Coflex棘突间动力重建系统治疗腰椎退变性疾病18例

背景：近年来脊柱非融合技术一直是脊柱外科研究与争论的热点。Coflex棘突间动力重建系统作为腰椎后路非融合器材,国外虽已应用较长时间,但国内尚处于试用阶段。目的：探讨Coflex棘突间动力重建系统治疗腰椎退变性疾病的适应证,并对其早期临床疗效进行评价。方法：2008-10/2010-06使用Coflex棘突间动力重建系统治疗腰椎退变性疾病31例,对其中随访超过1年的18例患者临床资料进行分析总结。治疗方式均为后路髓核摘除,椎管减压、Coflex棘突间动力重建系统置入;1例患者术中置入2枚Coflex。治疗前及各次随访时均对患者进行日本骨科学会下腰痛功能量表、中文版Oswestry功能障碍指数量表及目测类比评分法评估,并测量治疗前后、各次随访时腰椎前屈后伸位置入节段及其上下节段活动范围、Colfex上下极板夹角及置入节段椎间隙高度。结果与结论：患者均获随访,随访时间12～20个月。末次随访时患者日本骨科学会下腰痛功能量表评分、中文版Oswestry功能障碍指数量表评分及目测类比评分均获显著改善;治疗前后置入节段椎间高度及其上下节段椎间活动度差异均无显著性意义（P〉0.05）,末次随访时Coflex上下极板夹角在过伸位较中立位显著增大（P〈0.05）。提示Coflex棘突间动力重建系统对腰椎间盘突出症、椎管狭窄及腰椎不稳等腰椎退变性疾病安全有效,在腰椎后伸时能够有效分担载荷,同时对腰椎生理活动影响较小,有利于维护腰椎功能,早期临床疗效肯定。     

Dynesys动态稳定系统置入内固定与后路腰椎间融合修复腰椎退行性病的比较

背景：后路腰椎椎体间融合是腰椎退行性疾病经典的治疗方法,目前大量研究表明,融合固定后的相邻节段会发生退变。近年来越来越多的学者关注脊柱的非融合固定技术发展。
　　目的：比较Dynesys动态稳定系统置入内固定和后路腰椎椎体间融合治疗腰椎退行性疾病的临床疗效。
　　方法：对2009年7月至2010年7月收治的56例退行性腰椎间盘疾病患者的临床资料进行回顾性对比分析,其中采用Dynesys动态稳定系统置入内固定治疗28例,采用后路腰椎椎体间融合治疗28例。比较两组患者的手术时间、出血量、治疗后住院时间,应用目测类比评分进行疼痛评估,以Oswestry功能评分评价临床疗效。
　　结果与结论：56例患者均获随访,随访时间18-24个月。两组患者治疗后12个月随访时的Oswestry功能评分、目测类比评分均较治疗前有明显改善(P<0.01)。两组患者手术时间、出血量、治疗后住院天数比较差异有显著性意义(P<0.01),Dynesys动态稳定系统组优于后路腰椎椎体间融合组。Dynesys动态稳定系统组活动度优于后路腰椎椎体间融合组(P<0.01)。随访期间Dynesys动态稳定系统组未发现钉绳系统和聚脂套管松动。提示与后路腰椎椎体间融合相比,Dynesys 动态稳定系统置入内固定治疗腰椎退行性疾病近期随访具有安全性高、创伤小、可保留固定节段一定活动度的优点,在预防相邻节段椎间盘退变方面有一定的作用。     

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.     

Coflex动态内固定与PLIF术治疗退变性腰椎管狭窄症的疗效比较

目的比较Coflex动态内固定与PLIF术治疗退变性腰椎管狭窄症的临床疗效。方法 68例退变性腰椎管狭窄症患者根据治疗意愿分为两组,PLIF组(n=34例)采用腰后路减压植骨融合内固定术(PLIF术)治疗,Coflex组(n=34例)采用腰后路减压Coflex棘突间动态内固定植入术治疗,所有患者均随访6个月,比较两组手术时间、术中出血量及术后住院天数,采用JOA评分系统、Oswestry功能障碍指数评分(ODI)及椎间活动度(ROM)对腰腿痛、功能障碍程度及椎间运动范围予以评估。结果 Coflex组患者手术时间、术中出血量及术后住院时间均明显少于PLIF组(P0.05);两组患者治疗后JOA总分、ODI评分及ROM较治疗前均明显改善(P0.05),且Coflex组改善较PLIF组更为明显(P0.05)。结论 Coflex动态内固定治疗退变性腰椎管狭窄症疗效明显优于PLIF术,可有效减轻腰腿痛、功能障碍程度及保持一定的椎间活动度。     

