颈椎单开门OsteoMed M3钉板内固定椎管扩大成形术生物力学及临床研究
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摘要
背景
随着社会的发展、人口老化、尤其是人们工作和生活方式的改变,颈椎病的发病率逐步增高,己成为临床常见病和多发病之一,对社会、家庭和患者造成很大的危害。医学的发展对颈椎疾患也有了较深刻的认识,治疗的方法也在不断的改进。虽然治疗方法存在争议,但大多数有症状体征及影像学支持的脊髓型颈椎病需要手术治疗。
颈椎手术根据入路分为前路、后路和前后路联合手术,前路手术直接摘除压迫脊髓和神经根的异常组织、植骨融合稳定颈椎。不利的因素包括需植骨、植骨块脱位不融合和邻近节段退变致症状复发等问题,尤其对3个或3个以上节段颈椎病变,每增加一个融合节段邻近节段退变等风险就增加更多。
后路手术的目的是扩大椎管,解除对脊髓的压迫。后路减压手术方法近来越来越受关注,包括后路椎板切除、椎板切除加内固定融合、椎板开门椎管扩大成形术。以前椎板切除术是最常使用的治疗后路多节段颈椎疾患的手术方法,但术后存在颈椎后凸畸形、医源性颈椎不稳,加重脊髓神经症状,术后疤痕增生致椎管再狭窄,轻微的创伤即可导致颈脊髓神经损伤。
为克服上述缺点,在行椎板切除术时加侧块钢板内固定稳定颈椎,可防止椎板切除术后后凸畸形。但存在内固定失败致颈椎生理曲度丢失、神经根病变、螺钉位置不正、需再次手术、邻近节段退变加重致颈椎不稳,这些均限制了其在临床的进一步应用。Pal和Cooper研究提示颈椎前方的椎体传导约36%的压力,而后柱传导64%的压力,后柱对传递脊柱的压力比前柱更为重要。这些激发了后路多种手术方法的发展,通过完整保留后方大部分结构保持术后稳定性,重新设计配置椎板和开放椎管。
“单开门”椎管扩大成形术越来越受重视,适用于多节段颈椎病、后纵韧带骨化、先天性颈椎管狭窄或以上情况同时存在需后方脊髓减压的患者。“单开门”椎管扩大成形术较椎板切除不融合或融合术有较多优点：保留了颈椎后方棘突和椎板结构、比椎板切除术降低了术后后凸畸形的发生；保存了颈椎的活动度,较椎板切除融合手术后邻近节段退变的发生率低；解除了脊髓背侧压迫因素、使脊髓后移,从而使脊髓前方间接减压,改善了脊髓的血液循环；取得脊髓减压的同时保存了颈椎的稳定性；硬膜外瘢痕轻且无加重脊髓损伤的危险。颈椎单开门手术较颈椎其他开门方式简单、安全,手术后的理想结果是脊髓足够的减压和开门侧的稳定。
一当椎板被打开、脊髓压迫被解除,防止椎管再狭窄成为研究的热点。临床上常用的办法是将棘突根部缝线固定于门轴侧的椎旁肌或小关节囊上打结固定维持开门,但手术可能医源性损伤沿关节囊背外侧走行的颈神经后支的中间分支,引起颈部疼痛不适,且易出现再关门。
为克服上述缺点,有作者设计了在侧块打入螺钉将棘突根部缝线固定于螺钉上的锚定法,但仍存在不稳、术后再关门现象。
为克服上述缺点,有许多的方法被设计保持开门后状态,包括自体骨块、同种异体骨、羟基磷灰石塑形后植入椎板的开门侧和小钢板固定。自体骨是最理想的融合物,有着优越的骨传导和骨诱导性能,然而术后供骨区出血、疼痛和感觉障碍等并发症,需另外一处切口取骨均限制了其在临床上的广泛应用。同种异体骨能够提供开门侧的支撑,但同种异体骨具有一定的抗原性,来源有限,且有传播疾病的危险。羟基磷灰石(Hydroxyapatite,简称HA)能够提供开门侧的支撑,但羟基磷灰石比较脆使用可靠性差、且不易骨愈合。无论是自体骨、异体骨还是HA均需要塑形成合适的自锁固定形状,置于开门侧有可能脱位,如脱入椎管内压迫脊髓将导致严重的后果,且骨替代物价格昂贵,这些均限制其在临床上的进一步使用。
为克服上述缺点,单开门椎管成形术中使用钛板内固定,此种方法可减少以前的开门后椎管再狭窄,可允许病人进行康复功能锻炼计划,减少以前的手术方式术后出现的颈部轴性痛症状的发生以及颈部活动度丢失情况。Rhee等研究表明仅仅用钢板固定可有效的保持椎管的扩大,未出现其他手术方法如丝线结扎等术后出现的再关门椎管狭窄现象。但目前使用的钢板内固定材料费用昂贵。那么理想的手术方法应该是技术简单、提供安全的椎板固定防止再关门、最大限度的减少医源性损伤及手术时间、术后能防止椎管的再狭窄、减少术后轴性症状及神经瘫痪等并发症的发生、且费用适中。
颅颌面手足重建固定系统/OsteoMed M3(美国OsteoMed公司)系统包括钛板和螺钉,已广泛应用于颅颌面、手和足的骨折、关节固定和重建术。其钛板为网孔状,面积为4cmX5cm、厚度0.5mm大小；自钻螺丝钉一开始就能进入骨中,螺钉直径2.Omm、长度5.Omm。OsteoMed M3钉板系统的螺钉长度适中,既降低了螺钉过长损伤脊髓神经及椎动脉的风险,又避免了螺钉过短影响固定的效果；钛板较大呈网状,一块可修剪成多条小钢板使用可明显降低耗材费用,在颈椎后路行C3至C7每个部位固定整套价格在3000元左右,仅相当于一块手指钛板的费用,比较适合我国的国情,具有广阔的应用前景。
研究在颈椎单开门椎管扩大成形术中使用OsteoMed M3钉板内固定。对其进行生物力学及临床应用评价,包括5mm长的螺钉拧入时进钉点距离椎管、椎动脉孔及神经根通道之间的距离；六个模型组的三维运动稳定性试验、在新鲜颈椎标本上行包括OsteoMed M3钉板内固定二个模型组的疲劳试验、螺钉不同角度固定的拔出力的大小以及回顾性分析在临床上在颈椎单开门椎管扩大成形术中使用OsteoMed M3钉板内固定后的治疗效果。为其在临床上广泛应用及颈后路手术优化选择提供理论依据。
目的
1、研究在颈后路单开门中使用OsteoMed M3钉板内固定系统中的螺钉拧入时进钉点距离椎管、椎动脉孔及神经根通道之间的距离,评价5mm长的螺钉拧入后损伤脊髓神经及血管的风险。
2、通过脊柱三维运动稳定性实验评价在颈椎单开门术中在开门侧应用OsteoMed M3钉板内固定重建颈椎稳定性的效果。
3、通过疲劳实验评价在颈椎单开门椎管扩大成形术中使用OsteoMed M3钉板内固定重建颈椎稳定性的效果。
4、通过拔出力学实验研究在颈椎单开门OsteoMed M3钉板内固定椎管扩大成形术中螺钉不同角度固定的拔出力的大小。
5、回顾性分析在临床上行颈椎单开门椎管扩大成形术中使用OsteoMed M3钉板内固定,评价其在颈椎疾患手术中应用后的治疗效果。
方法
1、颈椎测量：自粤北人民医院影像诊断科CT室工作站随机调出颈椎CT检查的病人资料,选取既往无颈椎受伤等病史,检查结果考虑无明显颈椎疾患的病人资料100份,其中男50份,平均年龄为51.32岁,年龄在20-86岁；女50份,平均年龄为43.54岁,年龄在17～74岁。通过HIS及PACS系统打开CT图像,利用PACS系统中辅助测量的功能进行测量指标的测量并记录,测量指标：①颈3-7椎板外侧缘与侧块内侧缘交界处至椎管内的垂直最短距离；②颈3-6侧块内侧缘至侧块中点之间距离横突孔的最短距离；③颈3-7侧块内侧缘至侧块中点之间距离神经根通道的最短距离。
2、在6具新鲜人尸体颈椎标本上,截取其颈1至胸1(C1～T1),作为自身对照性实验,先后依次进行正常的完整颈椎、后路单开门丝线结扎组、后路单开门侧块螺钉丝线结扎组、后路单开门OsteoMed M3钉板内固定组、后路椎板切除组、后路椎板切除加侧块钉棒内固定组的三维运动活动度检测。在脊柱三维运动试验机上对各组标本行屈伸、左右侧弯和左右旋转6个运动方向的稳定性测试,施加的力偶矩为2.0N.m。多节段的运动测量使用Motion Analysis运动捕捉分析系统,该系统包括在颈椎标本周围共放置6台红外线摄像机,颈椎每个椎体上固定有4个不共线排列的球形红外线接收标记物,由红外线摄像机对标记物的运动进行实时运动测量,测试屈伸、左右侧弯、左右旋转6个方向的运动角位移参数,包括运动范围(range of motion, ROM)、中性区(neutral zone, NZ)和弹性区(elastic zone, EZ)。并由计算机直接得出每个标记物运动坐标,利用EVaRT软件计算每个标本节段的角位移,将各椎体的角位移相加得出颈椎的运动范围。对正常的完整颈椎、后路单开门丝线结扎组、后路单开门侧块螺钉丝线结扎组、后路单开门OsteoMed M3钉板内固定组、后路椎板切除组、后路椎板切除加侧块钉棒内固定组的颈椎运动范围进行分析和讨论。
3、在6具颈椎标本上,分别行后路单开门丝线结扎及OsteoMed M3钉板内固定,在脊柱三维运动试验机上行颈椎前屈后伸疲劳运动试验,观察有无丝线断裂或钛板螺钉脱出、断裂现象,如有则停止试验并记录发生时的周期。
4、利用成人新鲜的颈椎标本6具,6具颈椎标本随机编号,选择颈3、颈4及颈5节段共18个节段按顺序编号,分别行后路单开门OsteoMed M3钉板内固定,在关节突关节侧按螺钉固定角度垂直于侧块皮质0。、外倾30°及外倾45。位3组顺序分别在编号的颈椎节段行螺钉固定,使用ElectroForce测试仪测试螺钉的最大拔出力,以2mm/min的速度轴向拔出,记录全过程的拔出曲线至螺钉被拔出,曲线的最高峰即为最大拔出力。
5、选择多节段椎间盘突出并椎管狭窄等颈椎疾患25例,行颈椎单开门OsteoMed M3钉板内固定椎管扩大成形手术治疗,术后随访半年以上,平均随访时间9月(7月～3年)。其中男性18例,女性7例；年龄46-75岁,平均61.4岁；病史7月～8年,平均3年1月。手术方式如下：患者俯卧位,颈椎保持在适度前屈。标准颈后正中切口至棘突,常规切断附着于棘突上的肌肉并沿椎板两侧骨膜下剥离至两侧侧块的中点,应注意避免损伤关节囊,颈6或颈7的棘突过长部分应用咬骨钳切除至颈5棘突同样高,可防止在开门时挤压肌肉不利于开门。拟开的骨槽位于椎板外侧缘与侧块内侧缘交界处,用4到5mm的高速磨钻纵形开槽至内板,对拟手术的狭窄节段由头侧向尾侧逐个磨除外板；侧作为开门侧,另一侧作为门轴侧,选择症状较重一侧作为开门侧,可给予行神经根减压。利用2-3mmm薄的枪状咬骨钳咬除拟开门侧的椎板内板及黄韧带；另一侧作为门轴侧,需完全切除背侧皮质和磨薄内层皮质以利于在开门时能形成门轴侧的青枝骨折,需保证内层皮质骨完整,所开的骨槽要偏大以防开门时挤压,如门轴侧内侧皮质出现断裂则给予改椎板切除术。所有的病例在开门侧抬起的椎板与侧块内侧缘至侧块中点之间选用由OsteoMed M3钉板剪成的合适长度多条小钢板并塑形后予以螺钉内固定,保持开门后的状态,术后4周即让患者进行颈椎活动功能锻炼。应用日本整形协会(Japaneses Orthopaedoc Association) JOA评分法对术前及术后的脊髓功能改善情况进行对比及评价。对影响术后疗效的相关因素进行分析。
