Bryan人工颈椎间盘置换治疗颈椎病的中期临床随访

背景：Bryan人工颈椎间盘置换的短期疗效优良已被大多数学者公认,但有关其中长期临床效果及并发症的资料较少。 目的：总结Bryan人工颈椎间盘置换治疗颈椎病的中期临床效果。 方法：选择2004-11/2007-12在四川大学华西医院骨科接受Bryan人工颈椎间盘置换的颈椎间盘突出症患者34例,其中单节段置换30例,双节段置换4例。于置换前、置换后7 d、3,6,12,24,36,48个月行SF-36生活质量量表评分、JOA评分、颈部及上肢疼痛目测类比评分;以颈椎正侧位及功能位X射线片测量手术节段、邻近节段及C2~7屈伸活动度的变化,手术节段和邻近节段椎间高度变化及手术节段的轴向平移情况。 结果与结论：所有患者置换后神经症状均明显好转,各随访点SF-36生活质量量表躯体评分和心理评分、JOA评分、颈部和上肢疼痛目测类比评分较置换前明显改善(P < 0.05),3个月之后各随访时点两两比较差异无显著性意义(P > 0.05)。置入的Bryan假体历次随访均保留了>2°的活动度,未发现手术节段异位骨化与自发性融合,随访48个月时手术节段及C2~7屈伸活动度较置换前略有增加,但差异无显著性意义(P > 0.05);上下邻近节段屈伸活动度维持了置换前水平;手术节段的椎间高度由置换前的(6.04±1.02) mm增加到(8.44±0.43) mm(P < 0.05);上下邻近节段椎间高度及手术节段的轴向平移均维持了置换前水平。说明Bryan人工颈椎间盘治疗颈椎间盘退变性疾病的中期临床效果良好,较好的保留了手术节段、邻近节段及整个颈椎的运动学特性,且近中期并发症很少。     

人工颈椎间盘置换早期运动学分析：55例资料验证

背景：颈椎前路椎间盘切除椎间融合被认为是治疗颈椎病的金标准,但是融合后产生临近节段的加速退变。采用人工颈椎间盘置换治疗颈椎病和颈椎间盘突出症在解除患者脊髓压迫的同时保持了颈椎的活动度和稳定性,恢复椎间盘正常的生物力学特点,防止邻近椎间盘的加速退变。 目的：观察颈椎Prodisc人工颈椎椎间盘置换的临床应用效果及术后的运动学变化。 方法：选择55例69个椎间盘,其中双节段受损14例;男29例,女26例,年龄48(31~76)岁;脊髓型颈椎病32例,神经根型颈椎病9例,混合型颈椎病14例。取颈椎前横切口或斜切口入路行Prodisc人工颈椎间盘置换。于置换前、置换后3,6,12,24个月观察颈椎正侧位、过伸过屈、左右侧屈位片,JOA评分分析置换前后椎间盘功能改善情况。 结果与结论：随访55例69个椎间盘, 41例行单节段人工颈椎间盘置换, 14例行双节段人工颈椎椎间盘置换。置换后随22(56~48)个月。 置换后JOA评分显示椎体功能改善率达56%。置换后手术节段椎间盘矢状面、冠状面活动度与置换前比较差异无显著性意义(P = 0.45, 0.74),并保持了和邻近间隙同样的活动度和稳定性。说明颈椎人工椎间盘置换后保留了原来的椎间盘的活动度,患者恢复快,对邻近椎间盘的影响小。     

Bryan人工椎间盘置换术治疗脊髓型颈椎病

目的总结应用Bryan人工椎间盘置换术治疗脊髓型颈椎病的疗效。方法回顾性分析应用Bryan人工椎间盘置换术治疗的20例脊髓型颈椎病患者,共25个置换节段,其中单节段15例,双节段5例。应用JOA17分法评价术前和末次随访时的临床神经功能状况,并作统计学检验。观察末次随访时颈椎侧位X线片上假体与椎体的相互位置关系以及假体所在椎间隙的活动度。结果所有病人得到随访,随访时间3～24个月,平均15个月。病人术后症状有明显缓解,JOA评分由术前平均10．4分上升至术后平均15．2分。术后随访未见有假体松动、下沉和周围骨化融合,置换间隙前屈后伸活动范围平均为（4．8±1．7）°。结论Bryan人工椎间盘置换术早期临床效果良好,能达到确切的稳定性和部分的活动度保留。     