腰椎棘突间置入动态内固定Coflex系统治疗中年腰椎旋转不稳:近期腰椎稳定性评价

背景:腰椎棘突间动态内固定Coflex系统主要用于治疗轻度腰椎管狭窄病例,其适应范围是否可有进一步的扩大?目的:观察腰椎棘突间动态内固定Coflex系统治疗中年腰椎旋转不稳的近期疗效。方法:对腰椎旋转不稳的11例中年患者行Coflex内固定术,均为L4～5节段性不稳定。所有患者术前及术后均行日本骨科学会(JOA)评分;观测影像指标包括手术前术后椎间隙中立角,过伸角,过屈角和L4～5活动度。观察手术时间,术中出血量。结果与结论:全部患者随访6个月。Coflex置入时间平均72.6min,平均出血85.7mL。术后6个月随访时,JOA评分由术前14.45±2.42提高到21.00±2.24,差异有显著性意义(P<0.05)。L4～5活动度由术前(13.18±2.04)°减少到(8.09±0.94)°,差异有显著性意义(P<0.05)。提示腰椎棘突间动态内固定Coflex系统治疗中年腰椎旋转不稳的近期疗效良好,腰椎稳定性有明显提高,中远期疗效尚待观察。     

腰椎棘突间置入动态内固定Coflex系统治疗中年腰椎旋转不稳：近期腰椎稳定性评价

背景：腰椎棘突间动态内固定Coflex系统主要用于治疗轻度腰椎管狭窄病例,其适应范围是否可有进一步的扩大？目的：观察腰椎棘突间动态内固定Coflex系统治疗中年腰椎旋转不稳的近期疗效。方法：对腰椎旋转不稳的11例中年患者行Coflex内固定术,均为L4～5节段性不稳定。所有患者术前及术后均行日本骨科学会（JOA）评分;观测影像指标包括手术前术后椎间隙中立角,过伸角,过屈角和L4～5活动度。观察手术时间,术中出血量。结果与结论：全部患者随访6个月。Coflex置入时间平均72.6min,平均出血85.7mL。术后6个月随访时,JOA评分由术前14.45±2.42提高到21.00±2.24,差异有显著性意义（P〈0.05）。L4～5活动度由术前（13.18±2.04）°减少到（8.09±0.94）°,差异有显著性意义（P〈0.05）。提示腰椎棘突间动态内固定Coflex系统治疗中年腰椎旋转不稳的近期疗效良好,腰椎稳定性有明显提高,中远期疗效尚待观察。     

腰椎棘突间非融合植入物的特点及生物力学特性

背景：非融合技术可以避免椎间盘髓核摘除和脊柱融合固定治疗椎退行性病变导致的椎间盘丧失原有的生物力学功能或加剧蜕变。目的：总结各种腰椎棘突间非融合植入物特点、疗效及置入后生物力学的变化。方法：作者检索1990/2012 PubMed数据库及中国知网数据库检索与腰椎棘突间非融合植入物治疗脊柱退行性病变的相关研究。结果与结论：共纳入31条文献。棘突间非融合植入物能撑开病变节段棘突间隙,防止过度后伸,从而增加相应水平椎管横截面积和椎间孔高度,降低椎间盘负荷和小关节负荷,控制异常活动,保持运动功能来预防邻近节段退变,使失稳的腰椎达到正常状态的活动特性,实现动态重建腰椎序列。腰椎棘突间植入物可根据其特性及作用特点分为静态和动态两类,分别以X-STOP和Coflex为代表。由于不同的腰椎棘突间非融合植入物具有不同的特点,因而适应症状有所不同,应通过鉴别患者的不同发病原因,选择最合适的棘突间非融合器械进行个体化治疗,使其植入后更加符合生理情况应力分布。     

