Results of the prospective,randomized, controlled multicenter Food and Drug Administration investigational device exemption study of the ProDisc-C total disc replacement versus anterior discectomy and fusion for the treatment of 1-level symptomatic cervical disc disease

Background contextCervical total disc replacement (TDR) is intended to address radicular pain and preserve functional motion between two vertebral bodies in patients with symptomatic cervical disc disease (SCDD).PurposeThe purpose of this trial is to compare the safety and efficacy of cervical TDR, ProDisc-C (Synthes Spine Company, L.P., West Chester, PA), to anterior cervical discectomy and fusion (ACDF) surgery for the treatment of one-level SCDD between C3 and C7.Study design/settingThe study was conducted at 13 sites. A noninferiority design with a 1:1 randomization was used.Patient sampleTwo hundred nine patients were randomized and treated (106 ACDF; 103 ProDisc-C).Outcome measuresVisual analog scale (VAS) pain and intensity (neck and arm), VAS satisfaction, neck disability index (NDI), neurological exam, device success, adverse event occurrence, and short form-36 (SF-36) standardized questionnaires.MethodsA prospective, randomized, controlled clinical trial was performed. Patients were enrolled and treated in accordance with the US Food and Drug Administration (FDA)–approved protocol. Patients were assessed pre– and postoperatively at six weeks, 3, 6, 12, 18, and 24 months.ResultsDemographics were similar between the two patient groups (ProDisc-C: 42.1±8.4 years, 44.7% males; Fusion: 43.5 ± 7.1 years, 46.2% males). The most commonly treated level was C5–C6 (ProDisc-C: 56.3%; Fusion=57.5%). NDI and SF-36 scores were significantly less compared with presurgery scores at all follow-up visits for both the treatment groups (p<.0001). VAS neck pain intensity and frequency as well as VAS arm pain intensity and frequency were statistically lower at all follow-up timepoints compared with preoperative levels (p<.0001) but were not different between treatments. Neurologic success (improvement or maintenance) was achieved at 24 months in 90.9% of ProDisc-C and 88.0% of Fusion patients (p=.638). Results show that at 24 months postoperatively, 84.4% of ProDisc-C patients achieved a more than or equal to 4° of motion or maintained motion relative to preoperative baseline at the operated level. There was a statistically significant difference in the number of secondary surgeries with 8.5% of Fusion patients needing a re-operation, revision, or supplemental fixation within the 24 month postoperative period compared with 1.8% of ProDisc-C patients (p=.033). At 24 months, there was a statistically significant difference in medication usage with 89.9% of ProDisc-C patients not on strong narcotics or muscle relaxants, compared with 81.5% of Fusion patients.ConclusionsThe results of this clinical trial demonstrate that ProDisc-C is a safe and effective surgical treatment for patients with disabling cervical radiculopathy because of single-level disease. By all primary and secondary measures evaluated, clinical outcomes after ProDisc-C implantation were either equivalent or superior to those same clinical outcomes after Fusion.     

颈椎间盘置换术与颈前路椎间融合术治疗双节段颈椎间盘退变性疾病疗效的Meta分析

目的 :系统评价颈椎间盘置换术(TDR)与颈前路椎间盘切除椎间植骨融合术(ACDF)治疗相邻两个节段颈椎间盘退变性疾病的疗效。方法:检索Pubmed、Medline、Embase等数据库,筛选应用两种手术方式治疗相邻两个节段颈椎间盘退变性疾病的前瞻性临床对照研究;各研究中观察组术式为TDR(TDR组),对照组术式为ACDF(ACDF组);两组病例数均不少于10例;随访时间均不少于2年;术后疗效评价指标至少包括以下指标中的一项:颈痛及上肢痛VAS评分(VAS),颈部功能障碍指数(NDI),健康调查简表SF-36评分(SF-36),术后不良事件(AE)等指标。采用Doowns-Black评分及NOS评分评价纳入研究的质量。结果:共纳入5篇英文文献,2篇为随机对照研究(RCT),3篇为前瞻性队列研究,研究质量Doowns-Black评分均在18分及以上,NOS评价前瞻性队列研究质量均为6星。共纳入593例患者,其中TDR组314例,ACDF组279例。经Meta分析合并效应指标,末次随访时颈痛VAS评分标准化均数差(SMD)及不良事件发生相对危险度(RR)两组比较无显著性差异(P0.05);TDR组上肢痛VAS评分、NDI评分、邻近上节段和下节段屈伸ROM、邻近节段退变低于ACDF组(P0.05),SF36-PCS躯体健康评分及手术节段屈伸ROM SMD高于ACDF组(P0.05)。结论 :相邻两个节段颈椎间盘退变性疾病行TDR的疗效较ACDF具有优势,安全性较高,但需要更多大样本随机对照研究以及更长时间的随访结果来验证。     

