Bryan人工颈椎间盘置换术与椎间融合术治疗颈椎病的中期疗效比较

目的 分析对比Bryan人工颈椎间盘置换术与颈前路减压植骨融合术(anterior ceryical discectomy and fusion,ACDF)治疗颈椎病的中期疗效.方法 2003年11月至2004年2月,16例患者行Bryan人工颈椎间盘置换术(A组),35例患者行ACDF(B组),于术前、出院前、术后6周、3、6、12、24个月及随后每半年一次随访,通过日本矫形外科协会(JOA)评分、简明健康状况调查表(SF-36评分)、颈椎残障功能指数(neck disability index,NDI)评定治疗效果.同期摄X线片,检测病变节段的稳定性和活动度.结果 两组患者术中、术后均无严重并发症发生.所有患者均获得6年以上随访,平均73.5个月.A组术后无假体移位、脱落等并发症发生,1例发生自发融合;置换节段活动度与置换前活动度的差异无统计学意义(P＞0.05).B组术后6个月X线片示植骨全部达骨性融合.两组患者术后随访时临床症状均明显缓解,疗效满意.两组患者的JOA评分及SF-36评分、NDI,术后随访时均较术前有明显提高(P＜0.05).B组活动度较术前明显减小(P＜0.01),而A组手术前后差异无统计学意义(P＞0.05);两组术后活动度差异有统计学意义(P＜0.05).结论 Bryan人工颈椎间盘置换术疗效良好,同时还可保留颈椎病变节段活动度,减少轴性症状,为颈椎病治疗提供一种新的方法.

Abstract：

Objective To compare the clinical outcomes of Bryan disc replacement with anterior cervical discectomy and fusion (ACDF) in patients with cervical spondylopathy. Methods Sixteen patients underwent Bryan cervical disc replacement (A group), and 35 patients underwent traditional ACDF (B group) were included in the study. Patients were followed up at regular intervals. The JOA score, SF-36, neck disability index (NDI) score and the dynamic flexion-extension radiographs were used to evaluated the oucomes.Results All the patients were followed up for more than 6 years (mean, 73.5 months). There were no severe adverse events in both groups. In A group, there were no differences between postoperative and preoperative mobility of surgical segments (P＞0.05). All patients obtained bone fusions 6 month after surgery in group B.In both groups, the clinical symptoms relieved obviously after surgery. The postoperative scores of the JOA,SF-36 and NDI significantly improved compared with those of preoperative ones (P＜0.05). In B group, range of motion (ROM) was significantly decreased postoperatively (P ＜0.01); in A group, there were no significant differences between postoperative and preoperative ROM (P＞0.05). The difference between two groups regarding ROM was noted (P＜0.05). Conclusion The mid-term outcomes of Bryan cervical arthroplasty are satisfied. And the cervical arthroplasty which can maintain the mobility of the segment, and decrease the incidence of the postoperative neck axial symptoms is a viable alternative to cervical spondylopathy.     

Bryan人工颈椎间盘置换术的中期随访结果分析

目的 观察Bryan人工颈椎间盘置换术后临床和影像学结果以及相邻节段退变的情况.方法 回顾性分析术后随访时间超过2年的26例单节段置换患者的临床资料,临床效果采用JOA和Odom评分进行评定.采用x线片观察手术节段活动度和椎旁骨化.采用X线片和MRI观察对比相邻节段退变情况.术前X线片示置换节段的活动度为2°～12°,平均为6.9°.结果 (1)临床结果:18例脊髓型颈椎病患者随访时JOA评分平均16分,平均改善率84%,8例神经根型颈椎病患者随访时临床症状全部消失.Odom分级:优秀15例,良好7例,一般4例.(2)X线片:术后置换节段的活动度为1°～14°,平均7.8°;7例出现假体周围异位骨化,仅1例假体运动消失,其余6例平均活动度为5.3°.相邻节段椎间隙高度术后无明显变化.(3)MRI T2加权像:根据Pfirrmann椎间盘退变分级方法,相邻节段椎间盘的分级术后无明显加重表现;相邻节段黄韧带肥厚对椎管的侵占率术后无明显加重;但是上下相邻椎间盘侵占率均略有增加.结论 Bryan人工颈椎间盘置换术保留了置换节段的运动性,避免了相邻节段的加速退变,2年以上随访效果优良.     

