计算机辅助导航技术的临床应用研究
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摘要
第一部分计算机辅助导航技术的实验研究
注册方式对导航手术精确性及注册时间的影响
研究目的：考察不同的注册方式(点注册与表面注册)对计算机导航手术精确度、注册时间的影响,从中寻找导航手术的最佳注册方式。
对象与方法：取新鲜小牛尸体颈椎标本(8具),包括完整的C1-C8,共64个椎体,根据导航手术常用的注册方式,随机分为两组：点注册组、表面注册组。匹配误差(PA,Predicted Accuracy)在注册过程中由导航系统软件直接显示。注册时间为从开始注册到导航精确度达到预期值为止的时间。统计分析两组在匹配误差与手术时间上的差异。
研究结果：①、注册时间：计算机辅助导航手术中,点注册组平均注册时间为292±45s,表面注册组平均注册时间为245±32s,两组比较无统计学差异(p>0.05)。②、匹配误差：计算机辅助导航手术中,点注册组平均匹配误差为1.1±0.23mm,表面注册组平均匹配误差为0.8±0.11mm,差异有统计学意义(P=0.031)。
结论：①、计算机辅助导航手术中,不同的注册方式对导航手术精确度、注册时间均有影响。②、点注册方式与表面注册方式相比,注册所需时间并无明显差异。③、点注册方式具有简单、快速的特点,但表面注册方式具有更高的注册精度,实际操作中,可将两者结合起来,灵活应用。
第二部分计算机辅助导航技术的临床应用研究
一、导航技术在胸腰椎椎弓根钉植入中的应用
研究目的：研究计算机辅助导航在椎弓根内固定技术中的应用,了解其对椎弓根钉植入的安全性和精确性,评估该技术在椎弓根植入中的临床使用意义。
对象与方法：对29例腰椎滑脱患者、24例胸椎后路椎弓根螺钉内固定患者采用计算机导航辅助下植钉。统计手术时间及射线暴露时间,术后进行CT扫描观察椎弓根螺钉位置,分析计算机导航辅助下植钉与常规手术组患者的植钉准确率和手术时间以及射线暴露时间上的差异。
研究结果：
①胸椎：CT三维导航系统组102枚椎弓根钉植入前获得的匹配精确度误差平均为0.85mm(0.7-1.1mm),其中,上胸椎平均为0.75mm(0.6-1.0mm),中下胸椎平均为0.9mm(0.8-1.1mm)。术后CT扫描：102枚胸椎椎弓根钉Ⅰ级99枚(97.1%,其中上胸椎26枚,中下胸椎73枚),Ⅱ级3枚(其中上胸椎1枚,中下胸椎2枚),Ⅲ级0枚。Ⅱ级有1枚螺钉位置偏于椎弓根内侧(为中下胸椎),其余均偏在椎弓根外侧,临床无神经损伤症状。C臂机透视组98枚椎弓根钉术后CT扫描：Ⅰ级88枚(89.8%,其中上胸椎20枚,中下胸椎68枚),Ⅱ级8枚(其中上胸椎2枚,中下胸椎6枚),Ⅲ级2枚(均为中下胸椎)。Ⅱ级和Ⅲ级所有螺钉位置偏于椎弓根外侧,Ⅲ级中一例患者出现顽固性胸背痛。两组Ⅰ级差异有显著性意义(p<0.05)。
②腰椎：CT三维导航系统组116枚椎弓根钉,术后CT扫描：Ⅰ级116枚,无Ⅱ级、Ⅲ级。徒手植钉组116枚椎弓根螺钉中,植钉位置Ⅰ级104枚,Ⅱ级8枚,Ⅲ级4枚。Ⅱ级和Ⅲ级所有螺钉位置偏于椎弓根外侧,无临床症状。经等级资料的秩和检验,两组植钉准确率分级有统计学意义(P=0.038)。
③植钉时间：统计腰椎两组手术时间,透视植钉组为64～110分钟,平均85.93±12.86分钟,导航植钉组为58～103分钟,平均79.04±13.74分钟,经独立样本t检验,P=0.053,两组无统计学差异。随着采用导航技术的时间推移,导航植钉组所用手术时间逐步下降,而徒手植钉组无明显改变。因此,将病例按时间排序,自2007年4月后,徒手植钉组共完成21例、平均用时87.14±11.23分钟,导航植钉组完成20例手术,平均用时72.95±10.70分钟,经独立样本t检验,两组有统计学差异(P=0.000)。
④射线暴露时间：统计两组手术中射线暴露时间,各时间段导航植钉组射线暴露时间均显著少于徒手植钉组。透视组累计射线暴露时间7.83±2.30秒,导航组累计射线暴露时间1.21±0.42秒,经独立样本t检验,两组有统计学差异(P=0.000)。
结论：①、计算机辅助导航技术利用CT三维重建影像进行椎弓根钉植入术中导航,给术者提供即时的,多维的清晰图像,利于术者准确地按照计算机设计的精确进钉路线进行手术内固定。其植钉精确度高于C臂机透视组,大大减少了神经、血管损伤的风险,尤其适用于颈、胸椎后路椎弓根钉手术,有助于椎弓根螺钉技术的推广应用。②、该技术的临床应用：一方面提高了脊柱手术中椎弓根钉植入的安全性和精确性,提高了椎弓根内固定手术的成功率；一方面有效地缩短同类手术时间和术者术中射线暴露时间。③、本研究为计算机导航技术在椎弓根钉植入技术中的应用提供了临床资料依据,证实了该项技术是值得推广的一项临床技术。
二、导航技术在人工全膝关节置换术中的应用
研究目的：探讨计算机导航辅助下人工全膝关节置换手术的经验和临床结果,评估其对关节假体植入的准确性及可操作性的临床意义。
对象与方法：对照组采用标准全膝关节置换手术,导航组采用计算机导航辅助下人工全膝关节置换术,观察导航手术组在手术时间、术中出血和术后引流量、术后3个月HSS评分等指标与对照组之间的差异。并从影像学方面分析对照组和导航组术后的下肢力线和假体位置。
研究结果：行计算机导航辅助下人工全膝关置换术32例36膝。对照组与导航组的手术时间平均为(91.2±18.3)min和(120.4±24.5)min；术中出血及术后引流量分别为(910.6±110.6)ml和(640.8±90.7)ml；术后3个月HSS评分分别为(87.8±2.4)分和(92.6±1.9)分。统计学分析显示以上几项指标导航组与对照组比较,差异均有统计学意义(P<0.05)。术后对照组与导航组的MFTA分别为1.82°±1.2°和0.87°±0.76°,两者比较差异有统计学意义(t=2.32,P<0.05)；STCA分别为4.32°±1.10°和2.81°±0.61°,两者比较差异有统计学意义(t=4.15,P<0.05)。随访结果证实导航辅助下人工全膝关节置换术,与常规手术组相比,假体植入更准确,下肢力线更佳,早期疗效满意。
