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If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product’s use and effects.” (1) Reference 1. “Off-Label” and Investigational Use of Marketed Drugs, Biologics, and Medical Devices. Guidance for Institutional Review Boards and Clinical Investigators: https://www.fda.gov/ regulatory-information/search-fda-guidance-documents/label-and-investigational-use- marketed-drugs-biologics-and-medical-devices Additional Notice: The appearance of any product name or registered design without designation as proprietary is not to be construed as a representation that the name or design is in the public domain. CONTRIBUTORS Owoicho Adogwa, MD, MPH R. Carter Cassidy, MD Spine Fellow Associate Professor Orthopaedic Surgery Orthopaedic Surgery Washington University UK Healthcare St. Louis, MO Lexington, KY Bradley Anderson Jens R. Chapman, MD Syracuse University Orthopaedic Spine Surgeon New York, NY Orthopaedic and Neurosurgery Swedish Hospital, Seattle, WA D. Greg Anderson, MD Orthopaedic Surgeon Stephen L. Demeter, MD, MPH Rothman Orthopaedics Private Practice Bensalem, PA Las Vegas, NV; Retired Professor and former Head of Pulmonary and Professor Critical Care Medicine, Northeastern Ohio College of Departments of Orthopaedic and Neurological Surgery Medicine Thomas Jefferson University Past President of the International Academy of Philadelphia, PA Independent Medical Evaluators (IAIME; formerly Paul A. Anderson, MD the American Academy of Disability Evaluating Professor Physicians) Orthopaedic Surgery and Rehabilitation Editor of Disability Evaluation Editions 1 & 2 University of Wisconsin Vincent J. Devlin, MD, FAAOS Madison, WI Orthopaedic Surgeon Mundeep S. Bawa, BS Fulton, MD Department of Orthopaedic Surgery Doniel Drazin, MD, MA Rush University Medical Center Neurosurgeon Chicago, IL Neurosurgery Andrew M. Block, BS Evergreen Health Department of Orthopaedic Surgery Kirkland, WA Rush University Medical Center Mostafa H. El Dafrawy, MD Chicago, IL Fellow-Spine Surgery Christopher R. Brigham, MD, MMS Orthopaedic Surgery Consultant Washington University in St. Louis Hilton Head Island, SC and Portland, ME; St. Louis, MO Editor, Guides Newsletter; Benjamin D. Elder, MD, PhD Senior Contributing Editor, AMA Guides to the Evaluation Assistant Professor of Permanent Impairment, Sixth Edition Neurosurgery Author, Living Abled and Healthy: A Guide to Injury and Mayo Clinic Illness Recovery Rochester, MN Thomas N. Bryce, MD Winston Fong, MD Professor Chief Rehabilitation and Human Performance Department of Spine Surgery Icahn School of Medicine at Mount Sinai McBride Orthopaedic Hospital New York, NY Oklahoma City, OK Alejandro Carrasquilla, MD Munish C. Gupta, MD Resident Chief of Spine, Professor of Orthopaedics Neurosurgery Department of Orthopaedic Surgery Icahn School of Medicine at Mount Sinai Washington University in St. Louis New York, NY St. Louis, MO vii