Zigler Jack E, Delamarter Rick B
Texas Back Institute, Plano, TX.
Spine Research Foundation, Santa Monica, CA ; Cedars-Sinai Spine Center, Beverly Hills, CA.
Int J Spine Surg. 2013 Dec 1;7:e1-7. doi: 10.1016/j.ijsp.2013.01.001. eCollection 2013.
Surgical treatment of patients with mechanical degenerative disc disease has been controversial, but improvements in clinical outcomes have been shown in properly selected patients with disease-specific diagnoses, with fusion arguably now becoming the "gold standard" for surgical management of these patients. No published study thus far has been designed for prospective enrollment of patients with specific inclusion/exclusion criteria in whom at least 6 months of conservative therapy has failed and who are then offered a standardized surgical procedure and are followed up for 5 years.
The study group was composed of the patients in the prospective, randomized Food and Drug Administration Investigational Device Exemption trial comparing ProDisc-L (Synthes Spine, West Chester, Pennsylvania) with 360° fusion for the treatment of single-level symptomatic disc degeneration. Of 80 patients randomized to 360° fusion after failure of non-operative care, 75 were treated on protocol with single-level fusions. Follow-up of this treatment cohort was 97% at 2 years and 75% at 5 years and serves as the basis for this report. Patients in the trial were required to have failure of at least 6 months of nonoperative care and in fact had failure of an average of 9 months of nonoperative treatment. The mean Oswestry Disability Index score indicated greater than 60% impairment. The mean entry-level pain score on a visual analog scale was greater than 8 of 10.
After fusion, not only did patients have significant improvements in measurable clinical outcomes such as the Oswestry Disability Index score and pain score on a visual analog scale but there were also substantial improvements in their functional status and quality of life. Specifically, over 80% of patients in this study had improvements in recreational status that was maintained 5 years after index surgery, indicating substantial improvements in life quality that were not afforded by months of conservative care. The percentage of patients using narcotics at the 5-year follow-up visit was less than half the percentage of patients who had used narcotics as part of their prior conservative treatment.
The 5-year results of this post hoc analysis of 75 patients involved in a multicenter, multi-surgeon trial support 360° fusion surgery as a predictable and lasting treatment option to improve pain and function in properly selected patients with mechanical degenerative disc disease. These improvements occurred dramatically immediately after surgery and have been maintained through the scope of this follow-up period, with 98% follow-up at 2 years and 75% of patients available at 5 years.
机械性椎间盘退变疾病患者的外科治疗一直存在争议，但对于经过特定疾病诊断且选择恰当的患者，临床疗效已有所改善，融合术如今可以说是这类患者外科治疗的“金标准”。迄今为止，尚无已发表的研究按照特定的纳入/排除标准进行前瞻性患者招募，这些患者至少6个月的保守治疗失败，随后接受标准化外科手术并进行5年随访。
研究组由参加美国食品药品监督管理局前瞻性随机研究器械豁免试验的患者组成，该试验比较了ProDisc-L（辛迪斯脊柱公司，宾夕法尼亚州韦斯特切斯特）与360°融合术治疗单节段症状性椎间盘退变的效果。在80例非手术治疗失败后随机接受360°融合术的患者中，75例按方案接受了单节段融合术治疗。该治疗队列的2年随访率为97%，5年随访率为75%，本报告以此为依据。试验中的患者被要求至少6个月非手术治疗失败，实际上他们平均9个月的非手术治疗失败。Oswestry功能障碍指数平均得分表明功能损害超过60%。视觉模拟量表上的平均初始疼痛评分为10分制中的8分以上。
融合术后，患者不仅在可测量的临床结果方面有显著改善，如Oswestry功能障碍指数评分和视觉模拟量表疼痛评分，而且其功能状态和生活质量也有大幅改善。具体而言，本研究中超过80%的患者娱乐状态得到改善，在初次手术后5年仍保持，这表明生活质量有显著改善，而数月的保守治疗并未带来这种改善。在5年随访时使用麻醉药品的患者百分比不到接受过麻醉药品治疗的患者在先前保守治疗期间使用麻醉药品百分比的一半。
这项对75例参与多中心、多外科医生试验患者的事后分析的5年结果支持360°融合手术作为一种可预测且持久的治疗选择，用于改善经恰当选择的机械性椎间盘退变疾病患者的疼痛和功能。这些改善在术后立即显著出现，并在整个随访期内得以维持，2年随访率为98%，5年时有75%的患者可供随访。
