Siepe Christoph J, Korge Andreas, Grochulla Frank, Mehren Christoph, Mayer H Michael
Spine Center, Ortho-Center Munich, Harlachinger Strasse 51, 81547, Munich, Germany.
Eur Spine J. 2008 Jan;17(1):44-56. doi: 10.1007/s00586-007-0519-3. Epub 2007 Oct 31.
Although a variety of biomechanical laboratory investigations and radiological studies have highlighted the potential problems associated with total lumbar disc replacement (TDR), no previous study has performed a systematic clinical failure analysis. The aim of this study was to identify the post-operative pain sources, establish the incidence of post-operative pain patterns and investigate the effect on post-operative outcome with the help of fluoroscopically guided spine infiltrations in patients from an ongoing prospective study with ProDisc II. Patients who reported unsatisfactory results at any of the FU-examinations received fluoroscopically guided spine infiltrations as part of a semi-invasive diagnostic and conservative treatment program. Pain sources were identified in patients with reproducible (> or =2x) significant (50-75%) or highly significant (75-100%) pain relief. Results were correlated with outcome parameters visual analogue scale (VAS), Oswestry disability index (ODI) and the subjective patient satisfaction rate. From a total of 175 operated patients with a mean follow-up (FU) of 29.3 months (range 12.2-74.9 months), n = 342 infiltrations were performed in n = 58 patients (33.1%) overall. Facet joint pain, predominantly at the index level (86.4%), was identified in n = 22 patients (12.6%). The sacroiliac joint was a similarly frequent cause of post-operative pain (n = 21, 12.0%). Pain from both structures influenced all outcome parameters negatively (P < 0.05). Patients with an early onset of pain (< or =6 months) were 2-5x higher at risk of developing persisting complaints and unsatisfactory outcome at later FU-stages in comparison to the entire study cohort (P < 0.05). The level of TDR significantly influenced post-operative outcome. Best results were achieved for the TDRs above the lumbosacral junction at L4/5 (incidence of posterior joint pain 14.8%). Inferior outcome and a significantly higher incidence of posterior joint pain were observed for TDR at L5/S1 (21.6%) and bisegmental TDR at L4/5/S1 (33.3%), respectively. Lumbar facet and/or ISJ-pain are a frequent and currently underestimated source of post-operative pain and the most common reasons for unsatisfactory results following TDR. Further failure-analysis studies are required and adequate salvage treatment options need to be established with respect to the underlying pathology of post-operative pain. The question as to whether or not TDR will reduce the incidence of posterior joint pain, which has been previously attributed to lumbar fusion procedures, remains unanswered. Additional studies will have to investigate whether TDR compromises the index-segment in an attempt to avoid adjacent segment degeneration.
尽管各种生物力学实验室研究和放射学研究都强调了全腰椎间盘置换术(TDR)相关的潜在问题,但此前尚无研究进行过系统的临床失败分析。本研究的目的是确定术后疼痛来源,确定术后疼痛模式的发生率,并借助荧光镜引导下的脊柱浸润,对一项正在进行的使用ProDisc II的前瞻性研究中的患者术后结果的影响进行调查。在任何一次随访检查中报告结果不满意的患者,接受荧光镜引导下的脊柱浸润,作为半侵入性诊断和保守治疗方案的一部分。在疼痛可重复(≥2次)显著(50%-75%)或高度显著(75%-100%)缓解的患者中确定疼痛来源。结果与视觉模拟量表(VAS)、Oswestry功能障碍指数(ODI)和患者主观满意度等结果参数相关。在总共175例接受手术的患者中,平均随访29.3个月(范围12.2-74.9个月),总体上58例患者(33.1%)共进行了342次浸润。在22例患者(12.6%)中确定了小关节疼痛,主要在手术节段水平(86.4%)。骶髂关节也是术后疼痛的常见原因(21例,12.0%)。来自这两个结构的疼痛对所有结果参数都有负面影响(P<0.05)。与整个研究队列相比,疼痛早发(≤6个月)的患者在后期随访阶段出现持续不适和结果不满意的风险高2至5倍(P<0.05)。TDR的节段对术后结果有显著影响。在腰5/骶1以上的TDR在L4/5节段取得了最佳结果(后关节疼痛发生率为14.8%)。在L5/S1节段的TDR(21.6%)和L4/5/S1节段双节段TDR(33.3%)分别观察到较差的结果和后关节疼痛的发生率显著更高。腰椎小关节和/或骶髂关节疼痛是术后疼痛的常见且目前被低估的来源,也是TDR术后结果不满意的最常见原因。需要进一步进行失败分析研究,并根据术后疼痛的潜在病理情况建立适当的挽救治疗方案。TDR是否会降低先前归因于腰椎融合手术的后关节疼痛发生率的问题仍未得到解答。还需要进行更多研究,以调查TDR是否会为避免相邻节段退变而损害手术节段。