AAOS Establishes Orthobiologics Registry to Advance Evidence-Based Orthobiologics Research

Pilot program addresses critical evidence gap in emerging regenerative medicine treatments for 32.5 million Americans with knee osteoarthritis

ROSEMONT, Ill., Dec. 5, 2025 /PRNewswire/ -- The American Academy of Orthopaedic Surgeons (AAOS) announced the development of the AAOS Orthobiologics Registry (OBR), a disease and condition-focused registry designed to measure the long-term safety, efficacy, and real-world outcomes of orthobiologic therapies for patients diagnosed with knee osteoarthritis. The pilot program will begin with 10 participating sites, with plans for methodical expansion over the next three to five years.

With an estimated 32.5 million American adults suffering from symptomatic knee osteoarthritis and direct medical costs exceeding $65 billion annually¹, the need for reliable, evidence-based data on emerging treatment options has never been more critical. Orthobiologics therapies that leverage the body's natural healing processes, including platelet-rich plasma (PRP) injections and other blood-derived injectables, have gained popularity as alternatives to traditional treatments, yet robust real-world data on their effectiveness remains limited.

"As orthobiologics continue to grow in popularity, we're at a critical juncture where we need facts, not fiction, about their effectiveness," said Jason Dragoo, MD, FAAOS, chair of the AAOS OBR and AAOS Committee on Devices, Biologics and Technology. "This registry will help us understand which patients benefit most from these therapies and under what circumstances, ultimately guiding orthopaedic surgeons in providing the highest quality, evidence-based care to their patients dealing with osteoarthritis of the knee."

Addressing a Critical Gap in Orthobiologics Evidence
The AAOS OBR directly addresses AAOS' mission to provide the highest quality musculoskeletal care through evidence-based practice. Despite growing patient interest in orthobiologics, current AAOS guidelines call for additional research on orthobiologics use. While PRP treatments have shown promise in improving some patient-reported outcomes, existing studies have substantial limitations, including inconsistent reporting of treatment protocols and a lack of long-term data².

"As new therapies become increasingly popular due to their potential to regenerate tissue, enhance bone healing, and reduce pain, AAOS recognizes the need for reliable and credible sources of evidence-based information," said Dr. Dragoo. "The OBR further demonstrates AAOS' desire to separate science from hope, with the goal of helping patients receive the highest quality of evidence-based care."

The registry will focus on patient-reported outcomes and longitudinal tracking, with unique attributes including:

• Research-focused registry design with patient consent
• Centralized follow-up for patient-reported outcome measures (PROMs) completion
• Linkage to the BARB Biorepository for biological sample analysis
• Integration with standardized hemoanalyzer configuration
• Detailed adherence protocol to ensure high-quality data collection

Strategic Industry Partnerships
AAOS has partnered with Elimu Informatics and PatientIQ to develop the technical infrastructure for the OBR. Elimu provides analysis and design support, establishing the registry model using the AAOS Master Data Dictionary and tools, while PatientIQ has developed a cloud-based registry consistent with OBR data specifications that facilitate the input of procedure and patient-reported outcomes data.

"It's exciting to help lay the groundwork for enabling scientific discovery, furthering science that impacts patient care through ensuring quality data in registry design," said Edna Shenvi, MD, MAS, senior clinical informatician at Elimu Informatics. 

"At PatientIQ, we are proud to provide the data infrastructure that empowers organizations like AAOS to turn promising innovation into proven, evidence-based practice," said Matthew Gitelis, CEO of PatientIQ. "By combining high-quality clinical data with real-world patient-reported outcomes, this registry sets a new standard for understanding the safety and efficacy of orthobiologic therapies in everyday care."

The OBR is a unique offering within the AAOS family of registries, developed with support from the American Orthopaedic Society for Sports Medicine, the Arthroscopy Association of North America, and the Biologic Association.

AAOS Biologics Initiative and Growing Need for Data
In 2019, AAOS announced a strategic investment in the field of biologics. Over the following five years, the Academy prioritized research and development for a biologics-focused competency within its existing business. The focus of this effort has been to create evidence-based, unbiased information as tracked by the AAOS Biologics Dashboard; thought-leadership, position statements; and educational content to help shape and guide orthopaedic surgeons and their patients within this space.

The launch of the AAOS OBR represents the next phase of this commitment and comes at a pivotal time. The convergence of an aging population, rising obesity rates, and greater emphasis on staying active continues to drive demand for innovative orthobiologic treatment options. With over 18% of the population over age 55 experiencing symptomatic knee osteoarthritis³, the social and physical impact of this condition continues to be widespread.

For more information about the impact of biologics on the treatment of musculoskeletal injuries, visit the AAOS website. To schedule an interview or learn more about the AAOS OBR, email [email protected].

AAOS Registry Program
The AAOS Registry Program's mission is to improve orthopaedic care through the collection, analysis, and reporting of actionable data. The American Joint Replacement Registry (AJRR), the Academy's hip and knee replacement registry, is the cornerstone of the AAOS's Registry Program, and the world's largest national registry of hip and knee joint replacement data by annual procedural count, with more than 4.6 million procedures contained within its database. Additional registries include the Musculoskeletal Tumor Registry (MsTR), the Shoulder & Elbow Registry (SER), and the American Spine Registry (ASR), a collaborative effort between the American Association of Neurological Surgeons (AANS) and the AAOS. 

About AAOS
With more than 39,000 members, the American Academy of Orthopaedic Surgeons is the world's largest medical association of musculoskeletal specialists. 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. 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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¹ https://oaaction.unc.edu/wp-content/uploads/sites/623/2024/05/OA-Prevalence-and-Burden-final-updated-5.30.24.pdf
² https://pmc.ncbi.nlm.nih.gov/articles/PMC9382248/pdf/ABJS-10-536.pdf
³ Global Burden of Disease (GBD) Study 2021. Institute for Health Metrics and Evaluation. Accessed October 6, 2025. https://vizhub.healthdata.org/gbd-results/

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SOURCE American Academy of Orthopaedic Surgeons