July 12, 2024 • 31 mins
Listen to the inaugural Joint Ventures podcast to hear renowned surgeons dive into the world of bioinductive augmentation with the REGENETEN◊ Implant. In a vibrant discussion, they share extensive experiences with this innovative implant and its associated technique, the strength of supporting data and impressive outcomes they’ve observed. Featuring: Dr Ian Lo, Dr Michael O’Brien, and Dr Scott Trenhaile.
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Episode Transcript
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Speaker 1 (00:06):
Hello everybody. Welcome to Joint Ventures by
Smith and Nephew Sport Medicine.I'm your host Ian Lowe and today
we have two guests with us,Doctor. Michael O'Brien, Tulane
University and Doctor. ScottTrenhill, Ortho Illinois.
Thanks for joining me guys.Today I think we're going to
talk a little bit about rotatorcuff rotator cuff tears, how
your practice has changed reallyover the last ten years or so,
(00:27):
and really about the REGENETENimplant how that has changed the
outcomes for your patients. NowScott, I know you were involved
with this implant really for anumber of years. Tell me about
your experience initially beforeyou had this implant. How were
your rotator cuff patientsdoing?
Speaker 2 (00:45):
I mean, always think that our patients are doing
fantastic until we really startto look at our results
critically. There was always agap or a void in my treatment
armamentarium where I justwanted to do better and thought
I could do better with thesepatients. And I actually started
(01:06):
my whole experience on the largeto massive rotator cuff
conundrum.
Speaker 1 (01:11):
Right.
Speaker 2 (01:12):
Not the partials side of things. And I explored every
patch, so to speak, that was outthere trying to find something
to do better for my patients andand make make the outcomes
better and and Injectables andEverything. RP. Yes. Yeah.
Speaker 1 (01:31):
Yeah. Mean, have been so many biologics out there
really haven't stood the test oftime. And, you know, when they
first come out, you're like, oh,this could be the next thing
best thing since sliced bread.
Speaker 2 (01:41):
Mhmm. Right.
Speaker 1 (01:41):
Critical appraisal, I think the outcomes are very
different.
Speaker 2 (01:45):
Agreed. Yeah. So I started on the on the massive
cuff tear side.
Speaker 1 (01:51):
And you started augmenting those with different
types of implants?
Speaker 2 (01:56):
Yeah. You know, I I, of course, was augmenting
everything that was in danger ofretear, radiographic retear is
where it's at. Right. Just thethe outcomes weren't
predictable. And so I that'swhen I gave her Jenna actually,
back then, it was under adifferent name, but Yeah.
I gave it a try, I was like,this is different. Right. That
(02:20):
was my start.
Speaker 1 (02:21):
So what's your early experience?
Speaker 3 (02:23):
Very similar. And so Buddy Savoy is my boss, and he
was an early adopter of theimplant, and actually helped, I
think, design the arthroscopicimplementation tool with Jeff
Abrams. And similar to Scott,where you have these large and
massive tears, and when youreally follow them critically,
(02:43):
you realize more fail than wewant or that we want to accept.
Speaker 1 (02:47):
Right.
Speaker 3 (02:48):
And we follow ours with ultrasound, so then you can
see at that three, four monthmark that it's failed even if
your patient's doing well. Sothen what do you do? So
Regenetin became available, andI started, like Scott, using it
as an augment on top of largeand massive tears. And I had
tried other things too,different forms of biologics,
(03:09):
you know, but wasn't gettinggood results with that. And when
I first started using it, I wassuper skeptical.
I didn't think it would work.But I had heard people like Rick
Rioux and Jeff Abrams presenttheir data and Buddy Savoy and
see their MRI outcome studiesand show that they were getting
these tears to heal. So Istarted using it. And following
(03:32):
them long term, we could see it,like, in their range of motion,
in their strength, following iton ultrasound. We could see the
implant on top of the rotatorcuff, and then between three and
four months, you can see it kindof disappear so you know it's
integrating into the Right, yes.
Speaker 1 (03:47):
So this is interesting. So you routinely
follow your rotator cuff repairson serial ultrasound like with
every Every one. Follow-upvisit?
Speaker 3 (03:55):
Four weeks, eight weeks, twelve weeks, and then
their last visit, whenever thatis.
Speaker 1 (03:59):
So just tell me then anecdotally, what do you see on
these ultrasound with thatimplant, the interface, maybe
the tendon thickness? What areyou looking at?
Speaker 3 (04:07):
What do you That's, yeah, all of those things. So if
you get someone to put theirhand on their hip, it brings the
greater tuberosity forward fromunder the acromion. And so then
you can see the greatertuberosity, and you can see
where your anchors are, so youknow exactly where your repair
is.
Speaker 1 (04:21):
Oh,
Speaker 3 (04:22):
interesting. And early on, you can see a space
between the implant and thetendon. And early on, it's about
two millimeters, so you canmeasure the thickness of your
tendon and then the thicknesswith the implant, which adds
about two millimeters as theimplant swells a little bit. And
then I think it's around fourmonths that the implant
completely integrates, and thenit just looks like one tendon.
(04:44):
And so we follow that over timeinitially just to kind of show
that they were healing and notre tearing.
And we also kind of used that toguide their therapy. So if their
repair looks kind of thin, wemight not start strengthening
right away. If the repair'slooking good, we might start
strengthening a little sooner,like ten weeks versus twelve
weeks or fifteen weeks. But thatwas one thing that really led me
(05:07):
to believe in the utility ofthis implant.
Speaker 1 (05:10):
So who do you feel like you know, REGENETEN's
probably not gonna help thisparticular patient or repair? I
Speaker 2 (05:17):
certainly, you've got patients who are arthritic.
Speaker 1 (05:21):
Okay. Yep.
Speaker 2 (05:22):
You know, more on the their their their joint is just
a little too far gone.
Speaker 1 (05:27):
Like a cuff arthropathy patient.
Speaker 2 (05:28):
Yeah. Pre cuff arthropathy patient with a
really large tear.
Speaker 1 (05:32):
Yes.
Speaker 2 (05:32):
Probably north of 70 to 75 years old, and I can't
prove that, but I just myclinical suspicion with with
tendon healing in general andhow you add all those factors
together, there's there's onlyso much this can do. Right?
There's guardrails, and I thinkthose are some of the big
(05:54):
factors where you'd say, thisthis doesn't make sense.
Speaker 3 (05:59):
Yeah. Similar. You know? Because I my current
algorithm now is I put it onevery large and massive tear,
even somebody young, because ifthey fall skiing and tear their
whole cuff Right. You need thatto heal.
So even a young person withoutmedical comorbidities, you need
that to heal. Every revisioncase, I have now started using
(06:19):
it on the partial thicknesstears. That's where I'm not
really sure what is the cutoff,you know? So in my mind, if it's
fifty percent or less partialtear that I use Regenetin for,
if it's over 50% or 80%, thenthat's where I'm not sure if
that is enough to get that toheal. Then I still add an anchor
(06:40):
in those high grade partialthickness So the one I don't use
it is the arthritic patient.
Sometimes if the tendon quality,if you can get a repair, but the
tendon quality is really, reallypoor, where you almost realize
in there, like, maybe I shouldbe doing something else than a
rotator cuff repair right now.And I don't use it on one
centimeter tears because I don'tthink it needs it. You know? The
(07:03):
healing rates are so high Right.With one centimeter tears.
Yep. But, I mean, there's datathat supports putting it on
every single tendon.
Speaker 1 (07:12):
Okay. So have been using it for partial tear. Have
you been using it for partialtears as well, Scott? Yes. So
what's your experience been withpartial thickness tears?
Speaker 2 (07:21):
Well, first and foremost, it's a when you look
at how patients do with thatover a takedown and repair
Speaker 1 (07:30):
Yes. Or a transcend repair.
Speaker 2 (07:32):
Yeah. Which I really don't do at all anymore. K. But
when you look at those patientsclinically, they are so much
happier just out of the box. Youknow, they're less narcotics.
They drive sooner. They go backto work sooner. They do all
these things in their life.They're get they're out of the
slinging couple of weeks. Youknow, they're they're they're
(07:53):
just returning back to life muchsooner than a takedown or
repair.
