Sasso Rick C, Best Natalie M, Metcalf Newton H, Anderson Paul A
Indiana Spine Group, Indiana University School of Medicine, Indianapolis, IN, USA.
J Spinal Disord Tech. 2008 Aug;21(6):393-9. doi: 10.1097/BSD.0b013e318150d121.
Prospective, randomized, multicenter clinical trial.
Kinematic analysis of target level and adjacent motion segments after Bryan artificial cervical disc replacement versus anterior cervical fusion.
Disc arthroplasty has been shown to provide short-term clinical results that are comparable or better than those attained with traditional anterior cervical discectomy and fusion. One purported benefit of arthroplasty is the ability to prevent or delay adjacent level operations.
All patients received either a single-level anterior cervical discectomy and fusion with an anterior cervical plate (Atlantis anterior cervical plate, n=221) or a single-level artificial cervical disc replacement (Bryan cervical disc prosthesis, n=242) at C3 to C7. Flexion, extension, and neutral lateral radiographs were obtained preoperatively, and at regular intervals of 24 months. Cervical vertebral bodies were tracked to calculate the functional spinal unit motion parameters, including flexion/extension range of motion and translation. If visible, the functional spinal unit parameters were obtained at the operative level as well as the level above and below.
Significantly more motion was retained in the disc replacement group than the plated group at the index level. The disc replacement group retained an average of 7.95 degrees at 24 months. The preoperative motion was 6.43 degrees and there was no evidence of degradation of motion over 24 months. In contrast, the average range of motion in the fusion group was 1.11 degrees at 3-month follow-up and gradually decreased to 0.87 degrees at 24 months. The preoperative motion was 8.39 degrees. The Bryan disc did not migrate. At 24-month follow-up, there was no case of subsidence of the Bryan disc. There was no evidence of bridging bone across any of the Bryan implant disc spaces.
The Bryan disc treatment, on average, maintained flexion/extension range of motion without degradation over 24 months. No ectopic bridging ossification was seen in any of the Bryan discs and no subsidence or displacement of the Bryan disc occurred.
前瞻性、随机、多中心临床试验。
对比Bryan人工颈椎间盘置换术与颈椎前路融合术后目标节段及相邻运动节段的运动学分析。
椎间盘置换术已显示出短期临床效果与传统颈椎前路椎间盘切除融合术相当或更优。椎间盘置换术的一个据称益处是能够预防或延迟相邻节段手术。
所有患者在C3至C7节段接受单节段颈椎前路椎间盘切除融合术并使用颈椎前路钢板（Atlantis颈椎前路钢板，n = 221）或单节段人工颈椎间盘置换术（Bryan颈椎间盘假体，n = 242）。术前及术后每隔24个月定期拍摄颈椎前屈、后伸及中立位侧位X线片。追踪颈椎椎体以计算功能性脊柱单元运动参数，包括屈伸活动度和平移。若可见，在手术节段以及上下节段获取功能性脊柱单元参数。
在目标节段，椎间盘置换组保留的运动明显多于钢板固定组。椎间盘置换组在24个月时平均保留7.95度。术前运动度为6.43度，且24个月内无运动度下降的证据。相比之下，融合组在3个月随访时平均活动度为1.11度，在24个月时逐渐降至0.87度。术前运动度为8.39度。Bryan椎间盘未发生移位。在24个月随访时，未出现Bryan椎间盘下沉病例。没有证据表明Bryan植入物椎间盘间隙有骨桥形成。
平均而言，Bryan椎间盘治疗在24个月内维持了屈伸活动度且无下降。在任何Bryan椎间盘中均未见到异位骨桥形成，且未发生Bryan椎间盘下沉或移位。