结论：①、计算机辅助导航技术应用于人工全膝关节置换术,手术时间较常规手术有所延长。②、辅助导航技术应用于人工全膝关节置换术,假体植入更加准确,对于肢体下肢力线能提供更佳的操作方案,同时使操作具有高的准确性和可重复性。③、导航技术操作下,不干扰股骨髓腔、可以明显减少患者术中、术后出血量,减少输血量,并且减少脂肪栓塞的发生率。④、关节假体功能早期评估获得满意的疗效,为临床推广使用提供了有效理论依据。
Part I Empirical study of computer-assisted navigation system
Influence of different registration mode to accuracy and registration-time of computer-assisted navigation system
Objective:To investigate influence of accuracy and registration-time of different registration style in operation of computer-assisted navigation system.
Methods:We used cervical vertebra of fresh calf, randomized to point-registration group and surface registration group by reconstructing three-dimensional image of cervical vertebra of calf. PA (Predicted Accuracy) and registration-time were evaluated.The PA was direct displayed by navigation system.The registration-time was the time from beginning of registration to getting a satisfactedaccuracy.
Results:①Among computer-assisted navigation surgery,registration-time of point-registration was292±45s,registration-time of surface-registration was245±32s,which have no difference between two groups (p>0.05).②Among computer-assisted navigation surgery,predicted accuracy (PA)of point-registration was1.1±0.23mm,and PA of surface-registration was0.8±0.11mm. Difference between two groups have statistically significant (P=0.031)
Conclusion:①In the operation of computer-assisted navigation system, different registration style make the difference in the accuracy and registration-time.②Registration-time of point-registration and surface-registration have no difference, but surface-registration can improve accuracy in navigation operation.
Part II Clinical application of computer-assisted navigation system
-Pedicle Screw fixation of spine assisted by CT-based navigation system
Objective:To investigate security and accuracy in pedicle screw fixation of spine assisted by CT-based navigation system.
Methods:24patients with thoracic vertebra fracture and29patients with isthmic spondylolisthesis were treated by posterior pedicle screws and randomized to CT-based navigation group and control group.The accuracy of pedicle screws insertion postoperatively CT scan were analyzed.The registration-time of both series and X-ray exposure time was compared.
