Current Evidence For Biologic Augmentation Of Rotator Cuff Tears

Hello, thanks for having a look at this presentation titled Biologic augmentation of Rotator Cuff Repairs. This talk was first presented at the 40th annual Shoulder Course in San Diego on June 15th, 2023. I want to thank Doctor Larry Field and Doctor Jim Esh for the invitation to participate and for putting on a fantastic course.

The handout for this talk can be found at Buford.info/Sandiego23 or you can use the QR code to be taken directly to the handout.

These are my disclosures. They're also available online at our orthopedicci websites.

So the first question, what if the next great advancement in improving Rotator cuff repair outcomes is actually found in harnessing the biology of healing?

And the follow up question would be, what if the best use of Orthobiologics is that the first procedure to ensure healing and to prevent revisions.

So, let's review the evidence that we have. I'm going to focus on human outcome studies using FDA regulatory compliant Orthobiologics as of June.

We're going to focus primarily on Platelet-rich plasma from the blood, on Bone Marrow Concentrate, and on adipose tissue, and specifically, uh, the type of adipose that is regulatory compliant, meaning non-enzymatically digested adipose.

This paper published in 2019 by Dr. Tom Vangs Ness and his colleagues was a meta-analysis of 18 level one studies evaluating PRP augmentation of Rotator Cuff repairs. What they found, which is going to be a recurring theme in this short talk, is that the PRP group showed a decrease in retears.

The patient group treated with PRP showed functional improvements, but those improvements were not statistically significant because they did not meet the minimally clinically important um uh difference.

So, the results were heterogeneous in terms of functional outcome, in my opinion, primarily due to differences in how the PRP was obtained, made, and in some instances even even applied.

Just this year in 2023.

There were 16 level 1 studies evaluated and another meta-analysis. Some of these studies overlapped with Doctor Bang's Nest study, but the conclusion was the same, that the combination of PRP treatment and arthroscopic Shoulder Rotator cuff repair shows a lower retear rate than those patients that are treated with arthroscopic Rotator cuff repair alone. And again, there's a trend towards functional improvement with PRP use, but it, it did not reach statistical significance.

In this study, which is a retrospective review of registry data,

A large number of patients received PRP augmentation, smaller number received bone marrow aspirate concentrate, and then a very large number had just Rotator cuff repair. And what the authors found was that the Bone Marrow Concentrate patients had 64% fewer revisions at 2 years.

They also noted that the PRP treated patients showed no significant difference in revisions over those patients that just had arthroscopic repair alone. But uh uh the same caution applies here with registry data. All PRP is not the same, all technique for getting Bone Marrow.

Concentrate is not the same, so we have to be careful when we put all of these different papers into one basket and try and get a conclusion. Nonetheless, it's interesting to note that the Bone Marrow Concentrate patients did have a statistically significant improvement in that there were fewer revisions.

In this study, which evaluated Bone Marrow Concentrate only, there were 45 patients that received Bone Marrow aspirin concentrate, 45 patients were treated just with the arthroscopic Rotator cuff repair, and what Doctor Cole and his colleagues found was that the group treated with Bone Marrow Concentrate showed improved tendon quality by MRI scan at 1 year, and also that the control group showed a greater retear rate um at 1 year on MRI scan.

It's important to start to note, as Doctor Cole and his colleagues did, where we're getting the Bone Marrow from. So here it's iliac crest, how much Bone Marrow, 60 cc's, what system was used, that was the Arthrex Angel, and what the dose was. And so here we see that their CFU count was 25,000 MSCs.

This is probably the landmark study looking at Bone Marrow Concentrate augmentation of Rotator Cuff repairs, and this came out of Paris. This is Doctor Philippe Hernego's publication from 2014. 45 controlled patients with no BMC, 45 patients with BMC. And so how much BMC? 150 ccs. Where did he get it from? Iliac crest.

The dosage was 51,00012 cc's of BMC and then and the HL, which is critical, 2/3 of that was injected into the bone at the Rotator Cuff footprint. So, one way to conceptualize this is he put these MSCs back into the MSC bank in the in the bone, where they could then participate in a longer term fashion in the healing response.

The Other 1/3 was injected at the tendon bone interface.

The results were fantastic.

In the group that he treated with this technique, 100% healed at 6 months. 87% were still healed a decade later by MRI scan.

2/3 of the patients treated or not treated with BMC were healed at 6 months, and less than half of those were still healed a decade later. So, BMC was noted to have a significant clinical impact when used in this fashion.

There's really only one recent study looking at adipose augmentation, and this is a microfracture technique where larger pieces of adipose are broken, uh, mechanically debrided into smaller pieces of adipose, and then injected into the subacromial space. They only had one statistically significant finding, which was a higher constant score at 6 months. At every Other time point, the groups were equal. So we don't have enough data to really have a solid opinion on whether adipose makes a difference or not.

I think we can help improve Rotator cuff repair outcomes with Biologic augmentation at the index procedure, but the dose and the how of augmenting is clearly going to be important to note.

The current same day data, which is what we're doing in the US, is trending that Bone Marrow concentrates going to be a better biologic option than PRP or adipose if all Other things are equal.

In terms of future directions, Doctor Rich in Barcelona is leading a clinic where they culture MSCs to a count of 20 million to treat tendonopathy and Osteoarthritis. Their published and unpublished results are really truly amazing. Uh, here's an example at the bottom of a person with a chronic 3 centimeter gap in an Achilles tendon. They do one Injection with 20 million stem cells, and what they find is healing that progresses almost remodels back to a normal tendon 2 years later, and

You may sit in the audience and think this isn't amazing, but this is an 81-year-old with a chronic tear. So, they were still able to stimulate this healing response where it hadn't happened up to that point.

Based out of San Diego, Doctor Chris Rogers is at San Diego Ortho Biologics, and he's one of the principal investigators in an FDA approved trial where they are treating Knee Osteoarthritis with autologous cultured adipose derived MSCs. If this effort is successful, and I think it will be, this will be the first.

Cultured MSC drug for an orthopedic application in the USA and the cool thing about that for all of us in this room is once we have a cultured drug that has an on-label indication, we can use that drug off label. So we could go and use this cultured adipose MSC drug for Rotator cuff repair, for example.

So thank you very much.