下腰椎L4/5与L5/S1节段Coflex动态固定的有限元模型试验设计

目的 模拟临床手术,探讨Coflex动态稳定装置在下腰椎L5/S1退变性疾病中应用的可行性。方法 在第2代中国数字化人体“男性23号”数据集平台上,选取下腰椎骶骨数字模型,运用CAX相关软件建立下腰椎及Coflex应用于下腰椎的3组有限元模型(健康者下腰椎模型、Coflex固定L4/5节段模型及Coflex固定L5/S1节段模型);根据脊柱三柱加载理论和下腰椎生理运动,采用直立、前屈和后伸3种生理载荷分别进行计算、验证和对照分析。结果 建立了健康者下腰椎骶骨有限元模型、Coflex固定L4/5节段有限元对照模型、以及Coflex固定L5/S1节段有限元试验模型。根据3组有限元模型对照试验的稳定性和相容性等各种生物力学指标,发现两种动态内固定方式的下腰椎具有相近的生物力学效果。结论 本有限元模型对照试验的设计为研究下腰椎L5/S1节段Coflex动态固定手术提供了生物力学循证依据,对Coflex植入L5/S1节段这一新手术的临床应用具有指导意义。     

Complications in degenerative lumbar disease treated with a dynamic interspinous spacer (Coflex)

Purpose

The purpose of this study was to quantify the intra- and postoperative complications of an interspinous process device (Coflex) in managing degenerative lumbar diseases and to investigate corresponding therapeutic strategies.

Methods

Between January 2008 and December 2012, we retrospectively analysed a total of 131 patients who underwent decompressive surgery along with the Coflex system for the treatment of degenerative lumbar diseases. The related complications were reported, and appropriate measures were taken. Clinical outcomes and radiological data were collected and analysed, and clinical outcomes were evaluated with paired-samples T test.

Results

Related complications occurred in 11 patients. Among them, six cases were found with surgical technique-related complications, including device-related complications in three cases: spinal process fracture (n = 1), Coflex loosening (n = 1), fixed-wing breakage (n = 1), dura mater tear in two cases and superficial wound infection in one case. All of them received corresponding conservative treatment and obtained a good result. The other five cases had non-device-related complications and required additional spinal surgery. The conservative therapy group had apparent improvement of VAS score and ODI, and remained well to final follow-up (P < 0.05). The second operation group also improved postoperatively (each P < 0.05).

Conclusion

The Coflex dynamic interspinous process device shows a low complication and re-operation rate. Standard operation and strict follow-up observation can effectively avoid surgical technique-related complications. The key points to ensure surgical effect and to reduce non-device-related complications are mastering surgical indications and thorough intra-operative decompression.     

Coflex植入术治疗退行性腰椎管狭窄症41例的临床观察

目的探讨腰椎后路棘突间Coflex植入术治疗退行性腰椎管狭窄症（DLSS）的临床疗效。方法 2012年2月至2013年9月期间收治的74例DLSS患者,按愿意分为对照组33例和治疗组41例,其中对照组接受全椎板减压植骨融合内固定术,治疗组接受Coflex植入术。比较两组手术时间、出血量、并发症;日本整形外科学会（JOA）下腰痛评分、疼痛视觉模拟标尺（VAS）评分、美国脊柱损伤协会（ASIA）神经功能分级;X线片测定植入节段椎间隙前后缘的高度、椎弓根间距及Cobb角。结果治疗组与对照组相比,手术时间缩短[（1.02±0.32）h vs（2.13±0.58）h]、术中出血量减少[（145.5±36.0）mL vs（279.3±56.8）mL]、并发症减少（0 vs 9.1%）（P〈0.05）;两组JOA下腰痛评分均较术前明显增高,VAS评分较术前明显降低（P〈0.05）,治疗组术后VAS评分较对照组更低[（2.3±0.3）vs（2.6±0.6）,P〈0.05];术后两组神经功能均有一定程度恢复,但组间比较差异无统计学意义（P〉0.05）;两组患者手术前后植入节段椎间隙前缘高度、椎弓根间距及Cobb角均无明显变化,椎间隙后缘高度均增大[治疗组术前与术后比较[（7.31±1.36）mm vs（8.98±1.56）mm],对照组术前与术后比较[（7.19±1.08）mm vs（8.61±1.41）mm,P均〈0.05],但组间比较差异无统计学意义。结论腰椎后路棘突间Coflex植入术是一种治疗退行性腰椎管狭窄症安全、有效的手术方法。     

