YES, THERE IS EVIDENCE THAT ORTHOBIOLOGICS DOES WORK!
In this issue of the The Orthobiologic Clinic News, we are going to compare research supporting Orthopedic Surgery procedures to the research supporting Orthobiologics. Believe it or not, new research studies show, that orthopedic surgeons have a long way to go before most of their surgeries have that same high-level research backing. Most referring primary care physician are not aware of this issue, likely because of the newness of Orthobiologics. Also, many are fearful because of the unscrupulous providers out there peddling unapproved procedures that have no scientific backing, just to make a buck. This puts us physicians that do legitimate Orthobiologics in a bad light and in the position of having to educate our colleagues about what we do. I have to admit that when I was first introduced to this new field of medicine, I was a little skeptical about some of the things I heard. It was not until I delved into books on the subject and attended conferences hosted by reputable societies such as the Interventional Orthobiologic Foundation (IOF), of which I am now a Fellow Member, and The Orthobilogic Institute (TOBI), did I start to dicover that this new field of medicine can help many many patients with orthopedic conditions, spine conditions and sports injuries. Orthobiologics can also sometimes help some patients avoid surgery which is always a higher risk procedure than a simple injection of Platelet Rich plasma(PRP), or Bone Marrow Concentrate(BMC).
HOW DID I GET HERE?
You may ask how did I get to where I am in this new field of Medicine and what influenced me to investigate it further? As an anesthesiolgist and interventional pain physician I got discouraged with doing cortisone injections and other procedures like spinal cord stimulators and even destructive procedures like ablations that would not last and and in the long run made things worse. I also got sick and tired of dealing with drug addicts being referred to my office by every Tom, Dick and Harry in town after they became a problem for them. I knew there had to be a better way to deal with with painful conditions.
SO WHAT CAME FIRST?
The first technique in Regenerative Medicie which I mastered was Hypertonic Glucose Prolotherapy of which the US surgeon general Chris Evertt Koop was a great supporter. I was influenced into this new field by my friend Felix Linetsky MD who has written many books chaters on the subject.
MY FIRST PATIENT
Believe it or not, my fist patient was a very important one to me, not only because it was my first one but because she was our youngest daughter. She had suffered and ankle injury palying sports. From here I expanded into Platelet Rich Plasma (PRP), Bone Marrow Concentrate and Fat Transfer procedures such as Progenekine. From then on it has been ten years of learning attending international conferences and implementing the newest techniques in our office to help our patients.
LEVEL OF STRENGTHOF EVIDENCE IN MEDICAL RESEARCH.
In medicine it is vital that before we start to use any treatment modality we ascertain that it is safe and efficacious for the condition being treated. In the field of Orthobiologics we have researcher like for example Don Buford MD, Chris Centeno MD and Peter Evert PhD FSRM, among several others doing the research to have the needed evidence that Orthobiologics is safe and that it can really work.
Evidence in medical research studies is basically divided into five levels, with level 1 evidence being the best.
Level 1. In this group, there are the randomized controlled trials, or the review of several randomized controlled trials.
Level 2. This group is reserved for non-randomized studies where treatment A is compared to treament B
Level 3. This group is a case-controlled study or one where the records of patients who have had a specific treatment are picked apart to see why some responded and others did not.
Level 4. A case series or group of patients who are followed to see how they responded to a particular modality.
Level 5. This is basically just an expert opinion.
TWO GROUPS OF ORTHOPEDIC SURGEONS.
As Dr. Centeno puts it, we basically can devide orthopedic surgeons into two groups:
a) Forward thinking open minded orthopedic surgeons that have seen the light and have embraced Orthobiologics. These don’t feel threatened by the idea that Platelet Rich Plasma (PRP) or Bone Marrow Concentrate (BMC) procedure may take the place of some surgical procedures. These surgeons offer PRP and BMC to their patient. They are the exception.
b) Close minded, not forward thinking orthopedic surgeons that feel very theartened by regenerative medicine. They like to say that the only way for them to embrace regenerative procedures, is that level one evidence needs to exist. However, they conveniently forget that many of the orthopedic surgical procedure they already perform, do not have that level one evidence. In fact, orthopedic surgery is one of the most poorly studied disciplines.
Presently, to the surprise of this second group of orthopedic surgeons, there is a study by a prominent orthopedic surgeon in Dallas Texas by the name of Dr. Don Buford, who himself embraces the use of Orthobiologics. Dr. Buford’s study brings to light that the average level of evidence available for traditional orthopedic surgery is a level 3. Think about that for a minute! Getting a new drug approved so that it can be used by an internist requires level 1 evidence! A new surgical procedure? Only a level 3 or less!! Follow this link to read Dr. Buford study:
https://www.dropbox.com/s/m4ui4b25v0nk4hd/Avg%20level%20of%20Evidence%20paper%2012%3A7%3A20.pdf?dl=0
Another interesting article to read is a review titled “Platelet Rich Plasma in Orthopedic Surgical Madicine” in the Journal “Platelets” in which Peter Everets PhD of Golf Coast Biologics is one of the authors. Here is the link:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7589810/
LET’S COMPARE THE QUALITY OF ORTHOPEDIC SURGEY RESEARCH VS ORTHOBIOLOGICS.