颈椎间盘置换术与颈椎融合术治疗双节段颈椎病疗效比较的Meta分析

目的系统评价颈椎间盘置换术(total disc replacement,TDR)与颈椎融合术治疗双节段颈椎病的疗效与安全性。方法对2004年1月至2014年1月中文科技期刊数据库(VIP)、万方数据库、中国知网、PubMed Central(PMC)、MEDLINE、OVID、Google Scholar数据库中的相关文献进行电子检索及手工检索,纳入TDR(置换组)与颈椎融合术(融合组)治疗双节段颈椎病的随机对照试验(randomized controlled trial,RCT),根据Jadad评分标准评价纳入研究项目的质量。采用Rev Man5.2统计学软件进行Meta分析。结果 8项研究符合纳入标准,共计1 100例患者。Meta分析结果显示,置换组术后2年的患者满意率、颈椎活动度(ROM)、日本骨科协会(Japanese Orthopaedic Association,JOA)评估治疗分数及疼痛视觉模拟评分(visual analogue scale,VAS)均优于融合组,置换组术后2年的再手术率及并发症低于融合组,其余各项指标差异均无统计学意义。结论 TDR治疗双节段颈椎病的疗效与安全性较颈椎融合术有优势,但仍需更多的大样本RCTs进行验证。     

Comparison of cervical kinematics between patients with cervical artificial disc replacement and anterior cervical discectomy and fusion for cervical disc herniation

Background contextAlthough anterior cervical discectomy and fusion (ACDF) is an effective treatment option for patients with cervical disc herniation, it limits cervical range of motion, which sometimes causes discomfort and leads to biomechanical stress at neighboring segments. In contrast, cervical artificial disc replacement (ADR) is supposed to preserve normal cervical range of motion than ACDF. A biomechanical measurement is necessary to identify the advantages and clinical implications of ADR. However, literature is scarce about this topic and in those available studies, authors used the static radiological method, which cannot identify three-dimensional motion and coupled movement during motion of one axis.PurposeThe purpose of this study was to compare the clinical parameters and cervical motion by three-dimensional motion analysis between ACDF and ADR and to investigate the ability of ADR to maintain cervical kinematics.Study designThis was a prospective case control study.Patient samplePatients who underwent ADR or ACDF for the treatment of single-level cervical disc herniation.Outcome measuresVisual analog scale (VAS), Korean version of Neck Disability Index (NDI, %), and three-dimensional motion analysis were used.MethodsThe patients were evaluated by VAS and the Korean version of the NDI (%) to assess pain degree and functional status. Cervical motions were assessed by three-dimensional motion analysis in terms of sagittal, coronal, and horizontal planes. Markers of 2.5 cm in diameter were attached at frontal polar (Fpz), center (Cz), and occipital (Oz) of 10–20 system of electroencephalography, C7 spinous process, and both acromions. These evaluations were performed preoperatively and 1 month and 6 months after surgery.ResultsThe ACDF and ADR groups revealed no significant difference in VAS, NDI (%), and cervical range of motion preoperatively. After surgery, both groups showed no significant difference in VAS and NDI (%). In motion analysis, significantly more range of motion was retained in flexion and extension in the ADR group than the ACDF group at 1 month and 6 months. There was no significant difference in lateral tilt and rotation angle. In terms of coupled motion, ADR group exhibited significantly more preserved sagittal plane motion during right and left rotation and also showed significantly more preserved right lateral bending angle during right rotation than ACDF group at 1 month and 6 months. There was no significant difference in other coupled motions.ConclusionThree-dimensional motion analysis could provide useful information in an objective and quantitative way about cervical motion after surgery. In addition, it allowed us to measure not only main motion but also coupled motion in three planes. ADR demonstrated better retained cervical motion mainly in sagittal plane (flexion and extension) and better preserved coupled sagittal and coronal motion during transverse plane motion than ACDF. ADR had the advantage in that it had the ability to preserve more cervical motions after surgery than ACDF.     