人工颈椎间盘植入治疗颈椎病

目的 颈椎病前路融合术后颈椎活动度下降与邻近节段椎间盘退变加速越来越受到人们的重视,人工颈椎间盘置换术可在进行脊髓减压并提供稳定的同时保持手术节段颈椎的活动度,为颈椎病的外科治疗开辟了新的途径.方法 自2005年12月至2008年3月,对16例颈椎病患者进行显微减压后椎间植入Bryan人工颈椎间盘,平均随访时间17个月.结果 所有患者术后症状均明显缓解,脊髓功能明显改善,颈椎活动度良好,1例术后发生短暂声音嘶哑,无手术死亡率.结论 人工颈椎间盘植入为颈椎病的外科治疗开辟了新的手段,在提供颈椎稳定的同时保持手术节段颈椎的良好活动度,把握严格的适应证和手术技术能取得满意的效果.     

27例单节段Bryan颈椎间盘假体置换临床研究

目的观察单节段Bryan颈椎间盘假体置换术后的稳定性和植入节段的活动度,评价早期治疗效果。方法对27例脊髓型颈椎病病人行Bryan颈椎间盘假体置换术。手术前和术后6个月进行JOA评分,术后6个月进行Odom评级;术后3、6个月随访时摄置换节段前屈后伸位、左右侧屈位X-线片。术后6个月进行置换间隙CT扫描。结果经1￣10个月随访,病人术后症状均明显缓解。随访时间超过6个月者10例;JOA评分由术前平均8.9分(7￣13分)上升至术后平均15.7分(14￣17分);Odom评级7例优,3例良。X-线检查未发现偏移或假体下沉,置换节段前屈后伸活动度平均5.71°(5.0°￣6.9)°;左右侧屈活动度分别为平均3.5°(2.5￣°4.8)°和3.4°(2.4°￣4.8)°。术后6个月置换间隙CT扫描示假体上、下金属壳偏离中央2例,金属终板的骨长入良好。结论颈人工椎间盘置换术可保持前路减压的良好效果,同时取得了良好的术后即刻稳定性,维持了颈椎的正常活动度。     

Bryan人工颈椎间盘置换治疗脊髓型颈椎病8例

回顾性分析2007-05/2008-07南通大学第二附属医院脊柱外科和上海长征医院骨科收治的脊髓型颈椎病患者8例,男2例,女6例;年龄36~58岁,病程8~24个月;病变节段：均为单节段,C4~5 5例,C5~6 3例。全部患者均采用Bryan人工颈椎间盘置换,置换后3个月行JOA评分,摄置换节段前屈后伸位、左右侧屈位X射线平片,观察假体置入后的稳定性及置换颈椎节段的活动度。结果显示置换过程中和置换后未出现神经和血管损伤的并发症,平均置换时间135 min。8例患者均进行门诊随访,随访时间3~13个月,所有患者置换后症状明显缓解。JOA评分由置换前平均8.9分(6~12分)增加到置换后第3个月平均15.2分(12~17分)。置换后3个月置换节段前屈后伸活动范围平均5.3°(4.3°~6.1°);左右侧屈活动范围分别为平均3.4°(2.8°~4.3°)和3.5°(2.9°~4.3°)。假体无偏移或下沉。末次随访未发现置换节段异位骨化、假体松动、下沉或颈椎生理曲度的改变。提示Bryan人工椎间盘置换治疗脊髓型颈椎病近期临床效果良好,能维持颈椎正常的活动范围和生理曲度。     

