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 Welcome to UAB MedCast, a continuing education podcast for medical professionals. Providing knowledge that is moving medicine forward. Here's Melanie Cole.

Melanie Cole: A massive and irreparable rotator cuff tear is a diagnosis that no patient, especially an active patient, wants to receive. Now, orthopedic physicians at UAB Medicine offer a new procedure that has the ability to bring relief for patients with a massive rotator cuff tear previously deemed irreparable.

Welcome to UAB Med Cast. I'm Melanie Cole. Joining me in this panel are Dr. Amit Momaya, he's the Chief of Sports Medicine; Dr. Aaron Casp, he's an assistant professor and an orthopedic surgeon and an orthopedic sports medicine specialist; and Dr. Eugene Brabston, he's an assistant professor and an orthopedic surgeon. They're all with UAB Medicine.

Gentlemen, thank you so much for joining us today. And Dr. Momaya, I'd like to start with you and traditionally rotator cuff repairs have a high failure rate proportional to the tear size. What have you learned about rotator cuff injuries in the last decade or so, and any patient-specific factors that influence healing rates? Speak to us about that for just a minute.

Dr. Amit Momaya: Sure. Rotator cuffs continue to be an issue with many patients, especially a growing population as we age. And the failure rates are higher than we would like. A lot of times rotator cuffs become massive and some factors involve the lack of healing include age of the patient. The older the patient is, oftentimes the more difficult it becomes to achieve healing. Also, the size of the rotator cuff often is predictive if it's going to heal or not, in addition to some muscle atrophy or wasting away where sometimes fat can be embedded into the muscle belly, and that can lead to lack of healing after repair. And so, you know, one of the things we've looked at closely is looking at some of these tears that become so massive and deemed irreparable. And those are very challenging patients to deal with from a surgical technique and from a healing perspective.

Melanie Cole: Dr. Casp, I'd like you to tell us about the subacromial balloon space or procedure for relief of those rotator cuff tears that Dr. Momaya was just speaking about.

Dr. Aaron Casp: Sure. Yeah. You know, as Dr. Momaya had mentioned, having a massive and irreparable rotator cuff tear is a challenging problem. And previously, the solution was not very good kind of frankly. It would require cadaver graft and several anchors and a long surgery and still their outcomes were not as favorable as we had liked.

The subacromial balloon spacer puts a bioabsorbable, biocompatible, saline-filled balloon into the subacromial space, which is where the rotator cuff tendons used to live. And what it does is it essentially keeps the humeral head or the ball and of the ball and socket joint of the shoulder in place, so your shoulder can function. Basically, it pushes down on the humeral head and keeps the joint centered, so the rest of the muscles can take over and function appropriately where the rotator cuff used to.

Dr. Eugene Brabston: And I completely agree with that, Aaron. And in terms of that big important part of why this surgery actually works, we think that it works by rebalancing the shoulder. When you actually have an irreparable rotator cuff tear, somehow you lose the balancing of the ball and the socket. And that's where a lot of folks get pain as well as inability to get their arm up over their head as well as dysfunction. So the thought about the spacer is in a way it rebalances the shoulder. So over time, and we don't know if it's scar tissue, if it's these rotator cuff muscles that are still attached, somehow the shoulder relearns how to function. We know that it does very well in terms of improving pain and also improving function. But we have to be very careful in terms of who we select this surgery for.

Melanie Cole: So then along those lines, Dr. Brabston, one thing I found interesting is that this spacer is designed to restore more normal acromial humeral interval to allow for that normal shoulder kinematics. Do you feel it works more as a biological spacer or cushion? Or is it helping to restore a more normal shoulder biomechanics? Tell us a little bit about that and why patient selection is so important. Tell us about patient selection.

Dr. Eugene Brabston: That's a really good question. And the short answer is we don't exactly understand how it works. I think it's probably both of those items in terms of physically distancing the humeral head from the acromion and, in addition, kind of rebalancing it over time. So the initial thought is that you put it in and what it does is it does provide a space. You know, if the humeral head can't hold itself down, then this is actually a biological way to do that. So it provides that space initially, and then over time, the muscles and essentially, you know, the way that you're functioning that shoulder, you relearn how to hold the humeral head down.

