Chinese Journal of Tissue Engineering Research ›› 2019, Vol. 23 ›› Issue (24): 3862-3867.doi: 10.3969/j.issn.2095-4344.1224
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Online:
2019-08-28
Published:
2019-08-28
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Chang Shan, Professor, Master’s supervisor, Chief physician, the First Affiliated Hospital of Chengdu Medical University, Chengdu 610000, Sichuan Province, China
About author:
Xiao Yongchuan, Master candidate, the First Affiliated Hospital of Chengdu Medical University, Chengdu 610000, Sichuan Province, China
CLC Number:
Xiao Yongchuan, Liang Chuandong, Xu Zechuan, Li Yugang, Chang Shan.
2.1 由来 1994年Coflex被Jacques Samani医生所发明,开始被称为棘突间U型装置,2005年更名为 “cofunction of flexion and extension”,简称“Coflex”。Coflex由钛合金制成,Coflex系统从侧面看类似U形,具有抗压缩和牵拉的良好性能,因此具有一定的弹性。上下两侧均为有齿翼,翼上具有许多小齿可将两翼固定于上下棘突间,在“U”形体的上下面也有小齿,有利于整个装置固定于腰椎,防止装置滑脱移位[7]。 2.2 临床治疗研究 2.2.1 Coflex与单纯减压术 Schmidt等[8]在德国7个医院将230例患腰椎管狭窄症的患者按1∶1的情况随机分配到单纯减压组与Coflex层间稳定减压组进行治疗,术后2年的随访结果表明,使用Coflex棘突间稳定减压与单纯减压相比,Coflex棘突间稳定减压组不管在椎间孔、椎间盘高度的恢复及维持,还是对患者行Oswestry功能障碍指数、苏黎世跛行问卷评分、目测类比评分、行走耐受性评估和X射线片影像学表现都提示Coflex棘突间稳定减压比单纯减压更彻底、更稳定,患者术后神经症状恢复更好,更能耐受疼痛。 2.2.2 Coflex与传统腰椎融合内固定术 Kong等[9]进行临床随访报道比较Coflex系统和腰椎后路椎间植骨融合术治疗42例单节段(L4/5)腰椎管狭窄症患者,术后均行目测类比评分和Oswestry功能障碍指数,结果表明2组患者术后腰背痛和下肢痛均有明显改善,并且进行了1年的随访显示,Coflex系统在减少临近节段椎间盘、小关节压力方面明显优于腰椎后路椎间融合术,但是Coflex组术后临近节段活动度明显小于腰椎后路椎间植骨融合组。Li等[10]和Kuang等[11]进行Meta分析后报告,Coflex组与传统腰椎融合内固定术手术组相比,在临床结果、Oswestry功能障碍指数、目测类比疼痛评分上具有类似的结果,但Coflex显示出更少的失血,更短的住院时间和更少的器械相关并发症,最终得出Coflex棘突间非融合技术是安全有效的。刘建等[12]进行了Coflex系统与后路椎间融合内固定治疗腰椎退行性疾病的Meta分析,共纳入1 248例病例,Coflex组与腰椎后路椎间植骨融合组相比,术后Oswestry功能障碍指数及目测类比评分无明显差异;手术时间、手术出血量、住院天数比较,Coflex组均优于腰椎后路椎间植骨融合组,并能保留手术节段的活动度,同时对临近节段的活动度影响较小。 2.2.3 Coflex临床随访结果 目前Coflex的临床疗效报道多为短期随访结果良好,中长期随访结果较少,就这一问题王振林等[13]进行了为期4年的临床调查研究,对比分析棘突间动态非融合装置Coflex与腰椎后路融合固定治疗单节段(L4/5)腰椎管狭窄症的中期疗效,通过术后目测类比评分、Oswestry功能障碍指数、椎间孔高度、临近椎间盘退变改良Pfirrmann分级等比较,得出棘突间动态非融合Coflex治疗退行性腰椎管狭窄症可达到与腰椎融合内固定同样的中期临床疗效,并且在减少相邻节段退变方面具有一定优势。