Four-year follow-up results of lumbar spine arthrodesis using the Bagby and Kuslich lumbar fusion cage

STUDY DESIGN: This was a prospective multicenter clinical trial of a lumbar interbody fusion cage with a minimum of 4 years' follow-up. OBJECTIVES: To determine whether the early positive clinical results in fusions with lumbar cages, such as the Bagby and Kuslich (BAK) cage, are maintained beyond 2 years. SUMMARY OF BACKGROUND DATA: Threaded cages have been used increasingly for the treatment of symptomatic degenerative intervertebral disc disease. Concerns about the long-term clinical outcomes of this procedure have been posed, particularly regarding bony fusion viability, revision rates, potential adjacent level disease, and late complications. METHODS: The study cohort was a 196-patient subset from a prospective investigational device exemption. In addition to early postoperative examinations, these patients were examined biannually with a minimum of 4 years' follow-up. Patient outcome was assessed by a 6-point scale that evaluated pain relief, and functional improvement was determined by changes in activities of daily living. Fusion rates and return to work were determined. Complications and secondary operations were reported and categorized as non-device related or device related. RESULTS: The patient cohort with 4-year follow-up represented 25.6% of the original study population eligible at that time. Overall, the largest percentage of pain relief and functional improvements occurred by 3 months, and these improvements were maintained at each follow-up. Overall fusion rate was 91.7% and 95. 1% at 2 and 4 years, respectively. In this cohort, 39.5% of patients were working or were able to work within 3 months of surgery. After 4 years, 62.7% of patients were gainfully employed or able to work. The late-occurring complication rate in this cohort was 13.8% (27/196). Complications necessitating a second operation occurred in 8.7% (17/196), whereas reoperations that were deemed device related were performed in 3.1% (6/196). CONCLUSIONS: This study indicates that the early positive benefits of interbody fusion cage procedures are maintained through 4 years with acceptably low morbidity.     

后路腰椎间融合与经椎间孔腰椎间融合治疗单纯腰椎不稳的对比研究

[目的]对后路腰椎间融合(Posterior Lumbar Interbody Fusion,PLIF)及经椎间孔腰椎间融合(Transforami-nal Lumbar Interbody Fusion,TLIF)治疗单纯腰椎不稳的手术创伤、并发症及术后疗效进行比较。[方法]将2006年2月～2009年7月收治的单纯腰椎不稳患者采用随机数字表法将患者分为PLIF组(110例)、TLIF组(108例)。术前评估两组患者一般资料差异无统计学意义,具有可比性。分别对两组患者的手术创伤、术中并发症及功能恢复情况进行比较。[结果]术后随访时间14～36个月,平均21个月。手术时间:PLIF组为(125.6±45)min,TLIF组为(124.9±44)min(P>0.05);失血量:PLIF组为(1 000±450)ml,TLIF组为(995±405)ml(P>0.05);术中并发症:PLIF组为3例,TLIF组为0例(P<0.05);术后优良率:PLIF组为93.6%,TLIF组为94.4%(P>0.05);术后融合率:PLIF组为96.4%,TLIF组为98.1%(P>0.05);JOA评分:PLIF组为14.5...     

A preliminary comparative study of radiographic results using mineralized collagen and bone marrow aspirate versus autologous bone in the same patients undergoing posterior lumbar interbody fusion with instrumented posterolateral lumbar fusion.