In terms of some of the indications, we know that this does do better in certain kinds of tear patterns. So for instance, if you have a really big tear that extends all the way to the front of the shoulder and actually extends to a muscle called the subscapularis, this is probably not the best surgery. In addition, we also know that if folks have arthritis or wear and tear changes of the actual cartilage in the joint, this probably is not great solution for them either. But in terms of, you know, age, ages typically for this kind of a procedure, we're doing this in younger patients, as opposed to patients that we would do in a replacement surgery. And I don't think we quite have hit the upper limit of what is oldest that we can do this procedure in and I think that time will tell.

Melanie Cole: Dr. Momaya, what about the balloon itself? Tell other providers what this material is and how long it's expected to last.

Dr. Amit Momaya: Sure. The actual spacer material is a biodegradable polymer. It's a polymer that's commonly found in a lot of other medical devices. It's not necessarily novel in that respect. But overall, in terms of how long it lasts, you know, the actual balloon is thought to deflate approximately three months after implantation, but it actually degrades over a period of years. Now, we've looked at studies where we're looking at MRIs after someone has received this, the actual material likely incorporates into scar tissue. So we see a spacer effect probably much longer than that. And one of the things that you had mentioned was the acromial humeral interval, which is a space between the roof and the ball. And one would think that if you were to have a device that degrades in a relatively short period of time, let's say within a year or so, that space would not be maintained beyond that.

UAB, we were the first in the United States to perform a systematic review looking at 200 patients that received this type of treatment. And we found that actually beyond one year, going on to two to three years, the space was actually maintained to a certain level, which was somewhat of a surprising finding. But overall, the spacer is biodegradable and likely forms a little bit of scar tissue. And again, as Dr Brabston mentioned, it retrains the muscles and restores what we call a force couples in that area to allow the shoulder to function better.

Melanie Cole: Very cool. The technology now that you're using at UAB is really amazing. And this is a big problem. It affects a lot of people. And Dr. Casp, as you're speaking to other providers that are looking to the experts at UAB for the procedure itself, is there a learning curve? Are there any tips and tricks, technical considerations you'd like to share with other providers that are looking to add this to their armamentarium of therapies?

Dr. Aaron Casp: Absolutely. You know, I think the biggest benefit and beauty of this procedure is that it's very simple. Just like any new procedure, there's a little bit of a learning curve. But if you can put an arthroscope into a shoulder and do some procedures, you can certainly do this procedure. It uses the standard arthroscopic portals. It doesn't necessarily require any additional procedures beforehand, though most people are doing some amount of getting rid of some scar tissue or taking a little bit of the underside of the acromion so it doesn't pinch or impinge on any of the structures. And then, there's really just one implant, one thing that comes essentially out of the box. You measure the size that you're supposed to use, and there's measuring device that comes with it. And then you know the size and then you insert the implant and then basically remove the sheath, fill it up with saline to the appropriate amount. And then, you'd close the balloon and that's pretty much it.

Compared to the previous procedure, which was what we called a superior capsular reconstruction, this takes a fraction of the time, maybe 10 minutes, whereas the previous procedure could take a couple hours. So it's very fast, very time-conserving and very simple and easy to use.

Melanie Cole: Nice. And Dr. Brabston, I'd like you to tell us about the patient experience and the outcomes that you've seen and post-surgical shoulder function. Has there been a need for revision surgery? What's the recovery like? What's the range of motion like? Tell us a little bit about your outcomes.

Dr. Eugene Brabston: Sure. You know, in terms of that procedure, I think one of the most amazing things is how patients get such a significant relief of pain so quickly after surgery. And, you know, we don't quite understand if that's because of the spacer itself or the surgery, whenever we're doing the arthroscopy, when we go in with a scope, obviously we try to clean any scar tissue out, any bursitis or inflammatory tissue in that area. But we're kind of surprised at how well patients do immediately after surgery. You know, a lot of them will come back and say that their pain is significantly better, which even for a regular rotator cuff tear, whenever you're repairing those, it's variable in terms of how much pain relief patients get immediately after surgery.

In terms of kind of what we do with these patients, usually we treat them in a sling for several weeks' time to really kind of let things calm down after surgery. And then after, you know, somewhere in the range of four to six weeks, we initiate physical therapy, starting to work on motion. And the big idea with motion is obviously getting the motion back that they may have lost over time and then retraining those muscles that are still attached to actually do the work.