郑晓青等[14]在Coflex棘突间固定装置置入术治疗腰椎管狭窄症7年随访中得出结论:Coflex系统技术和腰椎融合内固定技术在治疗退变性腰椎管狭窄症均具有良好的临床疗效,并进行7年随访结果显示均满意,2组差异无显著性意义,但是Coflex组在围术期手术切口小、出血少、术后恢复快等优点,Coflex棘突间固定装置在延缓邻近节段椎间盘、小关节退变、维持责任节段及临近节段椎间隙高度上具有优势,对于其临床应用价值有待更长期的随访观察。梁昌详等[15]在Coflex置入治疗L4/5退变性腰椎管狭窄症的5年随访结果发现,术后不管在手术相邻节段椎间孔的高度、椎间活动度及临床疗效,Coflex组和椎间融合组均相似,且能有效避免融合手术所致的手术相邻节段椎间活动度过大问题,但对延缓相邻节段退变的作用有待更长期的观察。可见目前Coflex治疗腰椎管狭窄的短中期临床效果优于融合组,但是都缺乏长期随访观察结果。在Davis等[16]在美国选取了322例患者进行Coflex治疗轻度腰椎滑脱伴椎管狭窄症的随机对照试验中,其中Coflex组215例,腰椎融合内固定组107例,结果显示Coflex组在治疗轻度腰椎滑脱伴椎管狭窄症好于腰椎融合固定融合术,并且在术后苏黎世跛行问卷评分中Coflex组患者满意度优于传统腰椎融合内固定组。在医疗费用上,Schmier等[17]研究发现Coflex手术组比于传统腰椎融合内固定手术组费用更低,性价比更高。 2.2.4 Coflex置入腰椎节段 目前Coflex棘突间装置更多的应用于L4/L5及L3/L4节段,在L5/S1节段的应用较少。Xu等[18]探讨了Coflex装置在治疗L5/S1水平退行性腰椎疾病是可行的、有效的和安全的,并进行了为期4年的随访,所有患者的临床疗效均有明显改善,但是在总共33例患者中有14例患者由于S1棘突过短,是通过翻转假体完成手术的,这为提醒手术医生术前评估手术患者S1棘突长短,做好行翻转假体的准备。Cabraja等[19]进行了Coflex棘突间装置的置入与经皮小关节去神经支配术治疗复发性腰椎小关节疼痛的短期和中期疗效对比显示,棘突间Coflex装置可以改善临床短期和中期疗效中的小关节疼痛,但是其效果没有经皮小关节去神经支配术治疗复发性腰椎小关节疼痛效果明显。可见Coflex可用于腰椎多个节段,甚至在条件允许下可同时连续使用多个腰椎节段[20]。 2.3 生物力学研究 2.3.1 Coflex生物力学 Coflex在最初的设计理念是在用于治疗腰椎管狭窄症时既恢复椎间孔的高度,又缓解小关节、椎间盘的应力,减少临近节段的受力,在保证手术节段稳定性的前提下尽可能的恢复腰椎的活动度。Tsai等[21]进行体外生物力学实验研究,Coflex系统对腰椎病变失稳节段的稳定作用,结果显示Coflex系统置入后对后伸活动具有良好的稳定作用,甚至可以恢复到完整健康标本的活动范围;对前曲活动和轴向旋转活动也具有较好的稳定作用,可基本恢复失稳节段正常的前曲及轴向旋转活动,但在左右侧屈活动时,Coflex却没有表现出较好的稳定性。但是Kettler等[22]的研究结果表明,Coflex的置入在稳定性方面,后伸状态最好,腰椎前屈、左右侧屈和轴向旋转的方向不能提供较好的稳定性,可见Coflex置入对腰椎前屈、左右侧屈、轴向旋转状态的稳定还有争议。 Coflex在置入深度上对脊柱生物力学也有影响。祖丹等[23]和宋红芳等[24]便进行了Coflex不同置入深度对相邻节段运动范围的影响的体外生物力学研究,发现当Coflex的U形顶端与硬脊膜的距离≤5 mm时,对上下邻近节段在前屈、后伸、左右侧弯、轴向旋转运动范围无明显影响。但是此实验结果发现,并不是Coflex的U形顶端距离硬脊膜越近其生物力学越好,0 mm组较5 mm的上下邻近节段运动范围与完整组相比相差更远。所以作者结合Coflex最佳的置入距离是U型顶端距离硬脊膜≤ 5 mm,但是置入Coflex最好不要过深,不仅不具有较好的生物力学稳定性,加大邻近节段退变的风险,甚至可能压迫脊髓、神经根,出现神经症状。所以目前认为置入深度在2-5 mm最为合适。 2.3.2 Coflex与同类棘突间稳定装置的比较 Wilke 等[25]进行一项体外生物力学实验,将24个腰椎标本随机分为4组,分别建立完整模型、失稳模型、置入棘突间装置后模型(Coflex、Wallis、Diam、X-Stop),再给予前屈、后伸、左右侧屈及轴向旋转力学加载,比较3组模型腰椎的稳定性、活动度及上位椎间盘应力发现,置入棘突间装置后腰椎前屈、后伸活动度达到了完整模型的50%,但是在左右侧屈及轴向旋转中与失稳模型相当。