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.     

腰椎Coflex棘突间动态稳定术后再手术原因分析

目的:评价腰椎退变性疾病应用Coflex棘突间动态稳定术治疗的再手术发生情况,探讨其原因及治疗方法。方法:2007年9月~2015年7月,295例腰椎退变性疾病患者在我院接受减压及Coflex棘突间动态稳定手术。采用回顾性分析方法,统计本组患者术后再手术的发生情况,探讨其再手术原因和处理方法,并对所有再手术患者进行随访,根据患者主观满意度评价再手术效果。结果:295例患者中,再次手术患者共16例,再手术率为5.4%。所有再手术患者二次手术时间距离首次手术15.1±23.4个月(0.1~60个月)。16例再手术患者中,非内固定相关并发症者6例(37.5%),其中切口感染2例、伤口深层血肿形成4例,均采取感染清创或血肿清除(1例因行棘突切除取出Coflex)治疗后痊愈;内固定相关并发症者10例(62.5%),其中2例Topping-off术后患者再手术原因为融合节段内固定松动或神经根粘连,更换内固定及神经根松解后症状缓解;另8例单节段Coflex置入患者主要原因为原手术节段或邻近节段退变,接受再次探查减压、融合后症状缓解,其中1例为新发节段症状,予以减压融合后症状缓解。本组所有再手术患者中,无1例因Coflex内固定直接相关并发症(内固定移位、松动、脱出或棘突骨折)再次手术。所有再手术患者术后随访时间28.6±12.6个月(6~48个月),末次随访时患者主观满意度总体优良率为93.8%。结论:Coflex棘突间动态稳定术治疗腰椎退变性疾病再手术原因与Coflex装置无直接相关,主要影响因素与切口感染、深层血肿及原手术或邻近节段退变有关。     

单节段棘突间动态稳定装置置入术后1年棘突骨质吸收现象及其风险因素

【摘要】 目的：研究单节段L4/5棘突间动态稳定装置（Wallis）置入术后1年的L4及L5棘突骨质吸收现象,并行多因素回归分析对可能的原因进行探讨。方法：回顾性研究我科2009年~2011年间行单节段L4/5 Wallis置入手术的患者,通过比较术后1年与术后1周时两组X线片上L4及L5棘突高度、长度及厚度的差异,将患者分为两组：骨质吸收组与非骨质吸收组。比较两组患者性别、年龄、BMI、是否吸烟、骨质疏松、手术时间、术中出血量、腰背肌肉锻炼、佩戴腰围时间、L4/5棘突间距、L4/5椎间隙高度及腰椎前凸角度,并于术前及术后1年通过腰椎MRI对腰椎间盘退变程度进行分级以及对症状进行VAS、JOA、ODI评分。应用卡方检验、T检验及二分类多因素回归分析进行统计分析。结果：完成随访患者44例,男24例,女20例,平均年龄42.7岁。有29例发生骨质吸收,女性16例,占55.2%,其中L4和L5同时发生骨质吸收者16例,以L4、L5棘突高度骨质吸收最为严重,骨吸收率分别为（16.28±1.46）%、（22.93±1.63）%。术前存在骨质疏松的患者共7例,均发生了骨质吸收。棘突骨质吸收的独立危险因素有BMI（OR：1.337,95% CI：1.048～1.705）,30°<术前腰椎前凸角≤40°（OR：8.953,95% CI：1.011～79.269）,40°<术前腰椎前凸角≤50°（OR：11.160,95% CI：1.112～111.961）,术前腰椎前凸角>50°（OR：11.718,95% CI：1.535～89.436）;两组患者MRI、VAS、JOA及ODI评分比较无显著统计学差异（P>0.05）。结论：棘突间弹性内固定装置Wallis置入术后1年可观察到棘突的骨质吸收现象,该现象较为普遍并存在一定规律,患者术前BMI及腰椎前凸角度是其独立风险因素,骨质疏松也是其可能的原因之一,但是该现象与术后症状是否缓解及影像学改变无显著关联。     

L4/5棘突间植入椎间融合器的稳定性及对相邻节段的生物力学特性和生物相容性的影响

目的:探讨L4/5棘突间植入椎间融合器的稳定性及对相邻节段的生物力学特性与生物相容性的影响.方法:采集18组新鲜成人冰冻脊柱标本,其中模拟L4/5棘突间植入椎间融合器为研究组,而正常标本为对照组,两组各9例,两组标本进行编号后经棘突间弹性内植入并用固定器进行固定.结果:研究组于各个植入处在前屈、中心压缩、侧屈及后伸下的应变变化均较对照组小(P均<0.05).于施加最大载荷600N下,研究组椎体的角位移与线性位移在左侧屈、左旋转、前屈、后伸状态下均小于对照组(P均<0.05).结论:L4/5棘突间植入椎间融合器可有效改善伤椎的活动度,保留其稳定性,有助于减轻椎间盘应力.     

