Clinical application of artificial lumbar disc replacement: Present and future

doi:10.3969/j.issn.2095-4344.2013.35.016

Abstract

Abstract:

BACKGROUND: The basic idea of artificial disc replacement is the intension to minimize the impact on adjacent segments based on the premise of stabilizing index segment, then prevent and reduce the incidence of adjacent segment degeneration.
OBJECTIVE: To explore the indications and contraindications of artificial disc replacement, peri-operative economics considerations, long-term complications, as well as the effect of artificial lumbar disc replacement combined with fusion surgery.
METHODS: The PubMed database, CNKI database and SinoMed database over the past decade were searched for the related articles. The retrospective and prospective clinical trials of artificial lumbar disc replacement were included. Repetitive studies and stale perspectives were excluded. A total of 34 articles were summarized and analyzed in the end.
RESULTS AND CONCLUSION: Since the first artificial lumbar disc prosthesis designed to be commercially distributed in 1982, there have been a plenty of clinical trials on lumbar disc replacement. However, there is no answer to many problems that encountered in clinical trials. The effect of the number of replaced segment on the clinical outcomes, the effect of facet joint degeneration on the clinical outcomes, selection of the patients with the history of lumbar disc surgery, age of the patients and the rest time before disc replacement should be taken into consideration in the researches on indications and contraindications of artificial disc replacement. The intraoperative blood loss, operation time and hospital stay after replacement can be used to evaluate whether lumbar disc replacement is better than the traditional lumbar fusion surgery or not. The complications after lumbar disc replacement include heterotopic ossification, implants mechanical failure, and facet joint and adjacent segment degeneration. The combination of lumbar disc replacement and fusion surgery for the treatment of multi-segmental lumbar disc diseases can achieve complement and thus obtaining the efficacy that better than the application of one surgery alone.

Key words: bone and joint implants, review of bone and joint implants, artificial prosthesis, artificial disc, arthroplasty, lumbar spine, clinical trials, provincial grants-supported paper

CLC Number:

R318

Bai Wen-yuan, Gu Hong-sheng, Liao Zhen-hua, Liu Wei-qiang. Clinical application of artificial lumbar disc replacement: Present and future[J]. Chinese Journal of Tissue Engineering Research, 2013, 17(35): 6321-6326.