结果
1、男女颈3-6侧块内侧缘至侧块中点之间距离横突孔最短距离的95%正常参考值下限及颈3-7侧块内侧缘至侧块中点之间距离神经根通道最短距离的95%正常参考值下限均大于我们在颈椎单开门术中所使用的OsteoMed M3钉板内固定系统中的螺钉长度5mm；而男女颈3-7椎板外侧缘与侧块内侧缘交界处至椎管内垂直最短距离的95%正常参考值下限部分小于我们在颈椎单开门术中所使用的OsteoMed M3钉板内固定系统中的螺钉长度5mm,尤其对女性。
2、在单开门手术后,开门侧行侧块钉棒内固定组在各个运动状态下的运动范围均明显减少,稳定性增加,运动范围的差异有统计学意义(P<0.05)。在单开门手术后,正常组在后伸、前屈及左侧弯状态下的运动范围均与丝线组、丝线螺钉组、椎板切除及侧块钉棒固定组之间的差异有统计学意义(P<0.05),而与钢板固定组的差异无统计学意义,说明钢板内固定组的稳定性与正常组接近,稳定性好；在右侧弯及右旋状态下正常组的运动范围与椎板切除及侧块钉棒固定组之间的差异有统计学意义(P<0.05),而与丝线组、丝线螺钉组及钢板固定组的差异无统计学意义；在左旋状态下正常组的运动范围与其他各组之间的差异有统计学意义(P<0.05)。
行后路钢板内固定组,在后伸和右侧弯状态下运动范围与椎板切除组及侧块钉棒组之间的差异有统计学意义(P<0.05)；在前屈状态下运动范围与丝线组、椎板切除组及侧块钉棒组之间的差异有统计学意义(P<0.05)；在左侧弯状态下运动范围与丝线组、丝线螺钉组、椎板切除组及侧块钉棒组之间的差异有统计学意义(P<0.05)；在左旋状态下运动范围与其他各组之间的差异有统计学意义(P<0.05)；在右旋状态下运动范围与丝线螺钉组、椎板切除组及侧块钉棒组之间的差异有统计学意义(P<0.05)。
3、丝线结扎组的试验显示所有标本均出现部分缝合的关节囊韧带撕裂、门轴侧易活动,甚至有2次实验时分别在疲劳运动第73次和第1806次时出现关节囊撕裂、丝线脱落及再关门；而在OsteoMed M3钉板内固定组不损伤关节囊,试验显示未出现钢板螺钉松动、断裂,未出现再关门现象。
4、在拔出试验中,外倾0°组最大拔出阻力平均为(81.60±7.33)N,外倾30°和外倾45°组的最大拔出阻力分别平均为(150.05±15.57)N和(160.08±17.77)N。外倾0°的拔出力小于外倾30°及外倾45°位组,差异有统计学意义(P<0.05),而外倾30°及外倾45°位组之间相近,差异无统计学意义(P>0.05)。
5、25例患者全部得到随访,术后随访半年以上,术前JOA评分：9.40±1.658(5～13),术后JOA评分：13.80±1.958(7-16),差异有统计学意义(t=-21.137,P=0.000),大部分病人症状明显改善,术后改善率57.9%。术后X光片、MRI及CT检查提示椎管的矢状径和椎管均明显扩大,3例症状改善不明显的患者,2例二期实施前路减压固定融合术后症状缓解,1例后纵韧带骨化症患者恢复欠佳；1例病人术后症状改善,在后期的随访过程中因其他疾病死亡；无1例出现继发性椎管狭窄引起神经功能变坏或手术相关的并发症。
结论
1、根据CT影像学资料测量的结果显示在颈后路行单开门OsteoMed M3钉板内固定时螺钉固定在侧块内侧缘至侧块中点之间是安全的,螺钉的进钉稍偏向外上方不会损伤血管神经及脊髓。
2、在颈椎单开门术中在开门侧应用OsteoMed M3钉板内固定生物力学稳定性好,可重建颈椎稳定性。
3、在颈椎单开门椎管扩大成形术中应用OsteoMed M3钉板内固定具有良好的生物力学性能,能重建颈椎稳定性,可满足颈椎后路手术的要求。
4、颈椎单开门OsteoMed M3钉板内固定椎管扩大成形术中螺钉外倾30°以上角度固定抗拔出能力高。
5、在颈椎单开门椎管扩大成形术中应用OsteoMed M3钉板内固定具有避免开门后再关闭,保持椎管扩大效果,同时对脊柱活动度影响小的优点,且操作简单,并发症少,适合临床运用。
Background
Cervical spondylosis has become one of the common and frequently occurring illness in clinic and brought great hazardous to suffers, their families and society along with the development of society, population aging, and alteration of people's work and life styles especially. Technique of treatment is also in constant improvement following the development of medical science in a profound understanding of cervical disease. Although conflicting evidence exists, the majority of available evidence suggests that CSM is largely a surgical disease in the presence of symptoms and signs, appropriate radiographic evidence.
Surgical techniques can be broadly divided into anterior surgery, posterior surgery, or combined anterior and posterior surgical techniques. Anterior decompression and fusion (ADF) allows direct removal of the compressive abnormality that compresses the spinal cord and nerve root from the front, with stabilization obtained by anterior arthrodesis. However, The disadvantages include the need for graft healing, related to bone grafting, such as dislodgement, fracture, and nonunion of the grafted bone and recurrence of myelopathy due to adjacent segment degeneration. Particularly, when three or more segments are involved, accelerated complication rates associated with anterior surgery, adjacent segment degeneration seen more obvious.
The purpose of posterior surgical approaches is to expand spinal canal and to gain the decompression of the spine cord. Cervical laminoplasty has recently received increased attention for the treatment of cervical spondylotic myelopathy. Posterior based operations-such as laminectomy, laminectomy and fusion, and laminoplasty. Prior to the advent of anterior cervical spine surgery, laminectomy was the most common approach to decompression for multilevel myelopathy. However, there were significant problems associated with postlaminectomy kyphosis secondary to iatrogenic destabilization of the cervical spine, and lead to delayed neurological deterioration. Restenosis of spinal canal due to scar tissue formation, and will lead to spinal cord injury due to mild trauma.