Comparison of adverse events between cervical disc arthroplasty and anterior cervical discectomy and fusion: a 10-year follow-up

BACKGROUND CONTEXTCervical disc arthroplasty (CDA) has been advocated as an alternative to anterior cervical discectomy and fusion (ACDF) with the added potential to reduce the risk of adjacent level disc degeneration and segmental instability. However, the long-term adverse events of arthroplasty have yet to be fully reported.PURPOSETo investigate the 10-year follow-up adverse events rates between CDA and ACDF.STUDY DESIGN/SETTINGThe study was a randomized, prospective, multicenter Investigational Device Exemption (IDE) trial and its continued follow-up as a postapproval study (PAS). Single level surgeries were performed for cervical disc pathologies between May 2002 and October 2004.PATIENT SAMPLEn=463 patients.OUTCOME MEASURESAdverse events comparison of CDA and ACDF from self-reported and physiologic measures.METHODSAt each evaluation time point, subjects were queried for adverse events since their last visit; and all adverse events were documented, regardless of whether or not they appeared related to the surgery or device. Adverse events were recorded, categorized, and assessed for severity and relationship to the study device and/or surgical procedure. The 10-year cumulative rates for each type of adverse events were summarized using a life-table method for the time-to-event analysis. A log-rank test was used to compare the two treatment groups.RESULTSA total of 242 patients received CDA and 221 patients received ACDF. At 10-year follow-up, 54% (130/242) of CDA patients and 47% (104/221) of the ACDF subjects were evaluated. At up to 10-year follow-up, 231 patients in the CDA group (cumulative rate 98.4%) and 199 patients in the ACDF group (cumulative rate 98.7%) had at least one adverse event. Overall, the difference in the cumulative rate of all adverse events over 10 years was not statistically different (p=0.166). The cumulative rates of the following adverse events were not different between the two groups for cancer, cardiovascular, death, dysphonia/dysphagia, gastrointestinal, infection, urogenital, respiratory, implant displacement/loosening, implant malposition, neck and arm pain, neurological, other pain, spinal events, and intraoperative vascular injury. However, there were more adverse events in the CDA group resulting from trauma (p=.012) and more spinal events at the index level (p=.006). The ACDF group had significantly more nonunion events (p=.019), and nonunion outcome pending (p=.034), adjacent level spinal events (p=.033), and events that fell into the “other” category (p=.015).CONCLUSIONSThe cumulative rates of patients who had any adverse events were not different between the artificial cervical disc and the anterior cervical arthrodesis groups. In addition, the cumulative rates were not different between the two groups for the majority of categories as well.     

Bryan颈椎人工椎间盘置换术后10年随访结果

目的 :观察Bryan颈椎人工椎间盘置换术后10年随访结果和并发症。方法:纳入在我院骨科行Bryan颈椎人工椎间盘置换术且获得长期随访、临床和影像学资料均完整的60例患者,其中神经根型颈椎病15例,脊髓型颈椎病41例,混合型颈椎病(脊髓型+神经根型)4例。47例患者为单节段置换,12例为双节段置换,1例为3节段置换。随访时间为124.0±8.3个月(117～150个月)。采用mJOA评分和VAS评分分别评估脊髓型颈椎病和神经根型颈椎病临床疗效,分析二次手术的原因和二次手术方案;颈椎屈伸位X线片评估末次随访时节段活动度情况,采用McAfee异位骨化分级观察末次随访时异位骨化情况。结果:脊髓型颈椎病患者术前mJOA评分为13.4±2.2分,末次随访时为15.8±1.1分(P0.05)。神经根型颈椎病患者术前上肢VAS评分为5.7±2.2分,末次随访时为0.7±0.9分(P0.05);术前颈痛VAS评分为4.7±2.2分,末次随访时为1.0±1.0分(P0.05)。混合型颈椎病患者术前m JOA评分为13.3±3.6分,末次随访时为15.4±1.1分;术前上肢VAS评分为4.3±2.6分,末次随访时为1.0±1.4分;术前颈痛VAS评分为2.8±1.5分,末次随访时为2.5±1.9分。7例患者接受了二次手术治疗,其中6例为手术节段异位骨化(包括初次手术单节段椎间盘置换术5例,双节段置换术1例;二次手术时3个节段异位骨化分级为Ⅲ级,4个节段为Ⅳ级)导致的新症状而行手术节段二次手术,1例为邻椎病行后路单开门椎管扩大成形术。74个手术节段的术前活动度为7.0°±2.9°,末次随访时活动度为4.6°±4.1°(P0.05)。末次随访时74个手术节段中有53个节段出现异位骨化,根据Mc Afee异位骨化分级,其中5个节段为Ⅱ级,21个节段为Ⅲ级,27个节段为Ⅳ级。结论:Bryan颈椎人工椎间盘置换术后随访10年取得了较好的疗效,但异位骨化的发生率较高,降低了手术节段的活动度,严重的异位骨化会导致手术节段出现新的神经症状而被迫行二次手术。     

