van den Bent M J, Oosting J, Wouda E J, van Acker R E, Ansink B J, Braakman R
Department of Neurology, Dr. Daniel den Hoed Cancer Centre, Rotterdam, The Netherlands.
Spine (Phila Pa 1976). 1996 Apr 1;21(7):834-9; discussion 840. doi: 10.1097/00007632-199604010-00011.
A prospective randomized trial with assessment of treatment results by an independent observer and by patient questionnaire.
This study evaluated whether implantation of polymethylmethacrylate after anterior cervical discectomy improved clinical results and whether polymethylmethacrylate provided a solid bony union with preservation of anatomical relations of the cervical spine.
Discectomy without fusion disturbs anatomical relations of the cervical spine. Use of an autologous bone graft frequently causes donor-site complications. Therefore, synthetic materials such as polymethylmethacrylate have been used instead of bone to obtain spinal fusion. Whether these implants improve the clinical results of anterior discectomy is unknown. In addition, the radiological follow-up of discectomy with polymethylmethacrylate has hardly been investigated.
Between April, 1986, and April, 1990, all patients with radiologically proven cervical disc pathology and a radicular syndrome were eligible for this study. The primary endpoint of the study was the clinical result after 2 years. Assessment of the result was rated both by an independent observer using Odom's criteria and by the patient using a written questionnaire. Before surgery and during follow-up, radiographs were obtained.
Two patients died during follow up. A good result was obtained in 28 of 42 patients (70%) treated with polymethylmethacrylate and in 30 of 39 patients (77%) of patients treated with discectomy only. Pre-operative neck pain subsided earlier if polymethylmethacrylate was used, but the difference was temporary and clinically insignificant. The use of polymethylmethacrylate resulted in a significant lower bony union rate. Polymethylmethacrylate frequently migrated into adjacent vertebrae.
No relevant clinical differences between treatments were found. The radiological results of anterior discectomy with polymethylmethacrylate were inferior to those of discectomy only. Based on these results, the use of polymethylmethacrylate to obtain fusion after anterior discectomy is not recommended.
一项前瞻性随机试验,由独立观察者和患者问卷对治疗结果进行评估。
本研究评估颈椎前路椎间盘切除术后植入聚甲基丙烯酸甲酯是否能改善临床效果,以及聚甲基丙烯酸甲酯在保留颈椎解剖关系的情况下能否实现牢固的骨融合。
不进行融合的椎间盘切除术会扰乱颈椎的解剖关系。使用自体骨移植常常会引发供区并发症。因此,已采用聚甲基丙烯酸甲酯等合成材料替代骨来实现脊柱融合。这些植入物是否能改善前路椎间盘切除术的临床效果尚不清楚。此外,对聚甲基丙烯酸甲酯辅助椎间盘切除术的影像学随访研究极少。
在1986年4月至1990年4月期间,所有经影像学证实存在颈椎间盘病变且有神经根综合征的患者均符合本研究条件。该研究的主要终点是2年后的临床结果。结果评估由独立观察者采用奥多姆标准进行,同时患者通过书面问卷进行评价。在手术前及随访期间拍摄X线片。
两名患者在随访期间死亡。接受聚甲基丙烯酸甲酯治疗的42例患者中有28例(70%)效果良好,仅接受椎间盘切除术的39例患者中有30例(77%)效果良好。如果使用聚甲基丙烯酸甲酯,术前颈部疼痛缓解得更早,但这种差异是暂时的,临床意义不大。使用聚甲基丙烯酸甲酯导致骨融合率显著降低。聚甲基丙烯酸甲酯经常向相邻椎体迁移。
未发现不同治疗方法之间存在相关临床差异。聚甲基丙烯酸甲酯辅助前路椎间盘切除术的影像学结果不如单纯椎间盘切除术。基于这些结果,不建议在颈椎前路椎间盘切除术后使用聚甲基丙烯酸甲酯来实现融合。