A randomized prospective study of an anterior cervical interbody fusion device with a minimum of 2 years of follow-up results

Abstract

Object. Despite variations in technique, inherent problems persist with current approaches to anterior cervical fusion. This study was performed to determine whether anterior cervical fusion performed using an investigational device was safe and effective in the treatment of degenerative cervical disc disorders and whether this device offered advantages over current techniques. Methods. Fifty-four patients with radiculopathy with or without mild myelopathy due to one- or two-level cervical degenerative disc disease were randomized as part of a Food and Drug Administration device study. Following microsurgical discectomy, the control group was treated with iliac crest graft fusion; the experimental study group underwent insertion of an interspace cage and placement of a local autograft. All patients received postoperative follow-up care for at least 2 years. Good or excellent results were found in approximately 97% of the experimental group and 88% of the control group. A solid fusion was achieved in all patients who underwent one-level cage placement, and a solid fusion at one or both levels was achieved in over 90% of both groups. Chronic donor site pain was reported by 31% of the control group. Conclusions. In this study, the use of an interbody fusion cage avoided donor site morbidity and placement of autograft achieved a high rate of good or excellent results. Interbody fusion cages appear safe and effective, and their use helps to avoid some of the inherent problems in performing current anterior cervical fusion techniques.