To address problems related to laminectomy, another alternative technique is laminectomy and fusion, which allows posterior canal expansion and maintains stability. This modification theoretically avoids problems associated with laminectomy alone, and it may allow reduction of kyphosis to lordosis. However, complications related to fixation include hardware failure with loss of alignment, radiculopathy, screw malposition, and the need for a repeated operation, and related to cervical instability due to accelerated adjacent segment degeneration. Laminectomy and fusion was limited further application in the clinical as these complications. Pal and Cooper found that 36% of the total load applied on the top of the specimen is transmitted through the anterior column formed by bodies and intervertebral discs, and 64% in posterior cervical columns formed by the facet joints and articular processes. The posterior columns plays a more important role in load transmission than anterior column. These prompted the development of a variety of methods to decompress the spine posteriorly, yet maintain postoperative stability by retaining the bulk of the posterior elements, redesigning configuration lamina and canalis vertebralis.
Cervical laminoplasty has recently received increased attention for the treatment of cervical spondylotic myelopathy. Cervical laminoplasty has been used for the posterior decompression of the cervical spinal cord caused by cervical spondylosis, ossification of the posterior longitudinal ligament (OPLL), congenital spinal stenosis, or a combination of the above. Laminoplasty offers several advantages over traditional laminectomy and laminectomy with instrumented fusion. By preserving the posterior elements (lamina, spinous processes), it has been suggested that laminoplasty may decrease the incidence of postlaminectomy kyphotic deformity compared with laminectomy alone. Compared with laminectomy with instrumented fusion, laminoplasty may have a decreased incidence of adjacent level spondylosis by preserving cervical range of motion. Posterior-based procedures for spinal cord indirect decompression and its associated microcirculation rely on the ability of the cord to drift away from the anterior lesions as a result of releasing the posterior tethers (laminae, ligamentum flavum). Expansive laminoplasty was developed to achieve posterior spinal cord decompression while preserving cervical spine stability. There is small epidural scar and no aggravating spinal cord injury due to mild trauma. Among various methods of laminoplasty, unilateral open-door laminoplasty has been considered easier and safer than other methods. A desired outcome after open door cervical laminoplasty is the reconstruction of a stable laminar arch with sufficient room for the decompressed spinal cord.
Once the laminae have been opened and the spinal cord has been decompressed, preventing restenosis is a primary concern. It is the most traditional way of maintaining door patency by sutures, and the lamina door is tethered open by sutures between the spinous process and facet capsule or paravertebral muscle fascia on the hinge side. However, there has the possibility of iatrogenic injury to the medial branches ramified from the dorsal ramus of the cervical nerves along the dorsolateral part of the facet joints during the cervical posterior approach, and it will cause neck pain, and hinge closure is easy to exist.
To address problems related to sutures, another modified technique is unilateral open-door laminoplasty with suture anchor fixation, and tying and fixation of the sutures onto the holed lateral mass screws was used instead of the conventional method. However, cervical instability and hinge closure is still existence.
To address problems related to way of maintaining door patency, various methods have been employed to maintain hinge patency and provide secure fixation, including autogenous or allogenic bone grafting, hydroxyapatite spacer and the miniplate osteosynthesis. Autografts are certainly the ideal spacer, offering considerable osteogenic and osteoconductive potential. However, donor site morbidity such as bleeding, ache, and sensation obstacle, and a second operation to harvest the graft are major disadvantages of autografts, and these were prohibited extensive application in the clinical. Allografts can provide structural support. However, the source is narrow and potential risk of viral transmission cannot be eliminated. Hydroxyapatite can provide structural support. However, it is poor reliability and difficult to use due to brittle, and it is not easy to acquire bone healing. Either autografts, allografts or Hydroxyapatite are needed to fashion into a self-locking configuration, relying on precise carpentry, the recoil of the hinges, and the force of the overlying musculature to secure the interlocking bone edges. Otherwise, additional instruments should be employed to avoid the risks of graft dislodgement. The expensive cost of commercial bone substitutes prohibits their use in developing countries.
To address problems related to way of maintaining door patency, use of the titanium miniplate can help to minimize the problems with loss of canal expansion previously seen while facilitating the procedure. Use of the plate may also allow the patient to engage in rehabilitation protocol and possibly decrease the incidence of postoperative axial neck symptoms and loss of motion previously associated with laminoplasty. Rhee demonstrate that plate-only laminoplasty was effective in maintaining canal expansion without the need for supplemental bone graft struts, and it was not associated with the restenosis owing to hinge closure or dislodgements reported using alternative forms of fixation such as sutures. However, the cost of plate curently used is expensive. Ideally, a method of achieving laminar fixation should be technically straightforward, provide secure laminar fixation, and be rapid to minimize the risk of iatrogenic injuries, blood loss, and operative time, and be safe to minimize the risk of restenosis of the canal, and decrease axial neck pain following laminoplasty, and nervous paralysis, moreover cost is moderate.
OsteoMed M3 plate and screws has been widely used in neurosurgery, maxillofacial, hand, and foot fractures, joint fixed and reconstruction surgery. The titanium plate is mesh shape, and the area is 4cmX5cm, and the thickness is 0.5 mm size. Self drilling screw, with diameter 2.0 mm and length 5.0 mm, can be easily twisted into bone. The length of screw is moderate, which decrease the risk of damaging spinal cord, nerve and vertebral artery due to too long screws, and avoid the risk of influence of fixed effect due to too short screws. OsteoMed M3 plates of sufficient size can be clipped into multiple small steel use, and can obviously reduce consumable expenses. In cervical posterior line plates were placed at all levels from C3 to C7 to allow adequate enlargement of the spinal canal, and the price is only 3,000 yuan which is equal to the cost of a piece of hand titanium plate, and which is more suitable for developing national condition, and has wide application prospects.
To study the method for that OsteoMed M3 titanium plate and screws were used to secure the posterior elements in the open position after expansive unilateral open-door laminoplasty. The biomechanical clinical evaluation index:to measure the shortest distance between the entry point of 5mm screws and spinal canal, transverse foramen, and nerve root port, and to compare three-dimensional motional stability of 6 groups including OsteoMed M3 titanium plate and screws group, and to compare the fatigue experiment on expansive unilateral open-door laminoplasty of the cervical spine with OsteoMed M3 plate and screws, and to evaluate the pullout strength of different screw orientation, and to retrospectively review the surgical results of OsteoMed M3 titanium plate and screws were used to secure the posterior elements in the open position after expansive unilateral open-door laminoplasty. The object is to provide the theoretic basis for the widely clinical application and optimal selection of cervical posterior surgery.
Objective
1、To measure the shortest distance between the entry point of screws and spinal canal, transverse foramen, and nerve root port when OsteoMed M3 titanium plate and screws were used to secure the posterior elements in the open position after expansive unilateral open-door laminoplasty, and to evaluate the risk of damaging spinal cord, nerve and vertebral artery due to screws of 5mm length.
2、To compare three-dimensional motional stability of different groups including OsteoMed M3 titanium plate and screws group, and to evaluate the method for that OsteoMed M3 titanium plate and screws were used to secure the posterior elements in the open position after expansive unilateral open-door laminoplasty and its immediate effects and initial stability of cervical vertebrae.
3、To evaluate the method for that OsteoMed M3 titanium plate and screws were used to secure the posterior elements in the open position after expansive unilateral open-door laminoplasty and its immediate effects and initial stability of cervical vertebrae.
4、To evaluate the method for that OsteoMed M3 titanium plate and screws were used to secure the posterior elements in the open position after expansive unilateral open-door laminoplasty and to evaluate the pullout strength of different screw orientation.
5、We retrospectively described the technique and reviewed the surgical results of OsteoMed M3 titanium plate and screws were used to secure the posterior elements in the open position after expansive unilateral open-door laminoplasty.
Method
1、The CT scans of 100 patients without traumatic and cervical spine disease were random extracted and measured according to the imaging data by CT examination from The department of diagnostic radiology of Yuebei People's Hospital. There were 50 males with mean age 51.32 years (aged 20～86 years), and 50 females with mean age 43.54 years (aged 17～74 years). The anatomic data of cervical vertebrae in each group were measured and recorded using computerized image analysis software of HIS and PACS system.
Measure indexes on CT were as follows:①The vertical shortest distance between junction of the lamina lateral margins of C3-C7 with the lateral mass medial margins of C3-C7 and spinal canal.②The shortest distance between junction of the lamina lateral margins of C3-C6 with the lateral mass medial margins of C3-C6 and transverse foramen.③The shortest distance between junction of the lamina lateral margins of C3-C7 with the lateral mass medial margins of C3-C7 and nerve root port.