颈椎人工椎间盘置换术与颈椎前路椎间盘切除融合术治疗颈椎病的研究进展

颈椎前路椎间盘切除融合术（ACDF）是治疗颈椎病的经典术式,疗效明确,但因责任节段融合引起相邻节段椎间盘压力及未融合节段活动范围增加,导致术后手术关节活动度（ROM）欠缺、邻近节段退行性变（ASD）加速等。针对融合术式存在的弊端,非融合技术颈椎人工椎间盘置换术（CTDR）应运而生,应用于颈椎病的治疗,疗效可靠,可在完成神经减压后保留手术节段ROM,恢复椎间盘高度,降低邻近节段ASD的发生率,克服了ACDF的固有局限^[1-3]。CTDR有明确的适应证和禁忌证^[4],而ACDF的禁忌证较少,2种术式的优劣目前尚无定论。自2005年开始,多个研究中心围绕CTDR和ACDF的疗效优良率、关节ROM、颈椎功能障碍指数（NDI）等方面展开分析比较,得出2种术式的临床疗效相似的结论^[5-9],甚至有部分研究认为CTDR疗效优于ACDF^[10-12]。但因随访时间短,对于CTDR的疗效和预后仍存在争议^[10,13]。近年来,诸多研究^[14-19]在比较CTDR与ACDF预后的同时,还围绕2种术式的医疗支出、恢复周期、运动功能等展开讨论,为术式的个性化选择提供依据。     

Prospective,multicenter clinical trial comparing M6-C compressible six degrees of freedom cervical disc with anterior cervical discectomy and fusion for the treatment of single-level degenerative cervical radiculopathy: 2-year results of an FDA investigational device exemption study

BACKGROUND CONTEXTVarious designs of total disc replacement (TDR) devices have been compared to anterior cervical discectomy and fusion (ACDF) with favorable outcomes in FDA-approved investigational device exemption trials. The design of M6-C with a compressible viscoelastic nuclear core and an annular structure is substantially different than prior designs and has previously demonstrated favorable kinematics and clinical outcomes in small case series.PURPOSETo evaluate the safety and effectiveness of the novel M6-C compressible artificial cervical disc compared with ACDF for subjects with single-level degenerative cervical radiculopathy.STUDY DESIGN/SETTINGProspective, multicenter, concurrently and historically controlled, FDA-approved investigational device exemption clinical trial.PATIENT SAMPLESubjects with one-level symptomatic degenerative cervical radiculopathy were enrolled and assigned to receive M6-C or ACDF.OUTCOME MEASURESPain and function (Neck Disability Index, VAS), quality of life (SF-36), safety, neurologic, and radiographic assessments of motion (both flexion extension and lateral bending) were performed. The primary clinical endpoint was composite clinical success (CCS) at 24 months.METHODSUsing propensity score subclassification to control for selection bias, 160 M6-C subjects were compared to a matched subset of 189 ACDF controls (46 concurrent and 143 historical controls).RESULTSBoth ACDF and M6-C subjects reported significant improvements in patient-reported outcomes at all time points over baseline. Overall SF-36 Physical Component Score and neck and arm pain scores were significantly improved for M6-C as compared to ACDF treatment. CCS and mean Neck Disability Index improvements were similar between M6-C and ACDF. Correspondingly, there were significantly fewer subjects that utilized pain medication or opioids following M6-C treatment at 24 months relative to baseline. Range of motion was maintained in subjects treated with M6-C. Subsequent surgical interventions, dysphagia rates, and serious adverse events were comparable between groups.CONCLUSIONSM6-C treatment demonstrated both safety and effectiveness for the treatment of degenerative cervical radiculopathy. Treatment with M6-C demonstrated noninferiority for the primary endpoint, indicating a similar ability to achieve CCS at 24 months. However, for the secondary endpoints, M6-C subjects demonstrated significantly improved pain and function compared to ACDF subjects, while maintaining range of motion, improving quality of life, and decreasing analgesic and opioid usage at 2 years postoperatively relative to baseline.     

