What Level of Evidence Do Physicians Believe They Need to Use Orthobiologics?

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This past long weekend I ran a few polls on LinkedIn. One of the most fascinating was to find out how much scientific evidence most physicians believe they need to begin using an orthobiologic. This was especially important given that we have seen a number of news stories where some university talking heads with no or little experience using orthobiologics claim that no physician should be using them without what’s called “Level 1” evidence. So what do actual practicing physicians believe? After all, what most physicians say is the practice of medicine is in fact the practice of medicine. Let’s dig in.

What is an Orthobiologic?

Here we’re discussing autologous orthobiologics which are things like platelet-rich plasma, bone marrow concentrate, fat grafts like Lipogems, cytokine enriched plasmas and similar products. These are all minimally manipulated substances derived from your body and injected back into your body to help heal musculoskeletal damage.

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What is “Level 1” Evidence?

Medicine is run mostly on research. That’s good, as more information about whether some treatment works is always better than less. However, there’s an aspirational goal of “Level 1″ evidence which means that the treatment has undergone a randomized controlled trial and shown to be effective.

This goal is aspirational and not a hard and fast actual rule, despite the protestations of some academics. Why? The reason is that practicing physicians are often presented with unique patients with unique problems who don’t fit well into any prior study result. An example is orthopedic surgery, where many procedures don’t have level 1 evidence support. Some other procedures, like partial meniscectomy, are still widely performed but have been shown through level 1 evidence to be ineffective. Hence, in medicine, level 1 evidence seems to be more a goal to strive for than something that’s widely practiced.

Practice and Theory

This is one of my favorite quotes:

“In theory, there is no difference between theory and practice; but in practice, there is.”

It’s been attributed to many people including Yogi Berra and Einstein, but it’s older than that. However, it’s very appropriate for the results of the poll I took, so let’s dig in.

Do You Need an RCT?

The answer to this first question says it all, 90% of physicians actually using orthobiologics don’t believe they need level 1 evidence to use the stuff. That’s in direct contradiction to the university talking heads that show up in these stories. Why the disconnect? I suspect that our quote above applies. If you’re in the trenches treating patients you have a different view about evidence than someone who lives in an Ivory Tower.

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What Level of Evidence Do You Need?

This one is interesting, as you can see a clear cluster in the middle of the evidence spectrum. Meaning, most physicians said somewhere between case reports and comparison trials, or lower level evidence.

What Do You Use?

Here, most physicians use PRP and Bone Marrow Concentrate. Some use cytokine enriched plasmas like A2M and platelet lysate. The minority use fat or birth tissues.

How Often Do You Use It?

Here, about a third of doctors use orthobiologics daily. However, adding up the bottom two categories, we have 40% who use them very frequently (more than half of their entire practice). Under 14% use them less than daily and a whopping 86% use them at least daily!

The upshot? I think this poll makes clear that what we’re seeing in the media stories is Ivory Tower theory versus the reality of medical practice. Meaning, orthobiologics are being used widely, despite the hand wringing of a handful of academics. In addition, the vast majority of physicians actually practicing medicine and taking care of patients believe that much less evidence is required to use these healing tools than some academics claim.

Chris Centeno, MD is a specialist in regenerative medicine and the new field of Interventional Orthopedics. Centeno pioneered orthopedic stem cell procedures in 2005 and is responsible for a large amount of the published research on stem cell use for orthopedic applications. View Profile

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