Clinical long-term results of anterior discectomy without interbody fusion for cervical disc disease

There were 55 patients (soft disc, 21 and spondylosis, 34) who underwent anterior cervical discectomy without fusion (ACD) using an operating microscope. Discectomy of a single level was performed on 48 cases and two levels on 7. There were 37 patients with radiculopathy, and 18 patients with myelopathy or myeloradiculopathy who were followed clinically for 2-13 years postoperatively. Overall 81% of patients were improved in soft disc herniation, and no significant differences were noted between the group of radiculopathy and myelopathy. In spondylosis all but one patient reported initial relief of their preoperative symptoms; however, overall improvement was noted in only 16 patients (47%). The causes of symptomatic deterioration after ACD for spondylosis were later symptomatic recurrence in 5 patients, severe neck pain in 4, and development of new symptoms due to adjacent spur formation in 2. The authors eventually added interbody fusion in 4 cases. Cervical spine roentgenograms almost always showed a loss of height of the interspace and an anterior angulation immediately after ACD, but the alignment of the spine tended to improve with time, so that, at last follow-up, 82% had a good alignment. A spontaneous osseous fusion occurred in 74% of cases. An adjacent spur formation was observed in 3 patients with spondylosis. The most troublesome complication was neck and/or scapular pain. This pain usually subsided spontaneously, but this continued for more than 4 years postoperatively in 4 patients with spondylosis. Using an operating microscope ACD is a safe and effective procedure for patients with soft disc herniation, but the authors still prefer anterior cervical discectomy with interbody fusion for the patients with advanced spondylosis.     

Bryan人工间盘置换与前路减压融合治疗颈椎退行性疾病的中期随访研究

 目的 评价人工椎间盘置换术治疗颈椎退行性疾病的中期疗效,并探讨其是否可以减少邻近节段退变的发生。方法 前瞻性对比分析接受颈椎人工间盘置换术(置换组,45例)与颈椎前路减压融合术(融合组,48例)治疗的颈椎退行性疾病患者的随访6年临床疗效和影像学资料。临床疗效评价指标为日本骨科协会评分(Japanese Orthopaedic Association Scores,JOA)、颈椎功能残障指数量表(neck disability index,NDI)和Odom评分。影像学评价指标为矢状位曲度、活动度、邻近节段退变。结果28例置换组患者和35例融合组患者完成随访。两组患者末次随访的JOA评分和NDI均较术前有明显改善,组间比较差异无统计学意义。92.9%的置换组患者和97.1%的融合组患者Odom评分获得很好或较好的结果。两组患者颈椎矢状位曲度末次随访较术前均得到保持。颈椎整体活动度置换组末次随访与术前无明显差异,而融合组则是明显降低。置换组置换节段活动度术前为9.5°±3.7°,术后3个月为7.0°±3.0°,末次随访为6.6°±4.1°,末次随访较术后3个月无明显改变。邻近节段退变评估采用侧位X线片和MRI T2加权像,置换组上、下邻近节段退变均明显少于融合组。结论 Bryan人工椎间盘置换术6年的随访结果基本满意,能更好地保留颈椎生理活动及生物力学环境,从而降低邻近节段退变的发生率。     