系统综述颈椎间盘置换与椎间融合的临床疗效

[目的]系统评价多节段颈椎间盘置换术与颈椎前路减压椎间融合术(anterior cervical discectomy and fusion,ACDF)临床疗效的比较。[方法]检索Pubmed、Medline、EBSC0、Springer、Ovid、CNKI、Cochrane Library、外文医学期刊全文数据库(foreign journals integrations system)等数据库。收集1995～2010年发表的关于椎间盘置换与椎间融合临床疗效的随机对照试验(RCT),按Cochrane系统评价的方法评价纳入研究的质量和提取资料,并采用RevMan软件进行统计分析。术后疗效评价包括颈部功能残障指数(neck disability index,NDI),视觉模拟评分法(visual analogscale,VAS)及相应节段运动范围(range of motion,ROM)等常见指标。[结果]共8篇文献符合纳入标准,包括1734例患者;术后2年和4年NDI合并权重均差(weighted mean difference,WMD)分别为-7.82,(95%CI,-8.73～-6.91),(P<0.0...     

Assessment of fusion after anterior cervical discectomy

There is no established method to assess fusion in patients following anterior cervical discectomy. In this study we have made a series of measurements to detect movement between vertebrae adjacent to an operated space. The absence of movement implies structural union between adjacent vertebrae. Measurements have been made in two distinct surgical groups. Group A patients had anterior cervical discectomy with insertion of a BOP graft into the disc space. Group B patients underwent simple anterior cervical discectomy with no spacer or graft material inserted, the disc space being left empty. Details of the measurements and interpretation of results are described. In the absence of a 'gold standard' to assess bony union we propose that these measurement methods provide an objective and scientific method to assess fusion at the operated level after anterior cervical discectomy. Objective measurement of fusion will allow comparison between different surgical techniques that claim fusion as an end point. It will also become possible to study the influence of fusion on clinical outcome in different surgical populations.     

The 5-year cost-effectiveness of two-level anterior cervical discectomy and fusion or cervical disc replacement: a Markov analysis

Background Context

Anterior cervical discectomy and fusion (ACDF) and cervical disc replacement (CDR) are both acceptable surgical options for the treatment of cervical myelopathy and radiculopathy. To date, there are limited economic analyses assessing the relative cost-effectiveness of two-level ACDF versus CDR.