上位椎间盘应力方面,置入棘突间装置模型在前屈、左右侧屈及轴向旋转上与完整模型相似,在后伸上比完整模型有所减少。说明Coflex装置与同类型棘突间装置在腰椎稳定性、活动度及上位椎间盘应力方面具有相似的结果。 Hartmann等[26]开展了Aperius,In-Space,X-Stop和Coflex四种棘突间装置的体外生物力学实验,在无轴向压力时,4种装置均能减少脊柱后伸活动度,而前屈、左右侧屈和轴向旋转无明显影响。在给与轴向压缩时,4种装置在前屈、后伸时活动度减少,在左右侧屈及轴向旋转时活动度增加,作者认为这可能是加快临近节段椎间盘退变的原因。 2.4 有限元分析研究 1972年Brekelmans将有限元分析法引入骨科领域,之后Belytschko便将有限元法应用于脊柱生物力学。现在,将有限元技术用于脊柱内固定装置也逐渐风靡起来。 陈肇辉等[27]进行了一项Coflex在腰椎三维有限元分析研究发现,置入Coflex装置可以保留椎体责任节段部分活动度,降低责任节段小关节和椎间盘应力,并且对相邻节段活动度及椎间盘应力的影响较小,但是增加了临近上下节段小关节压力,可能导致临近节段小关节的增生退变;同时由于Coflex两翼受力于腰椎棘突,有限元分析显示其置入节段棘突应力升高,提示有增加棘突骨折的风险,这也与临床研究发现相一致。谷雪莲 等[28]进行了棘突间装置Coflex治疗单节段(L4/5)腰椎管狭窄症有限元模型分析,结果Coflex可以降低腰椎后伸活动度和责任节段椎间盘压力,对临近节段腰椎活动度及椎间盘压力无明显影响,因此Coflex是治疗腰椎管狭窄症的有效治疗方法。 2.5 Coflex Rivet和Coflex-NEW 由于棘突间装置Coflex可以为手术节段提供稳定性,但不会恢复脊柱整体运动的稳定性,因此Coflex rivet(在Coflex系统基础上增加了棘突固定螺钉)被开发出来。于是Kettler等[22]对Coflex Rivet进行体外生物力学研究发现,Coflex Rivet可明显提高腰椎稳定性,不但显著增加责任节段前屈、后伸状态的稳定性,也明显提高了轴向旋转及左右侧屈的稳定效果,因此甚至有学者提出该装置在生物力学方面的稳定作用可作为融合术的一种辅助手段。Hartmann等[26]也进行了体外生物力学实验发现Coflex rivet会减少脊柱后伸的活动度,但在左右侧弯和轴向旋转时,Coflex装置会引起整个脊柱的更高活动度,这可能会增加相邻节段退变的风险。Lo等[29]在进行了有限元分析后显示,Coflex rivet置入可以提供责任节段后伸,左右侧屈和轴向旋转的稳定性,并且除了后伸外,其在邻近节段处没有影响。Coflex rivet置入可以提供所有运动方向的稳定性并减少责任节段处的椎间盘应力。因此,Coflex rivet置入后腰椎在前屈和后伸时会加大相邻椎间盘的应力,加快临近椎间盘的退化。目前有限元方法用于Coflex内固定改进在不断进行,Guo等[30]用拓扑优化成形法发明的Coflex-NEW比Coflex rivet的体积大约减少了8%,然而该新装置却与Coflex rivet装置具有相似的生物力学性能。 2.6 Coflex并发症报道 尽管Coflex棘突间装置显示出较低的并发症和再手术率,但仍存在一些并发症,如假体松动、假体断裂和棘突骨折。Bae等[31]的临床研究在3年随访中置入Coflex装置后,215例患者中有11例患者发生了棘突骨折。Chung等[32]还报道了1例棘突间置入装置置入后双侧腰椎后方应力性骨折的病例。作者认为从生物力学的角度考虑,在加载方向上的错位和再稳定在棘突上产生压缩力,这种力可能是棘突骨折的原因。Cabraja等[19]的一项前瞻性研究中,20例患有小关节病的腰痛患者在L4-5接受了Coflex装置置入术,所有患者最初症状均有所改善,但在2年后症状有所恶化,考虑其原因可能和腰椎退行性变继续发展有关。Ramhmdani等[33]报道了在使用Coflex治疗腰椎小关节综合征后出现腰椎滑膜囊肿病例1例,并且提出小关节病可能不适合放置Coflex。Tian等[34]随访了经过单节段(L4-5)置入Coflex装置治疗腰椎管狭窄症的32例患者,随访时间为24-57个月,其中26例(81.2%)可检测到异位骨化。可见置入Coflex装置后异位骨化非常高,临床医生应该意识到这种可能的结果,并且应该进行更多的研究来阐明异位骨化的原因及机制。 "
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