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CME Surgery

Ultrasound Guided Tendon Repair with dHACM Micronized Injectable

David Bernstein, DPM

David Bernstein, DPM reviews the usage of Ultrasonography as a diagnostic modality to evaluate musculoskeletal pathology. Dr Bernstein then offers a treatment protocol when pathology exists via ultrasound guided amnion-chorion allograft injections. He reviews which patients are appropriate candidates.

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Goals and Objectives
  1. Understand the regulatory process and properties of amnion-chorion membrane allograft.
  2. Analyze tendon pathology and treatment methods.
  3. Discuss the use of ultrasonography in the foot and ankle
  4. Explain the ultrasound guided amnion-chorion allograft injection procedure for longitudinal tendon tears.
  5. Delineate appropriate candidates for amnion-chorion allograft application for tendon pathology.
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  • CPME (Credits: 0.5)

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    Release Date: 03/16/2018 Expiration Date: 12/31/2018

  • Author
  • David Bernstein, DPM

    Residency Director at Bryn Mawr Hospital
    Chief of Podiatry Department at Main Line Health Systems
    Wayne, PA

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  • Lecture Transcript
  • TAPE STARTS – [00:00]


    Male Speaker: David you’re here right, David Bernstein well known to us, he was down stairs in the workshop yesterday. Ultrasound Guided Tendon Repair with dehydrated human amnion chorionic matrix micronized and injectable. So let’s welcome David Bernstein, thank you.

    David Bernstein: Okay, there you go there. Thank you. Good morning everyone. We’re going to change the direction just a little bit and demonstrate what we’ve been trying to do with a different approach to tendon repairs.

    And we’ve created basically a format, protocol that we think is on the correct track but we do think that we need to open our eyes to not who should get it but most important is, who shouldn’t have it done.

    I am a paid consultant for my medics, our learning objectives today are; for us to understand the different regulatory processes and we’ll go through it as quickly to get to the main portion of our discussion, Tendon Pathology where ultrasound is in the world, and foot and ankle procedures and who is the perfect candidate to have this done.

    We’ve gone over this before about donor suitability, how do we get our gift from the patients that we can make into a product that we can use, we all have been through the guidelines knowing how strict they are so that we can produce something that’s safe, workable and works great.

    We all know that the Amnion Chorions have an immune privilege that means that they are not rejected by the body, they have multiple effects on the body and even use in multiple places and I think the Amnion Chorion world is just starting to scratch the surface on what it can be used for fracture repairs.

    People are now injected into non-union to see how they can stimulate the growth of that, certainly soft tissue repairs, burns ulcers, skin grafting. Today we’re going to talk specifically though how about how we used dHACM in our hospital system for tendon repairs. Anti-inflammatory, anti-microbial, it’s all about the growth factors in our world. We think the growth factors are the most important thing, we think – we know they come from the mesenchymal stem cells, we don’t concern ourselves with living cells.

    When you look at the – where did they come from, this growth factors, you look at the Amnion and the Chorion and you can see from this picture that the Amnion provides a certain amount 238 identified different healing factors but a majority of them comes from the Chorion.

    And that tells us that if you put them both together, then you can provide a better level of patient care because you got a bigger gun to go after the injury that you are trying to cure.

    Traditionally when you treat a foot and ankle tendon injury, we’ve all been through the rise, the anti-inflammatories, we’re not a big fan of cortisone injections but we do them on a limited basis but we’re also looking at the basics of how they get the patients started down the road.

    After the patient has gone through a 4 to 6 weeks of the traditional treatments, they come back to the office and we have a discussion about how we can help them next. We order an MRI, we do an ultrasound on them and we find that if their tendon is a certain – injury is a certain size injury then we have to decide how we going to help them whether they are a candidate or not.

    And traditionally, when you’re repairing tendon tears, you’re looking at the debridement, you’re looking at tuberization, you’re looking at tenodesis and these have been the classic techniques whether you choose to use a graft material in there, I think you always should. I think you can provide a lot better healing with a combination of using something for strength and something for healing as tendon in my mind is a poor healing structure. So in patient selection, I think this is really the most important thing in how we go about treating these people and how we understand, how to prevent them from failure.

    And we work very hard to develop a protocol for each patient that is specified to their needs and their lifestyle, and how they can function and return to work as quickly as possible.

    [0:05:06]

    The key here is ultrasound guided injections have been around for many years and the idea of ultrasonic graft came by and in 1942, was the first time that was actually being used, but well before that, physicians were taking a needle and stimulating a tendon trying to break up the scar tissue trying to help with the healing but years and years ago they had nothing to add to it.

