Good morning. Thank you for joining us for this AOSSM ICL on emerging technologies in the treatment of massive rotator cuff tears. I'll be speaking to you this morning about the use of the balloon spacer, a new technology that's been FDA approved since August of 2021. My disclosures are in the Academy Handbook. Why present on this topic? Well, I think that if you're somebody like myself and others on this panel who treats rotator cuff tears, you need to stay up to date on topics that are relevant in the treatment of rotator cuff tears. And one technology that's emerged more recently after a rigorous FDA study is the use of this in-space balloon spacer for the management of massive irreparable rotator cuff tears. This problem is not unique. Unfortunately, we see this quite frequently. This is one of my patients who was in their mid thirties and went around for about a year or so having this and by the time someone was able to operate on it, this was the quality of the tissue. So a really significant problem that affects a wide array of our patients. I'm not here to espouse being a hammer and nail surgeon. I'm here to really help promote the fact that surgeons need to look at all options when treating a patient and make the best situational decision for each patient based on their specific circumstances. So it's important that we have multiple tools in our belt as far as how we go into an operative procedure and our counseling of the patient. The goal of any procedure, and I don't think any procedure meets all these goals, is to find a permanent solution, to be, to have a solution that can be converted easily, to have a implant or device that's easy to engage or implant, and then also if necessary, easy to remove. The InSpace Balloon Spacer has been out in Europe since the early 2012 timeframe. It is a device that degrades gradually. It starts to degrade around three months. It should be completely resorbed at approximately one year and it's deployed arthroscopically. In Europe, there's been over 30,000 cases performed. I believe in the United States, to this point, there have been about 8,000 cases performed. The FDA-IDE, which was a important study, the pivotal study, which led to the approval of the InSpace device, is a study that myself and Nick Verma on the panel were involved in. It was a rigorous, blinded FDA-IDE with patients randomizing the OR after making sure they met the inclusion criteria. These patients were randomized into either an InSpace device or partial rotator cuff repair. There was no crossover of repairing plus a balloon. We had rigorous follow-up of two years with MRIs at six weeks in one year, functional assessment scores performed, as well as adverse event reporting. Anyone who's been involved with an FDA-IDE knows it's a very rigorous study. It is really probably the gold standard as far as doing prospective studies, especially with new devices. There were 31 investigators in 20 sites around North America, and you can see it's a diverse group of individuals. Inclusion criteria, patients had to be over the age of 40. They had to have a massive rotator cuff tear. They had to have failed conservative management for approximately four months, and obviously had to be somebody that was independent and able to comply with the post-operative evaluations and visits. As you can see, patients were screened, consented. Patient reported outcomes were collected. Verification of eligibility was performed. There was intraoperative randomization after verification of eligibility. Then they had their appropriate randomization treatment, and then rigorous follow-up for two years, followed by period of time in a sling for four weeks, and final study visit at two-year follow-up. You can see, and you can look at this further in the JBGS paper that was published in May. At 24 months, both groups enjoyed significant improvement in their range of motion, although the in-space group seemed to have a more significant increase in their forward elevation at two years. You can see also the Western arterial rotator cuff score improved in both groups as well at 24 months, as well as the constant score, which seemed to improve more significantly in the group that underwent the in-space device. Again, we see similar improvements in the BAS and ASES scores that were sustained at the two-year time point. As far as the approval of the device, the FDA, once it did its subgroup analysis, found that patients, particularly 65 and older, benefited the most and had the most significant improvement compared to partial repair, and thus the age of 65 being the FDA-approved guideline for utilization of the in-space balloon device. As far as safety, the device has been extremely safe as far as the IDE, with no device-related adverse events. Five subjects required subsequent surgery, three in the in-space group and two in the rotator cuff repair group. You can see the actual deployment time for the balloon once you've decided to deploy the balloon is about four minutes, which is really a very significant savings of time for the patient as well as for the OR. You can see here from this video, this is a pretty strong balloon, so people have asked, you know, is it a resilient balloon? Can it withstand a fair amount of force? This gentleman's over 6'3", and he's going to jump on this balloon, and you can see once he's jumped on it, balloon is still intact, and he'll do it again and demonstrate to you that it is a very strong device at time of implant time zero. This is a case presentation. This is a very interesting case presentation. This is the first patient I ever implanted in the United States, and he was part of the FDA IDE, and he was my first patient. He was 63. He had a previous cuff repair three years previously by an outside physician. He had progressive pain over the past six months and had tried corticosteroid treatment without benefit. You can see he's 5'9", 175 pounds. He could elevate actively to 90 degrees. It's important to note that in the study, as well as for on-label use, patients need to be able to elevate