人工颈椎间盘置换的生物力学系统评价

目的：评价人工颈椎间盘置换对颈椎运动范围及临近节段生物力学的影响。 方法：以计算机检索方法检索中国期刊全文数据库中(CNKI：2005/2009)关于人工颈椎间盘置换治疗颈椎病的临床随访、对照实验，检索词为“人工颈椎间盘置换、生物力学”。检索后对每项研究的资料结果进行提取、分析。 结果：共有21项实验469例颈动脉狭窄患者符合纳入标准，分析结果显示人工颈椎间盘置换后脊髓功能JOA 评分较置换前明显升高，置换节段稳定并部分恢复了颈椎正常的活动范围。而且与颈前路减压植骨融合术相比，人工颈椎间盘置换未增加临近节段的关节活动范围和应力负荷，阻止或降低了临近节段的退变及颈椎活动范围减小的发生率，随访时影像学均未见假体移位、脱落、下沉等并发症发生。 结论：人工颈椎间盘置换使颈椎运动范围得到一定保持，颈椎稳定性好，置换后对邻近节段影响较小，阻止了相邻节段的退变加速，是颈椎病治疗方面一种具有良好发展前景的治疗方法。但由于其临床应用时间短，其潜在的异位骨化、假体下沉、脱出等问题题仍有待于长期临床观察。     

颈椎间盘置换与颈前路椎间盘切除减压植骨融合治疗退变性颈椎病的Meta分析

背景：颈前路减压植骨融合是目前治疗退变性颈椎病手术方案中的“金标准”。但是,随着颈前路减压植骨融合技术使用的增加和随访资料的不断丰富,一些不良结果开始暴露出来。近20年来,人工颈椎间盘置换技术在国外和国内逐步推广并广泛应用于临床,文献报道治疗效果令人满意。 目的：系统评价颈椎间盘置换与传统的颈前路减压植骨融合治疗退变性颈椎病治疗效果的差异。 方法：计算机检索Medline(1966/2009-06),荷兰医学文摘(EMbase1966/2009-06),Cochrane图书馆(2009年第2期)、Cochrane协作网背痛专业试验数据库、中国生物医学文献数据库(CBM截止2009-06),CNKI(截止2009-06),手工检索中文文献,收集颈椎间盘置换与颈前路减压植骨融合比较治疗退变性颈椎病的随机、半随机对照试验,进行严格的质量评价,利用RevMan4.2.2软件对纳入研究结果进行Meta分析。 结果与结论：共纳入15个研究,Meta分析结果显示：颈椎间盘置换与颈前路减压植骨融合术比较平均出血量、手术时间、住院时间及术后并发症差异无显著性意义;术后2年再手术率颈椎间盘置换组低于颈前路减压植骨融合组;手术满意率两组差异无显著性意义;颈椎间盘置换组术后颈部功能异常指数较颈前路减压植骨融合组明显改善,术后SF-36评分改善显著优于颈前路减压植骨融合组;术后手术节段运动幅度颈椎间盘置换组显著大于颈前路减压植骨融合组,术后邻近节段运动范围颈前路减压植骨融合组明显较颈椎间盘置换组增大。但上述结果可能存在各种偏倚,因此需要更多高质量的临床随机对照试验来得出更为可靠的结论。     

前屈后伸载荷下颈椎间孔的孔径变化：Bryan颈人工椎间盘置换与颈椎钢板植骨内固定的比较

背景：诸多针对脊椎椎体间固定融合后相邻节段应力变化的生物力学测试结果并不尽相同,载荷控制与位移控制试验模式下所反映出的相邻节段应力状况其结果也相差甚远。 目的：分析椎间盘完整、椎间盘切除、Bryan颈人工椎间盘置换和前路颈椎植骨融合钢板内固定后,成人尸体颈椎标本分别在前屈后伸载荷下C5/6椎间孔孔径和面积的变化情况。 方法：分别测量C5/6椎间盘完整、椎间盘髓核摘除、Bryan颈人工椎间盘置换和前路钢板植骨内固定4种状态下以0.25,0.50,0.75,1.00,1.25,1.50 N•m的分级载荷加载于标本的前屈后伸状态时C5/6椎间孔孔径和面积的变化情况。 结果与结论：前屈后伸各级加载时,C5/6椎间孔上下径、上前后径、下前后径和面积椎间盘完整组、Bryan颈人工置换组和钢板植骨内固定组高于椎间盘髓核摘除组,差异有显著性意义(P < 0.05),Bryan颈人工置换组高于钢板植骨内固定组,差异有显著性意义(P < 0.05),可见颈椎间盘髓核摘除后C5/6椎间孔有效空间明显减少。     