    Over the years, different products came on the market, we had – we’ve had platelets, we’ve had saline, we’ve had dextrose, cortisones, and now we have the luxury of choosing our different Amnion or Amnion-Chorion products to augment the healing.

    Ultrasound in my mind should be in every person’s office. Patients love the technology, you may not be able to pick up how bad the tear is, but you certainly can pick up where it is, you can show it to the patient, you can show them how thick their plantar fascia is, you can show them how thick their perineal is, or how thick their Achilles tendon is.

    You can also demonstrate you know – if it’s a significant tear. It can be picked up easy. The basic process of how we do it in the hospital as the patient comes in, it’s done as intravenous procedure, we do a nerve block, we identify the area, we use our ultrasound head to illustrate it on our screen, we debride the tendon, and the next slide or two, I will show you the protocol and the instruments that we use to deliver care to this injured body part.

    So in – how do you do it – I mean all tendons are different sizes. So we try to simplify with anterior posterior tibial tendons and perineal tendons and we get them to the OR, we prefer intravenous sedations, some people prefer regional, any type of sedation you want is fine.

    We like to use a sterile 25 gauge needle on a 10cc syringe so you actually have something to hold on to, and we will debride and go through that tendon with the ultrasound to guide us 10 times based on the size of the tendons meaning you’re not going to have much luck doing an 18 gauge needle on a perineal tendon you’ll pretty much shred it. So we drop down our needle size for the area that we are treating.

    That patient has a preoperative protocol. They’re made a custom made orthotic – is introduced to deal with their imbalances. It’s fitted in to their cam boot so the day they have their procedure, they’ll leave the OR with a bandied, ace bandage and will merely go into a cam boot with the fitted orthotic to help them.

    6 weeks is our standard post-op care where we hope to get them out of the cam boot, and 6 weeks longer is our goal. So over a 12-week period, that’s what we’re trying to accomplish.

    The Achilles tendon, and we’ll show you some examples of that, I use an 18-gauge needle, I go through it 15 times, I know I tear it up. I haven’t had one rupture yet, and as soon as I say I’ve never had then I’m sure I’ll run into that next week. But it’s important that you recognize whether you have a tendonitis, a tendinosis or a partial tear. You have an area that hasn’t responded to conservative therapy.

    So in the past, there was no other choice but to open it up and debride it, fix it, graft it. And now there is a choice and what I think our cutting edge process is, is to determine who is the candidate for that. There is no question that anything you inject amnion, chorion, into an injured body part whether it be an ulcer, whether it be a tendon, it’s going to help. The question is, how long does it last and does it provide the patient a long-term solution?

    When we look at ultrasound, the most important things about ultrasound is to look at it in the two planes. One is called longitudinal, and here you see the Achilles tendon going across the top of the screen in green. And you can see how the ultrasound head runs parallel to the tendon itself.

    The other way to look at it is transverse. But if you look at this slide really clearly here, you can see, here’s your Achilles tendon right here, here’s your calcaneus, here’s your different structures, Kager’s fat and you can measure the Achilles tendon quite easily in your office. So when you’re dealing with the larger tendons of the body, the Achilles tendon and the plantar fascia – not exactly a tendon – but the learning curve is not steep to evaluate the larger structure.

    [10:00]

    When you start getting into the smaller structures, that will show you a little bit better, the learning curve becomes even more involved.

    So we always examine our tendons from two different ways. In the transverse plane, now the tendon is coming directly out of the screen and it’s coming directly out you, so you can look at it and you can appreciate it. And the most important thing when you’re doing an ultrasound is to realize that you are taking a three-dimensional object and you’re putting it on a two-dimensional screen. So the constant adjustment of the ultrasound head eliminates the false positives. You can look at it a tendon and the way you hold the head, you will swear that you have a tear. But if you tilt it a certain way up, down, left, right, you will see these different areas disappear. But if you do an exam both longitudinally and transverse and you see the lesion on both, pretty sure it’s there.

    Here’s an example of what the schematic looks like in terms of the real deal. Here’s your Achilles tendon coming out at you. What you’re looking for when you’re looking at a tendon is you’re looking at what we refer to as a homogenous presentation. You’re looking for something where the colors and the shades of black and white are the same, there’s not a significant deficit as we’ll see in a couple of slides later on.

    And also knowing how big the tendon is helps you determine helps you determine when you do your procedure is how deep do you want to go. And of course, you have the ultrasound in the OR that can help you with that, but you at least need a starting point to know whether you need an 18 gauge 1-inch needle or an 18 gauge 1.5-inch to safely do your procedure.

