for allowing me to present this. I apologize for not being in person. I had a nephew graduating from my alma mater, Georgetown, that I needed to attend. I hope you learn a lot during this session. I think it's a very important topic that we face for our patients. My conflicts are listed in the Academy website. Massive rotator cuff tears we know are very common, afflicting a large percent of our population, particularly over the age of 40, and getting larger as patients get into their 50s, 60s, and 70s. Classification of tears is done in various ways, but one of the things that's important is to understand the size of the tear, retraction, atrophy, and fatty degeneration. And when we're talking about massive irreparable rotator cuff tears, we're really talking about tears that have significant atrophy, Goutelier III and IV, with retraction to the glenoid margin. And oftentimes, these patterns can be various as far as which tendons are involved. It's important to understand that prior to proceeding with any treatment options or discussion. When we think about the rotator cuff, generally, it's in a balanced state between the rotator cuff, deltoid, and other periscopular muscles. But occasionally, things like this happen. Patients have an injury, the forced couple gets disrupted, and patients start having some problems, whether it be pain or functional. Oftentimes, though, patients are able to compensate very well, and we have a hard time telling that they actually have a rotator cuff tear. But then others of our patients have a problem. They have an elephant on their shoulder. Whether that be pain or dysfunction, there's something causing them an issue that they're seeking care for. And that's where the nuance of what treatment we provide, whether that be a partial repair, a superior capsule reconstruction, a tendon transfer, a balloon interposition arthroplasty, or a reverse shoulder arthroplasty. This problem is not uncommon. So this patient of mine, 37-year-old, neglected his rotator cuff for a year. When we went in, poor mobility of the tissue, good cartilage surface. He had an intact forced couple. The goal of this discussion is that, the hope is that you learn about the option of the in-space, and when it's indicated, it's not to turn you into a hammer and nail surgeon. That's clearly not the goal here. As we go into surgery, we have to have multiple tools in our belt. And in our discussions with the patients preoperatively, we have to discuss the pros and cons of each tool. And we need to understand that as a surgeon. And the tool that we choose has to be right for that patient, as well as for us in our skill sets as a surgeon. The goal with any procedure is the hope that it's permanent. There really are no permanent solutions. It can be converted easily. Well, some things can't, some things can't. It's easy to implant and easy to remove. The in-space balloon spacer is a device that's been out in Europe for about 10 years now. It's a biodegradable balloon made of essentially a material like Vicryl, and it's inflated intraoperatively with saline. Over the ensuing three to 12 months, it does dissolve. There's about 30,000 case experience in Europe. Since the launch in the United States, there's about 1,700 cases that have been done in the United States since August of 2021. There's increasing biomechanical data on how an in-space device works in the shoulder. And in my understanding or thoughts about this, I think of this as a rehab accelerator. The balloon goes in, it changes some of the length tension relationship amongst the muscles around the shoulder, including the deltoid, the remaining rotator cuff, pec, lat, et cetera. My colleague, John Levy, likes to say, it's like having training wheels on your bike again. You learn how to bike again, and then you take the training wheels off. And that's what happens when the balloon disappears. Hopefully the muscles have reeducated themselves to how to compensate for a massive rotator cuff tear. U.S. Pivotal study was a large undertaking that was started in 2016. It's a very robust study, just published at JBGS beginning of this month. I encourage you to read it and understand the study. It was a randomized control, single-blinded non-inferiority study. It compared the in-space device to a partial rotator cuff repair for massive irreparable tears. These patients were randomized in the OR. They had MRIs at six weeks, one year, and they were followed for two years with in-office visits. There were 31 investigators from North America, as you can see here. The inclusion criteria was fairly strict, had to be over the age of 40. Subscapularis had to be intact. No significant arthritic changes. Patients had to fail conservative management. Exclusion criteria, as stated, significant glenohumeral arthritis, a fully reparable rotator cuff, concomitant subscapularis tearing, or any labral-type surgery was an exclusion from the study. Worker's scalp was also excluded. We can see from the study that patients did well and regained their motion. In the first six weeks, the in-space group regained their motion faster. They all regained significant amount of motion, at least 70% of them or so, in both groups. And if you look at it, it's significant as far as the range of motion increase between the partial repair and the in-space, which is the gold line there. The Western Ontario Rotator Cuff Score improved in both groups, as well as the constant score, a bit more in the in-space group than the partial repair group. BAS, again, improved, and