And so there's that patient, andthen there's the patient that
and maybe it it was a patientwho was getting an
acromioplasty, but their cuffreally didn't look good. Looked
tendinopic. Very sick lookingtendon. And that patient even,
(08:16):
they seemed to do clinicallybetter early on with less pain,
more motion, activity levels,
Speaker 3 (08:25):
all of I love that indication because before this
implant, we would see thosewhere you're going in there and
you're doing an acromioplasty.They're having rotator cuff
pain. But then when you look atit arthroscopically, the tendon
doesn't it's not torn, but itdoesn't look healthy. Right.
It's all kind of beat up andfrayed, which now I think we
recognize is just early rotatorcuff disease.
(08:47):
Right. And that's one indicationthat I think is great because I
think it kind of halts theprogression of that, you know?
And you're bringing in bloodsupply and you're adding
collagen to the bursal surfaceand you're helping that sick
tendon heal before it becomes atear.
Speaker 1 (09:00):
I mean, at least you feel like you're doing something
biologic. Totally. You're doinga chromoplasty, that's like a
mechanical thing almost, likedecreasing the impingement, but
I feel You kind of
Speaker 3 (09:08):
feel like you're not doing anything with just an
acromoplasty.
Speaker 1 (09:09):
Yeah. I mean, sometimes I feel when not often,
but you're doing anacromioplasty for that disease.
I'm like, are they just reallydoing rehab again? Or what are
what are we really doing forthis person? Yeah.
I wanted to book that myself. Soare you doing this in all types
of partial tears, like bursalsurface, in substance tears,
articular surface tears?
Speaker 3 (09:29):
Intra substance, yes. I think it's a great indication
for an intra substance tear.It'll trephinate the tendon with
a needle, and then I might takethe gold ball and micro fracture
the tuberosity a little bit andthen put regenerative on top. If
it's articular sided, less than50%, I'm using regenerative and
accelerated rehab protocol, likeScott mentioned. If it's 50%
(09:51):
bursal sided, I usually use ananchor.
But then I still might addregenerative if the remaining
tendon quality looks really bad.Right.
Speaker 1 (10:00):
So there is this concern, though, I think, with
the rehab protocols anddeveloping stiffness after the
use of the REGENETEN implant.What's been your experience with
stiffness and REGENETEN?
Speaker 2 (10:10):
Yeah. I think the thing, in my experience, that
you have to understand is thisdevice really accelerates
healing. And with healing, youcan get accelerated
inflammation, good inflammation.There's good and bad
inflammation, of course.
Speaker 3 (10:28):
I mean,
Speaker 1 (10:28):
all healing starts with inflammation.
Speaker 2 (10:30):
Right. And so patients you'll see patients
that are doing fantastic, andthen between nine and eleven
weeks, they start to get sore.They're they may lose a little
bit of range of motion. And it'sall about counseling those
patients and kinda weatheringthe storm because there's a
there's a lot of goodinflammation going on. Sometimes
(10:50):
it's too good.
Speaker 1 (10:53):
And I think it's important for them to also
understand the rehabilitationprotocol, particularly for
treatment of partial tears. Yes.Because if they've had a
traditional rotator cuff repairbefore, that patient might think
that's the rehabilitationprotocol that's appropriate, but
you've got to move them early,right?
Speaker 3 (11:08):
Yeah. And I think the physical therapists as well. So
when this first came out and wewere using it for partial tears
on the physical therapy order, Iwould send a protocol, but then
the therapist looks at it andsays, Wait, you just had a
rotator cuff repair. You shouldbe in a sling. You can't be
raising your arm up yet.
So I think educating thepatients that it's okay to move
your arm because we didn't haveto reattach anything. This
(11:31):
implant is on the top, it'sstable, it's not going anywhere.
And then also educating thephysical therapist that it's
okay to push these patients alittle harder and start
strengthening at six weeks.
Speaker 1 (11:41):
I totally agree with that because I used to write
just rotated cuff repair withgraft, but traditionally if
Speaker 2 (11:47):
we would
Speaker 1 (11:47):
use a different type of graft, it was super slow,
super mobilized, I was like,this is a huge mistake. I should
have never wrote that.
Speaker 3 (11:56):
And I think that's what they think when they see
that. Yeah. And so they'rethinking, oh, sling for six
weeks, no strengthening tilltwelve weeks. And so sometimes
I'll try and send the protocolwith them.
Speaker 1 (12:05):
Yes.
Speaker 3 (12:06):
Say, like, sling for a week. Out of the sling at one
week, start using your arms,start active motion, start
strengthening at week six.Hopefully, by educating patients
and physical therapists, that'llhelp that.
Speaker 2 (12:17):
It's interesting because when this came out and
we got into all those kind ofmiscommunications about all
this, we ended up developingsmall cuff protocol, large cuff
protocol Same. Bio inductiveimplant protocol, sub scap
precautions, all of theselayers, and everybody got
smarter. You know? Everyoneeveryone involved through the
(12:39):
continuum of care. It gotbetter.
Speaker 1 (12:41):
So with that now, is stiffness a problem?
Speaker 2 (12:44):
No. Because we anticipate it, and we don't make
the mistake of locking people upin a sling too long. You know,
I've got cases of people where Iwas really concerned early on
with these large to massivetears. I put the device on,
locked them up in a sling like Ialways do, and next thing I
know, I got a stiff shoulderbecause I waited too long.
Speaker 3 (13:05):
Right. I think stiffness is really rare, and I
think probably we all have seena couple where using Regenitin
on the bursal surface for apartial tear where some
stiffness develops, and I don'tknow if that's the inflammatory
response. I don't know if it'sthe patient being extra
cautious, but kinda like Scottsaid, for me, it's that eight to
ten week time point wherethey're doing okay and then they
(13:28):
start getting a little stiff.That's pretty rare. It's pretty
rare.
It's pretty rare. I don't see itin using it as an augment for
the large and massive tears.They don't get stiff. Right. You
know?
And that's a traditional rehabprotocol where they're still in
the sling for six weeks andstart strengthening at week
twelve. They don't get stiff.
Speaker 2 (13:46):
You know, I this is just kind of a sidebar, but I
always try to point out topeople, like, we have to make
sure that we're treating rotatorcuff disease and not treating
impingement, which may also beearly early onset frozen
shoulder. Because those canpresent similarly. And is this
(14:06):
is this a cuff problem orsomething else? And you don't
wanna get thrown into thatcategory by mistake, that's why
we don't rush into surgery rightaway. We try to rehabilitate
people and avoid surgery if wecan.
Speaker 3 (14:20):
Yeah, absolutely. If you have somebody that is
getting a little stiff, and theyhave a regenerative implant in,
will you put a cortisoneinjection in the subacromial
space and at what time frame?
Speaker 2 (14:33):
That's eleven week. Yes. And it's it's later.
Speaker 3 (14:37):
Me too. Twelve weeks.
Speaker 1 (14:38):
Like, three a month or yeah.
Speaker 2 (14:39):
Yeah. Mean, like, three a month or I'm usually
eleven because by then, they'rein my office and, you know,
they're worried.
Speaker 3 (14:46):
Right? Yeah. So but it's it's it's really rare.
Agreed.
Speaker 1 (14:49):
But you have to remember too, like, you know,
even though there's thisincidence of stiffness per se,
you know, if you were to do atraditional takedown and repair,
small parts of those ones usedto get stiff all the time.
Speaker 2 (14:59):
They get way worse.
Speaker 1 (15:00):
They're like worse. Those are actually I find them
my my angriest patients.
Speaker 3 (15:04):
Oh, angry. And it's usually young males. You know,
they're in their forties.They're super stiff. They're
unhappy because they still hurt.
Yes. They can't raise their armup. And I think it's just by
doing a takedown and repair,you're shortening the tendon. So
you're changing the naturallength of that tendon than it
was meant to be. And so it makessense that that would lead to
lead to stiffness.
Stiffness.
Speaker 1 (15:22):
Yeah. Yep. And those are the ones you wanted to get
back early. Like, those are theyoung people who are like, oh,
yeah. Sorry.
You still can't work now becausethat thing bloody hurts.
Speaker 3 (15:30):
And they're so unhappy. And that's where
Regenetin has been a gamechanger Yeah. In those patients.
