The American Academy of Orthopaedic Surgeons (AAOS) announced development of the AAOS Orthobiologics Registry (OBR), a disease and condition-focused registry aimed at measuring long-term safety, efficacy, and real-world outcomes of orthobiologic therapies for patients with knee osteoarthritis (OA).

AAOS said the pilot program will start with ten participating sites with plans to expand over the next three to five years. 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.

However, 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 orthopedic surgeons in providing the highest quality, evidence-based care to their patients dealing with osteoarthritis of the knee.”

Despite growing patient interest in orthobiologics, current AAOS guidelines call for additional research on orthobiologics use. PRP treatments have shown promise in improving some patient-reported outcomes, but 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,” 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 center on patient-reported outcomes and longitudinal tracking. It will feature a research-focused registry design with patient consent and centralized follow-up for patient-reported outcome measures (PROMs) completion. There will be linkage to the BARB Biorepository for biological sample analysis and integration with standardized hemoanalyzer configuration, as well.

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.”

In September, AAOS named the foundational sponsors of its inaugural Launchpad Program.