颈椎人工椎间盘置换与椎间盘切除融合术后邻近节段退变比较研究的Meta分析

目的 :通过Meta分析系统评价颈椎人工间盘置换术(cervical total disc replacement,TDR)与颈前路椎间盘切除融合术(anterior cervical discectomy and fusion,ACDF)对邻近节段退变(adjacent segment degeneration,ASDeg)、邻近节段病(adjacent segment disease,ASDis)发生的影响。方法 :根据Cochrane系统评价指南,通过Pub Med、Medline、EMBASE、Cochrane图书馆、中国生物医学文献数据库(CBM)和万方数据库(Wanfang Database)检索2002年1月~2016年6月之间关于TDR和ACDF术后出现ASDeg、ASDis的随机对照试验(randomized controlled trials,RCTs),由两名研究人员独立筛选文章。纳入文献的方法学质量和偏倚风险通过Cochrane系统评价指南进行评价,提取数据包括ASDeg、ASDis以及再手术率的相关信息,研究结果以ASDeg和ASDis的发生作为直接结果,以邻近节段再手术率作为间接结果评估邻近节段病变的发生,并根据随访时间和研究地点分层进行亚组分析,最终对整篇Meta分析通过证据质量分级和推荐强度系统(the grades of recommendation,assessment,development and evaluation,GRADE)进行质量评估。结果 :共纳入了11篇RCTs,包括2632名研究对象。对于整体的ASD(包括直接和间接结果),TDR的发生率明显低于ACDF(OR=0.6;95%CI[0.38,0.73];P0.00001),差异有统计学意义。ASDeg和再手术率方面,TDR相对于ACDF具有明显优势(分别为OR=0.58,95%CI[0.46,0.72],P0.00001和OR=0.52,95%CI[0.30,0.87],P=0.01)。以随访时间5年为分界点,不论随访5年还是≥5年,在ASDeg发生率上,TDR的优势都比ACDF显著(分别为OR=0.63,P=0.001;OR=0.49,P=0.0002),并且这种优势可能随时间延长有扩大趋势。以研究地点分层,不论在美国(7篇RCTs)还是中国(4篇RCTs),TDR在邻近节段退变(ASDeg)发生率上均有优势(P0.0001,P=0.03)。根据GRADE评分,该Meta分析的质量级别为中等质量。结论:与ACDF相比,TDR在降低ASDeg和再手术率方面具有优势。     

颈椎间盘置换术与前路减压椎间融合术术后疼痛及残障指数比较的Meta分析

目的 收集并分析有关颈椎间盘置换术与颈前路减压椎间融合术(anterior cervical dis-cectomy and fusion,ACDF)术后疗效比较的文献,对颈椎间盘置换术和ACDF术后疼痛及残障指数进行Meta分析.方法 检索Medline(1966年1月至2008年11月)、Embase(1966年1月至2008年11月)、AMED(1985年1月至2008年11月)和Cochrane Library等数据库中关于颈椎间盘置换术和ACDF术后疗效比较的随机对照研究,纳入符合标准的文献,提取相关数据输入Review Manager4.2软件进行统计学分析.臂部疼痛及颈部疼痛的视觉模拟评分(visual analogue scale,VAS)、颈部功能残障指数(neckdisability index,NDI)均采用权重均差(weighted mean difference,WMD)进行评价.结果共4篇文献符合纳入标准,经改良Jadad评分判定均为高质最研究.共纳入213例,干预组(颈椎间盘置换组)和对照组(ACDF组)术后6周臂部疼痛VAS合并WMD为-2.91[95%置信区间(-4.19,-1.62),P<0.05],术后6个月合并WMD值为-2.67[95%置信区间(-4.02,-1.33),P<0.05].干预组和对照组术后6周NDI合并WMD值为-11.93[95%置信区间(-15.66,-8.19),P<0.05],术后6个月合并WMD值为-11.2[95%置信区间(-14.74,-7.69),P<0.05].结论 颈椎间盘置换术后6周和6个月时患者臂部疼痛程度低于ACDF;颈椎间盘置换术后6周和6个月患者颈部功能恢复程度高于ACDF.     

人工颈椎椎间盘置换与颈前路减压融合术治疗脊髓型颈椎病的疗效分析

目的比较人工颈椎椎间盘置换术与颈前路椎间盘切除减压植骨融合术(anterior cervical discectomy and fu-sion,ACDF)治疗脊髓型颈椎病的临床疗效。方法回顾性分析本院收治的人工颈椎椎间盘置换术及ACDF治疗的脊髓型颈椎病病例。测量所有患者颈椎活动度(range of motion,ROM),置换节段及相邻节段的ROM,并行日本骨科学会(Japanese Orthopaedic Association,JOA)评分及Odom分级。结果所有患者术后JOA评分和Odom功能评定均得到显著改善。置换组术后颈椎ROM、置换节段及其邻近间隙平均ROM无明显改变,差异无统计学意义(P>0.05)。ACDF组患者中,术后颈椎ROM显著减小,邻近间隙ROM明显增大,差异有统计学意义(P<0.05)。置换组术后邻近节段的ROM明显小于ACDF组,差异有统计学意义(P<0.01)。结论人工颈椎椎间盘置换术能保持颈椎ROM,避免邻近节段退变,早、中期疗效满意,远期效果尚有待临床进一步研究。     

