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 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 available orthobiologics products in an easily searchable database, according to the release. The release noted it combines the most recent and readily available clinical evidence with guidance from 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, PhD, MBA, FAAOS, a member of the AAOS Committee on Devices, Biologics and Technology, said during a webinar.
Golish said the dashboard was designed to be intelligent and easy to use and 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,” he 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, the organizing principle will allow AAOS to “effectively synthesize the information and the highest quality information from all sources,” Golish said.
Use of the dashboard
To use the dashboard, surgeons enter four characteristics of the product, including the tissue type the product is derived from; the type of graft it is; the product’s processing method; and how the user plans to use the product, according to the release. The dashboard then visually illustrates the regulatory status of the orthobiologics product shown via a red, yellow or green color indicator. However, per the release, the color indicator 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 R. Dubin, MD, FAAOS, member of the AAOS Committee on Devices, Biologics and Technology, said during the webinar.
The release noted the dashboard is available exclusively to AAOS members and it will be updated and improved as evidence and federal guidance evolve and new products come on the market.
Position statement updates
The AAOS board of directors also has approved updated biologics-related position statements.
According to the release, the “Innovation and Novel Technologies in Orthopaedic Surgery” position statement highlights tracking clinical outcomes and adverse events associated with new technologies through open readily accessible databases, registries and other methods by the orthopedic specialty. The AAOS noted in the release that orthopedic surgeons should 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 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 surgery 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:
- AAOS advances biologics initiative with innovative dashboard. Available at: www.multivu.com/players/English/8776851-aaos-biologics-dashboard/. Accessed Jan. 13, 2021.
- 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).
- For more information:
- Jonathan R. Dubin, MD, FAAOS, can be reached at Truman Medical Centers/University Health, 2101 Charlotte St., Kansas City, MO 64108; email: jonathan.dubin@tmcmed.org.
- S. Raymond Golish, MD, PhD, MBA, FAAOS, can be reached at JFK Medical Center, 5301 S. Congress Ave., Atlantis, FL 33462; email: ray@golish.com.
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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