Figures/Tables 3

Charité假体器械豁免实验2年随访结果显示，置换组在患者满意率、目测类比评分和ODI评分明显优于融合组，然而其5年随访结果却与融合组没有统计学差异，患者满意率也与融合组接近。有人担心，因为在该FDA控制的实验中施行手术的都是最优秀的脊柱外科医生，患者的适应证选择非常严格，在随访时间较短的情况下容易得到满意的疗效。假体投放市场后，术后长期疗效可能降低，并发症增多。虽然Blumenthal等[12]报道了Charité假体进入市场1年后进行的4 000余例手术，并发症的发生率与器械豁免实验结果相似[17]，作者认为，腰椎间盘假体置换术后的短、中期随访结果是否能与融合术相媲美，远期随访结果是否能防止小关节和相邻节段退变，还需要大量前瞻性、大宗样本、长期随访的资料来证实。 2.2 腰椎间盘置换术的临床应用现状 2.2.1 人工腰椎间盘置换的适应证和禁忌证美国骨科医师协会制定的人工腰椎间盘置换适应证为有症状的椎间盘破裂、退变，脊柱融合所致相邻节段退变不稳。禁忌证为手术节段脊柱畸形、严重骨质疏松、Ⅱ级以上腰椎滑脱、骨性椎管狭窄、手术瘢痕粘连引起的腰痛。通过分析大量的临床实验结果，作者认为对于腰椎间盘适应证和禁忌证的选择，还应考虑如下内容：手术节段数对临床结果的影响：在许多临床实验报道中，单节段、双节段腰椎间盘退行性疾病都是腰椎间盘置换的理想适应证[5,7,15,18]。但Siepe等[19]进行ProDisc Ⅱ假体单、双节段置换实验中，双节段置换组患者有更多的并发症，患者满意度也较差。虽然FDA只批准了Charité Ⅲ在单节段置换术中的应用，然而对于ProDisc Ⅱ假体允许进行双节段置换术。而3节段腰椎间盘病变则很少采用单独的腰椎间盘置换治疗，可进行置换术与融合术的联合应用。小关节退变对临床结果的影响：椎间盘退变但没有继发小关节改变和腰椎不稳是现阶段临床实验中普遍认可的适应证，严格排除了小关节病变的临床实验也得到了很好的疗效[4,6,11-12]。而实际上，许多实验仅将有明显的小关节退变(Ⅲ-Ⅳ度)列为腰椎间盘置换术的禁忌证，即纳入轻症的小关节退变患者，相应随访结果中出现了较多的并发症[8-10]。因此作者认为，术前严格排除小关节退变，是人工腰椎间盘置换取得良好疗效的保障。既往有腰椎间盘手术史患者的选择：许多临床实验中对腰椎融合后有相邻节段椎间盘退变的患者和腰椎间盘切除后复发的患者行腰椎间盘置换[6,20-21]，均得到了较好的临床效果，与首次行腰椎间盘置换患者临床结果上没有显著差异。然而，其他临床实验中却得到了不同的结论。Lemaire等[8]发现经历过多次腰椎间盘手术的患者，Charité假体置换术后有较多的并发症，Blondel等[22]也发现既往有后路腰椎间盘切除术的患者术后临床效果较差。实际上既往有前路腰椎手术的患者，由于瘢痕组织的影响，极易发生术中并发症，所以不适合再进行前路的腰椎间盘置换手术。只要手术前仔细排除禁忌证，其他情况下的腰椎手术史则对置换术的疗效没有显著影响。患者年龄：一直以来，许多学者认为腰椎间盘置换仅适合18-45岁的患者。Sott等[23]在一次评估Charité假体置换结果中发现，大于45岁的患者在临床结果上没有明显差异。Bertagnoli等[18]对大于60岁患者进行腰椎间盘置换得到了较好的临床结果。尽管如此，在60岁以上患者的置换患者选择上要十分慎重，确定患者的骨质良好并没有中央型椎管狭窄。椎间盘置换前休息时间：Rohan等[24]对232例行Charité、ProDisc假体置换或融合手术的患者进行了统计，得到了一个有趣的结论：椎间盘置换前离开工作时间为0-13周的患者比大于13周的患者在术后有更好的目测类比评分和ODI改善。这一研究结论提示，椎间盘置换前适当的工作一段时间对术后的临床结果有促进作用。这种现象的原因可能是患者的心理因素对手术疗效有一定影响。在判断患者是否适合进行腰椎间盘置换手术前，需要对腰椎间盘退变进行分级，详细询问病史、体格检查、影像学检查、诊断性注射药物和椎间盘造影。术后患者疼痛缓解的程度、假体的结构设计以及材料的缺陷、患者的心理因素等都可能影响手术结果。腰椎间盘置换在扩大的适应证中可应用于多个节段、有轻微的小关节退化、既往有后路椎间盘切除手术史，已融合部位的邻近节段，45岁以上无骨质疏松的患者，但也应注意这些情况也有降低术后临床效果的风险。 2.2.2 人工腰椎间盘置换围手术期经济学考量评价腰椎间盘置换是否优于传统的腰椎融合，还可以从术中出血量、手术时间、术后住院时间等方面进行考量，这对于评价腰椎手术的安全性以及患者、医院在腰椎手术期间的经济性等都有重要意义。 Zigler等[11]和Sasso等[24]分别报道了在手术时间和出血量这两个指标上，腰椎间盘置换组都明显优于360°腰椎融合组。