the ASCS score improved. The important thing to remember about this is a lot of these patients improved, not immediately, but gradually, and started to surpass their preoperative level at around three months. So not all patients that received either the in-space or partial repair had immediate resolution or recovery of function. At the end, when the FDA reviewed the data, there was a greater number of patients who were in the cohort of over 65. This was a study that enrolled initially patients over the age of 40, but when they did their subgroup analysis, they saw that patients over the age of 65 showed the most significant improvement in their Western Ontario Rotator Cuff Score and ASCS score. And therefore, it was indicated, it has been indicated for patients over the age of 65 as far as on-label. The safety of this, it's well-tolerated. There was no significant adverse events as you compare the partial repair to the balloon. No device-related adverse events. Five subjects in the study of over 190 patients were converted to subsequent either reverse shoulder arthroplasty or further surgery. The actual implantation of the balloon itself is about four minutes on average in the study. It's also pretty strong. And if you watch here, this is a gentleman, he's 6'4", 240. He's jumping on the balloon. And here it is. His foot hurts, but the balloon is intact. So it is not a fragile piece of material. My ideal patient is over the age of 65. They failed non-operative treatment. They're independent and able to comply with post-operative evaluations and PT. Intact subscap support for an elevation of 90 degrees is critical, minimal to no way, and a truly irreparable tear. This should not be something you just put a balloon in and someone who has a reputable tear or a small tear that you really should be fixing. This is a case presentation I wanna share with you. This is the first patient I did in the United States, a 65-year-old Mason. He has a right rotator cuff tear that was previously treated, three years previously, and re-tore. He's having increasing pain and dysfunction. He's tried conservative modalities. You can see on his examination, he has forward elevation of 90 degrees, abduction to 80. These are his static images. His X-rays look pretty reasonable, maybe mild proximal human migration. His MRI on the T2 coronal, some proximal human migration. The axial, the subscap's intact. If you look at the sagittal views, he has severe atrophy of the supraspinatus infraspinatus. The muscle belly of the teres and subscap appear to be preserved. This is intraoperatively for this patient. He randomized into the study and randomized to get a balloon. See his cartilage is intact. You can see his subscap's intact. You can see the tendon from the lateral viewing portal is retracted to the glenoid margin. This is the actual procedure itself. This is me looking for the lateral portal, inserting the balloon. There's a protective sheath on the balloon that you put in. I've already sized it at this point, decided to go with a large balloon. Place the balloon overlying the humeral head and tuberosity underneath the acromion. Unfurl the balloon by insufflating it with saline to the desired amount that's recommended by the manufacturer. You can see here, the balloon is translucent. You can see I did not do anything with the biceps here. I'm not a significant biceps killer. So in this situation, I actually left the biceps alone. This patient came in to see me post-op. You can see the increase in the acromion humeral interval that happens, which you can understand why it potentially increases the length tension relationship between the other muscle groups. In a cadaver, you can see what the balloon does is it's dynamic spacer. You can see it's moving as you move your arm to provide really a buffer between the tuberosity and the acromion and tension that tissue. This is the patient at two weeks out. And he was pretty impressive to me as far as his ability to forward elevate. At two weeks post-op, you can see the steroids are still in his right shoulder. His abduction is quite good and he was happy. I followed this patient carefully for the ensuing six and a half years now. And this is him at one year out. He's doing well with the balloon. He's not having any pain. You can see he can raise his arms all the way up. He's happy with his outcome still. He can abduct his arm to 110 degrees. Looks really great at one year, but nothing ruins outcomes like long-term follow-up. Not saying that's what's gonna happen, but one year doesn't really necessarily mean much. Then we have him at five years out. This is now in COVID. This is 2020. So you can see at this point, he can raise his arm all the way up, still maintain to five years out. That's pretty good midterm result at this point. So I'd be pretty happy with this for a massive irreparable tear, whether I did a partial repair or balloon. In this case, I happened to do the balloon, obviously. The balloon does not help your external rotation. So if you notice, he never regained any increase in his external rotation, which you wouldn't expect it to do. Now, he saw me in October of 2021. And mind you, the balloon was released in August of 2021. He was having some increasing pain. So now he's about six and a half years out. And he is having a little more deliberate motion with his arm than he had previously as far as elevating his arm with more attention to it. So you can see, he can still elevate his arm, but he's having some increasing