DataBiologics is excited to announce their first hosted study supported by the Gerard Malanga Fund in collaboration with the Interventional Orthobiologics Foundation (IOF).
This real-world evidence study will evaluate the characterization of various Platelet Rich Plasma (PRP) devices correlated to real-world outcomes data. By examining the diverse devices available for PRP preparation, this study aims to provide valuable insights into their efficacy, safety, and clinical utility across different orthopedics applications.
With dozens of Platelet-Rich Plasma (PRP) devices and variables in processing and technique, understanding the optimal injectate to yield the most beneficial outcomes for a patient remains one of the most pressing questions of thought-leaders in this space. Quantification and classification of PRP was one of many initiatives of the late Gerard Malanga, MD. Research from scientists like Jeremy Magalon, PharmD, PhD has evaluated biologic parameters of various commercially available PRP commercial systems, yet additional research is required to help uncover the correlation between optimized PRP systems and patient outcomes. DataBiologics proposes that through increased availability of hematology analyzers and intuitive outcomes tracking software, this effort becomes attainable.
Objectives:
Further define the dose-response relationship
Better understand the mechanisms for PRP therapy responders
Uncover nuances of cell characterization and its effect on positive outcomes
Help physicians choose a system that meets specific needs for a given indication
End points: Adverse Events, Numeric Pain Rating Scale, Functional Outcome Measures (i.e. KOOS JR, QuickDASH), Desired Functionality (custom scale developed by Gerard A. Malanga, MD), Mental Health (PHQ-4)
Gerard Malanga, MD was a pioneer in the field of Interventional Orthobiologics. As the former president of the Interventional Orthobiologics Foundation, he called for the creation of a national registry to more closely evaluate the outcomes of these innovative treatments in order to help both physicians and their patients. He was the Founder and Partner of New Jersey Sports Medicine and New Jersey Regenerative Institute. He was board certified in physical medicine and rehabilitation, sports medicine and pain medication. Dr. Malanga was internationally recognized for his work in orthopedic medicine, but most importantly he was a leader and mentor, and a passionate advocate for his patients.