1. Taking the two most commonly used Orthobiologics, that is PRP and BMC for knee arthritis, there are 3 level 1 studies supporting the use of PRP and BMC.
2. Total knee replacement compared to physical therapy has only one level 1 study supporting its use!
3. If we compare Platelet Rich Plasma and Bone Marrow Concentrate to knee meniscectomy, it gets even worse. Here we have three level one study showing that knee meniscectomy is ineffective!
The above information tells you that common regenerative medicine procedure, such as PRP and BMC, used in common orthopedic conditions have better supporting evidence than surgery.
This evidence must not be well known out there among fellow physicians when they keep referring these patients for surgery, in spite of the poor evidence available for it. Not only are the results of surgery poor, but surgeries also summit the patients to the unnecessary risk of meniscectomy or knee replacement. Not that surgery is never indicated, but it certainly should not be the first choice! It should be the last !
FACTORS TO CONSIDER WHEN CONTEMPLATING TOTAL KNEE REPALCEMENT
Most of the patients view surgery as like getting a part fixed in their car. A part wears out, so you replace it or “fix it” with a new one.
I prefer to look at it like Doctor Centeno describes it: “Surgery is damage to accomplish a goal,” and that goal is not always accomplished. Let’s take this surgical damage concept to the knee. The damage caused during a knee replacement procedure is significant. Piece of cake!! Muscles split or cut, tendons cut, nerves pulled, bones cut, ligaments and tendons stretched. Minor stuff! Here are some issues to consider. Check this link:
https://www.theorthobiologicclinic.com/blog/facts-about-knee-replacement
What follows under the next heading is quote taken in its entirety from a blog by Dr. Chris Centeno, a pioneer in the field of Orthobiologics and the founder of the Interventional Orthobilogic Foundation. I sincerely believe it addresses the cause of the problem in Orthobiologics.
Interventonal Orthobiologics Upsets the Orthopedics Hegemony.
“Here’s my thesis. Orthopedic surgeons have long been kings of the hill when it comes to the definitive treatment of musculoskeletal problems. In a world where the conservative treatment options are steroid injections or physical therapy, that makes sense, as only orthopedic surgeons could deploy solutions that made an attempt at repairing or restructuring bones, cartilage, ligaments, muscles, or tendons. However, with the advent of orthobiologics, all of that dramatically changes. Let’s explore why.
If substances exist that can be precisely injected with imaging guidance, that can help tissues heal and reduce the need for surgery, then surgical rates begin dropping, and the status of orthopedic surgery changes. We know this because this is what has already happened in cardiothoracic surgery. For example, as interventional cardiology solutions like x-ray-guided and catheter-deployed stents came into common use, open heart surgery rates plummeted. The cardiothoracic surgeons went from kings of the proverbial heart care hill to only treating severe cardiac disease, with interventional cardiologists supplanting them as the primary providers for cardiac care.
To explore the disruptive impact of interventional orthobiologics further, let’s look at just three of about 100 orthopedic surgical procedures that will soon compete head to head with Interventional orthobiologics. First, let’s take the results of our Perc-ACL injection procedure Randomized Controlled Trial (RCT) and imaging case series (1-3). Based on an analysis of the data, I would estimate that somewhere between half to 2/3rds of every patient in the US who currently now gets an ACL reconstruction can be treated with a precise injection of bone marrow concentrate instead (1). Our case series and RCT data show the same for rotator cuff tears and the need for surgical repair (4,5). Finally, it’s clear based on our published knee arthritis case series and RCT and two RCTs published by Herigou that some percentage of knee replacements could be pushed off many years or not needed at all (6-8,13,14).
Let’s now explore how that impacts surgical rates by looking at how many of these orthopedic procedures are performed annually. On an annual basis, there are now approximately 100K ACL reconstruction procedures, 460K rotator cuff procedures, and 800K knee replacement surgeries that would be impacted. If half of those surgeries are no longer needed, that’s a drop in about 700,000 procedures annually. If you add in the dozens of orthopedic surgeries that would be prevented by the widespread adoption of interventional orthobiologics, millions of surgeries will no longer be needed.
Hence, interventional orthobiologics presents a first-in-history threat to the orthopedic surgery hegemony. On the one hand, it’s potentially devastating. On the other, if this is going to happen, then if you’re an orthopedic surgeon, you need to get a handle on this phenomenon and control it.”
For a consultation with Dr. Dieguez for him to evaluate your conditon and see if you are a candidate for any of these advanced procedures, please call our office in at (904) 824-0955. For additional information about our practice please visit our website at www.TheOrthobiologicClinic.com. You may also want to follow office Facebook page at https://www.facebook.com/TheOrthobiologicClinic .
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