From the Departments of *Neurosurgery and
†Anesthesiology, Baylor College of Medicine, and Veterans Affairs Medical Center, Houston, Texas,
‡Jackson Hospital, Montgomery, Alabama,
§Division of Neurological Surgery, Barrow Neurological Institute, and St. Joseph’s Hospital and Medical Center, Phoenix, Arizona, and
∥ Clear Lake Regional Medical Center, Webster, Texas.
Sponsored by Medtronic Sofamor Danek.
Acknowledgment date: March 25, 2002.
First revision date: June 13, 2002. Second revision date: September 30, 2002.
Acceptance date: November 14, 2002.
The devices and drugs described in this article are being evaluated as part of an ongoing FDA-approved investigational protocol (IDE) or a corresponding national protocol for assessment of safety and effectiveness, as compared with a control implant in the treatment of patients with one level or two adjacent levels of cervical symptomatic degenerative disc disease. The objectives of the protocol are to demonstrate that the surgical treatment of degenerative disc disease with the investigational implant is at least as safe and effective as that of a control implant.
Corporate and industry funds were received to support this work. Although one or more of the authors have received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this manuscript, benefits will be directed solely to a research fund, foundation, educational institution, or other nonprofit organization with which the authors have been associated.
Address correspondence and reprint requests to David S. Baskin, MD, Department of Neurosurgery, Baylor College of Medicine, 6560 Fannin, Suite 944, Houston, TX 77030, USA; E-mail: [email protected]