2、To select fresh cervical spine specimens(C1～T1)from 6 adult cadavers, and the specimens were dividede into intact cervical specimens group, sutures group, suture anchor fixation group, plate group, laminectomy group, and laminectomy and fusion group. The range of motion of different groups were measured by a three dimensional spinal stability test. The movement was applied with±2.0N.m loads in flexion/extension, left/right lateral bending, and left/right axial rotation on the three-dimension motion stability test. Multi-level motion was measured by using Motion Analysis motion capture system. The motion measure system included six infrared camera placed around cervical specimen and used specialized acceptable infrared, sphericity markers. Four markers were rigidly attached to each vertebral level(C3-C6) in noncolinear position and oriented to permit detection by infrared camera. Each marker motion coordinate was calculated by computer and angular displacement parameters were calculated, including the range of motion(ROM), neutral zone(NZ), and elastic zone(EZ), in flexion and extension, right/left lateral bending, and left/right rotation. ROM of treated cervical vertebrae were recorded and analyzed to evaluat effects of intact cervical specimens group, sutures group, suture anchor fixation group, plate group, laminectomy group, and laminectomy and fusion group.
3、OsteoMed M3 plate and screws and silk ligation were used for an expansive unilateral open-door laminoplasty in six fresh human cervical spine specimens respectively, and fatigue experiment were executed in positions of flexion and extension on three-dimension motional stability test. The cessation of testing would be when the incidence of thread rupture and of loosening of thread, plate and screws were recorded.
4、To select cervical spine fresh specimens(C1～T1)from 6 adult cadavers, and six fresh human cervical spine specimens were random numbered, and select C3,C4 and C5 total 18 segments sequence number. OsteoMed M3 plate and screws were used for an expansive unilateral open-door laminoplasty in these specimens respectively. The screws were inserted in lateral mass on the sequence and grouping at different extraversion angles:extraversion angle 0°group, extraversion angle 30°group and extraversion angle 45°group. The maxinum pullout strength was tested on the ElectroForce material testing machine. Axis pullout speed was 2mm/min, and whole pullout process of the screw was recorded, and the number of curve peaks was the maxinum pullout strength.
5、25 patients with multilevel cervical disc herniation and canal stenosis were treated with an expansive unilateral open-door laminoplasty with OsteoMed M3 plate and screws. The follow-up period was over 6 months, and average follow-up period was 9 months (7 months～3 year). There were 18 male cases and 7 female cases. The age varied from 46 years old to 75 years old, and the average age was 61.4years old. The description for expansive unilateral open-door laminoplasty of the cervical spine with OsteoMed M3 plate and screws is as follows. The patient is placed in the prone position, and cervical spine is maintained in appropriate lordosis. A standard posterior midline incision is made down to the spinous processes. The paraspinal muscles are dissected laterally out to the lamina and the medial aspect of the lateral masses in the standard fashion. Care is taken during lateral exposure, not to disrupt the facet capsules. C6 and C7 spinous processes are shortened using a rongeur to the same height as C5. This prevents C6 and C7 spinous processes from impinging on the adjacent muscles when the laminae are hinged open. After identification of the interval between the lamina and the lateral mass, a bony trough is created with the high-speed 4- to 5mm burr, decorticating the posterior aspect of the lamina. The depth of the trough stops just superficial to the anterior cortex of the lamina. This is extended cephalad to caudad direction from one level above to one level below the involved stenotic levels. One trough corresponds to the hinge side of the door and the opposite side the aperture side of the door. The side with the most apparent clinical radiculopathy is often chosen as the open side, allowing foraminal decompression if required. On the aperture side, a 2- to 3-mm Kerrison rongeur is then used to remove the thinned anterior aspect of the lamina and interconnecting ligamentum. By completely removing the dorsal cortex and thinning the ventral cortex until a greenstick deformation of the hinge could be produced. The anterior aspect of the lamina on the hinge side is not removed and must remain intact. Additionally, the width of the trough should be slightly larger on the hinge side to prevent the walls of the trough from abutting. If the hinge fracture occurs at multiple levels, the laminoplasty should become a laminectomy by default. In each case, OsteoMed M3 plates of sufficient size to allow for adequate enlargement of the spinal canal were chosen, and plates were placed at all levels.5 mm mini-screws were placed into the lateral mass and the cut edge of the lamina through the plate in all cases. We encouraged the patients to do early active cervical exercises after 4 weeks surgery. The evaluate the improvement of spinal function after surgeries under JOA of Japaneses Orthopaedoc Association to analyse the effects and releated facters.
Result
1、The 95% normal lower limit of the shortest distance between junction of the lamina lateral margins of C3-C6 with the lateral mass medial margins of C3-C6 and transverse foramen were all greater than the length of 5mm screw, and the 95% normal lower limit of shortest distance between junction of the lamina lateral margins of C3-C7 with the lateral mass medial margins of C3-C7 and nerve root port were all greater than the length of 5mm screw. The 95% normal lower limit of vertical shortest distance between junction of the lamina lateral margins of C3-C7 with the lateral mass medial margins of C3-C7 and spinal canal were part less than the length of 5mm screw, especially in female patients.
2、After expansive unilateral open-door laminoplasty, laminectomy and fusion group exhibited an decrease in angular motion in all directions and a significant increase in stability in all directions(P<0.05). Intact cervical specimens group was significantly different from sutures group, suture anchor fixation group, laminectomy group and laminectomy and fusion group in ROM of flexion/extension and left lateral bending(P<0.05), but intact cervical specimens group was not significantly different from the plate group. Intact cervical specimens group was significantly different from laminectomy group and laminectomy and fusion group in ROM of right lateral bending and right axial rotation(P<0.05), but intact cervical specimens group was not significantly different from sutures group, suture anchor fixation group and the plate group. Intact cervical specimens group exhibited a more significant different than other groups in ROM of left axial rotation (P<0.05).
After expansive unilateral open-door laminoplasty, the plate group exhibited a more significantly different in angular motion than laminectomy and laminectomy and fusion group in ROM of extension and right lateral bending (P<0.05), and it was not significantly different from other groups. The plate group exhibited a more significantly different in angular motion than sutures group, laminectomy group and laminectomy and fusion group in ROM of flexion (P<0.05), and it was not significantly different from other groups. The plate group exhibited a more significantly different in angular motion than sutures group, suture anchor fixation group, laminectomy group and laminectomy and fusion group in ROM of left lateral bending (P<0.05). The plate group exhibited a more significant different than other groups in ROM of left axial rotation (P<0.05). The plate group exhibited a more significantly different in angular motion than suture anchor fixation group, laminectomy group and laminectomy and fusion group in ROM of right axial rotation.
3、Partial rupture of joint capsule and easy move of the hinge side were seen in all of the specimens in the silk ligation. It was observed that rupture of joint capsule and cast of silk thread and reclose of the opened laminate as clinical widely used device for suture of joint capsule when the experiment was executed to the 73rd time and the 1806th time. There was no trauma on joint capsule in the OsteoMed M3 plate and screws, and no plate and screw loosening and rupturing and no reclose of the opened laminate.
4、The maxinum pullout strength was (81.60±7.33)N for extraversion angle 0°group, (150.05±15.57)N for extraversion angle 30±group, (160.08±17.77)N for extraversion angle 45±group. The maxinum pullout strength of extraversion angle 0±group were less than extraversion angle 30±and 45±group(P<0.05). The pullout strength of extraversion angle 30±and 45±group were equal (P>0.05)
5、All of 25 cases'follow-up period were over 6 months. Most of the patients had marked neurologic improvement after surgery. The mean JOA score increased significantly from 9.40±1.658 (range,5 to 13) before surgery to 13.80±1.958 (range,7 to 16) at final follow-up(t=-21.137, P=0.000). Mean recovery rate was 57.9%. Postoperative radiography, magnetic resonance imaging and computed tomography scan demonstrated significantly increased sagittal diameter and canal expansion. Two cases without relief of nurological symptoms underwent an additional anterior multilevel corpectomy. One case with ossification of the posterior longitudinal ligament had not good enough neurologic improvement after surgery. One patient had marked neurologic improvement after surgery, however died of another disease. No neurologic deterioration owing to hinge reclosure or major surgery-related complications were observed.
Conclusion
1、The results demonstrated that it was safer that the entry point of screws lied in the site among the lateral mass lateral margins and the lateral mass medial margins, and the risk of neural injury, spinal cord injury and vertebral artery injury could not occur.
2、Expansive unilateral open-door laminoplasty with OsteoMed M3 plate and screws meets clinical and biomechanical requirements, and can remain the immediate effects and initial stability of cervical vertebrae.
3、Unilateral open-door laminoplasty using OsteoMed M3 titanium plate and screws fixation is good for posterior cervical surgery because of its biomechanical advantage of maintaining significant stabilization of the spine.
4、The pullout strength of the screws inserted extraversion angle over 30°provides stronger fixation than extraversion angle 0°in the unilateral open-door laminoplasty using OsteoMed M3 titanium plate and screws fixation.
5、Unilateral open-door laminoplasty with OsteoMed M3 titanium plate and screws fixation effectively maintains expansion of the spinal canal and resists closure while preserving alignment and stability. This modified technique is easy to perform with a low complication rate and is good for clinical application.