然而，与腰椎前路融合或后路融合术相比，有报道显示腰椎间盘置换术在手术时间和出血量上没有显著差别[12]。在评价患者术后住院时间这一指标时，临床报道结果较一致，腰椎间盘置换术较传统融合术具有更短的住院时间[11,27]，FDA对Charité假体的器械豁免实验结果显示，Charité置换组在两个主要经济方面显示出明显优势，并有统计学意义：住院时间减少1 d，再手术率更低(5.4% vs. 9.1%)[12]。Guyer等[14]从患者和医院两个角度比较了一节段Charité腰椎间盘置换和腰椎融合在术中和术后两年内医院和患者的经济费用比较，腰椎间盘置换术较传统融合术更加经济。虽然在手术技术上腰椎间盘置换术更复杂，但是临床实验结果并没有显示其在手术中更大的出血量、更长的手术时间，所以腰椎间盘置换术在术中的经济性和安全性方面值得肯定。另外，值得考虑的是与脊柱融合术相比，人工腰椎间盘置换潜在优点之一是患者可以尽快参加康复训练。从现有的结果来看，腰椎间盘置换术与融合术相比，没有增加患者和医院双方的经济负担，但是对于全腰椎间盘置换手术的脊柱外科医生的训练、置换术后翻修手术的花费等还需更多的临床数据加以补充，才能确定其经济性是否与传统融合手术相仿。 2.2.3 远期并发症临床实验中腰椎间盘置换后短、中期疗效值得肯定，但是远期疗效尚有很多不尽如意的地方。腰椎间盘置换后较常见的并发症有异位骨化、植入物机械故障、相邻节段和小关节退变，下面分别进行介绍。异位骨化：腰椎间盘置换术后异位骨化导致手术节段的椎间隙自动融合，文献报道异位骨化的发生率为0.5%-15.2%。尽管人工腰椎间盘置换后异位骨化与其保留节段运动功能的初衷相悖，但大部分的异位骨化不影响疗效，只影响腰椎的活动度。通常，McAfee[27]定义的Ⅲ级以上的异位骨化腰椎活动度有所降低，但不影响患者的目测类比评分和ODI评分，也不影响临床疗效[28]。植入物机械故障：包括植入物磨损、移位、脱位、沉降等。Punt等[29]总结了1 000例Charité腰椎间盘置换术后10年随访资料，进行再手术的患者中76%是由植入物机械故障引起的，所以这类并发症受到越来越多的重视。随着脊柱外科医师行腰椎间盘置换术的熟练性增强、假体更大的终板面和即刻固定装置的发展，假体的移位、脱位、沉降等并发症已经明显减少。相邻节段和小关节退变：Trouillier等[30]用计算机断层扫描吸收法测定人工腰椎间盘置换术后对相邻节段和小关节的应力变化，结果显示相邻节段所受应力没有增加，在手术节段小关节所受应力明显减小。然而，在临床实验中相邻节段和小关节退变的发生率随着随访时间的增加而不断上升，一般在术后两年内较少发现相邻节段和小关节退变，而长期随访结果不容乐观。Tierry David等[10]在10年以上的随访中，发现有5%的患者发生了小关节退化，3%患者出现相邻节段病变。Putzier等[9]进行的17年随访中，有17%的患者出现了明显的相邻节段退变，这个结论与融合术后长达30年随访中相邻节段退变的发生率(14.2%)相近。Siepe等[31]也在置换术后发现20%患者出现小关节退变现象，尤以L5-S1节段为多。所以，腰椎间盘置换术对小关节和相邻节段的应力影响还需要进一步临床实验和观察。 2.2.4 人工腰椎间盘置换与融合术的混合使用由于采取人工腰椎间盘置换对腰椎融合后相邻节段退变的患者进行治疗得到较好的疗效[6,20]，有学者提出，可以灵活运用融合和置换手术，将两种手术同时用于治疗多节段腰椎间盘病变，使两种手术干预方法互补不足，得到优于单独使用的手术疗效。Grauer等[32]通过有限元方法分别在L4-S1节段进行双节段置换和混合手术，发现对于L3-L4节段，双节段置换组中运动度减小，在混合组中运动度增大。Qingan等[33]对尸体标本施行胸腰长脊柱融合术后，L4-L5和L5-S1节段活动度明显增大，在脊柱融合的尾端相邻节段施行Maverick假体单、双节段置换术后，这两个节段的活动度趋于正常。Cunningham等[34]发现Charité双节段置换组在屈伸运动时相邻节段的椎间盘内压力明显增大，而Charité与椎弓根螺钉混合手术组相邻节段的运动更接近正常生理状态。显然，腰椎融合术后相邻节段运动范围变大会对椎间盘和小关节产生一定的损伤，而混合手术则较好的矫正了这种现象。如今在同一次手术中不同节段行混合手术还少有报道，混合手术可用于多节段腰椎间盘退变，其中某些节段适合行腰椎间盘置换，而其他节段则不适合行腰椎间盘置换的情况(如该节段有骨赘、小关节已有病变、椎间隙过小不适合假体置换等)。施行混合手术的适应证、禁忌证、术后的康复训练、评价方式、翻修手术方法等问题还需更多的体外辅助实验和临床实验进行探索。"

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