Sasso Rick C, Smucker Joseph D, Hacker Robert J, Heller John G
Indiana Spine Group, Indiana University School of Medicine, 8402 Harcourt Rd., Suite 400, Indianapolis, IN 46260, USA.
Spine (Phila Pa 1976). 2007 Dec 15;32(26):2933-40; discussion 2941-2. doi: 10.1097/BRS.0b013e31815d0034.
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.
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.
总共115例患者按1:1比例随机分为两组，分别接受Bryan人工椎间盘置换术（56例）或同种异体骨加钢板前路颈椎融合术（59例）。
本研究旨在探讨这项前瞻性随机试验的功能结局和影像学结果，以确定Bryan人工颈椎间盘置换术在单节段颈椎间盘疾病患者中的作用。
人工颈椎间盘置换术已成为治疗神经根型颈椎病的一种选择。以往的研究评估了这种替代方法的疗效，但缺乏同期对照人群的科学严谨性。本研究是来自3个中心的汇总数据集，这些中心参与了美国食品药品监督管理局（FDA）评估Bryan人工椎间盘的研究性器械豁免试验。
本研究旨在探讨这项前瞻性随机试验的功能结局和影像学结果，以确定Bryan人工颈椎间盘置换术在单节段颈椎间盘疾病患者中的作用；110例患者有12个月的随访数据，99例患者有24个月的完整随访数据。Bryan组有30例男性和26例女性，融合组有32例男性和27例女性。平均年龄分别为43岁（Bryan组）和46岁（融合组）。使用颈部功能障碍指数（NDI）以及颈部和手臂疼痛的视觉模拟评分（VAS）评估残疾和疼痛情况。获得了SF - 36结局指标，包括身体成分以及精神成分评分。活动范围通过对屈伸位X线片进行独立的影像学评估来确定。我们报告一项前瞻性随机研究，比较颈椎间盘置换术与前路颈椎融合术的功能结局，99例患者2年的结果。前瞻性数据在手术前以及术后6周、3个月、6个月、12个月和24个月收集。
对照组平均手术时间为1.1小时，Bryan组为1.7小时。平均失血量分别为49毫升（对照组）和64毫升（Bryan组）。平均住院时间分别为0.6天（对照组）和0.9天（Bryan组）。术前两组的平均NDI无统计学差异：47（Bryan组）和49（对照组）。12个月随访时，Bryan组的NDI为10，对照组为18（P = 0.013）。在2年随访时，Bryan组的NDI为11，对照组为20（P = 0.005）。术前手臂疼痛的平均VAS评分分别为70（Bryan组）和71（对照组）。在1年随访时，Bryan组手臂疼痛的VAS评分为12，对照组为23（P = 0.031）。在2年随访时，Bryan组手臂疼痛的平均VAS评分为14，对照组为28（P = 0.014）。术前颈部疼痛的平均VAS评分分别为72（Bryan组）和73（对照组）。1年随访时的评分分别为17（Bryan组）和28（对照组）（P = 0.05）。在2年时：分别为16（Bryan组）和32（对照组）（P = 0.005）。SF - 36评分：身体成分——术前Bryan组为34，对照组为32。在24个月时：Bryan组为51，对照组为46（P = 0.009）。椎间盘置换组在手术节段术后保留的活动度比钢板固定组更多（在3个月、6个月、12个月和24个月时P < 0.006）。椎间盘置换组在24个月时平均保留屈伸活动度7.9度。相比之下，融合组在24个月时平均活动范围为0.6度。本系列中有6例额外手术：对照组4例，研究组2例。Bryan队列中无术中并发症、无血管或神经并发症、无自发融合、无器械故障或取出情况。
对于单节段颈椎间盘疾病患者的治疗，Bryan人工椎间盘置换术与前路颈椎间盘切除融合术相比具有优势。在2年随访时，两组之间在NDI、颈部疼痛和手臂疼痛VAS评分以及Bryan椎间盘组的SF - 36身体成分评分改善方面存在统计学显著差异。
