Published 12/17/2025
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.
The new registry is the latest addition to the AAOS Registry Program, which has a mission to improve orthopaedic care through the collection, analysis, and reporting of actionable data. The American Joint Replacement Registry, the Academy’s hip and knee replacement registry, is the cornerstone of the AAOS 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 within its database. Additional registries include the Musculoskeletal Tumor Registry, the Shoulder & Elbow Registry, and the American Spine Registry, a collaborative effort between the American Association of Neurological Surgeons and AAOS.
Addressing a critical gap in orthobiologics evidence
With an estimated 32.5 million American adults suffering from symptomatic knee osteoarthritis and direct medical costs exceeding $65 billion annually, the need for reliable, evidence-based data on emerging treatment options has never been more critical. Orthobiologic 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 remain 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.”
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. Although 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 data.
“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,” Dr. Dragoo said. “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 completion of patient-reported outcome measures
- 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 OBR. Elimu provides analysis and design support, establishing the registry model using the AAOS Master Data Dictionary and tools, whereas 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.”
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
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 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 more than 18% of the population older than age 55 experiencing symptomatic knee osteoarthritis, the social and physical effects of this condition continue to be widespread.
For more information about the impact of biologics on the treatment of musculoskeletal injuries, visit the AAOS website.
References
- Osteoarthritis Action Alliance. OA Prevalence & Burden. Accessed Oct. 27, 2025. https://oaaction.unc.edu/wp-content/uploads/sites/623/2024/05/OA-Prevalence-and-Burden-final-updated-5.30.24.pdf
- Moreno-Garcia A, Rodriguez-Merchan EC. Orthobiologics: Current role in orthopedic surgery and traumatology. Arch Bone Jt Surg. 2022;10(7):536-542. doi:10.22038/ABJS.2021.52770.2614
- Institute for Health Metrics and Evaluation. Global Burden of Disease Study 2021. Accessed Oct. 6, 2025. https://ghdx.healthdata.org/gbd-2021