腰椎人工髓核假体置换后并发症及疗效评估

目的：总结分析腰椎人工髓核假体置换后并发症发生情况，在早期临床随访的基础上，比较人工髓核假体置换与传统开窗腰椎间盘髓核摘除治疗腰椎间盘突出症的中、远期疗效。 方法：选择2002-02/2005-08南方医科大学附属南方医院脊柱骨病外科采用单枚人工髓核假体置换治疗单节段腰椎间盘突出症患者98 例, 获得24~60 个月随访患者63例。另外随机选择同期同年龄段单节段腰椎间盘单纯开窗髓核摘除患者200例，获有效随访94例。采用Oswestry 功能障碍指数和Stauffer-coventry疗效评定标准评价疗效，影像学分析手术节段活动度和椎间隙高度变化情况，同时观察假体位置情况。腰椎活动度= 后伸角度-前屈角度；椎间隙高度变化采用病变椎间隙前后缘高度均值与上位椎体中部矢状径的比值表示。 结果：①单纯髓核摘除组8例患者术后复发，行二次椎间盘手术；人工髓核假体置换组3例假体脱出二次翻修将假体取出。其余患者治疗后临床症状均明显改善。②两组Oswestry 功能障碍指数各随访时间点均较术前明显降低，差异有显著性意义( P < 0.05)。③两组Stauffer-coventry疗效评估各随访时间点差异无显著性意义（P > 0.05）。④随访中远期（3.0~5.0年）人工髓核假体置换组手术节段腰椎活动度均优于单纯椎间盘摘除组，差异有显著意义(P < 0.05)。⑤人工髓核假体置换组椎间隙高度比值各随访时间点与术前比较, 差异具有显著性意义(P < 0.05)。⑥主要并发症：人工髓核假体置换组早期出现术后一过性腰痛24 例, 假体脱出3 例。中、远期发现假体下沉32 例, 软骨终板损伤39 例。单纯髓核摘除组8例术后复发。所有病例无术后感染发生。 结论：人工髓核假体置换存在较严重并发症，人工髓核假体置换与传统腰椎间盘开窗髓核摘除中、远期疗效无明显差异。     

Comparative Analysis of Cervical Arthroplasty Using Mobi-C? and Anterior Cervical Discectomy and Fusion Using the Solis? -Cage

Objective

Although anterior cervical discectomy and fusion (ACDF) is the standard treatment for degenerative cervical disc disease, concerns regarding adjacent level degeneration and loss of motion have suggested that arthroplasty may be a better alternative. We have compared clinical and radiological results in patients with cervical disc herniations treated with arthroplasty and ACDF.

Methods

We evaluated 53 patients treated for cervical disc herniations with radiculopathy, 21 of whom underwent arthroplasty and 32 of whom underwent ACDF. Clinical results included the Visual Analogue Scale (VAS) score for upper extremity radiculopathy, neck disability index (NDI), duration of hospital stay and convalescence time. All patients were assessed radiologically by measuring cervical lordosis, segmental lordosis and segmental range-of-movement (ROM) of operated and adjacent disc levels.

Results

Mean hospital stay (5.62 vs. 6.26 days, p<0.05) and interval between surgery and return to work (1.10 vs. 2.92 weeks, p<0.05) were significantly shorter in the arthroplasty than in the fusion group. Mean NDI and extremity VAS score improved after 12 months in both groups. Although it was not significant, segmental ROM of adjacent levels was higher in the fusion group than in the arthroplasty group. And, segmental motion of operated levels in arthroplasty group maintained more than preoperative value at last follow up.