棘突间动态稳定装置Coflex治疗退行性腰椎疾病的临床疗效分析

目的 探讨棘突间动态稳定装置Coflex治疗退行性腰椎疾病的临床疗效.方法 回顾性研究我院2009年1月至2013年12月采用Coflex治疗的173例退行性腰椎疾病患者.单纯Coflex治疗104例,男47例,女57例;年龄27～84岁,平均57.8岁;Topping-off治疗69例,男37例,女32例,年龄39～78岁,平均59.4岁.记录手术时间、术中出血量及术后并发症.选用Oswestry功能障碍指数(oswestry disability index,ODI)、视觉模拟评分(visual analoguescale,VAS)评价临床疗效.拍摄腰椎站立位的正侧位X片,测量并记录Coflex节段的术前、术后3个月、术后1年、终末随访时的椎间角度和椎体后缘高度.结果 本组随访12～64个月,平均(28.1±12.2)个月.单纯Coflex的平均手术时间(92.2±24.6)min,平均出血量(195.5±62.2) ml;Topping-off的平均手术时间(173.7±28.7)min,平均出血量(415.5±80.7)ml.单纯Coflex术后伤口感染2例,术后5年翻修1例;Topping-off术后伤口感染2例,椎管内血肿2例,术后3年Coflex置入节段翻修1例,术后3年融合节段下位椎间盘突出行二次手术l例.术后1年随访的腰痛及腿痛VAS评分、ODI评分与术前比较,差异有统计学意义(P＜0.05).Coflex置入节段术后3个月椎间角度均小于术前,差异均有统计学意义(P＜0.05),术后1年、终末椎间角度与术前比较差异均无统计学意义(P＞0.05);术后3个月椎体后缘高度均大于术前,差异有统计学意义(P＜0.05),术后1年、终末椎体后缘高度与术前比较差异无统计学意义(P＞0.05).结论 棘突间动态稳定装置Coflex治疗退行性腰椎疾病的中短期随访临床疗效满意,Coflex节段的椎间角度及椎体后缘高度术后短期内可获得明显的改善.     

棘突间 CoflexTM 非融合固定的临床应用及疗效分析简

目的评价棘突间Coflex非融合固定治疗腰椎管狭窄症的临床效果及应用前景。方法对腰椎管狭窄症121例采用后路双侧椎板开窗减压,棘突间Coflex非融合固定手术。其中119例行单节段棘突间Coflex固定,2例行双节段棘突间Coflex固定。结果121例术后症状均得到明显改善,平均手术时间40．24min,平均失血量51．43ml;术前下腰椎JOA评分平均为13．62分,术后为25．06分;术前ODI评分平均为67．36％,术后为14．33％;术前腰痛VAS评分为7．89分,术后为2．01分：术前腿痛VAS疼痛评分平均为8．44分,术后为1．22分。结论应用双侧椎板开窗减压,棘突问Coflex非融合固定治疗腰椎管狭窄症具有良好的近期临床疗效。     

棘突间动力固定系统治疗腰椎管狭窄症的手术配合

<正>棘突间动力固定(Coflex)技术是脊椎系统动态固定技术的一种。该技术在解除神经压迫的同时,既恢复腰椎的稳定性又保留手术部位腰椎的运动功     

Coflex棘突间动力重建术与360°融合术治疗单节段腰椎退变性疾病的成本-效用分析

目的 从卫生经济学角度对Coflex棘突间动力重建术与360°融合术治疗单节段腰椎退变性疾病进行成本-效用分析,为临床医生及单节段腰椎退变性疾病患者选择最佳治疗方案提供参考.方法 对2008年10月至2010年11月期间,四川大学华西医院骨科采用后路减压联合Coflex棘突间动力重建术(A组)与椎间及后外侧360°植骨融合术(B组)治疗的腰4～5节段退变性疾病患者进行前瞻性非随机对照研究,以SF-36量表调查患者生活质量并计算质量调整生命年(QALY),同时收集治疗成本,比较两组的成本-效用比.结果 共纳入60例患者,其中A组29例,B组31例,平均随访16.4(12～23)月.其中A组男20例,女9例,年龄45.1(21～67)岁;B组男16例,女15例,年龄56.2(32～86)岁.A、B组医疗成本分别为51509.9:1:2422.9元、57409.7±9072.9元,生活质量分别较术前改善42.60%、42.82%,成本效用比分别为69 165.6± 716.0元/QALY、77 976.7±12 757.4元/QALY,A组每提高一个QAlY较B组可节约12.74%的成本.结论 Coflex棘突间动力重建术与360°融合术治疗单节段腰椎退变性疾病短期疗效相当.但比后者治疗成本低,更符合卫生经济学要求.     