BACKGROUND CONTEXT: Multiple bone graft substitutes for spinal fusion have been studied with varying results. PURPOSE: The purpose of this study was to assess the effectiveness of a mineralized collagen matrix combined with bone marrow, versus autologous bone, in the same patients undergoing a posterior lumbar interbody fusion and an instrumented posterolateral lumbar fusion. STUDY DESIGN/SETTING: A prospective, comparative study. PATIENT SAMPLE: Patients indicated for one-level posterior lumbar interbody fusion and instrumented posterolateral lumbar fusion, serving as self-controls. OUTCOME MEASURES: Thin-cut computed tomographic scans with sagittal reconstruction and plain radiographs, including lateral flexion/extension views were performed and assessed at 12 and 24 months after surgery. Oswestry Disability Index and Visual Analog Scale questionnaires were completed by all patients preoperatively and at 12 and 24 months after surgery. METHODS: After informed consent and failure of nonoperative treatment, 25 consecutive patients requiring one-level instrumented posterolateral fusion combined with posterior interbody fusion were enrolled in the study. Mineralized collagen bone graft substitute combined with bone marrow aspirate was used on one side of the posterolateral fusion, with iliac crest autograft on the contralateral side. RESULTS: A fusion rate of 84% (21/25) was achieved for the autologous bone grafts and 80% (20/25) for the bone graft substitute. The interbody fusion rate was 92% (23/25). Mean Oswestry Disability Index (ODI) scores decreased 57.2% at 12 months and 55.6% at 24 months, compared with baseline. CONCLUSIONS: Mineralized collagen bone graft substitute exhibited similar radiographic results compared with autograft in this model. Further trials incorporating bilateral fusion, as well as posterolateral fusion alone without interbody fusion are warranted to confirm the results of this study.     

PLIF与PLF技术治疗腰椎滑脱症的疗效比较

目的 回顾性比较后路椎间融合术（PLIF）和椎体后外侧融合术（PLF）治疗腰椎滑脱症的临床疗效。方法 自2007-06-2013-02在后路减压复位、椎弓根系统内固定的基础上行融合术治疗腰椎滑脱症42例：PLIF组13例,PLF组29例。结果 术后所有滑脱椎体均获得不同程度的复位。PLIF组与PLF组术中平均出血量分别为（816.6±69.3）ml、（355.2±45.8）ml;2组术后椎间隙后高均较术前增加（P〈0.05）,而末次随访PLIF组椎间后高优于PLF组（P〈0.05）。PLIF组术后翻修1例,余均获得融合,融合率92.3%,术中硬脊膜撕裂2例,未遗留神经症状;PLF组术后26例获得融合,融合率为89.7%,3例融合失败,随访椎间隙高度丢失,出现腰臀部疼痛复发,该组未出现神经损伤。术后PLIF组与PLF组ODI评分均较术前明显改善（P〈0.05）。结论 PLIF与PLF技术均为治疗腰椎滑脱症有效的融合方式,前者具有良好的椎间撑开作用,适合术前椎间高度丢失较多的患者;而后者手术出血少、术中并发症少,较适合体弱、高龄、椎间高度丢失不显著的患者。     

Autograft versus interbody fusion cage without plate fixation in the cervical spine: a randomized clinical study using radiostereometry

A primary object with a fusion cage is avoidance of graft collapse with subsequent subsidence and malalignment of the cervical spine that is observed after bone grafting alone. No randomized studies exist that demonstrate the difference between these two methods in terms of graft subsidence and angulation of the fused segment. The size of the study population was calculated to be 24 patients to reach a significant difference at the 95% CI level. Patients with one-level cervical radiculopathy scheduled for surgery were randomized to anterior discectomy and fusion (ACDF) with autograft or to fusion cage, both without plate fixation. Tantalum markers were inserted in the two adjacent vertebrae at the end of surgery. Radiostereometry was performed immediately postoperatively and at regular intervals for 2 years. Questionnaires were used to evaluate the clinical outcome and an unbiased observer graded the outcome after 2 years. No significant differences were found between the two methods after 2 years in regard of narrowing of the disc space (mean 1.7 and 1.4 mm, respectively) or deformation of the fused segment into flexion (mean 7.7° and 4.6°, respectively). Patients in the cage group had a significantly better clinical outcome. The findings of subsidence and flexion deformation of the fused segment after 2 years seem to be of no clinical importance after one-level cervical disc surgery. However, in multi-level surgery using the same methods, an additive effect of the deformations of the fused segments may affect the clinical outcome.     