Conclusion

Although clinical results were similar in the two groups, postoperative recovery was significantly shorter in the arthroplasty group. Although it was not significant, ROM of adjacent segments was less in the arthroplasty group. Motion of operated levels in arthroplasty group was preserved at last follow up.     

Clinical and radiologic comparison of dynamic cervical implant arthroplasty versus anterior cervical discectomy and fusion for the treatment of cervical degenerative disc disease

This study compared the clinical and radiological outcomes of dynamic cervical implant (DCI; Scient’x, Villers-Bretonneux, France) arthroplasty versus anterior cervical discectomy and fusion (ACDF) for the treatment of cervical degenerative disc disease. This prospective cohort study enrolled patients with single-level cervical degenerative disc disease who underwent DCI arthroplasty or ACDF between September 2009 and June 2011. Patients were followed up for more than 2 years. Clinical evaluation included the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36), Neck Disability Index (NDI), Japan Orthopedic Association (JOA) score, and visual analog scale (VAS) scores for neck and arm pain. Radiological assessments included segmental range of motion (ROM), overall ROM (C2–C7), disc height (DHI), and changes in adjacent disc spaces. The VAS, SF-36, JOA, and NDI scores improved significantly after surgery in both the DCI and ACDF groups. The VAS, JOA, and SF-36 scores were not significantly different between the DCI and ACDF groups at the final follow-up. The segmental ROM at the treated level and overall ROM increased significantly after surgery in the DCI group, but the ROM in the adjacent cephalad and caudal segments did not change significantly. The mean DHI at the treated level was significantly restored after surgery in both groups. Five patients (12.8%) in the DCI group showed new signs of adjacent segment degeneration. These results indicate that DCI is an effective, reliable, and safe procedure for the treatment of cervical degenerative disc disease. However, there is no definitive evidence that DCI arthroplasty has better intermediate-term results than ACDF.     

Prevalence of adjacent segment disc degeneration in patients undergoing anterior cervical discectomy and fusion based on pre-operative MRI findings

Anterior cervical discectomy and fusion (ACDF) is a widely accepted surgical treatment for symptomatic cervical spondylosis. Some patients develop symptomatic adjacent segment degeneration, occasionally requiring further treatment. The cause and prevalence of adjacent segment degeneration and disease is unclear at present. Proponents for motion preserving surgery such as disc arthroplasty argue that this technique may decrease the “strain” on adjacent discs and thus decrease the incidence of symptomatic adjacent segment degeneration. The purpose of this study was to assess the pre-operative prevalence of adjacent segment degeneration in patients undergoing ACDF. A database review of three surgeons’ practice was carried out to identify patients who had undergone a one- or two-level ACDF for degenerative disc disease. Patients were excluded if they were operated on for recent trauma, had an inflammatory arthropathy (for example, rheumatoid arthritis), or had previous spine surgery. The pre-operative MRI of each patient was reviewed and graded using a standardised methodology. One hundred and six patient MRI studies were reviewed. All patients showed some evidence of intervertebral disc degeneration adjacent to the planned operative segment(s). Increased severity of disc degeneration was associated with increased age and operative level, but was not associated with sagittal alignment. Disc degeneration was more common at levels adjacent to the surgical level than at non-adjacent segments, and was more severe at the superior adjacent level compared with the inferior adjacent level. These findings support the theory that adjacent segment degeneration following ACDF is due in part to the natural history of cervical spondylosis.     