Results:Of the102screws inserted by CT-based navigation system,99were I grade(97.1%);3were II grade;0was III grade.Of the98screws inserted by X-ray fluoroscopy,88were I grade (89.8%);8were II grade;2was III grade.One patient of III grade had the pain of refractoriness chest-back. Neural damage were not demonstrated in the study. The difference was statistically significant(P<0.05).A11the thoracic pedicle screws were provided from USS serial products of AO company.
The pedicle screw position was graded post-operatively with CT scanning into two groups and the accuracy of screw placemen with the use of navigation was superior to without (P=0.038<0.05). From2006October to2008May, computer-assisted image-guided spine surgery has shorter mean operative times (79.04±13.74minutes) when compared with conventional pedicle screw insertion technique(85.93±12.86minutes); but missed being statistically significant (P=0.0503).But from2007April, the mean operative times were72.95±10.70minutes and87.14±11.23minutes respectively, the difference was statistically significant(P=0.00). Computer-assisted spine navigation has overall demonstrated shorter mean radioactive ray exposure time when compared with conventional technique; an average of6.6seconds less per case (P=0.000.)
Conclusion:①Computer-assisted navigation system can increase accuracy of thoracic pedicle screw fixation obviously.②Computer-assisted navigation system obviously decurtate the operation time and exposure time of X-ray.③This study confirm that computer-assisted navigation system is a useful technique and deserved to be spreaded.
PartⅢClinical application of computer-assisted navigation system
-Total knee arthroplasty assisted by CT-based navigation system
Objective:To investigate accuracy of prothesis in total knee arthroplasty assisted by CT-based navigation system.
Methods:32cases(36joints) of TKA were perform utilizing CT-based navigation system. From January of2006to December of2006,10cases (12joints) of TKA were performed with conventional method. The differences between two groups in clinical results and blood loss and operating time and mechanical axes were statistically analyzed.
Results:There were significant differences(P<0.05) in parameters about the surgery time and the blood loss and HSS at postoperative3months between control group and navigation assisted group; Radiographic examination between these two groups:the MFTA and STCA of control groups and navigation assisted group with significant difference.
Conclusion:①Computer-assisted navigation system in TKA can obtain reliable clinical results with better mechanical axes.②Computer-assisted navigation system in TKA can decrease blood loss,it is a safe and reliable procedure in TKA.
注册方式对导航手术精确性及注册时间的影响
研究目的：考察不同的注册方式(点注册与表面注册)对计算机导航手术精确度、注册时间的影响,从中寻找导航手术的最佳注册方式。
