【作者】 陈浩；

【导师】 刘浩；

【作者基本信息】 四川大学 ， 外科学（骨科）（专业学位）， 2023， 硕士

【摘要】 目的:本研究通过回顾性研究,探究使用自行研制的可调式电动颈椎前路手术体位固定装置调节术中颈椎曲度后,对术后颈椎矢状位参数的影响,同时探究术前颈椎各矢状位参数与术中颈椎曲度调节值的关系,为后续探究该装置的适用范围提供依据;在回顾性研究的基础上,为进一步保证该装置的安全性,使用有限元研究分析该装置调节曲度正常、变直及反弓的颈椎模型时,各部分组织的应力分布及最大应力范围,从而进一步验证该装置的安全性;基于回顾性研究及有限元研究,开展随机对照试验,进一步探究该装置对颈前路手术的短期影响。材料和方法:回顾性分析既往使用自行研制的可调式电动颈椎前路手术体位固定装置调节术中颈椎曲度的患者数据,收集其术前、术中及术后的影像学资料,分析术中颈椎曲度调节值与术后颈椎曲度矫正值的关系,同时探究术前颈椎各矢状位参数对术中颈椎曲度调节值的影响;使用有限元分析(Finite Element Analysis,FEA),建立带颈部主要屈伸肌肉的颈椎曲度正常、曲度变直、曲度反弓三种有限元模型,模拟使用该装置调节颈椎曲度至10°、15°及25°的过程,分析该过程中颈椎各部分组织的应力分布及最大应力范围;在以上研究的基础上,开展随机对照试验,将颈前路手术患者按手术方式分为颈前路椎间盘切除减压融合术(Anterior Cervical Discectomy and Fusion,ACDF)组及颈椎间盘置换术(Cervical Disc Replacement,CDR)组,分别进行研究,在每组患者中,进一步分为使用该装置调节术中颈椎曲度组(调节组)及未使用该装置调节术中颈椎曲度组(未调节组),探究该装置对颈前路手术的短期影响。结果:1、回顾性研究共纳入167例患者,除10例患者术后失访外,其余患者均获得至少12月随访,平均随访时间15.45±2.2月,随访率94.35%。平均年龄46.75±8.65岁。在术中调节时,未出现术中诱发电位变化,调节过程中患者生命体征平稳;术后颈后部无红肿、张力性水泡等压力性损伤。在术后随访过程中,患者未出现神经功能的恶化。与术前相比,患者在术后3天时,颈椎整体曲度(Cervical Lordosis,CL)、手术节段曲度、胸1斜率(T1 Slope,T1S)较术前明显增加,虽然在术后12月随访时略有丢失,但相较于术前仍有统计学意义(P<0.05);与术前相比,患者矢状面垂直轴(Sagittal Vertical Alignment,SVA)、O-C2角、颈椎-颅骨角(Spino Cranial Angle,SCA)较术前明显下降,在术后12月随访时有一定增加,但相较于术前仍有统计学意义(P<0.05);对于整体活动度(Range Of Motion,ROM)、过伸及过屈活动度,术后3天较术前明显丢失,在12月时未能恢复至术前水平(P<0.05)。颈前路手术术中整体曲度调节值与术后各个随访时间点颈椎整体曲度改善值相关,相关系数分别为0.701、0.693、0.691和0.661,相关系数随着随访时间的推移逐渐降低。术前颈椎曲度、颈椎过伸活动度、颈椎过屈活动度、T1S是影响术中颈椎曲度调节值的因素。对以上影响因素进一步分析,在多因素分析中,颈椎过伸活动度、术前颈椎曲度是影响术中颈椎曲度调节的独立因素。2、有限元研究中:成功建立曲度正常、曲度变直、曲度反弓三种不同曲度的带主要屈伸肌肉的颈椎有限元模型。有限元结果显示,颈后部皮肤与装置接触部位出现最大应力5.280KPa;对于肌肉组织,最大应力为0.750KPa;对于椎间盘:最大应力0.597Mpa,椎间盘应力主要集中于椎间盘后部;对于椎体,最大应力值12.435Mpa,出现在颈7椎体后部;各模型未见明显应力集中现象。3、在随机对照试验中,ACDF手术患者共43例,调节组23例,未调节组20例。所有患者均未出现以上并发症,在随访期间未出现二次手术;与术前相比,两组患者术后各时间点整体曲度、手术节段曲度、T1S较术前明显增加(P<0.05),调节组在术后各时间点显著大于未调节组(P<0.05),两组患者术后各时间点SVA、SCA、O-C2角较术前明显下降,两组患者SVA、SCA调节组在各时间点小于未调节组(P<0.05),两组O-C2角在各时间点未见明显差别;两组患者术后症状均有明显改善(P<0.05),与术前相比,两组患者术后各时间点日本骨科协会(Japanese Orthopaedic Association,JOA)较术前显著增加(P<0.05),颈部功能障碍指数(Neck Disability Index,NDI)、手臂疼痛视觉模拟评分(Visual Analogue Scale,VAS)及颈部VAS较术前明显下降(P<0.05),组间比较发现,除颈部VAS评分术后3天时调节组明显小于未调节组外(P<0.05),两组其他评分在各时间点未见明显差别(P>0.05)。4、在随机对照试验中,CDR手术患者共39例,调节组20例,未调节组19例。所有患者均未出现以上并发症,在随访期间未出现二次手术;与术前相比,两组患者术后各时间点整体曲度、手术节段曲度、T1S较术前明显增加(P<0.05),调节组在术后各时间点明显大于未调节组(P<0.05),两组患者术后各时间点SVA、SCA、O-C2角较术前明显下降(P<0.05),两组患者SVA、SCA调节组在各时间点小于未调节组(P<0.05),两组O-C2角在各时间点未见明显差别(P>0.05);与术前相比,两组患者术后整体活动度在术后3天明显下降(P<0.05),但在随后的时间点恢复至术前水平,手术节段活动度在术后3天、术后3月明显下降(P<0.05),在6月及12月恢复至术前水平,调节组与未调节组在各时间点相差不大(P>0.05);两组患者术后症状均有明显改善(P<0.05),与术前相比,两组患者术后各时间点JOA较术前明显增加(P<0.05),NDI、手臂VAS及颈部VAS较术前明显下降(P<0.05),组间比较发现,除颈部VAS评分术后3天时调节组明显小于未调节组外(P<0.05),两组其他评分在各时间点未见明显差别(P>0.05)。结论:1、在颈前路手术中,使用自行研制的可调式电动颈椎前路手术体位固定装置调节术中颈椎曲度可以改善术后整体及手术节段曲度,能在一定程度改善术后颈椎矢状位参数;进一步分析发现,术中曲度调节值与术前颈椎整体曲度、术前过伸位活动度有一定关系;使用该装置,对于术前颈椎整体曲度低及术前颈椎过伸活动度好的患者,可能会有更好的改善效果。2、成功建立曲度正常、曲度变直、曲度反弓三种不同曲度的带主要屈伸肌肉的颈椎有限元模型。在此基础上,利用有限元分析对上述不同曲度的有限元模型调节颈椎曲度至10°、15°及25°模拟术中使用该装置调节颈椎曲度的过程,得到结果表明,颈部各部位组织应力与既往研究相似,该装置在术中调节颈椎曲度过程有一定的安全性。3、在ACDF手术及CDR手术两种术式中,使用该装置调节颈椎曲度后,术后颈椎整体曲度较未调节组明显增加,且能在一年的随访中保持。能否继续维持前凸曲度、后续能否降低邻近节段退变(Adjacent Segment Degeneration,ASD)的发生率,还需进一步观察。更多还原