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。     

Does an interspinous device (Coflex?) improve the outcome of decompressive surgery in lumbar spinal stenosis? One-year follow up of a prospective case control study of 60 patients

A number of interspinous process devices have recently been introduced to the lumbar spinal market as an alternative to conventional surgical procedures in the treatment of symptomatic lumbar stenosis. One of those “dynamic” devices is the Coflex™ device which has been already implanted worldwide more than 14,000 times. The aim of implanting this interspinous device is to unload the facet joints, restore foraminal height and provide stability in order to improve the clinical outcome of surgery. Published information is limited, and there are so far no data of comparison between the implant and traditional surgical approaches such as laminotomy. The purpose of our prospective study is to evaluate the surgical outcome of decompressive surgery in comparison to decompressive surgery and additional implantation of the Coflex™ interspinous Device. 60 patients who were all treated in the Spine Center of Klinikum Neustadt, Germany for a one or two level symptomatic LSS with decompressive surgery were included. Two groups were built. In Group one (UD) we treated 30 patients with decompression surgery alone and group two (CO) in 30 patients a Coflex™ device was additional implanted. Pre- and postoperatively disability and pain scores were measured using the Oswestry disability index (ODI), the Roland–Morris score (RMS), the visual analogue scale (VAS) and the pain-free walking distance (WD). Patients underwent postoperative assessments 3, 6 and 12 month including the above-mentioned scores as well as patient satisfaction. In both groups we could see a significant improve (p < 0.001) in the clinical outcome assessed in the ODI, in the RMS for evaluation of back pain, in the VAS and in the pain-free WD at all times of reinvestigation compared to base line. At 1-year follow up there were no statistically differences between both groups in all ascertained parameters including patient satisfaction and subjective operation decision. Because there is no current evidence of the efficacy of the Coflex™ device we need further data from randomized controlled studies for defining the indications for theses procedures. To the best of our knowledge this is the first prospective controlled study which compares surgical decompression of lumbar spinal stenosis with additional implanting of an interspinous Coflex™ device in the treatment of symptomatic LSS.     

黄韧带的正常与病理解剖

解剖人脊柱腰骶段３５例。对黄韧带的分布及传统插图提出了修改意见。黄韧带与棘间韧带并非融合或混合，而是两者相贴邻。两黄韧带后缘之间不存在裂隙。黄韧带后面不直接与肌肉相贴，也不存在所谓椎板间韧带，把黄韧带与肌肉相分隔者实为棘间韧带。不存在导致压迫神经的单纯黄韧带肥厚。建议重视使用盘－黄间隙－词。对目前通用的椎间盘突出压迫神经示意图提出修改意见，并提供了新图的设计。     

Bursting strength evaluation after different types of mesh fixation in laparoscopic herniorrhaphy

Background: In laparoscopic inguinal herniorrhaphy, meshes commonly have been fixed with a stapler. Recently, a new mode of fixation using a helical fastener has been introduced. The purpose of this experimental study was to compare the stability achieved by various types of mesh fixation. Methods: In 20 human cadavers, polypropylene meshes 10 × 15 cm in size were fixed in both groins by using either a helical fastener or a hernia stapler (4.8 mm). The mesh was fixed with 2, 4, and 8 elements and stressed with a dynamometer until the prosthesis ruptured. A paired and two-sided Student's t-test was used for statistical evaluation. Results: With the helical fastener, the mesh could be fixed always at the desired site. However, with the stapler, it was not possible to fix the mesh in the pubic bone or, at times, in the Cooper's ligament. When two fixation elements were used, the mesh fixed by the helical fastener was able to withstand a median load of 34 N (range 23–53 N), and that fixed by the stapler 7.5 N (range 3–12 N; p < 0.001). When four fixation elements were used, the mesh fixed by the helical fastener was able to withstand 70.5 N (range 53–80 N) and that fixed by the stapler 17.5 N (range 4–25 N; p < 0.001). With the use of eight elements, the mesh fixed by the helical fastener withstood 127 N (range 84–156 N) and that fixed by the stapler 32.5 N (range 15–59 N; p < 0.001). Thus, in all cases the helical fastener was significantly more stress resistant. The main reason for detachment of the mesh was tissue disruption or deformation of the fixation elements. Only when a stress of more than 130 N was applied did the mesh tear in two cases. Conclusions: The stress-bearing capacity (shear force resistance) of a mesh fixed by a helical fastener is up to four times that of a mesh fixed by a stapler. Therefore, the helical fastener provides significantly more stable fixation and will be able to protect the patient better from recurrent hernias caused by mesh migration. Received: 10 August 1998/Accepted: 26 March 1999