后路内固定加前路椎间融合治疗胸腰椎结核

目的 :探讨后路内固定加前路椎间融合治疗胸腰椎结核的临床效果。方法 :自 1999年以来对有适应证的胸腰椎结核采用后路椎弓根钉内固定加前路病灶清除椎间植骨融合 ,术后观察植骨融合、后凸畸形矫正、脊髓功能恢复、并发症发生等情况。结果 :本组 8例 ,随访时间最短 11个月 ,最长 3年半 ,平均 2 2个月。结核病灶全部愈合 ,椎间植骨融合 ,7例后凸角得到部分矫正 ,平均矫正 2 2°。下肢肌力进步 1～ 2级。发生断钉 1例。结论 :严格掌握适应证 ,在确保病灶彻底清除基础上 ,可合理使用内固定。椎间充分植骨是预防内固定失败的重要因素     

Minimally invasive transforaminal lumbar interbody fusion using the biportal endoscopic techniques versus microscopic tubular technique

BACKGROUND CONTEXTMinimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) with microscopic tubular technique is an established surgical procedure with several potential advantages, including decreased surgical-related morbidity, reduced length of hospital stay, and accelerated early rehabilitation. A recently introduced biportal endoscopic technique for spine surgery presents familiar surgical anatomy and can be conducted using a conventional approach with a minimal footprint; it is also applicable to TLIF.PURPOSETo compare the clinical and radiological outcomes of biportal endoscopic technique transforaminal lumbar interbody fusion (BE-TLIF) and microscopic tubular technique transforaminal lumbar interbody (MT-TLIF) in patients with single- or two-segment lumbar spinal stenosis with or without spondylolisthesis.STUDY DESIGNA retrospective cohort study.PATIENT SAMPLEOne hundred two participants with neurogenic intermittent claudication or lumbar radiculopathy with single- or two-level lumbar spinal stenosis with or without spondylolisthesis.OUTCOME MEASURESClinical outcomes were assessed using the visual analog scale (VAS) score for the back and leg pain, Oswestry Disability Index (ODI), and the Short Form-36 health survey Questionnaire (SF-36). Demographic data, operative data (total operation time, estimated blood loss, amount of surgical drain, postoperative transfusion, and length of hospital stay), and laboratory results (plasma hemoglobin, serum creatine phosphokinase, and C-reactive protein) were also evaluated. The fusion rate was assessed using the Bridwell interbody fusion grading system. Postoperative complications were also noted.METHODSPatients were divided into two groups: group A (BE-TLIF) and group B (MT-TLIF). The clinical outcomes, including VAS-Back and VAS-Leg, ODI, and SF-36 scores, were evaluated at 1 month, 6 months, and 1 year after surgery. Differences in demographics, operative data, and the laboratory and radiological results were assessed between the two groups. The fusion rate was assessed using standard standing lumbar radiographs and computed tomography scans conducted 1 year after surgery.RESULTSSeventy-nine patients were analyzed in this study, 47 from group A and 32 from group B. Demographic and operative data were comparable for both the groups. The VAS-Back and SF-36 scores were more significantly improved in group A than in group B at 1 month after surgery. However, there were no significant differences between groups for the mean VAS-Back, VAS-Leg, ODI, and SF-36 scores at 1year after the surgery. Although the total operation time was significantly longer in group A, the estimated blood loss and the amount of surgical drainage was significantly higher in group B (p < .001). There were no between-group differences for the fusion rate and postoperative complications.CONCLUSIONBoth BE-TLIF and MT-TLIF provided equivalent and favorable clinical outcomes and fusion rates. Further large-scale, randomized, controlled trials with long-term follow-ups are warranted.     

Biomechanics of an integrated interbody device versus ACDF anterior locking plate in a single-level cervical spine fusion construct

Background contextNo profile, integrated interbody cages are designed to act as implants for cervical spine fusion, which obviates the need for additional internal fixation, combining the functionality of an interbody device and the stabilizing benefits of an anterior cervical plate. Biomechanical data are needed to determine if integrated interbody constructs afford similar stability to anterior plating in single-level cervical spine fusion constructs.PurposeThe purpose of this study was to biomechanically quantify the acute stabilizing effect conferred by a single low-profile device design with three integrated screws (“anchored cage”), and compare the range of motion reductions to those conferred by a standard four-hole rigid anterior plate following instrumentation at the C5–C6 level. We hypothesized that the anchored cage would confer comparable postoperative segmental rigidity to the cage and anterior plate construct.Study designBiomechanical laboratory study of human cadaveric spines.MethodsSeven human cadaveric cervical spines (C3–C7) were biomechanically evaluated using a nondestructive, nonconstraining, pure-moment loading protocol with loads applied in flexion, extension, lateral bending (right+left), and axial rotation (left+right) for the intact and instrumented conditions. Range of motion (ROM) at the instrumented level was the primary biomechanical outcome. Spines were loaded quasi-statically up to 1.5 N-m in 0.5 N-m increments and ROM at the C5–C6 index level was recorded. Each specimen was tested in the following conditions:1. Intact2. Discectomy+anchored cage (STA)3. Anchored cage (screws removed)+anterior locking plate (ALP)4. Anchored cage only, without screws or plates (CO)ResultsROM at the C5–C6 level was not statistically different in any motion plane between the STA and ALP treatment conditions (p>.407). STA demonstrated significant reductions in flexion/extension, lateral bending, and axial rotation ROM when compared with the CO condition (p<.022).ConclusionsIn this in vitro biomechanical study, the anchored cage with three integrated screws afforded biomechanical stability comparable to that of the standard interbody cage+anterior plate cervical spine fusion approach. Due to its low profile design, this anchored cage device may avoid morbidities associated with standard anterior plating, such as dysphagia.     

