Institute for Evaluative Research in Medicine, University of Bern, Stauffacherstrasse 78, 3014, Bern, Switzerland.
Eur Spine J. 2012 Aug;21 Suppl 6(Suppl 6):S729-36. doi: 10.1007/s00586-011-1863-x. Epub 2011 Jun 10.
Currently, many pre-conditions are regarded as relative or absolute contraindications for lumbar total disc replacement (TDR). Radiculopathy is one among them. In Switzerland it is left to the surgeon's discretion when to operate if he adheres to a list of pre-defined indications. Contraindications, however, are less clearly specified. We hypothesized that, the extent of pre-operative radiculopathy results in different benefits for patients treated with mono-segmental lumbar TDR. We used patient perceived leg pain and its correlation with physician recorded radiculopathy for creating the patient groups to be compared.
The present study is based on the dataset of SWISSspine, a government mandated health technology assessment registry. Between March 2005 and April 2009, 577 patients underwent either mono- or bi-segmental lumbar TDR, which was documented in a prospective observational multicenter mode. A total of 416 cases with a mono-segmental procedure were included in the study. The data collection consisted of pre-operative and follow-up data (physician based) and clinical outcomes (NASS form, EQ-5D). A receiver operating characteristic (ROC) analysis was conducted with patients' self-indicated leg pain and the surgeon-based diagnosis "radiculopathy", as marked on the case report forms. As a result, patients were divided into two groups according to the severity of leg pain. The two groups were compared with regard to the pre-operative patient characteristics and pre- and post-operative pain on Visual Analogue Scale (VAS) and quality of life using general linear modeling.
The optimal ROC model revealed a leg pain threshold of 40 ≤ VAS > 40 for the absence or the presence of "radiculopathy". Demographics in the resulting two groups were well comparable. Applying this threshold, the mean pre-operative leg pain level was 16.5 points in group 1 and 68.1 points in group 2 (p < 0.001). Back pain levels differed less with 63.6 points in group 1 and 72.6 in group 2 (p < 0.001). Pre-operative quality of life showed considerable differences with an 0.44 EQ-5D score in group 1 and 0.29 in group 2 (p < 0.001, possible score range -0.6 to 1). At a mean follow-up time of 8 months, group 1 showed a mean leg pain improvement of 3.6 points and group 2 of 41.1 points (p < 0.001). Back pain relief was 35.6 and 39.1 points, respectively (p = 0.27). EQ-5D score improvement was 0.27 in group 1 and 0.41 in group 2 (p = 0.11).
Patients labeled as having radiculopathy (group 2) do mostly have pre-operative leg pain levels ≥ 40. Applying this threshold, the patients with pre-operative leg pain do also have more severe back pain and a considerably lower quality of life. Their net benefit from the lumbar TDR is higher and they do have similar post-operative back and leg pain levels as well as the quality of life as patients without pre-operative leg pain. Although randomized controlled trials are required to confirm these findings, they put leg pain and radiculopathy into perspective as absolute contraindications for TDR.
目前，许多术前情况被视为腰椎全椎间盘置换术（TDR）的相对或绝对禁忌证。神经根病就是其中之一。在瑞士，如果外科医生遵循一系列预先定义的适应证，何时进行手术则由其自行决定。然而，禁忌证的规定则不太明确。我们假设，术前神经根病的程度会给接受单节段腰椎TDR治疗的患者带来不同的益处。我们利用患者自述的腿痛情况及其与医生记录的神经根病的相关性来划分待比较的患者组。
本研究基于SWISSspine数据集，这是一个政府授权的卫生技术评估登记处。2005年3月至2009年4月期间，577例患者接受了单节段或双节段腰椎TDR手术，以前瞻性观察性多中心模式记录在案。本研究共纳入416例单节段手术病例。数据收集包括术前和随访数据（基于医生）以及临床结局（NASS表格、EQ-5D）。利用患者自述的腿痛情况和病例报告表上医生记录的“神经根病”诊断进行受试者工作特征（ROC）分析。结果，根据腿痛的严重程度将患者分为两组。使用一般线性模型比较两组患者的术前特征、术前和术后视觉模拟量表（VAS）疼痛评分以及生活质量。
最佳ROC模型显示，“神经根病”有无的腿痛阈值为40≤VAS>40。最终两组的人口统计学特征具有良好的可比性。应用该阈值，第1组术前平均腿痛水平为16.5分，第2组为68.1分（p<0.001）。背痛水平差异较小，第1组为63.6分，第2组为72.6分（p<0.001）。术前生活质量存在显著差异，第1组EQ-5D评分为0.44，第2组为0.29（p<0.001，可能的评分范围为-0.6至1）。平均随访8个月时，第1组平均腿痛改善3.6分，第2组改善41.1分（p<0.001）。背痛缓解分别为35.6分和39.1分（p=0.27）。第1组EQ-5D评分改善0.27，第2组改善0.41（p=0.11）。
被标记为患有神经根病的患者（第2组）术前腿痛水平大多≥40。应用该阈值，术前腿痛患者的背痛也更严重，生活质量显著更低。他们从腰椎TDR中获得的净益处更高，术后背痛和腿痛水平以及生活质量与术前无腿痛的患者相似。尽管需要随机对照试验来证实这些发现，但它们使腿痛和神经根病作为TDR的绝对禁忌证得到了重新审视。