Right. Because you can move themfaster, and at three months,
they're feeling pretty good.
I've had some folks partial tearwith Regenetin in three or four
months being back to everythingpickleball and tennis.
Speaker 1 (15:47):
I remember this distinct patient probably just
about six months ago. Operatedon him partial thickness tear,
bursal surface. Maybe I brokeprotocol a little bit, it was
probably 80 to 90% of the waythrough I was like, that's a
little dicey, like don't get mewrong. I treponated the bone, I
put the, regenetin on top justto kind of extend it out. This
(16:10):
guy, I saw him at three months.
He's like, oh, that's fantastic.Full range of motion. He's
curling 40 pounds dumbbellseither side and 80 pounds single
hand overhead. I'm like Wow.That is crazy.
Speaker 3 (16:23):
I thought he meant he was actually curling like the
sport up in Canada, butdumbbells.
Speaker 1 (16:27):
Well, I mean, partly, I mean, he was curling like, you
know, curling stones.
Speaker 3 (16:30):
Curling Yeah. Those are with curling stones.
Speaker 1 (16:34):
Thing. And
Speaker 3 (16:35):
I mean, that's that's a good outcome right there.
Speaker 1 (16:37):
I was crazy 80 pound dumbbell press I'm like, what?
Like, there's normal people whocan't do that. This is not a big
dude. I mean, he wasn't as bigas Scott, obviously.
Speaker 3 (16:48):
Few are.
Speaker 1 (16:48):
Yeah, few are. Here we go. Okay. Okay, so when
you're introducing this implantto patients, you know, there's
been some concern related to thesource material, which of
course, as we know, is bovine.And you know, industry wise, we
know this term xenograft hasbeen utilized for other
(17:10):
implants.
And so, when you first saw this,and it was, you know, bovine
sourced, what did you think?
Speaker 2 (17:18):
I thought I wanted to know more, obviously. I wanted
to know where it came from, howit was made, how it was
processed, what's in it, whatall the ins and outs. And, you
know, some of that informationis proprietary, so we didn't
know all of it. But I knewenough to know that this was
(17:39):
basically a highly purifiedcollagen graft, or implant
rather, that was derived from anAchilles tendon of a cow. The
way I explained so once Istarted to understand that, I I
basically just tell peopleexactly what it is.
(18:00):
You know? This is a this is anAchilles tendon of a cow. It's
broken down into its finiteelement elements. It's actually
broken down into a powder madeback into a slurry, and then
it's like a wet potato chip whenwe put it in. And it's
essentially a man made productwith very little to no DNA.
(18:20):
I mean, it's hard to trace. OnceI kinda walk people through
that, they seem pretty okay withit, because it's a it's an
engineered product.
Speaker 3 (18:29):
Yeah. I feel like I, yeah, knew way less about it
when I first started using it. Iknew it came from a cow Achilles
tendon, and that was it. Ididn't know how it was
bioengineered. And learningthat, especially in the last six
months, that the source DNA isremoved as this is highly
bioengineered and this is a purecollagen implant, helped me
(18:52):
understand how it works a littlebit better.
And with the high porosity, thathelps you understand how that
can bring in blood flow and thetenocytes can start growing into
the implant. I would first tellpatients, when I first started
using it, I had the brochureprovided by Smith and Nephew,
and I would show them a pictureof it and say, This is a
(19:14):
collagen implant that comes froma cow Achilles tendon. It's FDA
approved for this purpose. It'sthe size of a postage stamp.
We're going to fix your tendon,and then we're going to slide it
in and insert it over the top,and it should help the tendon
heal, and it should integrateinto the tendon within six
months.
(19:34):
I had two patients. Oh, here,yeah, when to not use it. One
lady told me, I have a beefallergy. Yeah. I was like, what?
I'm allergic to beef. So Icalled the engineers, and they
said, I wouldn't use it. So wedidn't.
Speaker 1 (19:50):
Right.
Speaker 3 (19:50):
And then I had a man who was a vegan. And so when I
said cow Achilles tendon, hesaid, I'm a vegan. And I said,
that's great. And he goes, Idon't want that in my body. And
I was like, oh, okay.
Yeah. So he chose not to go thatroute.
Speaker 1 (20:06):
And there are, of course, certain religions where
that may be looked down upon,but I've actually had people of
that religion, some areacceptable to it Mhmm. And some
are not acceptable to it. So Ijust explain exactly where it's
from Yep. It's processed and howit's made, some of them are
still agreeable to it. Yeah.
Some of them are like, if youfeel like this will make my
You're welcome. Better Yeah.Then I'm still okay.
Speaker 3 (20:26):
I trust you.
Speaker 1 (20:26):
Yeah.
Speaker 3 (20:27):
And now, you guys have probably had a similar
experience. Some people willcome in asking for it. So
they've heard from friends oracquaintances that they got this
collagen implant, and so they'llcome for a second opinion and
say, Can I get that implant?Because I've heard it helps with
healing. So I've had some peoplecome in asking for it.
Speaker 1 (20:47):
And in fact, I find that if I talk to the patient
about the implant, but I don'tput it in, they're so
disappointed.
Speaker 3 (20:55):
Oh, yes. Yes. They're like, Why did you put
Speaker 1 (20:57):
that in? Oh, what?
Speaker 3 (20:59):
And you're like, Well, I don't think it needed
it. You said it would make itbetter, so I learned that the
hard way too.
Speaker 2 (21:03):
Mean, hurt
Speaker 3 (21:04):
feelings, and then I felt like an idiot, and
Speaker 2 (21:06):
I'm already an We're having trouble enrolling
patients. You know, we're alwaysstudying this, right? We're
always doing research, and thepatients don't wanna be enrolled
because they're fearful of beingrandomized to one arm over the
other. They want the device.Yes.
Speaker 1 (21:20):
They the device.
Speaker 2 (21:22):
And that's that's our problem. Yep. Is that the the
the population has become a lotmore savvy to what this is and
what it can do.
Speaker 1 (21:30):
Okay, so if you have somebody who's thinking about
maybe using a regenerative, whatare your kind of tips and tricks
for that first case? Who's thebest patient to try it on, maybe
the easiest person to put it in?How would you approach that? I
think, and I guess
Speaker 3 (21:45):
it depends, if a user wants to start with a partial
tear or an Augment on a fullthickness tear. But on a partial
tear, I think my best tips areyou don't want to put it over
the rotator interval because ifthat creates thickening of the
rotator interval, that mightlead to some stiffness. And so
when I'm intra articular, I dropa spinal needle down at the
(22:09):
anterior aspect ofsupraspinatus, right behind the
biceps, and I leave it there. Sothen when I go up subacromial, I
see that spinal needle, and it'sa runway of where to put the
implant. And I have found I dothis in beach chair position,
and so my lateral portal tobring in the implant is lower
than my standard lateral portalbecause I'm trying to bring it
(22:30):
in parallel with the rotator.
Speaker 2 (22:32):
Land it like an airplane. Land it like an
airplane. That's you gotta comein flat.
Speaker 3 (22:37):
Yep. That's and so I get that angle with a spinal
needle. I put it in through acannula. I bring it in. I make
sure it stays posterior to thatspinal needle
Speaker 1 (22:45):
Yes.
Speaker 3 (22:46):
Marking the rotator interval. And I do I like the
peak bone staples. So I usethree soft tissue staples,
medial, one or two anterior, twoposterior, and I usually use one
peak bone staple. Scott, youdon't use the bone staples?
Speaker 2 (23:01):
No. I do about the same. Okay. You end up getting
one bone staple at that cornerMhmm. Where you run out of
tendon, and yet you want it'sall about coverage, right?
Right. So this it doesn't itdoesn't propagate beyond what
you've covered, so you need toget the implant over the
diseased tendon. Right. And, youknow, if you've got a flap or an
(23:23):
edge that's hanging over andit's on bone, then use the use
it. Use the staple.
It's
Speaker 3 (23:27):
okay. Yeah.
Speaker 2 (23:28):
But it's it's it's just purposeful that way, not
because you're trying to bearload immediately with it because
we know that's not the point.