Cage versus tricortical graft for cervical interbody fusion. A prospective randomised study

We conducted a prospective, randomised study of 42 cervical interbody fusions undertaken with either an autologous tricortical graft or a cage. The factors assessed in the two groups were: (1) time taken to achieve fusion; (2) neck disability index; (3) pain score; (4) interbody height ratio; (5) interbody angle and (6) the influence of smoking on fusion. No statistical difference was seen in the time taken to achieve fusion, neck disability index, interbody height ratio, or interbody angles. Smoking did not have any effect on the fusion process. The pain score was significantly lower in the tricortical graft group at six months. We conclude that both methods of fusion give similar results, although tricortical graft fusion is cheaper than cage fusion, and is more effective in reducing the pain score.     

阿仑膦酸钠与鲑鱼降钙素对腰椎后路椎间融合术后疗效的比较研究

【摘要】目的 探讨阿仑膦酸钠与鲑鱼降钙素对椎间融合临床疗效的差异。方法 回顾性分析我科自2010年9月~2012年8月间治疗168例腰椎管狭窄合并腰椎间盘突出症患者资料,所有患者均行椎弓根螺钉固定、后路椎间融合术。依照PLIF术后用药的不同将患者机分为阿仑膦酸钠组(A组,n=51),鲑鱼降钙素组(B组,n=52)和对照组(C组,n=65,不使用任何抗骨质疏松及补钙药物)。比较患者的基本情况、临床效果和影像学结果(融合率和手术节段椎间隙高度的变化)。结果 术后随访半年~2年1个月,平均18个月。A、B、C组三组的优良率分别为88.2%、88.5%、61.5%,A、B组优良率均较对照组明显提高,但A、B组间优良率差异无显著性意义;A组和B组在手术时间、失血量以及住院时间上差异也无显著性。术后1年随访时融合率A组为84.3%,B组84.6%,C组53.8%,A、B组均高于C组,A、B组间比较差异无显著性意义。三组患者术后椎间隙高度均有不同程度的丢失,A组1.1 (0.6~1.9)mm、B组1.1 (0.8~2.1) mm,两组间比较差异无显著性意义,但A、B组椎间隙高度丢失程度均较对照组C组4.0 (1.9~4.9) mm明显降低。结论 腰椎后路椎间融合术(PLIF)术后规范使用阿仑膦酸钠或鲑鱼降钙素能够获得令人满意的临床效果,具有较高的椎间植骨融合率及较少的椎间隙高度丢失。     

不同内固定在舟大小多角骨融合术中稳定性的比较研究

目的 比较舟骨和大、小多角骨(scaphoid-trapezium-trapezoid,STT)融合器与克氏针在STT融合术中内固定强度的差异.方法 12侧新鲜冷冻尸体前臂标本,随机分为融合器组(使用STT融合器)和克氏针组(使用克氏针)2组,模拟进行STT融合术,术后以夹具固定于腕动力测试仪上模拟腕关节主要活动.活动前后均拍摄腕关节标准正侧位X线片,测量桡舟角、桡舟间距、舟骨长度及STT融合体稳定角.结果 融合器组:当腕关节运动范围增加到屈曲45°、背伸40°、尺偏30°、桡偏15°时,客观指标与初始状态相比较变化差异均无统计学意义(P＞0.05).克氏针组:当腕关节运动范围增加到屈曲35°、背伸30°、桡偏10°时,客观指标与初始状态相比较变化差异均有统计学意义(P＜0.05).尺偏30°运动后融合体稳定角与初始状态相比较差异有统计学意义(P＜0.05).结论 STT融合器在舟骨和大、小多角骨融合术中内固定强度大于传统内固定物中的克氏针.     