    So the depth of the tendon and the debridement of the tendon, on the right here we show, the Achilles tendon in the transverse plane coming directly at us. And here we have an 18 gauge needle going across the tendon. So what our technique would be is we go in the side of the tendon and we will go 15 times in different directions, I’ll do seven or eight in the transverse plane and then I’ll switch in the longitudinal plane, do another seven or eight.

    And by passing the tendon through the – passing the needle through the injured part of the tendon, we have accomplished our debridement procedure, we have fenestrated the tendon, we have basically provided a debridement procedure of the damaged tendon tissue.

    Now, when we inject and inject our dHACM, we now have places for it to go. If anyone has ever done a cortisone shot into a tendon itself, it’s a pretty tough push with a syringe. Once you’ve debrided the tendon, now you can inject your dHACM and it will go in all the places that you created. So it’s very much – it’s just so important that you create a removal of the dead tissue, so that you can get right where you need to be.

    When you look at some of the other body parts and you require a little more technique in how you look at it, especially, when you look at the tarsal tunnel, we’re all aware of the, you know, Tom, Dick, very nervous Harry, and one of the neat things about it is when you look at it, you can see very clearly, here’s our posterior tibial tendon, here’s our flexor, here’s our neurovascular structure and our flexor hallucises over here.

    So one of the neat things about doing this procedure is there’s a color button and when you push the color button, your artery vein lights up. So if you’re moving your needle towards this area and it’s blinking, it’s exactly like the red light on the highway. Stop, turn and get away from it. So it’s the exact same concept that will give you a warning system to stay away from what you’re trying to debride or it will lead you the way you’re trying to debride and stay away from the vital structures that you don’t want anything to do with.

    In a longitudinal thing, when you look at peroneal tendons, now we’re looking at tendons that are far smaller. So here we have the brevis hugging the fibula, here we have the longus right behind it and as they come around the fibula, you can see them and they turn and go in different directions, and this is where it becomes essential by the examiner take the ultrasound head and constantly turn it in slightly different directions. And it’s similar to how we look at an MRI because when we’re tracing a peroneal tendon in an MRI, we know that’s it going to go in and out of all the different planes.

    So you’ll see it on one and then it disappears on another and depending on the thickness of the slice, so when you are doing an ultrasound study, it’s the same concept you have to recognize and this is why you have to go over it a couple of different times so here we have to transverse plane, where now the tendon is coming out at us and here’s a tendon – here’s an injured tendon, it’s a different shape altogether, and it’s quiet clear.

    [0:15:07]

    Here’s your fibula, here’s your injured tendon. See the difference between the two? That’s not good, that’s not good at all.

    But in the office it gives you that Intro information that says that patient walks out of your office knowing that they have an injured tendon, a partial tear and you set the stage for them starting their recovery, conservative care first and then move on to, based on the MRI, who gets it and who shouldn’t get it.

    So we’ve been very successful in doing this procedure but we’re getting better at it because we actually developed a protocol of the most important part is not who should have it, it’s who should not have it. And I think that is the key thing here. If you look here, here’s a classic transverse of an Achilles tendon and here’s your tear. And in that instance, we would debride that in two different plans and then inject our dHACM, but if we go back over here and we look, we believe that if a peroneal tendon tear is 1.5 centimeters or longer, we’re not going to touch it.

    Now the other factors that are so important is the what the patient brings into the examination. If you have an unstable foot, a cave of air, so if you have a ligament laxity, a positive drawer sign, you’re positive tilt, you can do your peroneal repair, it all heal great within, I would say two to three months because I’ve seen it come out of that boot, patients right back where they started from. And that’s the classic example of you recognize some of the pathology, but you didn’t take all of the pathology into account. So that’s a great example of a patient that should never have an ultrasound guided procedure because you’re not going to be able to use the ultrasound guided procedures to increase the stability of the ankle. You can repair the tendon on either side, but you can’t fix with debridement.

    Anterior-posterior tibial tendons, we follow the same protocol, we look for 1.5 centimeters on our MRI and that’s our make our break. With patients that have severe pronation or a flexible flat foot, these are the ones that we’ll still consider for the procedure, but don’t have that pre-operative cast molded orthotic scan or however you want to make your orthotic to be fitted into their CAM boot, and they’ll understand that they’ll wear that orthotic for the rest of our lives.