随着社会的发展、人口老化、尤其是人们工作和生活方式的改变,颈椎病的发病率逐步增高,己成为临床常见病和多发病之一,对社会、家庭和患者造成很大的危害。医学的发展对颈椎疾患也有了较深刻的认识,治疗的方法也在不断的改进。虽然治疗方法存在争议,但大多数有症状体征及影像学支持的脊髓型颈椎病需要手术治疗。
颈椎手术根据入路分为前路、后路和前后路联合手术,前路手术直接摘除压迫脊髓和神经根的异常组织、植骨融合稳定颈椎。不利的因素包括需植骨、植骨块脱位不融合和邻近节段退变致症状复发等问题,尤其对3个或3个以上节段颈椎病变,每增加一个融合节段邻近节段退变等风险就增加更多。
后路手术的目的是扩大椎管,解除对脊髓的压迫。后路减压手术方法近来越来越受关注,包括后路椎板切除、椎板切除加内固定融合、椎板开门椎管扩大成形术。以前椎板切除术是最常使用的治疗后路多节段颈椎疾患的手术方法,但术后存在颈椎后凸畸形、医源性颈椎不稳,加重脊髓神经症状,术后疤痕增生致椎管再狭窄,轻微的创伤即可导致颈脊髓神经损伤。
为克服上述缺点,在行椎板切除术时加侧块钢板内固定稳定颈椎,可防止椎板切除术后后凸畸形。但存在内固定失败致颈椎生理曲度丢失、神经根病变、螺钉位置不正、需再次手术、邻近节段退变加重致颈椎不稳,这些均限制了其在临床的进一步应用。Pal和Cooper研究提示颈椎前方的椎体传导约36%的压力,而后柱传导64%的压力,后柱对传递脊柱的压力比前柱更为重要。这些激发了后路多种手术方法的发展,通过完整保留后方大部分结构保持术后稳定性,重新设计配置椎板和开放椎管。
“单开门”椎管扩大成形术越来越受重视,适用于多节段颈椎病、后纵韧带骨化、先天性颈椎管狭窄或以上情况同时存在需后方脊髓减压的患者。“单开门”椎管扩大成形术较椎板切除不融合或融合术有较多优点：保留了颈椎后方棘突和椎板结构、比椎板切除术降低了术后后凸畸形的发生；保存了颈椎的活动度,较椎板切除融合手术后邻近节段退变的发生率低；解除了脊髓背侧压迫因素、使脊髓后移,从而使脊髓前方间接减压,改善了脊髓的血液循环；取得脊髓减压的同时保存了颈椎的稳定性；硬膜外瘢痕轻且无加重脊髓损伤的危险。颈椎单开门手术较颈椎其他开门方式简单、安全,手术后的理想结果是脊髓足够的减压和开门侧的稳定。
一当椎板被打开、脊髓压迫被解除,防止椎管再狭窄成为研究的热点。临床上常用的办法是将棘突根部缝线固定于门轴侧的椎旁肌或小关节囊上打结固定维持开门,但手术可能医源性损伤沿关节囊背外侧走行的颈神经后支的中间分支,引起颈部疼痛不适,且易出现再关门。
为克服上述缺点,有作者设计了在侧块打入螺钉将棘突根部缝线固定于螺钉上的锚定法,但仍存在不稳、术后再关门现象。
为克服上述缺点,有许多的方法被设计保持开门后状态,包括自体骨块、同种异体骨、羟基磷灰石塑形后植入椎板的开门侧和小钢板固定。自体骨是最理想的融合物,有着优越的骨传导和骨诱导性能,然而术后供骨区出血、疼痛和感觉障碍等并发症,需另外一处切口取骨均限制了其在临床上的广泛应用。同种异体骨能够提供开门侧的支撑,但同种异体骨具有一定的抗原性,来源有限,且有传播疾病的危险。羟基磷灰石(Hydroxyapatite,简称HA)能够提供开门侧的支撑,但羟基磷灰石比较脆使用可靠性差、且不易骨愈合。无论是自体骨、异体骨还是HA均需要塑形成合适的自锁固定形状,置于开门侧有可能脱位,如脱入椎管内压迫脊髓将导致严重的后果,且骨替代物价格昂贵,这些均限制其在临床上的进一步使用。
为克服上述缺点,单开门椎管成形术中使用钛板内固定,此种方法可减少以前的开门后椎管再狭窄,可允许病人进行康复功能锻炼计划,减少以前的手术方式术后出现的颈部轴性痛症状的发生以及颈部活动度丢失情况。Rhee等研究表明仅仅用钢板固定可有效的保持椎管的扩大,未出现其他手术方法如丝线结扎等术后出现的再关门椎管狭窄现象。但目前使用的钢板内固定材料费用昂贵。那么理想的手术方法应该是技术简单、提供安全的椎板固定防止再关门、最大限度的减少医源性损伤及手术时间、术后能防止椎管的再狭窄、减少术后轴性症状及神经瘫痪等并发症的发生、且费用适中。
颅颌面手足重建固定系统/OsteoMed M3(美国OsteoMed公司)系统包括钛板和螺钉,已广泛应用于颅颌面、手和足的骨折、关节固定和重建术。其钛板为网孔状,面积为4cmX5cm、厚度0.5mm大小；自钻螺丝钉一开始就能进入骨中,螺钉直径2.Omm、长度5.Omm。OsteoMed M3钉板系统的螺钉长度适中,既降低了螺钉过长损伤脊髓神经及椎动脉的风险,又避免了螺钉过短影响固定的效果；钛板较大呈网状,一块可修剪成多条小钢板使用可明显降低耗材费用,在颈椎后路行C3至C7每个部位固定整套价格在3000元左右,仅相当于一块手指钛板的费用,比较适合我国的国情,具有广阔的应用前景。
研究在颈椎单开门椎管扩大成形术中使用OsteoMed M3钉板内固定。对其进行生物力学及临床应用评价,包括5mm长的螺钉拧入时进钉点距离椎管、椎动脉孔及神经根通道之间的距离；六个模型组的三维运动稳定性试验、在新鲜颈椎标本上行包括OsteoMed M3钉板内固定二个模型组的疲劳试验、螺钉不同角度固定的拔出力的大小以及回顾性分析在临床上在颈椎单开门椎管扩大成形术中使用OsteoMed M3钉板内固定后的治疗效果。为其在临床上广泛应用及颈后路手术优化选择提供理论依据。
目的
1、研究在颈后路单开门中使用OsteoMed M3钉板内固定系统中的螺钉拧入时进钉点距离椎管、椎动脉孔及神经根通道之间的距离,评价5mm长的螺钉拧入后损伤脊髓神经及血管的风险。
2、通过脊柱三维运动稳定性实验评价在颈椎单开门术中在开门侧应用OsteoMed M3钉板内固定重建颈椎稳定性的效果。
3、通过疲劳实验评价在颈椎单开门椎管扩大成形术中使用OsteoMed M3钉板内固定重建颈椎稳定性的效果。
4、通过拔出力学实验研究在颈椎单开门OsteoMed M3钉板内固定椎管扩大成形术中螺钉不同角度固定的拔出力的大小。
5、回顾性分析在临床上行颈椎单开门椎管扩大成形术中使用OsteoMed M3钉板内固定,评价其在颈椎疾患手术中应用后的治疗效果。
方法
1、颈椎测量：自粤北人民医院影像诊断科CT室工作站随机调出颈椎CT检查的病人资料,选取既往无颈椎受伤等病史,检查结果考虑无明显颈椎疾患的病人资料100份,其中男50份,平均年龄为51.32岁,年龄在20-86岁；女50份,平均年龄为43.54岁,年龄在17～74岁。通过HIS及PACS系统打开CT图像,利用PACS系统中辅助测量的功能进行测量指标的测量并记录,测量指标：①颈3-7椎板外侧缘与侧块内侧缘交界处至椎管内的垂直最短距离；②颈3-6侧块内侧缘至侧块中点之间距离横突孔的最短距离；③颈3-7侧块内侧缘至侧块中点之间距离神经根通道的最短距离。
2、在6具新鲜人尸体颈椎标本上,截取其颈1至胸1(C1～T1),作为自身对照性实验,先后依次进行正常的完整颈椎、后路单开门丝线结扎组、后路单开门侧块螺钉丝线结扎组、后路单开门OsteoMed M3钉板内固定组、后路椎板切除组、后路椎板切除加侧块钉棒内固定组的三维运动活动度检测。在脊柱三维运动试验机上对各组标本行屈伸、左右侧弯和左右旋转6个运动方向的稳定性测试,施加的力偶矩为2.0N.m。多节段的运动测量使用Motion Analysis运动捕捉分析系统,该系统包括在颈椎标本周围共放置6台红外线摄像机,颈椎每个椎体上固定有4个不共线排列的球形红外线接收标记物,由红外线摄像机对标记物的运动进行实时运动测量,测试屈伸、左右侧弯、左右旋转6个方向的运动角位移参数,包括运动范围(range of motion, ROM)、中性区(neutral zone, NZ)和弹性区(elastic zone, EZ)。并由计算机直接得出每个标记物运动坐标,利用EVaRT软件计算每个标本节段的角位移,将各椎体的角位移相加得出颈椎的运动范围。对正常的完整颈椎、后路单开门丝线结扎组、后路单开门侧块螺钉丝线结扎组、后路单开门OsteoMed M3钉板内固定组、后路椎板切除组、后路椎板切除加侧块钉棒内固定组的颈椎运动范围进行分析和讨论。
3、在6具颈椎标本上,分别行后路单开门丝线结扎及OsteoMed M3钉板内固定,在脊柱三维运动试验机上行颈椎前屈后伸疲劳运动试验,观察有无丝线断裂或钛板螺钉脱出、断裂现象,如有则停止试验并记录发生时的周期。
4、利用成人新鲜的颈椎标本6具,6具颈椎标本随机编号,选择颈3、颈4及颈5节段共18个节段按顺序编号,分别行后路单开门OsteoMed M3钉板内固定,在关节突关节侧按螺钉固定角度垂直于侧块皮质0。、外倾30°及外倾45。位3组顺序分别在编号的颈椎节段行螺钉固定,使用ElectroForce测试仪测试螺钉的最大拔出力,以2mm/min的速度轴向拔出,记录全过程的拔出曲线至螺钉被拔出,曲线的最高峰即为最大拔出力。
5、选择多节段椎间盘突出并椎管狭窄等颈椎疾患25例,行颈椎单开门OsteoMed M3钉板内固定椎管扩大成形手术治疗,术后随访半年以上,平均随访时间9月(7月～3年)。其中男性18例,女性7例；年龄46-75岁,平均61.4岁；病史7月～8年,平均3年1月。手术方式如下：患者俯卧位,颈椎保持在适度前屈。标准颈后正中切口至棘突,常规切断附着于棘突上的肌肉并沿椎板两侧骨膜下剥离至两侧侧块的中点,应注意避免损伤关节囊,颈6或颈7的棘突过长部分应用咬骨钳切除至颈5棘突同样高,可防止在开门时挤压肌肉不利于开门。拟开的骨槽位于椎板外侧缘与侧块内侧缘交界处,用4到5mm的高速磨钻纵形开槽至内板,对拟手术的狭窄节段由头侧向尾侧逐个磨除外板；侧作为开门侧,另一侧作为门轴侧,选择症状较重一侧作为开门侧,可给予行神经根减压。利用2-3mmm薄的枪状咬骨钳咬除拟开门侧的椎板内板及黄韧带；另一侧作为门轴侧,需完全切除背侧皮质和磨薄内层皮质以利于在开门时能形成门轴侧的青枝骨折,需保证内层皮质骨完整,所开的骨槽要偏大以防开门时挤压,如门轴侧内侧皮质出现断裂则给予改椎板切除术。所有的病例在开门侧抬起的椎板与侧块内侧缘至侧块中点之间选用由OsteoMed M3钉板剪成的合适长度多条小钢板并塑形后予以螺钉内固定,保持开门后的状态,术后4周即让患者进行颈椎活动功能锻炼。应用日本整形协会(Japaneses Orthopaedoc Association) JOA评分法对术前及术后的脊髓功能改善情况进行对比及评价。对影响术后疗效的相关因素进行分析。