Assessment of radiological results of anterior cervical discectomy with different fusion cages]

The purpouse of this study was to compare results of anterior cervical decompression and fusion for cervical disc disease with 2 different interbody devices: titanium cylinder-design cage and carbon box-design cage. The results of operations of 46 patients (60 instrumented levels) divided in to groups according to implant type were examined to asses the restoration of disc height, clinical outcome, bony fusion and complication rate. In the cylinder-design cage group average postoperative restoration of disc height was 72% but with narrowing rate of 26% in follow up. In the carbon box group postoperative disc height restoration was 51% with narrowing in follow up to 6%. Clinical outcome was comparable in both groups and loss of disc height in cylinder-design cage group had no effect on clinical outcome. There were 2 cases of pseudoarthrosis in cylinder cage group. Overall the study shows better radiological outcome of carbon box-design cages in comparison to cylinder design cages with no influence on clinical effect.     

颈椎前路椎间盘切除融合术与人工颈椎椎间盘置换术治疗跳跃型颈椎椎间盘突出症的生物力学效应有限元分析

目的 探讨颈椎前路椎间盘切除融合术(ACDF)和人工颈椎椎间盘置换术(CDA)治疗跳跃型颈椎椎间盘突出症的生物力学改变情况.方法 建立正常人颈椎(C2～7)三维有限元模型,并与既往研究数据进行对比,验证模型的有效性.选择C3/C4和C5/C6建立节段跳跃ACDF(Zero-P系统)、跳跃CDA(Prestige-LP假...     

The change of adjacent segment after cervical disc arthroplasty compared with anterior cervical discectomy and fusion: a meta-analysis of randomized controlled trials

Background Context

Many meta-analyses have been performed to study the efficacy of cervical disc arthroplasty (CDA) compared with anterior cervical discectomy and fusion (ACDF); however, there are few data referring to adjacent segment within these meta-analyses, or investigators are unable to arrive at the same conclusion in the few meta-analyses about adjacent segment. With the increased concerns surrounding adjacent segment degeneration (ASDeg) and adjacent segment disease (ASDis) after anterior cervical surgery, it is necessary to perform a comprehensive meta-analysis to analyze adjacent segment parameters.

Cervical disc arthroplasty: Equivalent alternative to anterior cervical discectomy and fusion but unknown superiority

Cervical disc arthroplasty has been developed as an alternative to anterior cervical discectomy and fusion with the advantages of preserving intervertebral motion, eliminating the risk of pseudarthrosis, and theoretically reducing adjacent segment degeneration. Several large prospective randomized trials have been conducted to investigate the clinical and radiographic results of cervical disc arthroplasty versus anterior cervical discectomy and fusion. Long-term results from these studies, however, show no difference in functional outcomes and no evidence to date in reduction of adjacent segment disease with arthroplasty. Although cervical disc arthroplasty is a safe and equivalent alternative, its superiority is yet unknown.     

Bryan颈椎人工椎间盘置换术后5年随访结果

目的:观察Bryan颈椎人工椎间盘置换术后5年随访结果。方法:我院从2003年12月开展Bryan颈椎人工椎间盘置换术,术后达到5年的患者共70例,其中57例获得57～69个月(平均60个月)随访。单节段置换47例,双节段置换9例,3节段置换1例。C3/4 5例、C4/5 10例、C5/6 45例、C6/7 8例。术前和末次随访时进行mJOA、VAS、NDI评分,末次随访时进行Odom′s分级评估临床疗效;术前和末次随访时,在过伸过屈侧位X线片上测量置换节段活动度,在侧位X线片上采用McAfee异位骨化分级方法评定异位骨化情况,在MRIT2加权像上采用Miyazaki颈椎间盘退变分级方法评定相邻节段椎间盘退变情况,在MRI中矢状位T2加权像上测量相邻节段突出椎间盘对椎管的侵占率。结果:(1)mJOA评分术前为13.4±1.9分,末次随访时16.1±1.1分,平均改善率为75.0%;上肢痛VAS评分术前为3.3±1.9分,末次随访时0.9±1.2分;颈肩痛VAS评分术前为3.0±1.5分,末次随访时1.6±1.4分;NDI评分术前为14.8±8.6分,末次随访时5.7±4.2分;以上指标末次随访时与术前比较均有统计学差异(P<0.05)。末次随访时Odom′s分级优21例,良27例,可7例,差2例。(2)28例患者获得X线随访,术前置换节段活动度为6.9°±3.0°,末次随访时为7.2°±3.7°,无统计学差异(P>0.05);末次随访时,30个手术节段中12个(40%)出现异位骨化,其中3个(10%)节段丧失活动度。(3)25例患者获得MRI随访,末次随访时50个相邻节段中7个(14%)椎间盘退变分级加重1级,但无相关临床症状出现;相邻节段突出椎间盘对椎管侵占率的年度平均增幅为0.3%～0.5%。结论:Bryan颈椎人工椎间盘置换术后平均5年随访的临床和影像学结果满意,手术节段活动度得到较好保留,相邻节段退变发生率较低,无相邻节段疾病发生。     

