Artificial disc versus fusion: a prospective, randomized study with 2-year follow-up on 99 patients.Spine (Phila Pa 1976). 2007 Dec 15; 32(26):2933-40; discussion 2941-2.S
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).
The purpose of this study is to examine the functional outcome and radiographic results of this prospective, 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 radiculopathy. 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 Exemption trial evaluating the Bryan artificial cervical disc.
The purpose of this study is to examine the functional outcome and radiographic results of this prospective, 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 available 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 outcome measures were obtained including the physical component as well as the mental component scores. Range of motion was determined by independent radiologic 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.
The average operative time for the control group was 1.1 hours and the Bryan Group 1.7 hours. Average blood loss was 49 mL (control) and 64 mL (Bryan). Average hospital stay was 0.6 days (control) and 0.9 days (Bryan). The mean NDI before surgery was not statistically different between groups: 47 (Bryan) and 49 (control). Twelve-month follow-up NDI is 10 (Bryan) and 18 (control) (P = 0.013). At 2-year follow-up, NDI for the Bryan group is 11 and the control group is 20 (P = 0.005). The mean arm pain VAS before surgery was 70 (Bryan) and 71 (control). At 1-year follow-up, Bryan arm pain VAS was 12 and control 23 (P = 0.031). At 2-year follow-up, the average arm pain VAS for the Bryan group was 14 and control 28 (P = 0.014). The mean neck pain VAS before surgery was 72 (Bryan) and 73 (control). One-year follow-up scores were 17 (Bryan) and 28 (control) (P = 0.05). At 2 years: 16 (Bryan) and 32 (control) (P = 0.005). SF-36 scores: Physical component--Before surgery Bryan 34 and control 32. At 24 months: Bryan 51 and control 46 (P = 0.009). More motion was retained after surgery in the disc replacement group than the plated group at the index level (P < 0.006 at 3, 6, 12, and 24 months). The disc replacement group retained an average of 7.9 degrees of flexion-extension at 24 months. In contrast, the average range of motion in the fusion group was 0.6 degrees at 24 months. There were 6 additional operations in this series: 4 in the control group and 2 in the investigational group. There were no intraoperative complications, no vascular or neurologic complications, no spontaneous fusions, and no device failures or explantations in the Bryan cohort.
The Bryan artificial disc replacement compares favorably to anterior cervical discectomy and fusion for the treatment of patients with 1-level cervical disc disease. At the 2-year follow-up, there are statistically significant differences between the groups with improvements in the NDI, the neck pain and arm pain VAS scores, and the SF-36 physical component score in the Bryan disc population.