Speaker 3 (23:36):
Right? On revisions, I've brought it in both ways
too, from bringing it inlateral, in line with the tendon
fibers, or posterior,perpendicular to the tendon
fibers, and it doesn't seem tomatter. It doesn't seem to
affect the healing rates of theimplant. And so I think it's
kinda dealer's choice.
Speaker 2 (23:53):
By ultrasound, you mean? Yep. So why would you
bring it in lateral orposterior, rather?
Speaker 3 (23:59):
So in certain instances where if I'm able to
get it's a revision, and I canonly get a single row repair,
and I don't wanna bring it inover a big knot stack because
it's not gonna integrate over abig knot stack. So then I bring
it in from posterior, and I putit a little bit more medial and
use all soft tissue staples.Yep. If I can get a good double
(24:22):
row repair, then I bring it infrom lateral because I I believe
in covering that bone tendonjunction as a possible source of
failure.
Speaker 1 (24:31):
The other thing I find is if you are bringing in
it from lateral to medial,there's a tendency to push the
graft.
Speaker 3 (24:37):
Oh, yes. Right?
Speaker 1 (24:38):
Great tip. So what are your what are your tricks on
that?
Speaker 3 (24:40):
What I've seen is training residents and fellows,
the first couple times they useit, they think they have to push
really hard.
Speaker 2 (24:47):
Yeah.
Speaker 3 (24:47):
And so I'm holding the implant and I'm holding the
scope, and they might push toohard medial and then see the
whole thing shift medial. Yep.So I try and teach them ahead of
time, get your starting point,bring your hand up, and then
straight down, and you canreally feel two pops. You can
feel it pop through the implant,then pop through the tendon.
Yep.
And I tell them they don't haveto push hard. But, I definitely
(25:07):
made that mistake early on whereI pushed it more medial than I
wanted it
Speaker 1 (25:12):
to I find if if I put the middle staples in as opposed
to the medial staples in, itkind of stabilizes a little bit
easier. Where if you have themedial ones first, especially if
they're slightly oblique, ittends to push it a little bit
medial, so I try to stabilize itin the middle first and then go
medial
Speaker 3 (25:29):
and then go lateral. It's brilliant. I just Well,
your angle is better. It's
Speaker 1 (25:33):
more perpendicular. Yeah.
Speaker 2 (25:34):
More perpendicular. Makes sense.
Speaker 3 (25:36):
Yeah. That makes great sense.
Speaker 1 (25:37):
Okay. So previously, we only really had anecdotal
information to go off of as faras how your patients are doing.
They seem to be doing better.But now we really have some
level one clinical data. What doyou think about those recent
results, Mike?
Speaker 3 (25:52):
I think it's outstanding. And so prospective
level one randomized, tripleblinded, controlled trial, you
know, out of Madrid, Hundred AndTwenty patients, all one to four
centimeter tears, so medium andlarge tears, randomized, all
with a transosseous equivalent,randomized where half get
(26:14):
regenerative and half don't, andto show a one third retear rate
at twelve months on MRI, andmuch lower type two show failure
rate. I think that'soutstanding. It's great because
I think that validates whatwe've all been seeing and
feeling and knowing that thishas benefited our patients, and
(26:35):
this study actually proves it,in a much stronger way than the
previous studies did,retrospective reviews and even
the studies that you andBushnell did, are good But this
one, it's the holy grail oforthopedic research.
Speaker 2 (26:49):
It's liquid gold. It's what it is, because it just
helps us get this device in ourhands to help our patients.
Speaker 1 (26:58):
Right. It really gives data, you know, when you
talk to patients now, you cantalk to them about the trial,
actually. Actually, it's beenproven in the literature now
that this can help you, can helpheal your tendon. Right. And I
mean, it's really funny, like,you know, if you talk to Resy
Bond, I mean, when he was firstdesigning this trial, right, he
was like, I don't believe inthis technology.
I'm gonna prove that thistechnology doesn't work. So he
(27:21):
said, What's the most robustthing I can do? Multi standard,
prospective, randomized, tripleblinded study. And now, with his
results, he's a believer.
Speaker 3 (27:31):
I love it. And I found that so compelling to find
out that he set up a set out onthis study to prove that it
didn't work. And then hebelieves his own data, of
course, and now he is a believerand a big user. I find that so
compelling, you know?
Speaker 1 (27:46):
And I do think that, you know, some people will say,
well, you know, my retear rate'snot that high. But I'm like, no,
no, no, no, no, no, no, no, no,that's not what we're talking
about. Because all of thesepatients were, in quotes,
asymptomatic meat tears.Everybody got an MRI. Yep.
And if you MRI ed every singlepatient in your clinic, you
might be sorely disappointedwhat your true healing rate is.
(28:08):
One hundred percent.
Speaker 3 (28:09):
That's what I say to everyone too, that my patients
do
Speaker 2 (28:11):
find out of We as clinicians have actually been
lived through that.
Speaker 3 (28:14):
Right?
Speaker 1 (28:14):
Right.
Speaker 3 (28:15):
I have. I know you have. Yes.
Speaker 2 (28:17):
We've done research on how things were going. That
was actually a segue for tryingthe Regenotin back in the day
was we we started MRIing people,and I was like, they're telling
me they're doing great early on,and they get the MRI back, and
they're like, oh, boy. This isnot
Speaker 3 (28:36):
Retear rates much higher than we thought. Yeah.
Speaker 2 (28:39):
They get worse as they, you know, five years,
seven years, ten
Speaker 1 (28:44):
years. Midterms. Yeah. That's when everything
starts falling apart.
Speaker 3 (28:47):
Yeah. Yep. I think that's what's so great about the
Ruiz Iban study, because earlyon they're doing great, but now
we know that long term they'regonna do great. Because we know
all outcome studies show that ahealed cuff performs much better
long term than a retorn cuff,even if they feel better
initially.
Speaker 2 (29:03):
For joint preservation and Yeah.
Everything. I mean, it justopens up. It protects the joint
to continue to do what it'ssupposed to do rather than just
progression of disease andreversal later. Absolutely.
Speaker 3 (29:16):
Yeah. You know? Reversing reversal mania.
Speaker 2 (29:19):
Yeah. So There you go.
Speaker 1 (29:20):
And it's a funny thing, you know. I used to think
about this implant, like, Oh,don't want to do it in my older
patients and that type of ideabecause presumably they have a
compromised healing environment.But I'm kind of like a little
bit reversed now. Like in theyounger patient with a medium
sized tear, we still knowthere's a known failure rate.
And if that patient re tears inthat young population, it's like
(29:42):
a disaster.
Speaker 3 (29:43):
Disaster.
Speaker 1 (29:44):
Because you have I truly believe you've got one
chance to heal this thing. Thefirst chance is your best
chance.
Speaker 3 (29:49):
Absolutely.
Speaker 1 (29:50):
And so I'm like, I know you're young, but I think
you should just have this.
Speaker 3 (29:53):
Oh, absolutely. I agree. Like, I had a guy that
fell skiing and he had a fourcentimeter full tear of super
infra. He was 48. Yeah.
And I put a REGENETEN on.Because I agree with you. This
is our best shot to get thisright and get this guy to heal.
Especially with that size tear.
Speaker 2 (30:10):
Yeah. It's that's the bad actor. Yep. Right? That's
that's the one thatstatistically is could very well
have a bad outcome.
Speaker 3 (30:19):
Totally. Because then when those do re tear, the tear
is huge. Yeah. And your tendonlooks like garbage.
Speaker 1 (30:25):
And you might be thinking about a different
operation now. Big time. It'slike, oh Transfer or yeah. It's
like, disaster time for thisperson.
Speaker 3 (30:35):
Exactly. Dermal allograft, which hates me as
much as I hate it. I
Speaker 2 (30:42):
could get on board with that.
Speaker 1 (30:46):
Very good, guys. Well, Michael, thank you for
joining me today. Scott, thankyou for joining me today.
Speaker 3 (30:51):
Thanks Ian.
Speaker 2 (30:52):
Certainly. I think this
Speaker 1 (30:53):
has been a very interesting discussion about
Regenetin and how it's reallychanged your practice related to
rotated cuff tears.
Speaker 3 (30:59):
How it's changed our patients' lives. I think we're
really making our patientsbetter. I agree.