Bryan颈椎人工椎间盘置换术后长期疗效随访研究

目的：观察评估Bryan颈椎人工椎间盘置换术后长期疗效。 方法：本研究评估我院Bryan颈人工椎间盘置换术后患者长期临床疗效及影像学结果,采用mJOA、VAS、及NDI分别评价术前、术后1周、术后2年及末次随访临床效果并进行比较,末次随访时Odom’s分级评估临床疗效;X线侧位片及颈椎过屈过伸位片上采用Cobb法评估术前术后颈椎曲度、颈椎ROM,MRI T2加权相上根据Miyazaki分级标准评估Bryan人工椎间盘置换术后邻近节段退变,X线及CT上根据McAfee评估标准评价异位骨化（HO）发生情况。 结果：本研究共纳入患者20例,男性15例,女性5例,平均年龄43.85±3.70岁,平均随访时长88.5±16.29月,其中单节段9例,双节段11例,C3/4 2例、C4/5 9例、C5/6 15例、C6/7 5例;（1）mJOA、VAS、NDI评分术后较术前均明显改善,末次随访时Odom’s标准评级优（8例）,良（8例）,可（2例）,差（2例）;（2）FSU Cobb角、C2-7 Cobb角术前分别为2.33±4.08°、18.78±6.68°,末次随访为3.21±6.56°、15.61±6.73°,两者之间均无统计学差异（p=0.405,p=0.082）;FSU ROM术前为8.94±3.19°,术后早期及末次随访分别为9.47±3.81°、9.34±4.13°,术前术后比较均无统计学差异（p>0.05）,而C2-C7 ROM、上下邻近节段ROM术后均下降（p<0.05）;HO发生率为74.2%,其中严重HO（Ⅲ级或Ⅳ级）发生率为22.6%;末次随访时ASD发生率为46.5%,无症状性ASD发生。 结论：Bryan颈人工椎间盘置换术治疗颈椎退变性疾病可以取得持久稳定的临床效果,尽管异位骨化发生率较高,但大部分保留手术节段活动,同时邻近节段仍可见退变,但均无临床症状。     

Long-term follow-up results of anterior discectomy and interbody fusion for lumbar disc herniation]

The long-term postoperative clinical courses were evaluated in 40 patients who underwent trans-peritoneal anterior discectomy and interbody fusion at our institution from 1955 through 1959. Thirty-four out of forty patients were followed up by physical and radiological examinations, and six by telephone interview. All subjects have been evaluated at least every 10 years after surgery. The results were as follows: 1) Thirty-four of forty (85%) patients were rated as satisfactory after a minimum 30-year follow-up. 2) Deterioration of the clinical course was probably attributable to age-related physical weakness. 3) The clinical results in the one-level fusion group were better than those in the two-level fusion group. 4) In the L4/5 fusion group, the adjacent disc degeneration was noted especially at the L3/4 level. Narrowing of the L3/4 disc was observed around 15 years after surgery irrespective of the patient ages at the time of follow-up examination. 5) In the L4/5 fusion group, the clinically significant X-ray findings included disc space narrowing, posterior olisthy, and horizontal displacement at the adjacent cranial level.     