to 90 degrees. If they cannot, if they are pseudoparalytic, they are not candidates for this procedure. In addition, they need to have an intact subscapularis. They cannot have a torn subscapularis, and they cannot have any significant glenohumeral arthritis, so Hamada 3 or greater are patients that are not candidates for the in-space balloon device. You can see here on his x-rays and MRI sequences that he did not have significant arthritis in his x-rays. He had evidence of proximal humeral migration. He had cutellia stage 4 atrophy of the supraspinatus and infraspinatus. These are intraoperative photos. The one on the left from posterior, the one in the middle looking at the rotator interval in the subscapularis, and the one on the far right being a lateral view showing tear, retained suture, retraction to the glenoid margin. This is the actual deployment of the device. I choose to deploy my balloon using a lateral viewing portal and placing it on posterior. This is a protective sheath that you insert to allow you to insert the balloon. It's at first wrapped upon itself, and then based on the size of the balloon, they come in small, medium, and large. You insufflate the balloon to the appropriate volume. Once it's inflated to the appropriate volume, you take the arm for a range of motion to assess stability of the implant. It is important when you're doing the placement of the in-space device that you do a minimal to no bursectomy as you do not want to create channels or windows for the balloon to go into as the balloon is a dynamic spacer and with pressure will go to areas of least resistance. So, create new potential spaces that can go into those areas, and I think maintaining respect of the soft tissues around the tear and not doing a wide debridement or a subacromial decompression or CA release is important for our patients. This is that patient in December 2015 at two weeks, and I would say that this is a patient who did exceedingly well two weeks, better than majority of my patients, but still fairly remarkable to see at two weeks with something like this. So, clearly I was at that point with my level five experience intrigued with this device. This is him at one year. You can see that he has been able to maintain his elevation, and he elevates quite well. He's having minimal to no pain and is very happy with the procedure now at one year, presumably after the balloon has already dissolved at this point. This is him at five years. You can see during the pandemic now. This is 2020, and you can see again he's maintained his elevation and satisfaction with the procedure. He's able to abduct easily to 100 degrees. This device does not help with your external rotation, so it is not a device intended to improve your external rotation. You can see he can easily internally rotate to the mid thoracic spine. This is in October of 2021. He started to have actually some increasing symptoms and some, I would say, hitch in his movement as he was a little bit protective when he would elevate his arm, secondary denoting some pain as you can see here. At this point, he inquired with me about potential for re-implantation of the balloon device, which quite honestly at that point I hadn't really thought about doing, not at least in real time, this early in my experience with the FDA-approved product. So, I obtained x-rays of his shoulder at that point and noticed no significant progression of his arthritis. It seemed like his glenohumeral joint surfaces were well maintained. I did an MRI, and again he had this massive tear, but again I did not see any significant progression of his atrophy in the other muscle groups, such as the subscapularis and the teres minor. In addition, I looked carefully to make sure there was no significant progression of arthritis. So, as I thought about this case, I thought this was a patient that had this procedure, understood the pros and cons of it, and desired having it again after approximately six years of successful outcome. This is axial cuts. Again, you can see his subscap appears to be intact. Again, articular surfaces appear to be well preserved. This is his scope, and I, when I start my scopes, do a dry scope. This is a dry scope in the beginning. You can see there's really no remnant material to suggest that there's been a balloon here. His cartilage surfaces still look pretty good. The subscapularis on his assessment appeared to still be intact, and you can see that during his first surgery, and even now in his revision, I did not address his biceps tendon. I left it alone. I'm not a big biceps killer, and it has not been something that I've significantly regretted. This patient initially was slow to progress, and I thought maybe at this point I'd pushed too far. However, he came in just last month at about eight months post-op, and after doing rigorous physical therapy for about four and a half, five months, he turned the corner, and you can see now he is, uh, October of 2021. That was a revision. He's able to, at this point, uh, elevate his arm, uh, easily. He does state that the recovery this time around was harder than the first time around as far as his recollection. Again, he is, uh, about 70 at this point. Last time he was 63. This is his dominant arm. He enjoys fishing, and the biggest motivator was actually his wife told him that if he didn't start getting his arm up, she would cut his ponytail off because she was not going to tie it for him. You can see here at this point he's regained what I would say effective motion with that right arm. Again, external rotation has not changed, but he's very happy with the recovery he's made at this point. So, very interesting new technology. I'm sure we'll have lots of spirited discussion on this. It's great that we have Nick Verma, who is the PI on the FDA IDE, who, uh, I'm sure can answer many questions that may arise. This is, uh, thank you for this opportunity, and I apologize for not being there in person.

balloon spacer technology

massive rotator cuff tears

InSpace Balloon Spacer

treatment options

patient outcomes