“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,” said David S. Jevsevar, MD, MBA, FAAOS, Chair of the AAOS Committee on Devices, Biologics & Technology. “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.”
Understanding the Safety and Efficacy of Orthobiologic Interventions
The AAOS Biologics Dashboard is an online, interactive tool that aggregates the various types of orthobiologics products that are currently available in an easily searchable database. Available exclusively to AAOS members on the website (www.aaos.org/biologics), the dashboard was conceptualized and built from the ground up by orthopaedic surgeons across a variety of specialties who serve on the AAOS’ Committee on Devices, Biologics & Technology (DBT). The tool combines the most recent and readily available clinical evidence with guidance released by the U.S. Food and Drug Administration.
“Until now, there was not a tool or platform that could help our members clearly navigate emergent and established biologic-based products, the evidence which has accompanied their coming to market, and the various FDA approval pathways that exist for these types of products,” added Dr. Jevsevar. “We are excited to now be able to synthesize multiple regulatory guidance documents and principles with only a few clicks.”
The AAOS Biologics Dashboard allows the user to enter four characteristics of the product, including the tissue type the product is derived from, whether it is autograft (a patient’s self), allograft (from another person), or xenograft (from an animal), how the product is processed, and what use the user is considering for the product. Once inputted, the dashboard will reveal a red, yellow or green color indicator to help visually illustrate the regulatory status of the orthobiologics product shown. While not intended to be a definitive end point or imply endorsement, efficacy, or appropriateness for use by the AAOS, the color indicator offers guidance, rationale, and reference in one convenient tool.
As available evidence and federal guidance evolve, and new products come on the market, the AAOS Biologics Dashboard will also continue to be updated and improved to best serve AAOS members and their patients.
Updated Position Statements
Continuing on its mission to deliver accurate and evidence-based orthobiologics content related to musculoskeletal care and treatment, the AAOS Board of Directors recently approved two updated biologics-related position statements. These include:
- “Innovation and Novel Technologies in Orthopaedic Surgery” ― This position statement notes that it is incumbent upon the orthopaedic specialty to track the clinical outcomes and adverse events associated with new technologies using open readily-accessible databases, registries, and other methodologies to ensure that patients and society in general realize the benefits of these innovations and avoid undue risks. The AAOS believes that orthopaedic surgeons need to be aware that even though a product is marketed in the United States, having undergone regulatory review with the FDA, there may be lack of data or uncertainty around the long-term safety and efficacy profile of these products.
- “Use of Emerging Biologic Therapies” ― This 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,” said Martha Murray, MD, FAAOS, Professor of Orthopaedic Surgery at Boston Children’s Hospital and Harvard Medical School and Committee on Devices, Biologics & Technology member. “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.”
For more information about the AAOS’ efforts in orthobiologics, visit www.aaos.org/biologics. To speak with a member of the DBT Committee about how the AAOS is leading the way in evidence-based medicine as it pertains to the field of orthobiologics and the future of patient care or to request media access to the AAOS Biologics Dashboard, email [email protected]
About the AAOS
With more than 39,000 members, the American Academy of Orthopaedic Surgeons is the world’s largest medical association of musculoskeletal specialists. The AAOS is the trusted leader in advancing musculoskeletal health. It provides the highest quality, most comprehensive education to help orthopaedic surgeons and allied health professionals at every career level best treat patients in their daily practices. The AAOS is the source for information on bone and joint conditions, treatments and related musculoskeletal health care issues and it leads the health care discussion on advancing quality.
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