结果
1、男女颈3-6侧块内侧缘至侧块中点之间距离横突孔最短距离的95%正常参考值下限及颈3-7侧块内侧缘至侧块中点之间距离神经根通道最短距离的95%正常参考值下限均大于我们在颈椎单开门术中所使用的OsteoMed M3钉板内固定系统中的螺钉长度5mm；而男女颈3-7椎板外侧缘与侧块内侧缘交界处至椎管内垂直最短距离的95%正常参考值下限部分小于我们在颈椎单开门术中所使用的OsteoMed M3钉板内固定系统中的螺钉长度5mm,尤其对女性。
2、在单开门手术后,开门侧行侧块钉棒内固定组在各个运动状态下的运动范围均明显减少,稳定性增加,运动范围的差异有统计学意义(P<0.05)。在单开门手术后,正常组在后伸、前屈及左侧弯状态下的运动范围均与丝线组、丝线螺钉组、椎板切除及侧块钉棒固定组之间的差异有统计学意义(P<0.05),而与钢板固定组的差异无统计学意义,说明钢板内固定组的稳定性与正常组接近,稳定性好；在右侧弯及右旋状态下正常组的运动范围与椎板切除及侧块钉棒固定组之间的差异有统计学意义(P<0.05),而与丝线组、丝线螺钉组及钢板固定组的差异无统计学意义；在左旋状态下正常组的运动范围与其他各组之间的差异有统计学意义(P<0.05)。
行后路钢板内固定组,在后伸和右侧弯状态下运动范围与椎板切除组及侧块钉棒组之间的差异有统计学意义(P<0.05)；在前屈状态下运动范围与丝线组、椎板切除组及侧块钉棒组之间的差异有统计学意义(P<0.05)；在左侧弯状态下运动范围与丝线组、丝线螺钉组、椎板切除组及侧块钉棒组之间的差异有统计学意义(P<0.05)；在左旋状态下运动范围与其他各组之间的差异有统计学意义(P<0.05)；在右旋状态下运动范围与丝线螺钉组、椎板切除组及侧块钉棒组之间的差异有统计学意义(P<0.05)。
3、丝线结扎组的试验显示所有标本均出现部分缝合的关节囊韧带撕裂、门轴侧易活动,甚至有2次实验时分别在疲劳运动第73次和第1806次时出现关节囊撕裂、丝线脱落及再关门；而在OsteoMed M3钉板内固定组不损伤关节囊,试验显示未出现钢板螺钉松动、断裂,未出现再关门现象。
4、在拔出试验中,外倾0°组最大拔出阻力平均为(81.60±7.33)N,外倾30°和外倾45°组的最大拔出阻力分别平均为(150.05±15.57)N和(160.08±17.77)N。外倾0°的拔出力小于外倾30°及外倾45°位组,差异有统计学意义(P<0.05),而外倾30°及外倾45°位组之间相近,差异无统计学意义(P>0.05)。
5、25例患者全部得到随访,术后随访半年以上,术前JOA评分：9.40±1.658(5～13),术后JOA评分：13.80±1.958(7-16),差异有统计学意义(t=-21.137,P=0.000),大部分病人症状明显改善,术后改善率57.9%。术后X光片、MRI及CT检查提示椎管的矢状径和椎管均明显扩大,3例症状改善不明显的患者,2例二期实施前路减压固定融合术后症状缓解,1例后纵韧带骨化症患者恢复欠佳；1例病人术后症状改善,在后期的随访过程中因其他疾病死亡；无1例出现继发性椎管狭窄引起神经功能变坏或手术相关的并发症。
结论
1、根据CT影像学资料测量的结果显示在颈后路行单开门OsteoMed M3钉板内固定时螺钉固定在侧块内侧缘至侧块中点之间是安全的,螺钉的进钉稍偏向外上方不会损伤血管神经及脊髓。
2、在颈椎单开门术中在开门侧应用OsteoMed M3钉板内固定生物力学稳定性好,可重建颈椎稳定性。
3、在颈椎单开门椎管扩大成形术中应用OsteoMed M3钉板内固定具有良好的生物力学性能,能重建颈椎稳定性,可满足颈椎后路手术的要求。
4、颈椎单开门OsteoMed M3钉板内固定椎管扩大成形术中螺钉外倾30°以上角度固定抗拔出能力高。
5、在颈椎单开门椎管扩大成形术中应用OsteoMed M3钉板内固定具有避免开门后再关闭,保持椎管扩大效果,同时对脊柱活动度影响小的优点,且操作简单,并发症少,适合临床运用。
Background
Cervical spondylosis has become one of the common and frequently occurring illness in clinic and brought great hazardous to suffers, their families and society along with the development of society, population aging, and alteration of people's work and life styles especially. Technique of treatment is also in constant improvement following the development of medical science in a profound understanding of cervical disease. Although conflicting evidence exists, the majority of available evidence suggests that CSM is largely a surgical disease in the presence of symptoms and signs, appropriate radiographic evidence.
Surgical techniques can be broadly divided into anterior surgery, posterior surgery, or combined anterior and posterior surgical techniques. Anterior decompression and fusion (ADF) allows direct removal of the compressive abnormality that compresses the spinal cord and nerve root from the front, with stabilization obtained by anterior arthrodesis. However, The disadvantages include the need for graft healing, related to bone grafting, such as dislodgement, fracture, and nonunion of the grafted bone and recurrence of myelopathy due to adjacent segment degeneration. Particularly, when three or more segments are involved, accelerated complication rates associated with anterior surgery, adjacent segment degeneration seen more obvious.
The purpose of posterior surgical approaches is to expand spinal canal and to gain the decompression of the spine cord. Cervical laminoplasty has recently received increased attention for the treatment of cervical spondylotic myelopathy. Posterior based operations-such as laminectomy, laminectomy and fusion, and laminoplasty. Prior to the advent of anterior cervical spine surgery, laminectomy was the most common approach to decompression for multilevel myelopathy. However, there were significant problems associated with postlaminectomy kyphosis secondary to iatrogenic destabilization of the cervical spine, and lead to delayed neurological deterioration. Restenosis of spinal canal due to scar tissue formation, and will lead to spinal cord injury due to mild trauma.