置入棘突间稳定系统Wallis治疗腰椎退变性疾病:与单纯腰椎管减压的比较

背景:在早期,腰椎问盘退变性疾病的治疗临床常用髓核摘除或髓核摘除加刚性内固定融合技术,但是随着非刚性固定技术的发展,棘突间稳定系统固定和全椎间盘置换在脊柱非融合治疗中逐渐受到人们的重视,其优点日益突出.目的:与单纯腰椎管减压相比,评价腰椎管减压并棘突间稳定系统wallis置入固定治疗腰椎退变性疾病的效果.方法:选择2007-12/2008-12华中科技大学附属同济医院骨科收治的腰椎退变性疾病患者40例,随机选取20例行单纯髓核摘除(对照组),20例行突出髓核摘除加棘突间稳定系统wallis固定(实验组).分别于置入后1周,1年对两组患者分别进行JOA评分、目测类比评分.结果与结论:两组患者置入后1周JOA评分及目测类比评分差异均无显著性意义(P>0.05);术后1年JOA评分及目测类比评分差异均有显著性意义(P<0.05).提示两术式即刻效果无差异,均取得良好的效果,此效果主要依赖于手术有效的减压.实验组中期效果明显优于乙组,主要是棘突间稳定系统Wallis发挥良好的生物学作用,有效缓解了患者残余的慢性下腰痛.     

动态内固定Coflex系统治疗腰椎退变性疾病：椎间孔高度恢复与疗效

背景：近几年来国内各大医院广泛采用Coflex治疗腰椎间盘突出症及腰椎管狭窄症,并取得了良好的治疗效果。 目的：探讨Coflex棘突间动态稳定装置治疗腰椎退变性疾病的疗效,并通过随访治疗后椎间孔高度的变化及内固定后腰椎功能恢复情况来探讨椎间孔撑开高度与临床疗效之间的关系。 方法：行Coflex植入内固定治疗腰椎间盘突出及腰椎管狭窄症的病例,随访患者的椎间孔的高度、椎体前缘及后缘高度。记录患者内固定治疗前、治疗后1年及末次随访时的ODI及目测类比评分值。 结果与结论：内固定治疗后患者的椎间隙前缘高度、椎间隙后缘高度及椎间孔高度较内固定前均有明显的增高,治疗后1周内复查的X射线平片显示椎间孔及椎间隙高度达到最大值,此后随着随访时间的延长,各高度均随着时间的延长而不同程度的下降。在平均内固定后26.4个月随访时的椎间隙高度及椎间孔高度较内固定前的高度仍具有显著差异。根据ODI功能评分及目测类比评分疼痛评分结果,治疗后3个月即可见患者功能明显改善,在内固定后1年左右进一步改善,腰椎功能恢复效果达到最佳,末次随访时ODI评分值与内固定后1年随访值的差异无显著性意义。说明Coflex治疗腰椎间盘突出症及轻中度腰椎管狭窄症可取的较为理想的治疗效果,其治疗的效果主要来自于术中对硬膜及神经根的减压,而Coflex对椎间孔高度的恢复随着随访时间的延长会逐渐丢失。     

选择性责任节段减压并椎弓根螺钉系统置入内固定治疗腰椎退变性疾病

背景：腰椎退变性疾病的患者经保守治疗无效,感觉运动功能障碍、马尾综合征,疼痛难忍而影响：[作和生活的情况,需要通过手术的方法来治疗。 目的：分析腰椎退变性疾病的植入物置入内咧定治疗效果,深入了解腰椎退变性疾病患者的临床症状检食方法,吲顾腰椎退变性疾病采用植入物置入内固定治疗的相关文献。 方法：选取2010年12月29日至2011年1月27日在解放军第306医院骨科治疗的腰椎滑脱合并相邻节段和,或跳跃性节段退变性疾病的患者23例,存全麻下行后路腰椎管减压椎间融合器植入植骨融合椎弓根螺钉系统内周定,采用VAS、JOA和ODI评分对患者术前和术后进行评定,加用临床症状改善程度作为手术疗效的判定标准。并检索腰椎退变性疾病采用植入物置入内固定治疗的相关研究文献,对文献的实验方法和实验结果进行深入分析。     

