greater in the control cohort, controls failed twice at the rate and the new surface failure rate, however, is not zero. It's at 16%, which is a problem because that needs to be addressed with the FDA. Overall, the new surface meniscus replacement device works very well compared to meniscus allograft transplantation, certainly less complicated. None of the study patients were worse off and in fact, for most of them, they had significant improvement and this is an exciting technology. Thank you.

meniscus repair

middle-aged patients

polyurethane-based implant

VENUS study

meniscus replacement device