AAOS provides information on appropriate use of orthobiologics
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SAN DIEGO — With a rise in interest in orthobiologics, the American Academy of Orthopaedic Surgeons has developed tools to educate orthopedic surgeons on when it is appropriate to use orthobiologics in practice.
One of the biggest challenges that surrounds the use of orthobiologics in orthopedic surgery is the lack of clear guidance from the FDA, according to David S. Jevsevar, MD, MBA, FAAOS, chair of the AAOS Committee on Devices, Biologics and Technology. However, he noted the FDA had begun requiring evidence on orthobiologics currently available and those coming to market.
“It is burdensome but the companies that are in the market and coming into the market, they have to provide better evidence for the things they are doing for the FDA to OK them,” Jevsevar told Healio Orthopedics.
Biologics dashboard
Working with guidance from the FDA, Jevsevar noted the AAOS Committee on Devices, Biologics and Technologies developed the AAOS Biologics Dashboard. Launched in November 2020, he said the AAOS Biologics Dashboard was created to help orthopedic surgeons identify how, why and when an orthobiologics product could be used through a “red light/yellow light/green light” system.
“Red light means you should not use it. There is no evidence and there is no FDA approval for it,” Jevsevar said.
He added a green light means the product is appropriate to use, while a yellow light indicates there is either no evidence or unclear evidence for the use of the product.
“As an example, [platelet-rich plasma] PRP is indicated for augmentation for something like spinal arthrodesis, spinal fusion,” Jevsevar said. “There are a number of companies that have taken PRP and are applying it in other areas where there may or may not be real evidence or indications to use it. So, that would be an example of another reason why we give something the yellow light.”
Evidence-based systematic reviews
For products that fall under the yellow light indication, the AAOS Committee on Devices, Biologics and Technologies plans to perform evidence-based systematic reviews of the orthobiologics products or interventions and possible indications, according to Jevsevar.
“It can be challenging to read through all of the literature and make heads or tails of it. We are trying to get rid of the need for people to do that and provide them easy access to information that would be easy for our members to read and provide them with some good data to move forward,” Jevsevar said. “Everybody wants to do things that are right, and nobody wants to do things that do not work.”
As the AAOS continues to gather information regarding orthobiologics, Jevsevar noted orthopedic surgeons should take time to understand if a certain orthobiologic they want to use for a certain indication has supporting evidence.
“If it does, make sure you are following the evidence as to how to use it specifically, because that is the other area where we see deviations,” Jevsevar said. “Some of the products do work well when used for specific indications and in a specific way. So, we want to make sure that we cover all bases.”
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