【Abstract】 Objective:In this study,we investigated the effects on postoperative sagittal alignment after adjusting the intraoperative cervical lordosis using a self-developed adjustable electric anterior cervical surgical postural fixation device through a retrospective study,and also investigated the relationship between each preoperative cervical sagittal alignment and the intraoperative cervical curvature adjustment value to provide a basis for the subsequent investigation of the applicability of the device;on the basis of the retrospective study,to further ensure the based on the retrospective study,finite element analysis(FEA)study was conducted to analyze the stress distribution and the maximum stress range of each tissue when the device was used to adjust the cervical spine model with normal,straightening and kyphotic curvature,so as to further verify the safety of the device;based on the retrospective study and the FEA,a randomized controlled trial was conducted to further investigate the short effects of the device on the anterior cervical surgery.Materials and Methods:We retrospectively analyzed the data of patients who used the novel adjustable electric posturing device to adjust intraoperative cervical curvature,collected their preoperative,intraoperative and postoperative imaging data,analyzed the relationship between the intraoperative cervical curvature adjustment value and the postoperative cervical curvature correction value,and also investigated the influence of the preoperative cervical sagittal parameters on the intraoperative cervical curvature adjustment value;using the FEA,we established three finite element models with normal,straightening and kyphotic curvature of the main muscles of the neck were established,and the process of adjusting the cervical curvature to 10°,15°and 25° using the device was simulated,and the stress distribution and maximum stress range of the tissues in each part of the cervical spine during the process were analyzed;On the basis of the above study,a randomized controlled trial was conducted to investigate the short effects of the device on anterior cervical surgery by dividing patients into ACDF and CDR groups,and further dividing patients in each group into those who used the device to adjust intraoperative cervical curvature(adjusted group)and those who did not use the device to adjust intraoperative cervical curvature(unadjusted group).Results:1.A total of 167 patients were included in the retrospective study,and all patients received at least 12 months of follow-up except for 10 patients who were lost after surgery,with a mean follow-up time of 15.45 ± 2.2 months and a follow-up rate of 94.35%.The mean age was 46.75 ± 8.65 years.During intraoperative conditioning,no intraoperative evoked potential changes were observed,and patients’ vital signs were stable during conditioning.There were no postoperative pressure injuries such as erythema or tension blisters in the posterior neck.During the postoperative follow-up,the patient did not show any deterioration of neurological function.Compared with the preoperative period,the overall cervical lordisis(CL),surgical segmental curvature,and T1 S increased significantly at 3 days postoperatively compared with the preoperative period,and although they were slightly lost at the 12-month postoperative follow-up,they were still statistically significant compared with the preoperative period(P < 0.05).Compared with the preoperative