You know, in terms of kind of long-term outcomes, you know, we're still following up on that. And it's something that patients in terms of range of motion and pain control, they're doing exceptionally well with that. I think we're kind of waiting time-wise to really see strength-wise how much strength they're able to get back over time. And that's something that obviously takes a long period of time after a surgery to really retrain those muscles that are still attached to get strength.

Dr. Aaron Casp: I'd like to add just that, because you're not really relying on something to heal or scar in as much as big, massive rotator cuff repair or superior capsular reconstruction, you can be a little bit more aggressive with range of motion. And these patients are getting their motion back a little faster because you don't have to slow them down as much because you're not relying on as much bone to tendon healing as in an actual repair.

Dr. Amit Momaya: And just to piggyback on what Dr. Brabston said, you know, one of the things with the longer-term-- you know, when we're still in the short to midterm outcome range for this, but some of the averages that we've seen in terms of elevation of the arm is approximately 165 degrees of elevation and about 35 degrees of external rotation, which honestly, those are figures that are very respectable and favorable for a normal shoulder rotator cuff repair. And so, the outcomes have been positive and surprisingly better than expected.

Melanie Cole: It's very impressive. Such a fascinating technique. And I'd like to give you each a chance for a final thought. Dr. Momaya, are there any comparison studies, as we're talking about these outcomes and what we're hoping to see as you all perform more of these, and I'd like you all to come back and update us as we find out more, have you seen whether this treatment is for untouched shoulders? Is it revision? Have we done it on revision yet? I'd like your final thoughts on where you see this going, where you see the best uses for this.

Dr. Amit Momaya: Sure. It's been used in a lot of different settings. There has been one randomized controlled trial, comparing it to partial repair in a shoulder. And oftentimes, when someone has a massively irreparable rotator cuff, it most likely has been operated on before, but not necessarily. Where I see this going in the future, I think this is going to be ultimately either used for the shoulder that has an irreparable rotator cuff or, even better idea, I think is an augment to what we're already doing to help offload the forces across either we've repaired something, or we've done a partial repair. And I think that's going to be its greatest use, is to actually augment. And I can envision different sizes of the balloons and different techniques for when we're augmenting the procedures we're already doing to obtain better healing and function.

Melanie Cole: It's a great point. Dr. Casp, tell us about the multidisciplinary team. How do you all work together for these patients?

Dr. Aaron Casp: Yeah, I think that's just as important, if not more important than the actual surgery or the technology itself. Dr. Brabston, Dr. Momaya and I all run our patients by each other every week. We have a scheduled time where we can bounce ideas off each other and get sort of some input from our colleagues. We also work very closely with our physical therapists. And I always like to say that, you know, our physical therapist network is probably more important than anything that I could possibly do considering they see the patients more often, they are responsible for getting them strong, getting them back and sort of coaching them along in their recovery process.

We also have large team of non-operative sports medicine physicians here at UAB who see the patients oftentimes before we do, whenever they're starting to come in for shoulder pain or if they need injections. And eventually, if their condition worsens or if they need some extra help, they'll send them to us for further possible surgical evaluation. So you know, it really is a team here at UAB. And, you know, it goes from everybody they see at the front desk to us as the surgeons all the way to the outpatient physical therapist providers. And so we rely heavily on everybody here.

Melanie Cole: And Dr. Brabston, final thoughts, what you'd like other providers to take away from what you're doing at UAB Medicine and when you feel it's important that they refer.

Dr. Eugene Brabston: That's a really good question. So obviously, you know, we all kind of work here because we do like teaching, we like the research, we like being on the edge of innovation. And working at UAB really provides all of us that opportunity. So, you know, from our standpoint, we want to educate. We want to educate community. We want to educate community surgeons. And so we welcome any kind of questions, we welcome interest in this. And I think that long-term, you're going to see this procedure really kind of blossom and spread out in the community. And the good news is, you know, we obviously need to have a lot more outcomes to be able to follow the more that it's being done. But, it is something that, you know, we're here available for complicated issues, straightforward issues. And we just really want to be a national, if not international, institution to really promote our care and our service and really making patients better.

Melanie Cole: Thank you all so much for joining us and telling us about this innovation that you are doing at UAB Medicine for rotator cuff tears. A physician can refer a patient to UAB Medicine by calling the MIST line at 1-800-UAB-MIST or you can always visit our website at uabmedicine.org/physician. That concludes this episode of UAB MedCast. For updates on the latest medical advancements, breakthroughs and research, follow us on your social channels. I'm Melanie Cole.