Speaker 1 (31:04):
But there's actually even more information coming
out. Another prospectiverandomized level one study
showing REGENETEN improvingpatient's outcome again. But
thanks for joining me today onJoint Ventures by Smith and
Nephew Sport Medicine.
Hello everybody. Welcome to Joint Ventures by
Smith and Nephew Sport Medicine.I'm your host Ian Lowe and today
we have two guests with us,Doctor. Michael O'Brien, Tulane
University and Doctor. ScottTrenhill, Ortho Illinois.
Thanks for joining me guys.Today I think we're going to
talk a little bit about rotatorcuff rotator cuff tears, how
your practice has changed reallyover the last ten years or so,
(00:27):
and really about the REGENETENimplant how that has changed the
outcomes for your patients. NowScott, I know you were involved
with this implant really for anumber of years. Tell me about
your experience initially beforeyou had this implant. How were
your rotator cuff patientsdoing?
Speaker 2 (00:45):
I mean, always think that our patients are doing
fantastic until we really startto look at our results
critically. There was always agap or a void in my treatment
armamentarium where I justwanted to do better and thought
I could do better with thesepatients. And I actually started
(01:06):
my whole experience on the largeto massive rotator cuff
conundrum.
Speaker 1 (01:11):
Right.
Speaker 2 (01:12):
Not the partials side of things. And I explored every
patch, so to speak, that was outthere trying to find something
to do better for my patients andand make make the outcomes
better and and Injectables andEverything. RP. Yes. Yeah.
Speaker 1 (01:31):
Yeah. Mean, have been so many biologics out there
really haven't stood the test oftime. And, you know, when they
first come out, you're like, oh,this could be the next thing
best thing since sliced bread.
Speaker 2 (01:41):
Mhmm. Right.
Speaker 1 (01:41):
Critical appraisal, I think the outcomes are very
different.
Speaker 2 (01:45):
Agreed. Yeah. So I started on the on the massive
cuff tear side.
Speaker 1 (01:51):
And you started augmenting those with different
types of implants?
Speaker 2 (01:56):
Yeah. You know, I I, of course, was augmenting
everything that was in danger ofretear, radiographic retear is
where it's at. Right. Just thethe outcomes weren't
predictable. And so I that'swhen I gave her Jenna actually,
back then, it was under adifferent name, but Yeah.
I gave it a try, I was like,this is different. Right. That
(02:20):
was my start.
Speaker 1 (02:21):
So what's your early experience?
Speaker 3 (02:23):
Very similar. And so Buddy Savoy is my boss, and he
was an early adopter of theimplant, and actually helped, I
think, design the arthroscopicimplementation tool with Jeff
Abrams. And similar to Scott,where you have these large and
massive tears, and when youreally follow them critically,
(02:43):
you realize more fail than wewant or that we want to accept.
Speaker 1 (02:47):
Right.
Speaker 3 (02:48):
And we follow ours with ultrasound, so then you can
see at that three, four monthmark that it's failed even if
your patient's doing well. Sothen what do you do? So
Regenetin became available, andI started, like Scott, using it
as an augment on top of largeand massive tears. And I had
tried other things too,different forms of biologics,
(03:09):
you know, but wasn't gettinggood results with that. And when
I first started using it, I wassuper skeptical.
I didn't think it would work.But I had heard people like Rick
Rioux and Jeff Abrams presenttheir data and Buddy Savoy and
see their MRI outcome studiesand show that they were getting
these tears to heal. So Istarted using it. And following
(03:32):
them long term, we could see it,like, in their range of motion,
in their strength, following iton ultrasound. We could see the
implant on top of the rotatorcuff, and then between three and
four months, you can see it kindof disappear so you know it's
integrating into the Right, yes.
Speaker 1 (03:47):
So this is interesting. So you routinely
follow your rotator cuff repairson serial ultrasound like with
every Every one. Follow-upvisit?
Speaker 3 (03:55):
Four weeks, eight weeks, twelve weeks, and then
their last visit, whenever thatis.
Speaker 1 (03:59):
So just tell me then anecdotally, what do you see on
these ultrasound with thatimplant, the interface, maybe
the tendon thickness? What areyou looking at?
Speaker 3 (04:07):
What do you That's, yeah, all of those things. So if
you get someone to put theirhand on their hip, it brings the
greater tuberosity forward fromunder the acromion. And so then
you can see the greatertuberosity, and you can see
where your anchors are, so youknow exactly where your repair
is.
Speaker 1 (04:21):
Oh,
Speaker 3 (04:22):
interesting. And early on, you can see a space
between the implant and thetendon. And early on, it's about
two millimeters, so you canmeasure the thickness of your
tendon and then the thicknesswith the implant, which adds
about two millimeters as theimplant swells a little bit. And
then I think it's around fourmonths that the implant
completely integrates, and thenit just looks like one tendon.
(04:44):
And so we follow that over timeinitially just to kind of show
that they were healing and notre tearing.
And we also kind of used that toguide their therapy. So if their
repair looks kind of thin, wemight not start strengthening
right away. If the repair'slooking good, we might start
strengthening a little sooner,like ten weeks versus twelve
weeks or fifteen weeks. But thatwas one thing that really led me
(05:07):
to believe in the utility ofthis implant.
Speaker 1 (05:10):
So who do you feel like you know, REGENETEN's
probably not gonna help thisparticular patient or repair? I
Speaker 2 (05:17):
certainly, you've got patients who are arthritic.
Speaker 1 (05:21):
Okay. Yep.
Speaker 2 (05:22):
You know, more on the their their their joint is just
a little too far gone.
Speaker 1 (05:27):
Like a cuff arthropathy patient.
Speaker 2 (05:28):
Yeah. Pre cuff arthropathy patient with a
really large tear.
Speaker 1 (05:32):
Yes.
Speaker 2 (05:32):
Probably north of 70 to 75 years old, and I can't
prove that, but I just myclinical suspicion with with
tendon healing in general andhow you add all those factors
together, there's there's onlyso much this can do. Right?
There's guardrails, and I thinkthose are some of the big
(05:54):
factors where you'd say, thisthis doesn't make sense.
Speaker 3 (05:59):
Yeah. Similar. You know? Because I my current
algorithm now is I put it onevery large and massive tear,
even somebody young, because ifthey fall skiing and tear their
whole cuff Right. You need thatto heal.
So even a young person withoutmedical comorbidities, you need
that to heal. Every revisioncase, I have now started using
(06:19):
it on the partial thicknesstears. That's where I'm not
really sure what is the cutoff,you know? So in my mind, if it's
fifty percent or less partialtear that I use Regenetin for,
if it's over 50% or 80%, thenthat's where I'm not sure if
that is enough to get that toheal. Then I still add an anchor
(06:40):
in those high grade partialthickness So the one I don't use
it is the arthritic patient.
Sometimes if the tendon quality,if you can get a repair, but the
tendon quality is really, reallypoor, where you almost realize
in there, like, maybe I shouldbe doing something else than a
rotator cuff repair right now.And I don't use it on one
centimeter tears because I don'tthink it needs it. You know? The
(07:03):
healing rates are so high Right.With one centimeter tears.
Yep. But, I mean, there's datathat supports putting it on
every single tendon.
Speaker 1 (07:12):
Okay. So have been using it for partial tear. Have
you been using it for partialtears as well, Scott? Yes. So
what's your experience been withpartial thickness tears?
Speaker 2 (07:21):
Well, first and foremost, it's a when you look
at how patients do with thatover a takedown and repair
Speaker 1 (07:30):
Yes. Or a transcend repair.
Speaker 2 (07:32):
Yeah. Which I really don't do at all anymore. K. But
when you look at those patientsclinically, they are so much
happier just out of the box. Youknow, they're less narcotics.
They drive sooner. They go backto work sooner. They do all
these things in their life.They're get they're out of the
slinging couple of weeks. Youknow, they're they're they're
(07:53):
just returning back to life muchsooner than a takedown or
repair.