To address problems related to laminectomy, another alternative technique is laminectomy and fusion, which allows posterior canal expansion and maintains stability. This modification theoretically avoids problems associated with laminectomy alone, and it may allow reduction of kyphosis to lordosis. However, complications related to fixation include hardware failure with loss of alignment, radiculopathy, screw malposition, and the need for a repeated operation, and related to cervical instability due to accelerated adjacent segment degeneration. Laminectomy and fusion was limited further application in the clinical as these complications. Pal and Cooper found that 36% of the total load applied on the top of the specimen is transmitted through the anterior column formed by bodies and intervertebral discs, and 64% in posterior cervical columns formed by the facet joints and articular processes. The posterior columns plays a more important role in load transmission than anterior column. These prompted the development of a variety of methods to decompress the spine posteriorly, yet maintain postoperative stability by retaining the bulk of the posterior elements, redesigning configuration lamina and canalis vertebralis.
Cervical laminoplasty has recently received increased attention for the treatment of cervical spondylotic myelopathy. Cervical laminoplasty has been used for the posterior decompression of the cervical spinal cord caused by cervical spondylosis, ossification of the posterior longitudinal ligament (OPLL), congenital spinal stenosis, or a combination of the above. Laminoplasty offers several advantages over traditional laminectomy and laminectomy with instrumented fusion. By preserving the posterior elements (lamina, spinous processes), it has been suggested that laminoplasty may decrease the incidence of postlaminectomy kyphotic deformity compared with laminectomy alone. Compared with laminectomy with instrumented fusion, laminoplasty may have a decreased incidence of adjacent level spondylosis by preserving cervical range of motion. Posterior-based procedures for spinal cord indirect decompression and its associated microcirculation rely on the ability of the cord to drift away from the anterior lesions as a result of releasing the posterior tethers (laminae, ligamentum flavum). Expansive laminoplasty was developed to achieve posterior spinal cord decompression while preserving cervical spine stability. There is small epidural scar and no aggravating spinal cord injury due to mild trauma. Among various methods of laminoplasty, unilateral open-door laminoplasty has been considered easier and safer than other methods. A desired outcome after open door cervical laminoplasty is the reconstruction of a stable laminar arch with sufficient room for the decompressed spinal cord.
Once the laminae have been opened and the spinal cord has been decompressed, preventing restenosis is a primary concern. It is the most traditional way of maintaining door patency by sutures, and the lamina door is tethered open by sutures between the spinous process and facet capsule or paravertebral muscle fascia on the hinge side. However, there has the possibility of iatrogenic injury to the medial branches ramified from the dorsal ramus of the cervical nerves along the dorsolateral part of the facet joints during the cervical posterior approach, and it will cause neck pain, and hinge closure is easy to exist.
To address problems related to sutures, another modified technique is unilateral open-door laminoplasty with suture anchor fixation, and tying and fixation of the sutures onto the holed lateral mass screws was used instead of the conventional method. However, cervical instability and hinge closure is still existence.
To address problems related to way of maintaining door patency, various methods have been employed to maintain hinge patency and provide secure fixation, including autogenous or allogenic bone grafting, hydroxyapatite spacer and the miniplate osteosynthesis. Autografts are certainly the ideal spacer, offering considerable osteogenic and osteoconductive potential. However, donor site morbidity such as bleeding, ache, and sensation obstacle, and a second operation to harvest the graft are major disadvantages of autografts, and these were prohibited extensive application in the clinical. Allografts can provide structural support. However, the source is narrow and potential risk of viral transmission cannot be eliminated. Hydroxyapatite can provide structural support. However, it is poor reliability and difficult to use due to brittle, and it is not easy to acquire bone healing. Either autografts, allografts or Hydroxyapatite are needed to fashion into a self-locking configuration, relying on precise carpentry, the recoil of the hinges, and the force of the overlying musculature to secure the interlocking bone edges. Otherwise, additional instruments should be employed to avoid the risks of graft dislodgement. The expensive cost of commercial bone substitutes prohibits their use in developing countries.
To address problems related to way of maintaining door patency, use of the titanium miniplate can help to minimize the problems with loss of canal expansion previously seen while facilitating the procedure. Use of the plate may also allow the patient to engage in rehabilitation protocol and possibly decrease the incidence of postoperative axial neck symptoms and loss of motion previously associated with laminoplasty. Rhee demonstrate that plate-only laminoplasty was effective in maintaining canal expansion without the need for supplemental bone graft struts, and it was not associated with the restenosis owing to hinge closure or dislodgements reported using alternative forms of fixation such as sutures. However, the cost of plate curently used is expensive. Ideally, a method of achieving laminar fixation should be technically straightforward, provide secure laminar fixation, and be rapid to minimize the risk of iatrogenic injuries, blood loss, and operative time, and be safe to minimize the risk of restenosis of the canal, and decrease axial neck pain following laminoplasty, and nervous paralysis, moreover cost is moderate.
OsteoMed M3 plate and screws has been widely used in neurosurgery, maxillofacial, hand, and foot fractures, joint fixed and reconstruction surgery. The titanium plate is mesh shape, and the area is 4cmX5cm, and the thickness is 0.5 mm size. Self drilling screw, with diameter 2.0 mm and length 5.0 mm, can be easily twisted into bone. The length of screw is moderate, which decrease the risk of damaging spinal cord, nerve and vertebral artery due to too long screws, and avoid the risk of influence of fixed effect due to too short screws. OsteoMed M3 plates of sufficient size can be clipped into multiple small steel use, and can obviously reduce consumable expenses. In cervical posterior line plates were placed at all levels from C3 to C7 to allow adequate enlargement of the spinal canal, and the price is only 3,000 yuan which is equal to the cost of a piece of hand titanium plate, and which is more suitable for developing national condition, and has wide application prospects.
To study the method for that OsteoMed M3 titanium plate and screws were used to secure the posterior elements in the open position after expansive unilateral open-door laminoplasty. The biomechanical clinical evaluation index:to measure the shortest distance between the entry point of 5mm screws and spinal canal, transverse foramen, and nerve root port, and to compare three-dimensional motional stability of 6 groups including OsteoMed M3 titanium plate and screws group, and to compare the fatigue experiment on expansive unilateral open-door laminoplasty of the cervical spine with OsteoMed M3 plate and screws, and to evaluate the pullout strength of different screw orientation, and to retrospectively review the surgical results of OsteoMed M3 titanium plate and screws were used to secure the posterior elements in the open position after expansive unilateral open-door laminoplasty. The object is to provide the theoretic basis for the widely clinical application and optimal selection of cervical posterior surgery.
Objective
1、To measure the shortest distance between the entry point of screws and spinal canal, transverse foramen, and nerve root port when OsteoMed M3 titanium plate and screws were used to secure the posterior elements in the open position after expansive unilateral open-door laminoplasty, and to evaluate the risk of damaging spinal cord, nerve and vertebral artery due to screws of 5mm length.
2、To compare three-dimensional motional stability of different groups including OsteoMed M3 titanium plate and screws group, and to evaluate the method for that OsteoMed M3 titanium plate and screws were used to secure the posterior elements in the open position after expansive unilateral open-door laminoplasty and its immediate effects and initial stability of cervical vertebrae.
3、To evaluate the method for that OsteoMed M3 titanium plate and screws were used to secure the posterior elements in the open position after expansive unilateral open-door laminoplasty and its immediate effects and initial stability of cervical vertebrae.
4、To evaluate the method for that OsteoMed M3 titanium plate and screws were used to secure the posterior elements in the open position after expansive unilateral open-door laminoplasty and to evaluate the pullout strength of different screw orientation.
5、We retrospectively described the technique and reviewed the surgical results of OsteoMed M3 titanium plate and screws were used to secure the posterior elements in the open position after expansive unilateral open-door laminoplasty.
Method
1、The CT scans of 100 patients without traumatic and cervical spine disease were random extracted and measured according to the imaging data by CT examination from The department of diagnostic radiology of Yuebei People's Hospital. There were 50 males with mean age 51.32 years (aged 20～86 years), and 50 females with mean age 43.54 years (aged 17～74 years). The anatomic data of cervical vertebrae in each group were measured and recorded using computerized image analysis software of HIS and PACS system.
Measure indexes on CT were as follows:①The vertical shortest distance between junction of the lamina lateral margins of C3-C7 with the lateral mass medial margins of C3-C7 and spinal canal.②The shortest distance between junction of the lamina lateral margins of C3-C6 with the lateral mass medial margins of C3-C6 and transverse foramen.③The shortest distance between junction of the lamina lateral margins of C3-C7 with the lateral mass medial margins of C3-C7 and nerve root port.
2、To select fresh cervical spine specimens(C1～T1)from 6 adult cadavers, and the specimens were dividede into intact cervical specimens group, sutures group, suture anchor fixation group, plate group, laminectomy group, and laminectomy and fusion group. The range of motion of different groups were measured by a three dimensional spinal stability test. The movement was applied with±2.0N.m loads in flexion/extension, left/right lateral bending, and left/right axial rotation on the three-dimension motion stability test. Multi-level motion was measured by using Motion Analysis motion capture system. The motion measure system included six infrared camera placed around cervical specimen and used specialized acceptable infrared, sphericity markers. Four markers were rigidly attached to each vertebral level(C3-C6) in noncolinear position and oriented to permit detection by infrared camera. Each marker motion coordinate was calculated by computer and angular displacement parameters were calculated, including the range of motion(ROM), neutral zone(NZ), and elastic zone(EZ), in flexion and extension, right/left lateral bending, and left/right rotation. ROM of treated cervical vertebrae were recorded and analyzed to evaluat effects of intact cervical specimens group, sutures group, suture anchor fixation group, plate group, laminectomy group, and laminectomy and fusion group.