后路椎弓根系统内固定加前路植骨融合治疗胸腰椎结核

目的 :探讨应用后路椎弓根系统内固定加前路植骨融合术治疗胸腰椎结核的临床效果。方法 :回顾总结1 995年 3月至 2 0 0 0年 3月行后路椎弓根系统内固定同期前路植骨融合的胸腰椎结核患者 35例 ,包括植骨融合率、截瘫恢复情况和后凸畸形矫正状况。随访时间 1 5～ 5年 ,平均 3 4年。结果 :术后 1～ 1 5年所有患者均显示骨性融合 ;2 8例合并截瘫患者中 ,症状改善 2 6例 ,改善率 92 9% ;术后后凸畸形平均矫正 2 9 7° ,1 5～ 5年后随访 ,后凸角度平均丢失 2 9°。结论 :后路椎弓根系统内固定加前路植骨融合能加强脊柱的稳定性 ,促进骨融合和截瘫恢复 ,矫正后凸畸形     

Anterior interbody fusion in fractures and fracture-dislocations of the spine

Summary Twenty-five cases of unstable fractures and fracture-dislocations of the spine are reviewed. They were treated at the Catholic Medical College and Centre in a 3-year period, 1975 to 1978.1. Eleven of the 25 patients were treated by anterior interbody fusion performed at 6 to 8 weeks from injury or initial surgery.2. Eleven patients had neurological deficits, 3 with incomplete lesions and 8 with complete lesions. Open reduction and decompression laminectomies were performed on patients having neurological deficits prior to anterior interbody fusion. Two patients with incomplete paraplegia showed marked neurological recovery whilst one with complete paraplegia regained some sensation.3. Solid clinical fusion was obtained in all but one patient within four months of interbody fusion.4. Amongst the 18 patients with kyphosis at the time of admission 10 had a final improvement of their kyphosis ranging from 3 to 10 degrees (average 6 degrees). Three had no change and 5 demonstrated a mild increase of kyphosis (average 4 degrees).5. Pain was relieved in 21 patients out of 25.The advantages of this technique include effective stabilization, prevention of late deformity and relatively early mobilization without internal fixation.

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Résumé Présentation de 25 cas de fractures instables et de fractures-luxation du rachis, traitées au «Catholic Medical College and Centre» durant une période de 3 ans, de 1975 à 1978.1. Onze de ces 25 patients ont été traités par arthrodèse vertèbrale antérieure pratiquée 6 à 8 semaines après le traumatisme ou l'intervention chirurgicale initiale.2. Onze malades présentaient des lésions neurologiques, 3 paraplégies incomplètes et 8 complètes. Ils ont subi une réduction à ciel ouvert et une laminectomie de décompression préalablement à l'arthrodèse antérieure. Deux malades avec une paraplégie incomplète présentèrent une récupération notable et un avec paraplégie complète retrouva une certaine sensibilité.3. Une fusion cliniquement solide fut obtenue chez tous les opérés, sauf un, dans un délai de 4 mois après l'arthrodèse.4. Parmi les 18 patients présentant une déformation en cyphose au moment de l'admission, 10 furent améliorés, leur cyphose ayant diminué de 3° à 6° (en moyenne de 6°). Trois sont restés inchangés et cinq aggravés (en moyenne de 4°).5. Vingt-et-un malades sur 25 ont été soulagés de leurs douleurs.Les avantages de cette technique sont les suivants: stabilisation efficace, prévention des déformations résiduelles et mobilisation relativement précoce sans ostéosynthèse.

     

Biomechanical evaluation of stand-alone interbody fusion cages in the cervical spine.