Clinical adjacent-segment pathology after anterior cervical discectomy and fusion: results after a minimum of 10-year follow-up

Background context

Anterior cervical discectomy and fusion using cervical plates has been seen as effective at relieving cervical radiculopathy and myelopathy symptoms. Although it is commonly used, subsequent disc degeneration at levels adjacent to the fusion remains an important problem. However, data on the frequency, impact, and predisposing factors for this pathology are still rare.

Purpose

To evaluate the incidence, predisposing factors, and impact of radiographic and clinical adjacent-segment pathologies after anterior cervical discectomy and fusion using cervical plates and to analyze the efficacy of this surgical method over the long term, after a minimum follow-up period of 10 years.

Study design

Retrospective clinical study.

Patient sample

Our study was a retrospective analysis of 177 patients who underwent anterior cervical discectomy and fusion using cervical plates, with follow-up periods of at least 10 years (mean 16.2 years).

Outcome measures

Radiographic adjacent-segment pathology using plain radiographs and clinical adjacent-segment pathology after anterior cervical discectomy and fusion using cervical plates.

Methods

We defined a new grading system of plain radiographic evidence of degenerative changes in adjacent discs after anterior cervical discectomy and fusion using cervical plates; Grade 0 is considered normal, and Grade V consists the presence of posterior osteophytes and a decrease in disc height to less than 50% of normal. The incidence, predisposing factors, and impact of radiographic and clinical adjacent-segment pathologies were analyzed according to etiologies, number of fused segments, and plate-to-disc distance.

Results

Radiographic and clinical adjacent-segment pathologies were found in 92.1% and 19.2%, respectively, of patients. By etiology, clinical adjacent-segment pathology was observed in 13.5% of patients who had sustained trauma, 12.7% of those with disc herniation, and 33.3% of those with spondylosis. By number of fused segments, clinical adjacent-segment pathology was found in 13.2% of patients who underwent single-level fusion and in 32.1% of those who underwent multilevel fusion surgeries. Patients with a plate-to-disc distance of less than 5 mm, who had spondylosis, or who underwent multilevel fusion had a higher incidence of clinical adjacent-segment pathology after anterior cervical discectomy and fusion using cervical plates than other groups did (p<.05). Of all patients, only 6.8% needed follow-up surgery.

Conclusions

We found that over the long term, at a minimum follow-up point of 10 years, a plate-to-disc distance of less than 5 mm, having spondylosis, and undergoing multilevel fusion were predisposing factors for the occurrence of clinical adjacent-segment pathology. Nevertheless, the incidence of clinical findings of adjacent-segment pathology was much lower than the incidence of radiographic findings. Also, the rate of follow-up surgery was low. Therefore, anterior cervical discectomy and fusion using cervical plates can be considered a safe and effective procedure.     

Mid- to long-term outcomes after cervical disc arthroplasty compared with anterior discectomy and fusion: a systematic review and meta-analysis of randomized controlled trials

Purpose

To evaluate the mid- to long-term clinical outcomes after cervical disc arthroplasty (CDA) as compared with anterior cervical discectomy and fusion (ACDF) for the treatment of symptomatic cervical disc disease.

Methods

A systematic review and a meta-analysis were performed for articles published up to March 2013. Randomized controlled trials that reported mid- to long-term outcomes (≥48 months) after CDA as compared with ACDF were included. Two authors independently extracted the articles and the predefined data.

Results

Five US Food and Drug Administration randomized controlled trials that reported 4–6 years of follow-up data were retrieved. Patients who underwent CDA had a lower mid- to long-term rate of reoperation and had greater mid- to long-term improvements in the Neck Disability Index, neck and arm pain scores, and Short Form 36 Health Survey physical component score than did those who underwent ACDF. Segmental motion was maintained in patients who underwent CDA. The mid- to long-term rates of adjacent segment disease and neurological success were not significantly different between the two groups.

Conclusions

CDA may result in better mid- to long-term functional recovery and a lower rate of subsequent surgical procedures than ACDF would. A review of the literature showed that only an insufficient number of studies had investigated adjacent segment disease; therefore, it is mandatory that adequate future research should focus in this direction.