3、OsteoMed M3 plate and screws and silk ligation were used for an expansive unilateral open-door laminoplasty in six fresh human cervical spine specimens respectively, and fatigue experiment were executed in positions of flexion and extension on three-dimension motional stability test. The cessation of testing would be when the incidence of thread rupture and of loosening of thread, plate and screws were recorded.
4、To select cervical spine fresh specimens(C1～T1)from 6 adult cadavers, and six fresh human cervical spine specimens were random numbered, and select C3,C4 and C5 total 18 segments sequence number. OsteoMed M3 plate and screws were used for an expansive unilateral open-door laminoplasty in these specimens respectively. The screws were inserted in lateral mass on the sequence and grouping at different extraversion angles:extraversion angle 0°group, extraversion angle 30°group and extraversion angle 45°group. The maxinum pullout strength was tested on the ElectroForce material testing machine. Axis pullout speed was 2mm/min, and whole pullout process of the screw was recorded, and the number of curve peaks was the maxinum pullout strength.
5、25 patients with multilevel cervical disc herniation and canal stenosis were treated with an expansive unilateral open-door laminoplasty with OsteoMed M3 plate and screws. The follow-up period was over 6 months, and average follow-up period was 9 months (7 months～3 year). There were 18 male cases and 7 female cases. The age varied from 46 years old to 75 years old, and the average age was 61.4years old. The description for expansive unilateral open-door laminoplasty of the cervical spine with OsteoMed M3 plate and screws is as follows. The patient is placed in the prone position, and cervical spine is maintained in appropriate lordosis. A standard posterior midline incision is made down to the spinous processes. The paraspinal muscles are dissected laterally out to the lamina and the medial aspect of the lateral masses in the standard fashion. Care is taken during lateral exposure, not to disrupt the facet capsules. C6 and C7 spinous processes are shortened using a rongeur to the same height as C5. This prevents C6 and C7 spinous processes from impinging on the adjacent muscles when the laminae are hinged open. After identification of the interval between the lamina and the lateral mass, a bony trough is created with the high-speed 4- to 5mm burr, decorticating the posterior aspect of the lamina. The depth of the trough stops just superficial to the anterior cortex of the lamina. This is extended cephalad to caudad direction from one level above to one level below the involved stenotic levels. One trough corresponds to the hinge side of the door and the opposite side the aperture side of the door. The side with the most apparent clinical radiculopathy is often chosen as the open side, allowing foraminal decompression if required. On the aperture side, a 2- to 3-mm Kerrison rongeur is then used to remove the thinned anterior aspect of the lamina and interconnecting ligamentum. By completely removing the dorsal cortex and thinning the ventral cortex until a greenstick deformation of the hinge could be produced. The anterior aspect of the lamina on the hinge side is not removed and must remain intact. Additionally, the width of the trough should be slightly larger on the hinge side to prevent the walls of the trough from abutting. If the hinge fracture occurs at multiple levels, the laminoplasty should become a laminectomy by default. In each case, OsteoMed M3 plates of sufficient size to allow for adequate enlargement of the spinal canal were chosen, and plates were placed at all levels.5 mm mini-screws were placed into the lateral mass and the cut edge of the lamina through the plate in all cases. We encouraged the patients to do early active cervical exercises after 4 weeks surgery. The evaluate the improvement of spinal function after surgeries under JOA of Japaneses Orthopaedoc Association to analyse the effects and releated facters.
Result
1、The 95% normal lower limit of the shortest distance between junction of the lamina lateral margins of C3-C6 with the lateral mass medial margins of C3-C6 and transverse foramen were all greater than the length of 5mm screw, and the 95% normal lower limit of shortest distance between junction of the lamina lateral margins of C3-C7 with the lateral mass medial margins of C3-C7 and nerve root port were all greater than the length of 5mm screw. The 95% normal lower limit of vertical shortest distance between junction of the lamina lateral margins of C3-C7 with the lateral mass medial margins of C3-C7 and spinal canal were part less than the length of 5mm screw, especially in female patients.
2、After expansive unilateral open-door laminoplasty, laminectomy and fusion group exhibited an decrease in angular motion in all directions and a significant increase in stability in all directions(P<0.05). Intact cervical specimens group was significantly different from sutures group, suture anchor fixation group, laminectomy group and laminectomy and fusion group in ROM of flexion/extension and left lateral bending(P<0.05), but intact cervical specimens group was not significantly different from the plate group. Intact cervical specimens group was significantly different from laminectomy group and laminectomy and fusion group in ROM of right lateral bending and right axial rotation(P<0.05), but intact cervical specimens group was not significantly different from sutures group, suture anchor fixation group and the plate group. Intact cervical specimens group exhibited a more significant different than other groups in ROM of left axial rotation (P<0.05).
After expansive unilateral open-door laminoplasty, the plate group exhibited a more significantly different in angular motion than laminectomy and laminectomy and fusion group in ROM of extension and right lateral bending (P<0.05), and it was not significantly different from other groups. The plate group exhibited a more significantly different in angular motion than sutures group, laminectomy group and laminectomy and fusion group in ROM of flexion (P<0.05), and it was not significantly different from other groups. The plate group exhibited a more significantly different in angular motion than sutures group, suture anchor fixation group, laminectomy group and laminectomy and fusion group in ROM of left lateral bending (P<0.05). The plate group exhibited a more significant different than other groups in ROM of left axial rotation (P<0.05). The plate group exhibited a more significantly different in angular motion than suture anchor fixation group, laminectomy group and laminectomy and fusion group in ROM of right axial rotation.
3、Partial rupture of joint capsule and easy move of the hinge side were seen in all of the specimens in the silk ligation. It was observed that rupture of joint capsule and cast of silk thread and reclose of the opened laminate as clinical widely used device for suture of joint capsule when the experiment was executed to the 73rd time and the 1806th time. There was no trauma on joint capsule in the OsteoMed M3 plate and screws, and no plate and screw loosening and rupturing and no reclose of the opened laminate.
4、The maxinum pullout strength was (81.60±7.33)N for extraversion angle 0°group, (150.05±15.57)N for extraversion angle 30±group, (160.08±17.77)N for extraversion angle 45±group. The maxinum pullout strength of extraversion angle 0±group were less than extraversion angle 30±and 45±group(P<0.05). The pullout strength of extraversion angle 30±and 45±group were equal (P>0.05)
5、All of 25 cases'follow-up period were over 6 months. Most of the patients had marked neurologic improvement after surgery. The mean JOA score increased significantly from 9.40±1.658 (range,5 to 13) before surgery to 13.80±1.958 (range,7 to 16) at final follow-up(t=-21.137, P=0.000). Mean recovery rate was 57.9%. Postoperative radiography, magnetic resonance imaging and computed tomography scan demonstrated significantly increased sagittal diameter and canal expansion. Two cases without relief of nurological symptoms underwent an additional anterior multilevel corpectomy. One case with ossification of the posterior longitudinal ligament had not good enough neurologic improvement after surgery. One patient had marked neurologic improvement after surgery, however died of another disease. No neurologic deterioration owing to hinge reclosure or major surgery-related complications were observed.
Conclusion
1、The results demonstrated that it was safer that the entry point of screws lied in the site among the lateral mass lateral margins and the lateral mass medial margins, and the risk of neural injury, spinal cord injury and vertebral artery injury could not occur.
2、Expansive unilateral open-door laminoplasty with OsteoMed M3 plate and screws meets clinical and biomechanical requirements, and can remain the immediate effects and initial stability of cervical vertebrae.
3、Unilateral open-door laminoplasty using OsteoMed M3 titanium plate and screws fixation is good for posterior cervical surgery because of its biomechanical advantage of maintaining significant stabilization of the spine.
4、The pullout strength of the screws inserted extraversion angle over 30°provides stronger fixation than extraversion angle 0°in the unilateral open-door laminoplasty using OsteoMed M3 titanium plate and screws fixation.
5、Unilateral open-door laminoplasty with OsteoMed M3 titanium plate and screws fixation effectively maintains expansion of the spinal canal and resists closure while preserving alignment and stability. This modified technique is easy to perform with a low complication rate and is good for clinical application.
引文
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[15]Hyun SJ, Rhim SC, Roh SW, et al. The time course of range of motion loss after cervical laminoplasty:a prospective study with minimum two-year follow-up[J]. Spine,2009,34(11):1134-1139.
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[17]Lee JY, Hanks SE, Oxner W, et al.Use of Small Suture Anchors in Cervical Laminoplasty to Maintain Canal Expansion:A Technical Note[J]. J Spinal Disord Tech,2007,20(1):33-35.
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[1]Shibuya S, Komatsubara S, Oka S, et al. Differences between subtotal corpectomy and laminoplasty for cervical spondylotic myelopathy[J]. Spinal Cord,2010,48(3):214-20.
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