Point of View: Commentary on the Research Reports that Led to Food and Drug Administration Approval of an Artificial Disc

From the Departments of Orthopedic Surgery and Neurological Surgery, University of Washington, Seattle, WA. Supported by Grant # K23AR48979 from the National Institutes of Health/National Institute of Arthritis, Musculoskeletal and Skin Diseases. Additional support for spine-related research includes a gift of an endowed chair the University of Washington (UW) received in 1999 from Surgical Dynamics, a past manufacturer of spinal implants, to conduct outcomes research in spine surgery. The UW Department of Orthopedics has also received gifts of endowed chairs from Synthes® (Paoli, PA) in 2003 and DePuy Spine, Inc., (Raynham, MA) in 2005, a current manufacturer of spinal implants. Synthes® has also established a Spine End-Results Research Fund at UW for conducting safety and outcomes research on patients undergoing spine surgery. The principal investigator for this fund is a faculty member in the Orthopedics Department, and the fund is managed through the Grant and Contract Services Office of the UW. The sponsors of the endowments and the research fund have no control over design, conduct, data, analysis, review, reporting, or interpretation of clinical research conducted with the funds. Dr. Mirza is an investigator for some of this research work. He and the UW also hold two patents on surgical drills. These patents are licensed by Synthes®. Dr. Mirza and the UW do not conduct clinical research to evaluate clinical use of these surgical drills in patients. The device(s)/drug(s) is/are FDA-approved or approved by corresponding national agency for this indication. Corporate/Industry, Federal and Institutional funds were received in support of this work. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript. Address correspondence and reprint requests to Sohail K. Mirza, MD, MPH, Departments of Orthopedic Surgery and Neurological Surgery, University of Washington, Box 359798, Seattle, WA 98104; E-mail: [email protected]