Jason Dragoo, MD, highlights AAOS’ current and future biologics initiatives designed to support orthopaedic care

As both patient and surgeon interest in orthobiologics grows, AAOS has plans to expand its offering of resources to help its membership make evidence-based decisions when incorporating these products into clinical care. AAOS Now Editor-in-Chief Robert M. Orfaly, MD, MBA, FAAOS, sat down with Jason Dragoo, MD, FAAOS, chair of the AAOS Devices, Biologics, and Technology (DBT) Committee, to explore what is currently available to help surgeons navigate the biologics space and what is coming down the pike.

Dr. Orfaly: What work has the DBT Committee already done with biologics — including the Biologics Dashboard and other Academy resources — that not everyone may know about?
Dr. Dragoo: There are a couple of resources that have been available to orthopaedic surgeons on the Academy website. As part of that, the DBT Committee portion allows members to access real-time dashboards and get information on product recalls through the Biologics Dashboard. If you’re confused as a surgeon if a product is legal to use per the FDA, etc., [the dashboard] will give you feedback on the use of that product and at least the regulatory background of it.

We do multiple symposia every year in biologics, many of which are in collaboration with the Biologic Association. We also provide a lot of education, a lot of updates to surgeons about this vastly changing area of innovation, technology, and biologics.

As the Academy moves toward a focus on direct patient communication and interaction, what do you foresee for the DBT Committee interacting directly with the public? Obviously, there’s a ton of misinformation about biologics in particular, and people spending a lot of time and money on products that might not have any clinical value.
If you’re a patient, this is even more confusing than if you’re a doctor because you see the billboards [for biologic products when you are] driving down the street, and it’s hard to know what’s true and what’s not true. The DBT Committee is doing a lot of work by providing information at OrthoInfo, which is the Academy’s patient-facing site, regarding biologics, such as: What is a stem cell? What should I be asking for if I’m interested in biologics? What are the typical costs of these treatments? What are the typical results that can be expected from treatment with a biologic?

Now the latest innovation is the registry. Why don’t you tell us more about that?
I think most surgeons would agree that there’s a paucity of literature in this area [but] lots of interest. Patients come into the office wanting biologics of basically any type, and then surgeons say, “Well, okay, maybe that’s something that I can consider, but what’s the evidence and what are the guiding principles of its use?” And if you then go one step further and [wonder,] “Well, why is the literature not there?” Randomized, controlled trials are very expensive, so it’s very difficult — especially when this technology is changing so much — to spend three to five years with a randomized trial.

One of the best resources that AAOS provides is the Registry Program, and they’ve been collecting information on joint replacement, oncology cases, shoulder and elbow cases, and the list goes on. The new program that we’ve spearheaded in our committee is a new biologics registry here at the Academy. We are very excited to start this, because that’s going to involve a huge collection of patients, so we’ll get more information [on the performance of biologic products].

What’s also new is that this registry is linked to a biorepository run by the Biologic Association, the BARB Biorepository. At the end of the day, we’re going to have outcomes and demographics.

We’re also going to have all the science behind what was actually in patients’ tissues, and we’re going to be able to judge [whether] a certain specimen did not respond. That data will allow us to build better biologics in the future.

If someone wants to participate in that, what are the first necessary steps to contact AAOS to get involved?
The key to a new registry is starting small. We’re going to start with 10 centers and get this process honed right and get the data collection, the integration with medical records, the biological/blood assessment, and all of that integrated at 10 centers. Then we will methodically increase that over the next three to five years. Then that is a perfect time to contact the DBT Committee and Biologic Association to say, “I want my center to be a part of this registry program.”

Robert M. Orfaly, MD, MBA, FAAOS, is a professor in the Department of Orthopaedics and Rehabilitation at Oregon Health and Science University. He is also the editor-in-chief of AAOS Now and chair of the AAOS Now Editorial Board.