Indiana Spine Group, Indiana University School of Medicine, Indianapolis 46260, USA.
Spine (Phila Pa 1976). 2011 Jun;36(13):991-6. doi: 10.1097/BRS.0b013e3182076d70.
Prospective, randomized, Food and Drug Administration Investigational Device Exemption trial from one study site.
Examine the radiographic sagittal alignment of the Bryan cervical disc for one-level disease.
Prospective, randomized studies demonstrate Bryan arthroplasty provides statistically better functional outcomes than anterior cervical discectomy and fusion. Uncontrolled case reports describe kyphosis after disc replacement. No prospective study has critically assessed sagittal alignment after cervical arthroplasty.
Forty-eight patients reviewed with a minimum follow-up of 2 years. Quantitative motion analysis determined the change in overall (C2-C7) and treatment-level sagittal alignment, disc space heights, and range of motion.
Preoperatively, overall sagittal alignment was equivalent in the two groups. At 24-month follow-up, overall lordosis for the cohorts was not statistically different from preoperative values for each group. In addition, overall lordosis was not significantly different at 24 months when comparing Bryan patients with the fusion patients. The average change in disc angle from preoperative to immediate postoperative at the treated level in the Bryan disc group was a nonsignificant increase in lordosis of 0.92°. The anterior disc height was the same at all time points, but the posterior disc height was slightly (0.7 mm) more in the Bryan than in the fusion patients (P = 0.04). The angular range of motion in the Bryan group was statistically equivalent at all time points. At the fused levels, average range of motion decreased from 6.4° to 0.9° at 24 months (P < 0.0001).
With the Bryan disc, there was an insignificant increase in lordosis of 0.9° at immediate postoperative time point. Overall cervical sagittal alignment is not different between the experimental and control populations. This prospective study does not demonstrate a clinically significant increase in segmental kyphosis after Bryan disc arthroplasty. Global cervical lordosis is statistically equivalent between arthroplasty and fusion groups at 2 years follow-up.
来自一个研究地点的前瞻性、随机、食品和药物管理局研究性设备豁免试验。
检查 Bryan 颈椎间盘在单节段疾病中的放射矢状位排列。
前瞻性、随机研究表明，Bryan 关节成形术在功能结果方面明显优于前路颈椎间盘切除融合术。未经对照的病例报告描述了椎间盘置换后的后凸畸形。没有前瞻性研究对颈椎置换术后的矢状位排列进行过严格评估。
对 48 例患者进行了回顾性分析，随访时间至少为 2 年。定量运动分析确定了总（C2-C7）和治疗节段矢状位排列、椎间盘高度和活动范围的变化。
术前两组的总矢状位排列相当。在 24 个月的随访中，两组的总脊柱前凸与术前值无统计学差异。此外，在比较 Bryan 组和融合组患者时，24 个月时总脊柱前凸没有显著差异。Bryan 椎间盘组治疗节段从术前到术后即刻椎间盘角度的平均变化是脊柱前凸增加了 0.92°，但无统计学意义。前椎间盘高度在所有时间点都相同，但 Bryan 组的后椎间盘高度比融合组略高（0.7mm，P=0.04）。Bryan 组的角度活动范围在所有时间点均具有统计学意义。在融合节段，平均活动范围从 24 个月的 6.4°降至 0.9°（P<0.0001）。
Bryan 椎间盘在术后即刻有 0.9°的脊柱前凸轻度增加。实验组和对照组的颈椎整体矢状位排列没有差异。这项前瞻性研究没有显示 Bryan 椎间盘置换术后节段性后凸畸形有临床意义的增加。在 2 年随访时，颈椎整体前凸在关节成形术组和融合组之间具有统计学等效性。