两种不同术式治疗中青年腰椎间盘突出症患者疗效比较

目的 比较单纯腰椎间盘髓核摘除术(LD)与腰椎间盘髓核摘除加棘突间非融合弹性内固定术( LD with Coflex system)治疗中青年腰椎间盘突出症(LDH)患者的疗效.方法 收集郑州大学第一附属医院骨科2009年1月至2011年12月接受LD(A组)患者53例,随访时间(21.9±12.6)个月;接受LD with Coflex system(B组)患者21例,随访时间(13.0±9.7)个月.随访期间观察所有随访患者术前及术后的目本矫形外科协会评分(JOA)评分,比较两组受访者疗效.结果 术前术后3个月JOA评分A组为(13.3±1.2,19.0±1.1),B组为(13.0±1.2,19.4±1.3),两组比较差异无统计学意义(P＞0.05);术后12个月和24个月JOA评分A组为(21.9±1.2、24.2±0.9),B组为(25.1±0.8、27.0±1.0),两组比较差异有统计学意义(P＜0.05).结论 LD with Coflex system 在治疗中青年LDH患者远期疗效优于LD,此术式对中青年患者更有利.     

腰椎后路Cosmic非融合固定与Coflex非融合固定的疗效对比

目的比较Cosmic非融合固定与Coflex非融合固定治疗退行性腰椎疾病的疗效。方法2009年8月--2012年8月杭州市第一人民医院骨科收治的退行性腰椎疾病患者60例,根据随机原则分为Cosmic组和Coflex组,每组30例。对2组患者的临床指标、疗效、VAS评分、JOA评分和ODI指数进行比较。结果Cosmic组的总有效率为100％,显著高于Coflex组（93．3％）,差异具有统计学意义（P〈0．05）;Cosmic组的JOA评分显著高于Coflex组,ODI指数显著低于Coflex组,差异均具有统计学意义（t=2．120,2．104,P〈0．05）。结论Cosmic非融合固定术治疗退行性椎间盘疾病的综合疗效优于Coflex非融合固定。     

Evaluation of Coflex interspinous stabilization following decompression compared with decompression and posterior lumbar interbody fusion for the treatment of lumbar degenerative disease: A minimum 5-year follow-up study

Few studies have compared the clinical and radiological outcomes between Coflex interspinous stabilization and posterior lumbar interbody fusion (PLIF) for degenerative lumbar disease. We compared the at least 5-year clinical and radiological outcomes of Coflex stabilization and PLIF for lumbar degenerative disease. Eighty-seven consecutive patients with lumbar degenerative disease were retrospectively reviewed. Forty-two patients underwent decompression and Coflex interspinous stabilization (Coflex group), 45 patients underwent decompression and PLIF (PLIF group). Clinical and radiological outcomes were evaluated. Coflex subjects experienced less blood loss, shorter hospital stays and shorter operative time than PLIF (all p < 0.001). Both groups demonstrated significant improvement in Oswestry Disability Index and visual analogue scale back and leg pain at each follow-up time point. The Coflex group had significantly better clinical outcomes during early follow-up. At final follow-up, the superior and inferior adjacent segments motion had no significant change in the Coflex group, while the superior adjacent segment motion increased significantly in the PLIF group. At final follow-up, the operative level motion was significantly decreased in both groups, but was greater in the Coflex group. The reoperation rate for adjacent segment disease was higher in the PLIF group, but this did not achieve statistical significance (11.1% vs. 4.8%, p = 0.277). Both groups provided sustainable improved clinical outcomes for lumbar degenerative disease through at least 5-year follow-up. The Coflex group had significantly better early efficacy than the PLIF group. Coflex interspinous implantation after decompression is safe and effective for lumbar degenerative disease.