period,patients had a significant decrease in SVA,O-C2 angle,and SCA compared with the preoperative period,and there was an increase at the12-month postoperative follow-up,but it was still statistically significant compared with the preoperative period(P < 0.05).For overall ROM,extension and flexion mobility was significantly lost at 3 days postoperatively compared to preoperative levels,and failed to return to preoperative levels at 12 months(P < 0.05).Intraoperative overall CL adjustment values correlated with the improvement in overall cervical curvature at each postoperative follow-up time point,with correlation coefficients of 0.701,0.693,0.691,and 0.661,which gradually decreased with follow-up time.Preoperative CL,cervical extension range of motion,cervical flexion range of motion,and T1 S were the factors that influenced the intraoperative CL adjustment values.The above influencing factors were further analyzed,and in the multifactorial analysis,cervical extension range of motion and preoperative CL were independent factors influencing intraoperative CL adjustment value.2.In the FEA: finite element models of the cervical spine with major muscles of three different curvatures,normal,straightening and kyphotic,were successfully established.The FEA results showed that the maximum stress of 5.280 KPa occurs at the contact area between the skin and the device at the back of the neck.For the muscle tissue,the maximum stress was 0.750 KPa.For the spinal cord,the maximum stress was 0.597 Mpa,and the spinal cord stress was mainly concentrated in the posterior part of the disc.For the vertebral bone,the maximum stress value of12.435 Mpa appeared in the posterior part of the cervical 7 vertebral bone.No significant stress concentration was observed in the models.3.In the randomized controlled trial,there were 43 patients with ACDF surgery,23 in the adjusted group and 20 in the unadjusted group.All patients did not have any of the above complications,and no secondary surgery occurred during the follow-up period.Compared with the preoperative period,the overall CL,surgical segmental curvature,and T1 S increased significantly(P < 0.05)in both groups at all postoperative time points,and the adjustment group was significantly larger than the unadjusted group at all postoperative time points(P < 0.05).SVA,SCA,and O-C2 angle decreased significantly in both groups at all postoperative time points compared with the preoperative period.The SVA and SCA in adjustment groups were smaller than the unadjusted group at each time point in both groups(P < 0.05),and the O-C2 angle was not significantly different between the two groups at each time point.Postoperative symptoms improved significantly in both groups(P < 0.05),and compared with the preoperative period,JOA score increased significantly,and NDI score,arm VAS score and neck VAS score decreased significantly at each time point in both groups compared with the preoperative period(P < 0.05).No significant differences were seen between the two groups at each time point(P >0.05),except for the adjusted group,which was significantly smaller neck VAS score than the unadjusted group at 3 days after the surgery(P < 0.05).4.In the randomized controlled trial,there were 39 patients with CDR