How Does Orthopedic Surgery Stack Up to Interventional Orthopedics?

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As I have shown a few times, orthopedic surgery has an embarrassingly poor evidence base. I recently covered a new study that helped confirm this issue a few weeks ago and I have since performed a deep dive to compare how Interventional Orthopedics stacks up. Let’s dive in.

The Old Gaurd versus the New Kid

One of the things that orthopedic surgery suffers from is that the basic technology is decades old and came into being at a time when there were very low research standards for surgical care. Take for example a knee replacement. If this procedure didn’t exist and I were to propose to the FDA and insurance companies today that I wanted to amputate a major part of someone’s body and insert a metal and plastic replacement, both would require large randomized controlled trials and a decade of research before allowing this to be approved and covered. Despite that, it took decades before someone tested a knee replacement against conservative care. Why is that a big deal? Because we didn’t know until that study that whacking out someone’s knee joint and replacing it with a prosthesis was better than going to physical therapy. In addition, we still don’t have a single study that compares a knee replacement to a placebo procedure (the medical term is sham). Why is that critical? Because the placebo effect of major surgery is HUGE.

On the other hand, any new therapy coming into being in the 21st century has been placed through a comparative research gauntlet. Randomized controlled trials are required to even have the conversation of whether something can get insurance coverage. Hence, regenerative medicine has had to move quickly into higher-level research that often exceeds the research base for the procedures being replaced. For example, while it took almost half a century for someone to publish a single RCT on knee replacement versus conservative care, a single decade has passed since providers began using PRP to treat knee arthritis and now we have more than two dozen randomized controlled trials showing it’s efficacy.

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The Recent UK Study

You probably remember this graph from a few weeks ago. It’s from a UK study that reviewed hundreds of high-level studies on orthopedic surgery to find the handful that actually compared surgery to conservative care or placebo (1). Meaning that there is no scientific rationale for pulling the trigger on an invasive surgery if there is no data showing that the surgery is better than something less invasive or doing nothing. This meta-analysis concluded that 9/10 of the most common orthopedic surgeries in use today had no basic scientific evidence that they are effective.

A colleague asked the interesting question last week of how Interventional Orthopedics would stack up? More on that below.

How Does Interventional Orthopedics Measure Up?

First, what is Interventional Orthopedics (aka Interventional Orthobiologics)? These are procedures that use precise image-guided platelet-rich plasma (PRP) and bone marrow concentrate (BMC) injections to help heal or manage orthopedic tissue damage. There are other things that can be injected as well and they often replace the need for invasive orthopedic surgery. Hence, it’s reasonable to ask how they stack up using the same 10 clinical conditions listed above.

For this review, I searched the US National Library of Medicine for the same diagnoses being treated above for randomized controlled trials (RCTs) comparing PRP or BMC to conservative care or placebo (2-41). I tried to match (as best I could) the same clinical indications that prompt the surgeries in the above table. In some instances (like rotator cuff tear), that only a partial match as that surgery can be performed for anything from massive to partial tears and massive tears are not candidates for PRP or BMC injection. This data produced this new table:

The two new columns are off on the right in the red box. Notice that there are generally more RCTs for Interventional Orthopedics (IO) procedures than the surgical column entitled “Surgery Better than Conservative Care”. Hence, it’s not hard to conclude that IO is killing it versus surgery.

Let’s take the example of knee replacement. We have one RCT showing that knee replacement is better than physical therapy, but NONE showing it’s better than a faked placebo procedure. On the IO side, we have about two dozen RCTs that show that PRP works to treat knee arthritis against placebo and various other injection treatments. We also have 3 RCTs that show that BMC injections are effective when compared to knee replacement or physical therapy. Again, because IO is newer, its basic evidence base is BETTER than surgery.

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Where Could This Head?

I really think that in another 5 years that the evidence base supporting IO therapies could be so much better than surgery that national health systems and insurers could make a legitimate scientific argument that they need to start limiting coverage for orthopedic surgery in certain clinical situations in favor of Interventional Orthopedics. Meaning if I were an orthopedic surgeon, I would be concerned and pushing my colleagues to perform more basic studies versus conservative care.

The upshot? IO compares favorably to and in many instances beats the pants off of the basic science behind orthopedic surgery. Given that many of these PRP and BMC RCTs have been published in the past 12 months and that they are coming at a furious pace right now, the evidence base supporting IO is strong and getting stronger every month. I wish I could say the same about orthopedic surgery.

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References:

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  2. Centeno et al. Submitted for publication.
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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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NOTE: This blog post provides general information to help the reader better understand regenerative medicine, musculoskeletal health, and related subjects. All content provided in this blog, website, or any linked materials, including text, graphics, images, patient profiles, outcomes, and information, are not intended and should not be considered or used as a substitute for medical advice, diagnosis, or treatment. Please always consult with a professional and certified healthcare provider to discuss if a treatment is right for you.

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