STUDY DESIGN: An in vitro biomechanical investigation of the immediate stability in cervical reconstruction. OBJECTIVES: The purpose of this study was to compare the segmental stability afforded by the interbody fusion cage, the anterior locking plate, and the "gold standard" autograft. SUMMARY OF BACKGROUND DATA: Recently, interbody fusion cage devices have been developed and used for cervical reconstruction, but to the authors' knowledge no studies have investigated the biomechanical properties of the stand-alone interbody cage device in the cervical spine. METHODS: Using six human cervical specimens, nondestructive biomechanical testing were performed, including axial rotation (+/-1.5 Nm, 50 N preload), flexion/extension (+/-1.5 Nm) and lateral bending (+/-1.5 Nm) loading modes. After C4-C5 discectomy, each specimen was reconstructed in the following order: RABEA cage (cage), tricortical bone graft (autograft), cervical spine locking plate system (plate). Unconstrained three-dimensional segmental range of motion at C4-C5 and above and below were evaluated. RESULTS: In flexion/extension, the plate demonstrated significantly lower range of motion than did the cage and the autograft (P < 0.005), and the cage showed a significantly higher range of motion than did the intact spine (P < 0.05). Under axial rotation, the plate indicated a significantly lower range of motion than did all other groups (P < 0.05). No significant differences were indicated in lateral bending. Adjacent to C4-C5, an increased range of motion was observed. CONCLUSIONS: The increased motion adjacent to C4-C5 may provide an argument for acceleration of disc degeneration. From the biomechanical point of view, this study suggests that the cervical interbody fusion cage should be supplemented with additional external or internal supports to prevent excessive motion in flexion-extension.     

微创与开放经椎间孔椎体间融合术治疗腰椎单节段退行性疾病的临床疗效比较

【摘要】目的：对比微创经椎间孔椎体间融合术（minimal invasive posterior transforminal lumbar interbody fusion,MIS-TLIF）与开放经椎间孔椎体间融合术（open transforaminal lumbar interbody fusion,open TLIF）治疗单节段腰椎退行性疾病的椎间融合率及临床疗效,评价MIS-TLIF治疗腰椎退行性疾病的安全性及有效性。方法：回顾性研究单节段腰椎退行性疾病患者48例,22例采用MIS-TLIF治疗,其中男7例,女15例,手术时年龄26～65岁,平均49.4±12.1岁;26例采用open TLIF治疗,其中男11例,女15例,手术时年龄27～70岁,平均50.7±11.8岁。比较两组的手术时间、术中出血量、术后引流量,分别采用visual analogue scores（VAS）、Oswestry disability index（ODI）、Japanese Orthopedic Association scores（JOA）评价两组治疗效果,并采用X线及CT三维重建比较两组椎间植骨融合率。结果：两组患者年龄、性别、吸烟史、BMI、手术节段均无显著差异。术前MIS-TLIF组VAS腰痛评分、VAS腿痛评分、ODI评分、JOA评分分别为4.9±2.5分、6.6±2.4分、23.3±10.2分和14.7±5.8分;open TLIF组分别为5.4±2.2分、6.0±2.8分、23.8±9.0分和3.6±4.8分,组间比较无显著差异（P＞0.05）。MIS-TLIF组手术时间、术中出血量、术后引流量分别为235.8±46.3min、198.6±81.6ml和115.7±74.5ml;open TLIF组分别为127.8±45.8min、350.0±143.6ml和494.7±243.9ml。MIS-TLIF组手术时间长于open TLIF组（P＜0.05）,而术中出血量及术后引流量MIS-TLIF组均明显低于open TLIF组（P＜0.05）。平均随访时间1年（6个月~2年）,术后3个月内腰痛VAS评分MIS-TLIF组改善较明显,3个月以后VAS评分两组相比无显著差异（P＞0.05）。术后3个月、6个月及末次随访两组ODI、JOA评分相比无显著差异（P＞0.05）。末次随访时,行CT三维重建判定椎间融合率,MIS-TLIF组椎间融合率81.8%（18/22）,open TLIF组椎间融合率为92.3%（24/26）,两组间无统计学差异（P＞0.05）。均无神经损伤、脑脊液漏、感染等并发症发生。结论：MIS-TLIF治疗单节段腰椎退行性病变,可获得与open TLIF相同的临床疗效及植骨融合率,并且出血量、引流量较少,具有较高的安全性。