And so there's that patient, andthen there's the patient that
and maybe it it was a patientwho was getting an
acromioplasty, but their cuffreally didn't look good. Looked
tendinopic. Very sick lookingtendon. And that patient even,
(08:16):
they seemed to do clinicallybetter early on with less pain,
more motion, activity levels,
Speaker 3 (08:25):
all of I love that indication because before this
implant, we would see thosewhere you're going in there and
you're doing an acromioplasty.They're having rotator cuff
pain. But then when you look atit arthroscopically, the tendon
doesn't it's not torn, but itdoesn't look healthy. Right.
It's all kind of beat up andfrayed, which now I think we
recognize is just early rotatorcuff disease.
(08:47):
Right. And that's one indicationthat I think is great because I
think it kind of halts theprogression of that, you know?
And you're bringing in bloodsupply and you're adding
collagen to the bursal surfaceand you're helping that sick
tendon heal before it becomes atear.
Speaker 1 (09:00):
I mean, at least you feel like you're doing something
biologic. Totally. You're doinga chromoplasty, that's like a
mechanical thing almost, likedecreasing the impingement, but
I feel You kind of
Speaker 3 (09:08):
feel like you're not doing anything with just an
acromoplasty.
Speaker 1 (09:09):
Yeah. I mean, sometimes I feel when not often,
but you're doing anacromioplasty for that disease.
I'm like, are they just reallydoing rehab again? Or what are
what are we really doing forthis person? Yeah.
I wanted to book that myself. Soare you doing this in all types
of partial tears, like bursalsurface, in substance tears,
articular surface tears?
Speaker 3 (09:29):
Intra substance, yes. I think it's a great indication
for an intra substance tear.It'll trephinate the tendon with
a needle, and then I might takethe gold ball and micro fracture
the tuberosity a little bit andthen put regenerative on top. If
it's articular sided, less than50%, I'm using regenerative and
accelerated rehab protocol, likeScott mentioned. If it's 50%
(09:51):
bursal sided, I usually use ananchor.
But then I still might addregenerative if the remaining
tendon quality looks really bad.Right.
Speaker 1 (10:00):
So there is this concern, though, I think, with
the rehab protocols anddeveloping stiffness after the
use of the REGENETEN implant.What's been your experience with
stiffness and REGENETEN?
Speaker 2 (10:10):
Yeah. I think the thing, in my experience, that
you have to understand is thisdevice really accelerates
healing. And with healing, youcan get accelerated
inflammation, good inflammation.There's good and bad
inflammation, of course.
Speaker 3 (10:28):
I mean,
Speaker 1 (10:28):
all healing starts with inflammation.
Speaker 2 (10:30):
Right. And so patients you'll see patients
that are doing fantastic, andthen between nine and eleven
weeks, they start to get sore.They're they may lose a little
bit of range of motion. And it'sall about counseling those
patients and kinda weatheringthe storm because there's a
there's a lot of goodinflammation going on. Sometimes
(10:50):
it's too good.
Speaker 1 (10:53):
And I think it's important for them to also
understand the rehabilitationprotocol, particularly for
treatment of partial tears. Yes.Because if they've had a
traditional rotator cuff repairbefore, that patient might think
that's the rehabilitationprotocol that's appropriate, but
you've got to move them early,right?
Speaker 3 (11:08):
Yeah. And I think the physical therapists as well. So
when this first came out and wewere using it for partial tears
on the physical therapy order, Iwould send a protocol, but then
the therapist looks at it andsays, Wait, you just had a
rotator cuff repair. You shouldbe in a sling. You can't be
raising your arm up yet.
So I think educating thepatients that it's okay to move
your arm because we didn't haveto reattach anything. This
(11:31):
implant is on the top, it'sstable, it's not going anywhere.
And then also educating thephysical therapist that it's
okay to push these patients alittle harder and start
strengthening at six weeks.
Speaker 1 (11:41):
I totally agree with that because I used to write
just rotated cuff repair withgraft, but traditionally if
Speaker 2 (11:47):
we would
Speaker 1 (11:47):
use a different type of graft, it was super slow,
super mobilized, I was like,this is a huge mistake. I should
have never wrote that.
Speaker 3 (11:56):
And I think that's what they think when they see
that. Yeah. And so they'rethinking, oh, sling for six
weeks, no strengthening tilltwelve weeks. And so sometimes
I'll try and send the protocolwith them.
Speaker 1 (12:05):
Yes.
Speaker 3 (12:06):
Say, like, sling for a week. Out of the sling at one
week, start using your arms,start active motion, start
strengthening at week six.Hopefully, by educating patients
and physical therapists, that'llhelp that.
Speaker 2 (12:17):
It's interesting because when this came out and
we got into all those kind ofmiscommunications about all
this, we ended up developingsmall cuff protocol, large cuff
protocol Same. Bio inductiveimplant protocol, sub scap
precautions, all of theselayers, and everybody got
smarter. You know? Everyoneeveryone involved through the
(12:39):
continuum of care. It gotbetter.
Speaker 1 (12:41):
So with that now, is stiffness a problem?
Speaker 2 (12:44):
No. Because we anticipate it, and we don't make
the mistake of locking people upin a sling too long. You know,
I've got cases of people where Iwas really concerned early on
with these large to massivetears. I put the device on,
locked them up in a sling like Ialways do, and next thing I
know, I got a stiff shoulderbecause I waited too long.
Speaker 3 (13:05):
Right. I think stiffness is really rare, and I
think probably we all have seena couple where using Regenitin
on the bursal surface for apartial tear where some
stiffness develops, and I don'tknow if that's the inflammatory
response. I don't know if it'sthe patient being extra
cautious, but kinda like Scottsaid, for me, it's that eight to
ten week time point wherethey're doing okay and then they
(13:28):
start getting a little stiff.That's pretty rare. It's pretty
rare.
It's pretty rare. I don't see itin using it as an augment for
the large and massive tears.They don't get stiff. Right. You
know?
And that's a traditional rehabprotocol where they're still in
the sling for six weeks andstart strengthening at week
twelve. They don't get stiff.
Speaker 2 (13:46):
You know, I this is just kind of a sidebar, but I
always try to point out topeople, like, we have to make
sure that we're treating rotatorcuff disease and not treating
impingement, which may also beearly early onset frozen
shoulder. Because those canpresent similarly. And is this
(14:06):
is this a cuff problem orsomething else? And you don't
wanna get thrown into thatcategory by mistake, that's why
we don't rush into surgery rightaway. We try to rehabilitate
people and avoid surgery if wecan.
Speaker 3 (14:20):
Yeah, absolutely. If you have somebody that is
getting a little stiff, and theyhave a regenerative implant in,
will you put a cortisoneinjection in the subacromial
space and at what time frame?
Speaker 2 (14:33):
That's eleven week. Yes. And it's it's later.
Speaker 3 (14:37):
Me too. Twelve weeks.
Speaker 1 (14:38):
Like, three a month or yeah.
Speaker 2 (14:39):
Yeah. Mean, like, three a month or I'm usually
eleven because by then, they'rein my office and, you know,
they're worried.
Speaker 3 (14:46):
Right? Yeah. So but it's it's it's really rare.
Agreed.
Speaker 1 (14:49):
But you have to remember too, like, you know,
even though there's thisincidence of stiffness per se,
you know, if you were to do atraditional takedown and repair,
small parts of those ones usedto get stiff all the time.
Speaker 2 (14:59):
They get way worse.
Speaker 1 (15:00):
They're like worse. Those are actually I find them
my my angriest patients.
Speaker 3 (15:04):
Oh, angry. And it's usually young males. You know,
they're in their forties.They're super stiff. They're
unhappy because they still hurt.
Yes. They can't raise their armup. And I think it's just by
doing a takedown and repair,you're shortening the tendon. So
you're changing the naturallength of that tendon than it
was meant to be. And so it makessense that that would lead to
lead to stiffness.
Stiffness.
Speaker 1 (15:22):
Yeah. Yep. And those are the ones you wanted to get
back early. Like, those are theyoung people who are like, oh,
yeah. Sorry.
You still can't work now becausethat thing bloody hurts.
Speaker 3 (15:30):
And they're so unhappy. And that's where
Regenetin has been a gamechanger Yeah. In those patients.
Right. Because you can move themfaster, and at three months,
they're feeling pretty good.
I've had some folks partial tearwith Regenetin in three or four
months being back to everythingpickleball and tennis.
