The FDA Trial on P-15, co–authored by the Center for Spine and Orthopedic’s Dr. Michael Janssen, was published in the Spine Journal.
After years of diligent work, the FDA Trial on P-15 was recently completed. Read more about the paper, Efficacy of i-FactorTM Bone Graft versus Autograft in Anterior Cervical Discectomy and Fusion: Results of the Prospective Randomized Single-blinded Food and Drug Administration Investigational Device Exemption Study, as published in the Spine Journal, below.
The FDA Trial on P-15 took over a decade to complete and was recently published in the January publication of Spine Journal. The Scientific Summary of Bone Graft Material was also recently finished as well and is currently in the review process for the International Journal of Spine Surgery. The paper is complete with a detailed summary of the current technology and science as of 2016, and will withstand as a reference for many years to come!
Objective: This manuscript intends to provide a review of clinically relevant bone substitutes and bone expanders for spinal surgery in terms of efficacy and associated clinical outcomes, as reported in contemporary spine literature. Ever since the introduction of allograft as a substitute for autologous bone in spinal surgery, a sea of literature has surfaced, evaluating both established and newly emerging fusion alternatives. An understanding of the available fusion options and an organized evidence-based approach to their use in spine surgery is essential for achieving optimal results.