Artificial disc insertion following anterior cervical discectomy

OBJECTIVE AND IMPORTANCE: Fusion following anterior cervical discectomy has been implicated in the acceleration of degenerative changes in the adjacent spinal segments. Discectomy followed by implantation of an artificial cervical disc maintains the functionality of the spinal unit, while still providing excellent symptomatic relief. We describe our preliminary experience with implantation of the Bryan Cervical Disc System in two cases of single-level cervical disc herniation. CLINICAL PRESENTATION: Two male patients presented with a left C6 radiculopathy, without evidence of myelopathy. Magnetic resonance imaging revealed a disc herniation at C5-6 in both cases. Pre-operative flexion and extension radiographs demonstrated preserved motion at the involved levels. INTERVENTION/TECHNIQUE: Following a standard anterior cervical decompression, precision drilling of the vertebral endplates was carried out using a drill attached to a bed-mounted, gravitationally-referenced retraction frame. An artificial cervical disc, composed of a polyurethane nucleus with titanium endplates, was fitted between the contoured endplates without fixation to the vertebral bodies. No complications were experienced during the insertion of the prosthesis, or in the postoperative course. Both patients experienced immediate postoperative resolution of their radicular pain and were discharged from hospital the following day. At nine months following surgery, both patients continue to have complete relief of radicular symptoms. Postoperative radiographs at six months following surgery confirm accurate placement of the prosthesis and preserved mobility of the functional spinal unit. CONCLUSION: Insertion of the Bryan artificial cervical disc prosthesis following anterior cervical discectomy is a relatively straightforward procedure, which appears to be safe and provides good clinical results, without requiring additional surgical time. Long-term follow-up is required to assess its safety, efficacy, and ability to prevent adjacent segment degeneration.     

Outcomes of single-level cervical disc arthroplasty versus anterior cervical discectomy and fusion

Several studies have established the short-term safety and efficacy of cervical disc arthroplasty (CDA) as compared to anterior cervical discectomy and fusion (ACDF). However, few single-center comparative trials have been performed, and current studies do not contain large numbers of patients. We retrospectively reviewed all patients from a single military tertiary medical center between August 2008 to August 2012 who underwent single-level CDA or single-level ACDF and compared their clinical outcomes and complications. A total of 259 consecutive patients were included in the study, 171 patients in the CDA group with an average follow-up of 9.8 (±9.9) months and 88 patients in the ACDF group with an average follow-up of 11.8 (±9.6) months. Relief of pre-operative symptoms was 90.1% in the CDA group and 86.4% in the ACDF group with rates of return to full pre-operative activity of 93.0% and 88.6%, respectively. Patients who underwent CDA had a higher rate of persistent posterior neck pain (15.8% versus 12.5%), and patients who underwent ACDF were at risk for symptomatic pseudarthrosis at a rate of 3.4%. Reoperation rates were higher in the ACDF group (5.7% versus 3.5%). To our knowledge, this review is the largest, non-funded, comparison study between single-level CDA and single-level ACDF. This study demonstrates that CDA is a safe and reliable alternative to ACDF in the treatment of cervical radiculopathy and myelopathy resulting from spondylosis and acute disc herniation.     

Utilization trends of cervical artificial disc replacement during the FDA investigational device exemption clinical trials compared to anterior cervical fusion

While anterior cervical discectomy and fusion (ACDF) is the gold standard surgical treatment for cervical disc disease, concerns regarding adjacent segment degeneration lead to the development of cervical disc arthroplasty (CDA). This study compares the utilization trends of CDA versus ACDF during the period of the Food and Drug Administration Investigational Device Exemption clinical trials from 2004 to 2007. The Healthcare Cost and Utilization Project Nationwide Inpatient Sample database was used to identify CDA and ACDF procedures performed in the USA between 2004 and 2007. The prevalence of CDA and ACDF procedures was estimated and stratified by age, sex, diagnosis, census region, payor class, and hospital characteristics. The average length of hospital stay, total charges, and costs were also estimated. The number of CDA surgeries significantly increased annually from 2004 to 2007 and mostly took place at urban non-teaching hospitals. There were no regional differences between CDA and ACDF utilization. There was no difference between sex or admission type between CDA and ACDF patients. ACDF patients were older and had more diabetes, hypertension, and chronic obstructive pulmonary disease. CDA patients were more likely to be discharged home and had shorter hospital stays but had a higher rate of deep venous thrombosis than ACDF patients. Significantly more CDA patients had private insurance while more ACDF patients had Medicare. The average cost was higher for ACDF than CDA. While ACDF dominated surgical intervention for cervical disc disease during the trial period, CDA utilization increased at a significantly greater rate suggesting rapid early adoption.