    And we you’re talking about some of the senior citizen population, they can never tolerate an open procedure. So many times the close procedure, we will stretch our boundaries a little based on the age of the patient, we can eliminate that patient pain, and they have to wear an orthotic, it’s a very acceptable outcome versus going through an open procedure.

    The Achilles tendon being the largest tenant in the body, we can really take a lot of laxity in how we approach it. We can literally chew it up pretty well with an 18-gauge needle, we can go at a pretty good longitudinal tear. And the key thought throughout my speech today or my talk today is to understand that we are talking about longitudinal tears. If you have a horizontal tear, we have purposely excluded this from our study because I believe that most of them, they need open repair.

    When we talk about the different ways that dHACM has brought changes in our lives, it’s surprising to everyone when you believe in one thing and you’re trained in one thing and then a new idea comes along and you have to figure out how to embrace it and how you safely incorporate it into your patient practice. What we found is this has allowed our patients to get back to work sooner. If a patient has a procedure on a Friday, they can drive a car on Monday, they can go back to work on Monday.

    Now if they have a 12-hour standing job, there has to be some modification, they’re not on crutches, they’re not taking narcotic pain medications. So as we gather more information and we have about seven doctors now at our hospital that do this on the regular basis, so we’re doing about 30 to 35 of them per month and with the communication between our stocks, we’re able to sit down, have a round table discussion about what works, what doesn’t work. We all know what works. Like I said the most important thing is figuring out exactly what doesn’t work.

    Over the years, the different products have gotten better and better. I’m a big fan of open surgery.

    [0:20:02]

    I think many tendon cases require the classic approach, but there is a certain patient population that the closed procedures are very successful on, and with proper patient education from day 1, so they have a chance to actually do a little bit of research. Patients today in the office are very smart, I love them, they come in with their own ideas about what they think they have and what they’re afraid they might need to have done.

    And you can tell them that, alright, now we do ultrasound procedures here and we do have the ability to do a closed procedure and get you back to work sooner, get you go back to your family whether you’re traveling, family, work. In many cases, that patient, if we do an open peroneus brevis repair, that patient is going to be in a cast four to six weeks, patient is going to be non-wait bearing, the patient is not going to be able to drive a car if it’s the right foot. They come out of that cast, we don’t know what that leg looks like. Now it needs a good six weeks of physical therapy and the end result is somewhere around 12 months or 12 weeks, it can be 16 or 18 until the patient is really comfortable on that repaired tendon.

    We see ourselves as achieving the same result, we are not getting a result, we are not healing it in 12 weeks, I’m sorry, we’re not healing it in 6 weeks, but at 12 weeks, we’re getting the job done and the patient might go on for a full six months for a complete healing, but it’s a process that allows them to work. It saves a tremendous amount of money, they need less physical therapy, they need less time spent away from family, time spent away from work. And in today’s world, everyone – I’m stealing this from someone else, time is money and it is. If you can provide your patients with a quality of care and something that works and reduce their time that they’re off from work, then you truly have done something special.

    I would just like to say thank you very much for giving me this opportunity to present our research. We welcome criticism; somebody had to create a protocol. Now we don’t think ours is the best, it’s the just the only one out there, maybe the Achilles tendon should be debrided more or less. We think our needle size is appropriate, we think our quantity of dHACM, of how much we inject is appropriate. We like our pre-imposed top care, we’re just not exactly sure that we have the right exact numbers on the size of the tear, the amount of disqualifying factors that the patient has and I think those signs have to be considered.

    You have to look at the whole patient, you have to consider what will work, what won’t work in that individual patient. And as long as we treat and we respect all our patients as individuals, one patient might be a good candidate and we know darn well the next patient is not. So I would like to thank you all for giving me a little bit a time to express what we’ve been doing at Bryn Mawr Hospital and thank you all.

    Chuck Owen, Dr. Owen, one quick comment. Chuck was one of the forerunners in providing what a dHACM injection can do for plantar fasciatis. We’ve taken Chuck’s idea and we’ve run with it. We actually do an ultrasound debridement of that plantar fascia. We release the medial one-third attached to the medial portion of the tuberosity as a closed procedure, then we inject the dHACM, then that patient goes into an orthotic and a CAM boot.

    So, I believe that following some of the traditions of injecting tendons with the needle, not injecting tendons, debriding tendons or tendon-like structure like the plantar fascia is always the first step. You got to clean out the damage, you have to debride it, fenestrate it, aerate it, whatever times you drag a needle across the damaged tendon area, that’s the first step in healing when conservative care hasn’t come. Thank you all very much.


    TAPE ENDS - [24:27]