Speaker 1 (15:47):
I remember this distinct patient probably just
about six months ago. Operatedon him partial thickness tear,
bursal surface. Maybe I brokeprotocol a little bit, it was
probably 80 to 90% of the waythrough I was like, that's a
little dicey, like don't get mewrong. I treponated the bone, I
put the, regenetin on top justto kind of extend it out. This
(16:10):
guy, I saw him at three months.
He's like, oh, that's fantastic.Full range of motion. He's
curling 40 pounds dumbbellseither side and 80 pounds single
hand overhead. I'm like Wow.That is crazy.
Speaker 3 (16:23):
I thought he meant he was actually curling like the
sport up in Canada, butdumbbells.
Speaker 1 (16:27):
Well, I mean, partly, I mean, he was curling like, you
know, curling stones.
Speaker 3 (16:30):
Curling Yeah. Those are with curling stones.
Speaker 1 (16:34):
Thing. And
Speaker 3 (16:35):
I mean, that's that's a good outcome right there.
Speaker 1 (16:37):
I was crazy 80 pound dumbbell press I'm like, what?
Like, there's normal people whocan't do that. This is not a big
dude. I mean, he wasn't as bigas Scott, obviously.
Speaker 3 (16:48):
Few are.
Speaker 1 (16:48):
Yeah, few are. Here we go. Okay. Okay, so when
you're introducing this implantto patients, you know, there's
been some concern related to thesource material, which of
course, as we know, is bovine.And you know, industry wise, we
know this term xenograft hasbeen utilized for other
(17:10):
implants.
And so, when you first saw this,and it was, you know, bovine
sourced, what did you think?
Speaker 2 (17:18):
I thought I wanted to know more, obviously. I wanted
to know where it came from, howit was made, how it was
processed, what's in it, whatall the ins and outs. And, you
know, some of that informationis proprietary, so we didn't
know all of it. But I knewenough to know that this was
(17:39):
basically a highly purifiedcollagen graft, or implant
rather, that was derived from anAchilles tendon of a cow. The
way I explained so once Istarted to understand that, I I
basically just tell peopleexactly what it is.
(18:00):
You know? This is a this is anAchilles tendon of a cow. It's
broken down into its finiteelement elements. It's actually
broken down into a powder madeback into a slurry, and then
it's like a wet potato chip whenwe put it in. And it's
essentially a man made productwith very little to no DNA.
(18:20):
I mean, it's hard to trace. OnceI kinda walk people through
that, they seem pretty okay withit, because it's a it's an
engineered product.
Speaker 3 (18:29):
Yeah. I feel like I, yeah, knew way less about it
when I first started using it. Iknew it came from a cow Achilles
tendon, and that was it. Ididn't know how it was
bioengineered. And learningthat, especially in the last six
months, that the source DNA isremoved as this is highly
bioengineered and this is a purecollagen implant, helped me
(18:52):
understand how it works a littlebit better.
And with the high porosity, thathelps you understand how that
can bring in blood flow and thetenocytes can start growing into
the implant. I would first tellpatients, when I first started
using it, I had the brochureprovided by Smith and Nephew,
and I would show them a pictureof it and say, This is a
(19:14):
collagen implant that comes froma cow Achilles tendon. It's FDA
approved for this purpose. It'sthe size of a postage stamp.
We're going to fix your tendon,and then we're going to slide it
in and insert it over the top,and it should help the tendon
heal, and it should integrateinto the tendon within six
months.
(19:34):
I had two patients. Oh, here,yeah, when to not use it. One
lady told me, I have a beefallergy. Yeah. I was like, what?
I'm allergic to beef. So Icalled the engineers, and they
said, I wouldn't use it. So wedidn't.
Speaker 1 (19:50):
Right.
Speaker 3 (19:50):
And then I had a man who was a vegan. And so when I
said cow Achilles tendon, hesaid, I'm a vegan. And I said,
that's great. And he goes, Idon't want that in my body. And
I was like, oh, okay.
Yeah. So he chose not to go thatroute.
Speaker 1 (20:06):
And there are, of course, certain religions where
that may be looked down upon,but I've actually had people of
that religion, some areacceptable to it Mhmm. And some
are not acceptable to it. So Ijust explain exactly where it's
from Yep. It's processed and howit's made, some of them are
still agreeable to it. Yeah.
Some of them are like, if youfeel like this will make my
You're welcome. Better Yeah.Then I'm still okay.
Speaker 3 (20:26):
I trust you.
Speaker 1 (20:26):
Yeah.
Speaker 3 (20:27):
And now, you guys have probably had a similar
experience. Some people willcome in asking for it. So
they've heard from friends oracquaintances that they got this
collagen implant, and so they'llcome for a second opinion and
say, Can I get that implant?Because I've heard it helps with
healing. So I've had some peoplecome in asking for it.
Speaker 1 (20:47):
And in fact, I find that if I talk to the patient
about the implant, but I don'tput it in, they're so
disappointed.
Speaker 3 (20:55):
Oh, yes. Yes. They're like, Why did you put
Speaker 1 (20:57):
that in? Oh, what?
Speaker 3 (20:59):
And you're like, Well, I don't think it needed
it. You said it would make itbetter, so I learned that the
hard way too.
Speaker 2 (21:03):
Mean, hurt
Speaker 3 (21:04):
feelings, and then I felt like an idiot, and
Speaker 2 (21:06):
I'm already an We're having trouble enrolling
patients. You know, we're alwaysstudying this, right? We're
always doing research, and thepatients don't wanna be enrolled
because they're fearful of beingrandomized to one arm over the
other. They want the device.Yes.
Speaker 1 (21:20):
They the device.
Speaker 2 (21:22):
And that's that's our problem. Yep. Is that the the
the population has become a lotmore savvy to what this is and
what it can do.
Speaker 1 (21:30):
Okay, so if you have somebody who's thinking about
maybe using a regenerative, whatare your kind of tips and tricks
for that first case? Who's thebest patient to try it on, maybe
the easiest person to put it in?How would you approach that? I
think, and I guess
Speaker 3 (21:45):
it depends, if a user wants to start with a partial
tear or an Augment on a fullthickness tear. But on a partial
tear, I think my best tips areyou don't want to put it over
the rotator interval because ifthat creates thickening of the
rotator interval, that mightlead to some stiffness. And so
when I'm intra articular, I dropa spinal needle down at the
(22:09):
anterior aspect ofsupraspinatus, right behind the
biceps, and I leave it there. Sothen when I go up subacromial, I
see that spinal needle, and it'sa runway of where to put the
implant. And I have found I dothis in beach chair position,
and so my lateral portal tobring in the implant is lower
than my standard lateral portalbecause I'm trying to bring it
(22:30):
in parallel with the rotator.
Speaker 2 (22:32):
Land it like an airplane. Land it like an
airplane. That's you gotta comein flat.
Speaker 3 (22:37):
Yep. That's and so I get that angle with a spinal
needle. I put it in through acannula. I bring it in. I make
sure it stays posterior to thatspinal needle
Speaker 1 (22:45):
Yes.
Speaker 3 (22:46):
Marking the rotator interval. And I do I like the
peak bone staples. So I usethree soft tissue staples,
medial, one or two anterior, twoposterior, and I usually use one
peak bone staple. Scott, youdon't use the bone staples?
Speaker 2 (23:01):
No. I do about the same. Okay. You end up getting
one bone staple at that cornerMhmm. Where you run out of
tendon, and yet you want it'sall about coverage, right?
Right. So this it doesn't itdoesn't propagate beyond what
you've covered, so you need toget the implant over the
diseased tendon. Right. And, youknow, if you've got a flap or an
(23:23):
edge that's hanging over andit's on bone, then use the use
it. Use the staple.
It's
Speaker 3 (23:27):
okay. Yeah.
Speaker 2 (23:28):
But it's it's it's just purposeful that way, not
because you're trying to bearload immediately with it because
we know that's not the point.
Speaker 3 (23:36):
Right? On revisions, I've brought it in both ways
too, from bringing it inlateral, in line with the tendon
fibers, or posterior,perpendicular to the tendon
fibers, and it doesn't seem tomatter. It doesn't seem to
affect the healing rates of theimplant. And so I think it's
kinda dealer's choice.
