Nabhan A, Steudel W I, Nabhan Ah, Pape D, Ishak B
Department of Neurosurgery, Neurosurgical Department, University of Saarland, Homburg, Germany.
J Long Term Eff Med Implants. 2007;17(3):229-36. doi: 10.1615/jlongtermeffmedimplants.v17.i3.60.
Prospective, randomized and controlled clinical and radiological study.
The aim of this study was to assess the segmental kinematics and clinical outcome of disc replacement with ProDisc C versus anterior cervical discectomy and fusion (ACDF) for monosegmental disease 3 years after surgery.
Anterior cervical discectomy and fusion (ACDF), including plate fixation, is an accepted technique for treatment of symptomatic degenerative disc disease (DDD). However, various studies could show that fusion of a relative mobile spinal segment leads to heightens of stresses on the discs below and above fusion, which is manifested as adjacent level degeneration. Intervertebral disc replacement has been attempted to restore intervertebral disc height and to maintain segmental motion, which may be thought to avoid the accelerated degeneration to the adjacent level. In earlier studies, we could show that ProDisc C could maintain segmental motion for 1 year after surgery.
49 patients with cervical disc herniation underwent arthroplasty of a single level using ProDisc C disc prosthesis or received fusion using a cage and anterior titanium plate fixation. Clinical outcome was assessed using the visual analogue scale (VAS) and the neck disability index (NDI). Radiostereometry was performed immediately postoperative and then after 1, 2, and 3 years after surgery to quantify the segmental kinematics.
The range of motion of the treated segment with prosthesis remained unchanged 3 years after surgery in comparison to the 1-year result. The prosthesis shows a significant segmental motion in contrast to the fusion group at each RSA examination time (p < 0.05). After both procedures, a significant pain reduction in neck and arm was observed, without significant differences between both groups. During the course of the 3 years follow-up, no patients of the prosthesis group required further surgical intervention.
前瞻性、随机对照临床及影像学研究。
本研究旨在评估ProDisc C椎间盘置换术与颈椎前路椎间盘切除融合术(ACDF)治疗单节段疾病术后3年的节段运动学及临床疗效。
颈椎前路椎间盘切除融合术(ACDF),包括钢板固定,是治疗有症状的退行性椎间盘疾病(DDD)的一种公认技术。然而,各种研究表明,相对活动的脊柱节段融合会导致融合节段上下椎间盘应力增加,表现为相邻节段退变。人们尝试进行椎间盘置换以恢复椎间盘高度并维持节段运动,这可能被认为可避免相邻节段加速退变。在早期研究中,我们发现ProDisc C在术后1年内可维持节段运动。
49例颈椎间盘突出症患者接受了单节段ProDisc C椎间盘假体置换术或使用椎间融合器及前路钛板固定进行融合术。使用视觉模拟量表(VAS)和颈部功能障碍指数(NDI)评估临床疗效。术后即刻及术后1年、2年和3年进行放射立体测量以量化节段运动学。
与术后1年的结果相比,假体治疗节段的运动范围在术后3年保持不变。与融合组相比,在每次RSA检查时,假体均显示出显著的节段运动(p < 0.05)。两种手术术后均观察到颈部和手臂疼痛明显减轻,两组间无显著差异。在3年的随访过程中,假体组无患者需要进一步手术干预。