pain. And when he saw me, he really was interested in trying the balloon again to see if he can get some relief and improve motion again. And I thought about it a bit and I thought to myself, let's see what the studies show. So we did some studies on him. His x-rays, no profound change as far as arthritis, maybe a little bit more approximate human migration. Axillary, again, looks reasonable. If you look at his T2 coronal views, again, a tear is still what it was. There's no remnant of the balloon left from there. If you look at his sagittal views, again, he has significant atrophy. I think he's had some progression of atrophy in the teres minor, which at the time of doing this, I don't think I appreciate it as much as I could have. And then this is his axial views. You can see his subscaps intact. Subscap muscle belly looks pretty good. Teres minor's intact, but maybe some atrophy of teres minor there. So we proceeded to do a subsequent balloon on him. And this is my dry scope of his shoulder, which I do oftentimes when I start a case. You can see his cartilage looks good. There's no remnant of the balloon. The tear is still the tear that it was. No loose bodies or anything arthritic looking. And we look at his subscap, which looks pretty reasonable. So I did re-implant him with a balloon. He's now about five and a half months out. He's had a slower go of it. He has been in Florida. I'll be seeing him shortly. I think I'm probably gonna see that his results weren't as good as the first time around. This is another case I wanna share with you. This is a paraplegic patient that came to see me in his late fifties. And this patient had these x-rays. So no significant arthritis on x-ray. This is his right shoulder. His left shoulder had tough tear arthropathy and he was having pain with it, but it was not his dominant arm. His right one was bothering him more. We decided to do MRIs of his shoulder. And you can see on his MRI here, these are the actual cuts. It looks like his subscap generally is okay. Maybe a little bit of upper border damage to it. We looked at his T2 coronal views, and you can see here, again, a little bit fast there, but a large superior cuff tear involving two tendons. So proceed here to look at the fatty atrophy as well. He's got significant fatty atrophy on the coronals. We can see on the sagittals, again, fatty infiltration, particularly the superior cuff involving supra and infra. And this is the patient in the holding area. We did an interview with him as far as what he wants to get back to. And really prior to this, he ruptured his left triceps and was in a skilled nursing facility for four months. So he really wanted to be able to maintain some independence, not have to go to a long-term facility for a long period of time. And he wanted to maintain his own self-dignity in the sense that patients who are wheelchair dependent oftentimes have to have self-cathing. And oftentimes they want to be able to do that themselves, not have someone to do that for them for three, four months. This is his operation. So this is me scoping his shoulder. You can see his upper border of subscap is torn, which is a relative contraindication. But in this case, I felt that performing this, this repair of the subscap was something that would potentially benefit him to improve his force couple. I do it in a way when I do a new space balloon wire, minimally violate any of the rotator interval or soft tissue as you don't want to give the device any area to sort of move into as the in-space device tends to want to stay in this subacromial space. But if you violate a lot of the bursa and the CA ligament, the CA arch, then I think the balloon can go into areas such as anterior or posterior around your shoulder. So when you do the operation, I tend to be a minimalist. In most cases, I don't do anything except just put in the balloon. But in cases like this where I'm dealing with a paraplegic and I'm trying to help his force couples, I think it's worth the risk benefit ratio of doing an upper border subscap repair. So you can see here, I did an upper border subscap repair, fairly straightforward. Do a luggage tag, shoot your configuration to re-approximate the rotator cuff superiorly. Minimal debridement. Oftentimes I would debride more of the rotator interval if this was a patient without a massive cuff tear. You can see here now, we've finished that part of the case. And now we're inserting the balloon again, kind of like I showed you last time, into this patient. Again, a large patient, use a large balloon inflated to the right amount. You can see here, we unfurl the balloon by injecting saline. And so now this patient has completed the procedure and he was admitted overnight. He did go to a skilled nursing facility for about two weeks in order to help protect the arm a little bit longer than I would usually because of the subscap repair, but not nearly anything like he had for his triceps repair. So I think in closing, this is a fairly safe procedure, the in-space device. It's reasonably straightforward. In my experience, it hasn't really burned any significant bridges. And I think you should spend some time just learning more about this as an option for your patients. It's not for everybody. You have to keep the indications tight. Thank you so much for your time. Thank you again, Peter, and sorry I'm not there in person. Thank you.

massive irreparable rotator cuff tears

treatment options

in-space balloon spacer

biodegradable balloon device

specific needs