A Prospective, Randomized Study With 2-Year Follow-up on 99 Patients

Study Design. A total of 115 patients were randomized in a 1:1 ratio to a Bryan artificial disc replacement (56) or an anterior cervical fusion with allograft and a plate (59). Objective. The purpose of this study is to examine the functional outcome and radiographic results of this pro- spective, randomized trial to determine the role of the Bryan artificial cervical disc replacement for patients with 1-level cervical disc disease. Summary of Background Data. Artificial cervical disc replacement has become an option for cervical radiculop- athy. Previous studies have evaluated the efficacy of this alternative without the scientific rigor of a concurrent control population. This study is a pooled data set from 3 centers involved in the U.S. FDA Investigational Device Ex- emption trial evaluating the Bryan artificial cervical disc. Methods. The purpose of this study is to examine the functional outcome and radiographic results of this pro- spective, randomized trial to determine the role of the Bryan artificial cervical disc replacement for patients with 1-level cervical disc disease; 12-month follow-up is avail- able for 110 patients and 24 month follow-up complete for 99 patients. There are 30 males and 26 females in the Bryan group and 32 males and 27 females in the fusion group. The average age was 43 years (Bryan) and 46 years (fusion). Disability and pain were assessed using the Neck Disability Index (NDI) and the Visual Analog Scale (VAS) of the neck and of the arm pain. SF-36 out- come measures were obtained including the physical component as well as the mental component scores. Range of motion was determined by independent radio- logic assessment of flexion-extension radiographs. We report a prospective, randomized study comparing the functional outcome of cervical disc replacement to an anterior cervical fusion with results of 99 patients at 2 years. Prospective data were collected before surgery and at 6 weeks, 3, 6, 12, and 24 months after surgery. Results. The average operative time for the control group was 1.1 hours and the Bryan Group 1.7 hours.