Speaker 2 (23:53):
By ultrasound, you mean? Yep. So why would you
bring it in lateral orposterior, rather?
Speaker 3 (23:59):
So in certain instances where if I'm able to
get it's a revision, and I canonly get a single row repair,
and I don't wanna bring it inover a big knot stack because
it's not gonna integrate over abig knot stack. So then I bring
it in from posterior, and I putit a little bit more medial and
use all soft tissue staples.Yep. If I can get a good double
(24:22):
row repair, then I bring it infrom lateral because I I believe
in covering that bone tendonjunction as a possible source of
failure.
Speaker 1 (24:31):
The other thing I find is if you are bringing in
it from lateral to medial,there's a tendency to push the
graft.
Speaker 3 (24:37):
Oh, yes. Right?
Speaker 1 (24:38):
Great tip. So what are your what are your tricks on
that?
Speaker 3 (24:40):
What I've seen is training residents and fellows,
the first couple times they useit, they think they have to push
really hard.
Speaker 2 (24:47):
Yeah.
Speaker 3 (24:47):
And so I'm holding the implant and I'm holding the
scope, and they might push toohard medial and then see the
whole thing shift medial. Yep.So I try and teach them ahead of
time, get your starting point,bring your hand up, and then
straight down, and you canreally feel two pops. You can
feel it pop through the implant,then pop through the tendon.
Yep.
And I tell them they don't haveto push hard. But, I definitely
(25:07):
made that mistake early on whereI pushed it more medial than I
wanted it
Speaker 1 (25:12):
to I find if if I put the middle staples in as opposed
to the medial staples in, itkind of stabilizes a little bit
easier. Where if you have themedial ones first, especially if
they're slightly oblique, ittends to push it a little bit
medial, so I try to stabilize itin the middle first and then go
medial
Speaker 3 (25:29):
and then go lateral. It's brilliant. I just Well,
your angle is better. It's
Speaker 1 (25:33):
more perpendicular. Yeah.
Speaker 2 (25:34):
More perpendicular. Makes sense.
Speaker 3 (25:36):
Yeah. That makes great sense.
Speaker 1 (25:37):
Okay. So previously, we only really had anecdotal
information to go off of as faras how your patients are doing.
They seem to be doing better.But now we really have some
level one clinical data. What doyou think about those recent
results, Mike?
Speaker 3 (25:52):
I think it's outstanding. And so prospective
level one randomized, tripleblinded, controlled trial, you
know, out of Madrid, Hundred AndTwenty patients, all one to four
centimeter tears, so medium andlarge tears, randomized, all
with a transosseous equivalent,randomized where half get
(26:14):
regenerative and half don't, andto show a one third retear rate
at twelve months on MRI, andmuch lower type two show failure
rate. I think that'soutstanding. It's great because
I think that validates whatwe've all been seeing and
feeling and knowing that thishas benefited our patients, and
(26:35):
this study actually proves it,in a much stronger way than the
previous studies did,retrospective reviews and even
the studies that you andBushnell did, are good But this
one, it's the holy grail oforthopedic research.
Speaker 2 (26:49):
It's liquid gold. It's what it is, because it just
helps us get this device in ourhands to help our patients.
Speaker 1 (26:58):
Right. It really gives data, you know, when you
talk to patients now, you cantalk to them about the trial,
actually. Actually, it's beenproven in the literature now
that this can help you, can helpheal your tendon. Right. And I
mean, it's really funny, like,you know, if you talk to Resy
Bond, I mean, when he was firstdesigning this trial, right, he
was like, I don't believe inthis technology.
I'm gonna prove that thistechnology doesn't work. So he
(27:21):
said, What's the most robustthing I can do? Multi standard,
prospective, randomized, tripleblinded study. And now, with his
results, he's a believer.
Speaker 3 (27:31):
I love it. And I found that so compelling to find
out that he set up a set out onthis study to prove that it
didn't work. And then hebelieves his own data, of
course, and now he is a believerand a big user. I find that so
compelling, you know?
Speaker 1 (27:46):
And I do think that, you know, some people will say,
well, you know, my retear rate'snot that high. But I'm like, no,
no, no, no, no, no, no, no, no,that's not what we're talking
about. Because all of thesepatients were, in quotes,
asymptomatic meat tears.Everybody got an MRI. Yep.
And if you MRI ed every singlepatient in your clinic, you
might be sorely disappointedwhat your true healing rate is.
(28:08):
One hundred percent.
Speaker 3 (28:09):
That's what I say to everyone too, that my patients
do
Speaker 2 (28:11):
find out of We as clinicians have actually been
lived through that.
Speaker 3 (28:14):
Right?
Speaker 1 (28:14):
Right.
Speaker 3 (28:15):
I have. I know you have. Yes.
Speaker 2 (28:17):
We've done research on how things were going. That
was actually a segue for tryingthe Regenotin back in the day
was we we started MRIing people,and I was like, they're telling
me they're doing great early on,and they get the MRI back, and
they're like, oh, boy. This isnot
Speaker 3 (28:36):
Retear rates much higher than we thought. Yeah.
Speaker 2 (28:39):
They get worse as they, you know, five years,
seven years, ten
Speaker 1 (28:44):
years. Midterms. Yeah. That's when everything
starts falling apart.
Speaker 3 (28:47):
Yeah. Yep. I think that's what's so great about the
Ruiz Iban study, because earlyon they're doing great, but now
we know that long term they'regonna do great. Because we know
all outcome studies show that ahealed cuff performs much better
long term than a retorn cuff,even if they feel better
initially.
Speaker 2 (29:03):
For joint preservation and Yeah.
Everything. I mean, it justopens up. It protects the joint
to continue to do what it'ssupposed to do rather than just
progression of disease andreversal later. Absolutely.
Speaker 3 (29:16):
Yeah. You know? Reversing reversal mania.
Speaker 2 (29:19):
Yeah. So There you go.
Speaker 1 (29:20):
And it's a funny thing, you know. I used to think
about this implant, like, Oh,don't want to do it in my older
patients and that type of ideabecause presumably they have a
compromised healing environment.But I'm kind of like a little
bit reversed now. Like in theyounger patient with a medium
sized tear, we still knowthere's a known failure rate.
And if that patient re tears inthat young population, it's like
(29:42):
a disaster.
Speaker 3 (29:43):
Disaster.
Speaker 1 (29:44):
Because you have I truly believe you've got one
chance to heal this thing. Thefirst chance is your best
chance.
Speaker 3 (29:49):
Absolutely.
Speaker 1 (29:50):
And so I'm like, I know you're young, but I think
you should just have this.
Speaker 3 (29:53):
Oh, absolutely. I agree. Like, I had a guy that
fell skiing and he had a fourcentimeter full tear of super
infra. He was 48. Yeah.
And I put a REGENETEN on.Because I agree with you. This
is our best shot to get thisright and get this guy to heal.
Especially with that size tear.
Speaker 2 (30:10):
Yeah. It's that's the bad actor. Yep. Right? That's
that's the one thatstatistically is could very well
have a bad outcome.
Speaker 3 (30:19):
Totally. Because then when those do re tear, the tear
is huge. Yeah. And your tendonlooks like garbage.
Speaker 1 (30:25):
And you might be thinking about a different
operation now. Big time. It'slike, oh Transfer or yeah. It's
like, disaster time for thisperson.
Speaker 3 (30:35):
Exactly. Dermal allograft, which hates me as
much as I hate it. I
Speaker 2 (30:42):
could get on board with that.
Speaker 1 (30:46):
Very good, guys. Well, Michael, thank you for
joining me today. Scott, thankyou for joining me today.
Speaker 3 (30:51):
Thanks Ian.
Speaker 2 (30:52):
Certainly. I think this
Speaker 1 (30:53):
has been a very interesting discussion about
Regenetin and how it's reallychanged your practice related to
rotated cuff tears.
Speaker 3 (30:59):
How it's changed our patients' lives. I think we're
really making our patientsbetter. I agree.
Speaker 1 (31:04):
But there's actually even more information coming
out. Another prospectiverandomized level one study
showing REGENETEN improvingpatient's outcome again. But
thanks for joining me today onJoint Ventures by Smith and
Nephew Sport Medicine.
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