对象与方法：取新鲜小牛尸体颈椎标本(8具),包括完整的C1-C8,共64个椎体,根据导航手术常用的注册方式,随机分为两组：点注册组、表面注册组。匹配误差(PA,Predicted Accuracy)在注册过程中由导航系统软件直接显示。注册时间为从开始注册到导航精确度达到预期值为止的时间。统计分析两组在匹配误差与手术时间上的差异。
研究结果：①、注册时间：计算机辅助导航手术中,点注册组平均注册时间为292±45s,表面注册组平均注册时间为245±32s,两组比较无统计学差异(p>0.05)。②、匹配误差：计算机辅助导航手术中,点注册组平均匹配误差为1.1±0.23mm,表面注册组平均匹配误差为0.8±0.11mm,差异有统计学意义(P=0.031)。
结论：①、计算机辅助导航手术中,不同的注册方式对导航手术精确度、注册时间均有影响。②、点注册方式与表面注册方式相比,注册所需时间并无明显差异。③、点注册方式具有简单、快速的特点,但表面注册方式具有更高的注册精度,实际操作中,可将两者结合起来,灵活应用。
第二部分计算机辅助导航技术的临床应用研究
一、导航技术在胸腰椎椎弓根钉植入中的应用
研究目的：研究计算机辅助导航在椎弓根内固定技术中的应用,了解其对椎弓根钉植入的安全性和精确性,评估该技术在椎弓根植入中的临床使用意义。
对象与方法：对29例腰椎滑脱患者、24例胸椎后路椎弓根螺钉内固定患者采用计算机导航辅助下植钉。统计手术时间及射线暴露时间,术后进行CT扫描观察椎弓根螺钉位置,分析计算机导航辅助下植钉与常规手术组患者的植钉准确率和手术时间以及射线暴露时间上的差异。
研究结果：
①胸椎：CT三维导航系统组102枚椎弓根钉植入前获得的匹配精确度误差平均为0.85mm(0.7-1.1mm),其中,上胸椎平均为0.75mm(0.6-1.0mm),中下胸椎平均为0.9mm(0.8-1.1mm)。术后CT扫描：102枚胸椎椎弓根钉Ⅰ级99枚(97.1%,其中上胸椎26枚,中下胸椎73枚),Ⅱ级3枚(其中上胸椎1枚,中下胸椎2枚),Ⅲ级0枚。Ⅱ级有1枚螺钉位置偏于椎弓根内侧(为中下胸椎),其余均偏在椎弓根外侧,临床无神经损伤症状。C臂机透视组98枚椎弓根钉术后CT扫描：Ⅰ级88枚(89.8%,其中上胸椎20枚,中下胸椎68枚),Ⅱ级8枚(其中上胸椎2枚,中下胸椎6枚),Ⅲ级2枚(均为中下胸椎)。Ⅱ级和Ⅲ级所有螺钉位置偏于椎弓根外侧,Ⅲ级中一例患者出现顽固性胸背痛。两组Ⅰ级差异有显著性意义(p<0.05)。
②腰椎：CT三维导航系统组116枚椎弓根钉,术后CT扫描：Ⅰ级116枚,无Ⅱ级、Ⅲ级。徒手植钉组116枚椎弓根螺钉中,植钉位置Ⅰ级104枚,Ⅱ级8枚,Ⅲ级4枚。Ⅱ级和Ⅲ级所有螺钉位置偏于椎弓根外侧,无临床症状。经等级资料的秩和检验,两组植钉准确率分级有统计学意义(P=0.038)。
③植钉时间：统计腰椎两组手术时间,透视植钉组为64～110分钟,平均85.93±12.86分钟,导航植钉组为58～103分钟,平均79.04±13.74分钟,经独立样本t检验,P=0.053,两组无统计学差异。随着采用导航技术的时间推移,导航植钉组所用手术时间逐步下降,而徒手植钉组无明显改变。因此,将病例按时间排序,自2007年4月后,徒手植钉组共完成21例、平均用时87.14±11.23分钟,导航植钉组完成20例手术,平均用时72.95±10.70分钟,经独立样本t检验,两组有统计学差异(P=0.000)。
④射线暴露时间：统计两组手术中射线暴露时间,各时间段导航植钉组射线暴露时间均显著少于徒手植钉组。透视组累计射线暴露时间7.83±2.30秒,导航组累计射线暴露时间1.21±0.42秒,经独立样本t检验,两组有统计学差异(P=0.000)。
结论：①、计算机辅助导航技术利用CT三维重建影像进行椎弓根钉植入术中导航,给术者提供即时的,多维的清晰图像,利于术者准确地按照计算机设计的精确进钉路线进行手术内固定。其植钉精确度高于C臂机透视组,大大减少了神经、血管损伤的风险,尤其适用于颈、胸椎后路椎弓根钉手术,有助于椎弓根螺钉技术的推广应用。②、该技术的临床应用：一方面提高了脊柱手术中椎弓根钉植入的安全性和精确性,提高了椎弓根内固定手术的成功率；一方面有效地缩短同类手术时间和术者术中射线暴露时间。③、本研究为计算机导航技术在椎弓根钉植入技术中的应用提供了临床资料依据,证实了该项技术是值得推广的一项临床技术。
二、导航技术在人工全膝关节置换术中的应用
研究目的：探讨计算机导航辅助下人工全膝关节置换手术的经验和临床结果,评估其对关节假体植入的准确性及可操作性的临床意义。
对象与方法：对照组采用标准全膝关节置换手术,导航组采用计算机导航辅助下人工全膝关节置换术,观察导航手术组在手术时间、术中出血和术后引流量、术后3个月HSS评分等指标与对照组之间的差异。并从影像学方面分析对照组和导航组术后的下肢力线和假体位置。
研究结果：行计算机导航辅助下人工全膝关置换术32例36膝。对照组与导航组的手术时间平均为(91.2±18.3)min和(120.4±24.5)min；术中出血及术后引流量分别为(910.6±110.6)ml和(640.8±90.7)ml；术后3个月HSS评分分别为(87.8±2.4)分和(92.6±1.9)分。统计学分析显示以上几项指标导航组与对照组比较,差异均有统计学意义(P<0.05)。术后对照组与导航组的MFTA分别为1.82°±1.2°和0.87°±0.76°,两者比较差异有统计学意义(t=2.32,P<0.05)；STCA分别为4.32°±1.10°和2.81°±0.61°,两者比较差异有统计学意义(t=4.15,P<0.05)。随访结果证实导航辅助下人工全膝关节置换术,与常规手术组相比,假体植入更准确,下肢力线更佳,早期疗效满意。
结论：①、计算机辅助导航技术应用于人工全膝关节置换术,手术时间较常规手术有所延长。②、辅助导航技术应用于人工全膝关节置换术,假体植入更加准确,对于肢体下肢力线能提供更佳的操作方案,同时使操作具有高的准确性和可重复性。③、导航技术操作下,不干扰股骨髓腔、可以明显减少患者术中、术后出血量,减少输血量,并且减少脂肪栓塞的发生率。④、关节假体功能早期评估获得满意的疗效,为临床推广使用提供了有效理论依据。
Part I Empirical study of computer-assisted navigation system
Influence of different registration mode to accuracy and registration-time of computer-assisted navigation system
Objective:To investigate influence of accuracy and registration-time of different registration style in operation of computer-assisted navigation system.
