AAOS to navigate biologic-based interventions with new online tool
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The American Academy of Orthopaedic Surgeons launched a biologics dashboard, which is an online interactive tool, to help orthopedic surgeons navigate the approval status of biologic-based interventions.
“Orthobiologics is an evolving frontier. As new therapies, such as regenerative medicine therapies and stem-cell injections, become increasingly popular due to their potential to regenerate tissue and enhance bone healing and reduce pain, the AAOS continues to recognize a need for reliable and credible sources of evidence-based information,” David S. Jevsevar, MD, MBA, FAAOS, chair of the AAOS Committee on Devices, Biologics and Technology, said in a press release. “These new tools further validate AAOS’ leadership in separating science from hope with the goal of helping patients receive the highest quality of evidence-based care.”
Principles of the biologics dashboard
Conceptualized and built from the ground up by orthopedic surgeons across a variety of specialties, the AAOS Biologics Dashboard is an online interactive tool that aggregates the various types of orthobiologics products currently available in an easily searchable database, according to the release. The release noted it combines the most recent and readily available clinical evidence with guidance released by the FDA.
“When we conceptualized the AAOS Biologics Dashboard, we aimed to create an intelligent information system unlike any other in the orthopedic space,” S. Raymond Golish, MD, MBA, PhD, FAAOS, a member of the AAOS Committee on Devices, Biologics and Technology, said in a webinar hosted Nov. 12, 2020, introducing the AAOS Biologics Dashboard.
Golish noted the AAOS Biologics Dashboard was designed to be intelligent and easy to use for the practicing surgeon. He added it was also designed to “stick close to the source material when there are clear regulatory or evidentiary recommendations.”
“I emphasize the regulatory piece because this is what makes something ... legal to do in the United States and, therefore, available for patient care,” Golish said. “The evidentiary piece is directly related to the highest quality evidence that is often available from randomized clinical trials that are used for regulatory purposes.”
Finally, when no consensus is available in biologics, Golish said the organizing principle will allow the AAOS to “effectively synthesize the information and the highest quality information from all sources.”
Use of the biologics dashboard
To use the dashboard, the release noted surgeons enter four characteristics of the product, including the tissue type the product is derived from; whether it is autograft, allograft or xenograft; how the product is processed; and how the user is considering using the product. After all information is provided, the dashboard visually illustrates the regulatory status of the orthobiologics product shown by providing a red, yellow or green color indicator, according to the release. However, the release added the color indicator only offers guidance, rationale and reference in one convenient tool and is not intended to be a definitive endpoint or imply endorsement, efficacy or appropriateness for use by the AAOS.
“It is up to the individual physicians to make decisions with their patients on what treatment is best and the [AAOS Biologics Dashboard] is designed to specifically help guide the membership in this discussion,” Jonathan Dubin, MD, FAAOS, member of the AAOS Committee on Devices, Biologics and Technology, said during the webinar.
Available exclusively to AAOS members, the release noted the dashboard will continue to be updated and improved as available evidence and federal guidance evolve, and new products come on the market.
Position statement updates
In addition to the launch of the biologics dashboard, the board of directors of the AAOS approved two updated biologics-related position statements.
The “Innovation and Novel Technologies in Orthopaedic Surgery” position statement highlights the importance of tracking the clinical outcomes and adverse events associated with new technologies through open readily accessible databases, registries and other methods by the orthopedic specialty, according to the release. The release noted tracking these outcomes ensures patients and society in general realize the benefits of these innovations and avoid undue risks. The AAOS noted orthopedic surgeons should also be aware of the lack of data or uncertainty around the long-term safety and efficacy of these products, despite having undergone FDA review.
The release noted the “Use of Emerging Biologic Therapies” position statement stresses the importance of understanding the risks and benefits of stem cell and other biologic treatments for musculoskeletal joint conditions.
“As the world’s largest medical association of musculoskeletal specialists, we have a tremendous opportunity and responsibility to educate our patients about available evidence for orthobiologics treatments and to vastly improve patient care within this space,” Martha Murray, MD, FAAOS, professor of orthopedic surgeon at Boston Children’s Hospital and Harvard Medical School and AAOS Committee on Devices, Biologics and Technology member, said in the release. “By updating these AAOS position statements with standardized, modern language, we are able to better hold our specialty accountable with reference to current FDA regulatory pathways.”
References:
Dubin JR. FDA regulation of devices. Presented at: Introduction to Biologics Dashboard. Nov. 12, 2020 (virtual).
Golish SR. Green light demo. Presented at: Introduction to Biologics Dashboard. Nov. 12, 2020 (virtual).
Perspective
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Bert R. Mandelbaum, MD, DHL(hon)
Our dynamic world is defined today through innovation and technology that includes robotics, informatics, nanotechnology and biologics. These technologies and the developments accelerate through the kinetics of Moore’s law and follow Rogers’s Diffusion of Innovation Theory with respect to innovation and adoption leading to clinical practice. All orthopedic surgeons are confronted with regulatory, scientific efficacy and safety and socioeconomic nuances and realities of how best to incorporate orthobiologics into practice. The AAOS dashboard tool provides the clinician additional practical, meaningful evidence, guidelines and guidance to navigate through the gap between hope and knowledge.
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