Comparison of single-level cervical fusion and a metal-on-metal cervical disc replacement device

Cervical fusion is the common treatment for cervical disc disease but can cause secondary disorders. The Prestige ST cervical disc prosthesis (Medtronic Sofamor Danek, Memphis, TN) was designed to preserve spinal motion to potentially limit the secondary disorders. In this article, we report 2-year results from a single-center study comparing use of this device with use of anterior cervical discectomy and fusion (ACDF). Nineteen patients were prospectively randomized to receive the device or to undergo ACDF. Twenty-four months after surgery, patients who received the device demonstrated improvement in neck pain, arm pain, and neurologic function. In our cohort, patients who underwent arthroplasty demonstrated greater improvement in neurologic function and neck pain than patients who underwent cervical discectomy and fusion.     

Airway changes after anterior cervical discectomy and fusion

INTRODUCTION: Anterior cervical discectomy and fusion (ACDF) is a common procedure for radicular and spondylotic disease of the cervical spine. Radiographs are routinely used to evaluate complications in the postoperative ACDF patient, especially airway compromise. Our purpose was to establish baseline data on the amount of change that can be expected in the prevertebral soft tissues after this procedure in the uncomplicated asymptomatic (no airway compromise) 1 or 2-level ACDF patient. Our hypothesis was that the upper cervical spinal levels (C2-C4) would experience greater degrees of swelling than the lower cervical spine (C5-C7). To date no published data exist in the English literature upon which to judge symptomatic patients (experiencing postoperative airway distress) radiographically. METHODS: We prospectively evaluated preoperative and postoperative x-rays of 32 patients undergoing ACDF for radicular or spondylotic cervical pathology. Measurements were taken from the anterior body of the cervical spine to the posterior aspect of the airway. The postoperative differences for each level from C2 to T1 were calculated. RESULTS: We found that the greatest level of swelling or change in the prevertebral soft tissues occurred at the mid-body of C4 in uncomplicated cases with an average change of 10.7 mm. No patients measured greater than 25 mm at C4. CONCLUSIONS: As we predicted, the greatest edema was noted in the upper cervical spine. Studies need to be performed to compare the radiographic data of symptomatic patients with the baseline data we have collected.     

ActivC人工颈椎间盘置换术与颈前路椎间盘切除融合治疗单节段颈椎病的早期疗效比较

目的:观察比较Activ C人工颈椎间盘置换术(ACDR)和颈前路椎间盘切除融合(ACDF)治疗单节段颈椎病的早期临床效果。方法:自2009年7月至2012年9月,76例单节段颈椎病患者接受Activ C人工颈椎间盘置换手术(置换组)或颈前路椎间盘切除融合手术(融合组).其中置换组28例,男18例,女10例,年龄32～62岁,平均(45.2±6.2)岁;融合组48例,男28例,女20例,年龄33～60岁,平均(45.8±6.4)岁。分别在术前,术后1周,术后3、6、12、24个月,对患者进行疼痛视觉模拟评分(VAS)、日本矫形外科协会(JOA)脊髓功能评分和生活质量量表(SF-36)评估及影像学评估。结果:76例患者均获得随访,时间6～24个月,平均13.2个月。颈痛、上肢痛的VAS评分及JOA评分,术后均有改善(p<0.05),两组间差异无统计学意义(p>0.05).两组患者SF-36躯体评分、精神评分术后均有明显上升(p<0.05),置换组优于融合组(p<0.05).置换组术后手术节段及邻近节段屈伸活动度与术前比较差异无统计学意义(p>0.05).置换组中1例患者在6个月时椎体后缘周围出现异位骨化,1年随访时暂无融合现象;融合组中1例患者发生邻椎病并接受二次手术治疗。结论:单节段Activ C人工颈椎间盘置换术早期临床效果满意,能减少邻近节段退变,远期效果有待临床进一步研究。