Can a modified interspinous spacer prevent instability in axial rotation and lateral bending? A biomechanical in vitro study resulting in a new idea

BACKGROUND: Interspinous spacers are mainly used to treat lumbar spinal stenosis and facet arthrosis. Biomechanically, they stabilise in extension but do not compensate instability in axial rotation and lateral bending. It would therefore be desirable to have an interspinous spacer available, which provides for more stability also in these two planes. At the same time, the intervertebral disc should not completely be unloaded to keep it viable. To meet these requirements, a new version of the Coflex interspinous implant was developed, called "Coflex rivet", which can be more rigidly attached to the spinous processes. The aim was to investigate whether this new implant compensates instability but still allows some load to be transferred through the disc. METHODS: Twelve human lumbar spine segments were equally divided into two groups, one for Coflex rivet and one for the original Coflex implant. The specimens were tested for flexibility under pure moment loads in the three main planes. These tests were carried out in the intact condition, after creation of a destabilising defect and after insertion of either of the two implants. Before implantation, the interspinous spacers were equipped with strain gauges to measure the load transfer. FINDINGS: Compared to the defect condition, both implants had a strong stabilising effect in extension (P<0.05). Coflex rivet also strongly stabilised in flexion and to a smaller degree in lateral bending and axial rotation (P<0.05). In contrast, in these three loading directions, the original Coflex implant could not compensate the destabilising effect of the defect (P>0.05). The bending moments transferred through the implants were highest in extension and flexion. Yet, they were no more than 1.2 Nm in median. INTERPRETATION: The new Coflex rivet seems be a suitable option to compensate instability. Its biomechanical characteristics might even make it suitable as an adjunct to fusion, which would be a new indication for this type of implant.     

Coflex棘突间动力内固定装置植入治疗老年退行性腰椎管狭窄症临床观察

目的 探讨Coflex棘突间动力内固定装置植入治疗腰椎管狭窄的疗效和安全性.方法 83例腰椎管狭窄患者随机分为2组,获得随访80例.Coflex组(38例)应用Coflex植入治疗,PLIF组(42例)应用后路腰椎椎体间融合术(PLIF)治疗.比较2组手术创伤程度指标(手术时间、术中出血量、48 h内伤口引流量、术后3 d切口疼痛程度VAS评分、术后下地活动时间)及临床疗效指标(腰部及下肢疼痛VAS评分、采用13本矫形外科协会JOA评分、Oswestry功能障碍指数ODI评分),椎间隙高度及椎管矢状径(MSD).结果 手术时间[(104.3±9.5)、(174.6±24.2)min]、术中出血量[(230.7±29.6)、(536.8±163.3)ml]、48 h内伤口引流量[(110.6±34.5)、(319.2±142.8)ml]、术后3 d切口疼痛程度(VAS)评分[(3.2±1.3)、(4.8±2.7)分]、术后下地活动时间[(13.6±2.0)、(15.7±2.6)d],Coffex组显著少于PLIF组(t值分别为16.720、11.380、8.771、3.320、4.018,P均<0.01);腰腿痛VAS评分、JOA评分、ODI评分、椎间高度及MSD,2组患者术后均较术前有显著改善(P均<0.01).随访12个月2组均未出现内固定松动脱出及棘突骨折等严重并发症.结论 两种术式均可有效增加椎间孔面积并维持椎间隙的高度,保留了腰椎后柱结构的稳定性,但Coflex棘突间动力内固定装置植入术更具有手术时间短、出血少、创伤小、可早期进行功能锻炼等优点.