Methods:We used cervical vertebra of fresh calf, randomized to point-registration group and surface registration group by reconstructing three-dimensional image of cervical vertebra of calf. PA (Predicted Accuracy) and registration-time were evaluated.The PA was direct displayed by navigation system.The registration-time was the time from beginning of registration to getting a satisfactedaccuracy.
Results:①Among computer-assisted navigation surgery,registration-time of point-registration was292±45s,registration-time of surface-registration was245±32s,which have no difference between two groups (p>0.05).②Among computer-assisted navigation surgery,predicted accuracy (PA)of point-registration was1.1±0.23mm,and PA of surface-registration was0.8±0.11mm. Difference between two groups have statistically significant (P=0.031)
Conclusion:①In the operation of computer-assisted navigation system, different registration style make the difference in the accuracy and registration-time.②Registration-time of point-registration and surface-registration have no difference, but surface-registration can improve accuracy in navigation operation.
Part II Clinical application of computer-assisted navigation system
-Pedicle Screw fixation of spine assisted by CT-based navigation system
Objective:To investigate security and accuracy in pedicle screw fixation of spine assisted by CT-based navigation system.
Methods:24patients with thoracic vertebra fracture and29patients with isthmic spondylolisthesis were treated by posterior pedicle screws and randomized to CT-based navigation group and control group.The accuracy of pedicle screws insertion postoperatively CT scan were analyzed.The registration-time of both series and X-ray exposure time was compared.
Results:Of the102screws inserted by CT-based navigation system,99were I grade(97.1%);3were II grade;0was III grade.Of the98screws inserted by X-ray fluoroscopy,88were I grade (89.8%);8were II grade;2was III grade.One patient of III grade had the pain of refractoriness chest-back. Neural damage were not demonstrated in the study. The difference was statistically significant(P<0.05).A11the thoracic pedicle screws were provided from USS serial products of AO company.
The pedicle screw position was graded post-operatively with CT scanning into two groups and the accuracy of screw placemen with the use of navigation was superior to without (P=0.038<0.05). From2006October to2008May, computer-assisted image-guided spine surgery has shorter mean operative times (79.04±13.74minutes) when compared with conventional pedicle screw insertion technique(85.93±12.86minutes); but missed being statistically significant (P=0.0503).But from2007April, the mean operative times were72.95±10.70minutes and87.14±11.23minutes respectively, the difference was statistically significant(P=0.00). Computer-assisted spine navigation has overall demonstrated shorter mean radioactive ray exposure time when compared with conventional technique; an average of6.6seconds less per case (P=0.000.)
Conclusion:①Computer-assisted navigation system can increase accuracy of thoracic pedicle screw fixation obviously.②Computer-assisted navigation system obviously decurtate the operation time and exposure time of X-ray.③This study confirm that computer-assisted navigation system is a useful technique and deserved to be spreaded.
PartⅢClinical application of computer-assisted navigation system
-Total knee arthroplasty assisted by CT-based navigation system
Objective:To investigate accuracy of prothesis in total knee arthroplasty assisted by CT-based navigation system.
Methods:32cases(36joints) of TKA were perform utilizing CT-based navigation system. From January of2006to December of2006,10cases (12joints) of TKA were performed with conventional method. The differences between two groups in clinical results and blood loss and operating time and mechanical axes were statistically analyzed.
Results:There were significant differences(P<0.05) in parameters about the surgery time and the blood loss and HSS at postoperative3months between control group and navigation assisted group; Radiographic examination between these two groups:the MFTA and STCA of control groups and navigation assisted group with significant difference.
Conclusion:①Computer-assisted navigation system in TKA can obtain reliable clinical results with better mechanical axes.②Computer-assisted navigation system in TKA can decrease blood loss,it is a safe and reliable procedure in TKA.
引文
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