surgery,20 in the adjusted group and 19 in the unadjusted group.All patients did not have any of the above complications,and no secondary surgery occurred during the follow-up period.Compared with the preoperative period,the overall CL,surgical segmental curvature,and T1 S were significantly increased in both groups at each postoperative time point compared with the preoperative period(P < 0.05),and the adjusted group was significantly larger than the unadjusted group at each postoperative time point(P < 0.05).The SVA,SCA,and O-C2 angles decreased significantly at each postoperative time point in both groups compared to the preoperative period(P < 0.05),and the SVA and SCA-adjusted groups were smaller than the unadjusted group at each time point in both groups(P < 0.05),and no significant difference was seen in the O-C2 angle between the two groups at all time points(P > 0.05).Compared with the preoperative period,overall postoperative ROM decreased significantly in both groups at 3 days postoperatively(P < 0.05),but returned to preoperative levels at subsequent time points,and surgical segment ROM decreased significantly at 3 days and 3 months postoperatively(P < 0.05)and returned to preoperative levels at 6 and 12 months,with no significant difference between the adjusted and unadjusted groups at each time point(P > 0.05).Postoperative symptoms improved significantly in both groups(P < 0.05),and compared with the preoperative period,JOA score increased significantly,and NDI score,arm VAS score and neck VAS score decreased significantly at each time point in both groups compared with the preoperative period(P < 0.05).No significant differences were seen between the two groups at each time point(P > 0.05),except for the adjusted group,which was significantly smaller neck VAS score than the unadjusted group at 3 days after the surgery(P < 0.05).Conclusion:1.in anterior cervical surgery,adjusting intraoperative CL with the novel adjustable electric posturing device can improve the postoperative overall and surgical segmental curvature and can improve the postoperative cervical sagittal alignment.Further analysis revealed that the intraoperative CL adjustment value was related to the preoperative overall CL and preoperative extension ROM.And for patients with poor preoperative overall CL and good preoperative extension ROM,the device is more effective in adjusting intraoperative CL.2.The finite element model of cervical spine with major muscles in three different curvatures,normal,straightening and kyphotic,was successfully established.By adjusting the CL to 10°,15° and 25° with the above models to simulate the intraoperative process of using the device to adjust the CL.The stresses in the tissues of the cervical spine did not exceed the limit value in the finite element results,which verified the safety of the device in the intraoperative adjustment of cervical spine curvature.3.In ACDF surgery and CDR surgery,the overall postoperative CL increased significantly compared with the unadjusted group after using the device to adjust the cervical curvature,and the CL could be maintained until 1 year after surgery.Whether it can continue to maintain the anterior lordosis and reduce the incidence of ASD is to be further observed.更多还原