Abstract：

Objective To explore the efficacy and safety of coflex interspinous dynamic fixation device implantation in the lumbar spinal stenosis. Methods Eighty-three patients with lumbar spinal stenosis were randomly divided into two groups, and 80 cases were followed up. Coflex group (38 patients) received coflex implantation,posterior lumbar interbody fusion (PLIF) group(42 patients) received PLIF treatment. Indicators of surgical trauma degree (operation time, blood loss volume, wound drainage volume within 48 hours, incision pain (VAS) score after surgery 3 days,postoperative ambulation time),indicators of clinical effect (waist and leg pain VAS scores,Japan Orthopaedic Association JOA score,Oswestry functional disability index ODI score),intervertebral space height and median sagittal diameter (MSO) were measured and compared between the two groups. Results In the Coflex group, the operation time, blood loss volume, wound drainage volume within 48 hours, incision pain (VAS) score after surgery 3 days,postoperative ambulation time were (104.3 ±9.5) min,(230. 7 ±29.6) ml,(110. 6 ±34. 5)ml,3. 2 ±1.3, (13. 6 ±2.0) d,which were significantly lower than those of (174. 6 ±24. 2) min,(536. 8 ±163.3) ml, (319. 2 ± 142. 8) ml,4. 8 ±2. 7, (15. 7 ±2. 6) d in the PLIF group(t= 16. 720,11. 380,8. 771,3. 320,4.018,Ps <0. 01). In the back and leg pain VAS score,JOA score,ODI score,intervertebral height and MSD,indicators after surgery were significantly improved than before surgery in both groups(Ps <0. 01). There were no significant difference before and after treatment 12 months in both groups (Ps >0. 05) on severe complications such as internal fixation loosening and spinous process fractures.Conclusion The two surgical methods both can effectively increase the foraminal area and intervertebral height to maintain the stability of the spinal posterior colum. However, Coflex interspinous dynamic fixation device implantation had more advantages,such as shorter operation time,less bleeding,less trauma,and early functional exercises.     

Interspinous implants to treat spinal stenosis

Purpose of review

Lumbar spinal stenosis has historically been treated with open decompressive surgery which is associated with significant morbidity and may give rise to various complications. Interspinous spacers (ISS) have been developed as a less invasive strategy which may serve to avoid many of these risks. The two current spacers that are FDA approved and commercially available are the Coflex and Superion devices. The goal is to review these two implants, their indications, and patient selection.

Recent findings

The Coflex device has been shown to be analogous to decompression and fusion when treating moderate spinal stenosis. It provides dynamic stability after a decompression is performed, without the rigidity of pedicle-screw instrumentation. Recent results show improved outcomes in Coflex patients at 3 years of follow-up, as compared to decompression and fusion.The Superion implant is placed percutaneously in the interspinous space with minimal disruption of spinal anatomy. When compared to the X-Stop device (which is no longer available), the Superion implant shows improved outcomes at 3 years of follow-up.

Summary

ISS are lesser invasive options as compared to formal decompression and fusion for the treatment of lumbar spinal stenosis.

     

Application of the IntraSPINE® interlaminar device in patients with osteoporosis and spinal stenosis: two case reports

Osteoporosis is a rising concern in the aging population and should be considered before performing spinal surgery for older patients. Nonfusion surgery using interlaminar or interspinous devices is gradually gaining acceptance because adjacent segment disease seldom occurs postoperatively; however, other complications may occur. This report discusses the surgical outcomes of two women with osteoporosis treated by laminectomy and interlaminar device (IntraSPINE®) placement. Both patients had experienced low back pain for several years and had developed vertebral compression fractures. Several conservative treatments, including rehabilitation and local injections, were ineffective. Their bone mineral density levels were −3.0 and −2.8, indicating severe osteoporosis according to the definition established by the World Health Organization. They chose to undergo nonfusion surgery with IntraSPINE® interlaminar device placement. Their pain significantly decreased postoperatively, and their visual analog scale scores decreased from 8 to 2 and 3. Their extremity numbness and back pain resolved within 3 months. Both patients were satisfied with the surgical outcomes. No complications had occurred by 1 year postoperatively. These cases indicate that osteoporosis may not be an absolute contraindication for nonfusion spinal surgery. This report suggests a possible alternative surgical treatment for patients with osteoporosis that is refractory to conservative treatments.