| Research background：Anterior cervical operation is the main method of solving the spinal cord compression, spinal corddecompression, cervical spine fracture, stability and instability of cervical spondylolisthesis caused bycervical intervertebral disc herniation.The main modus of the operation contains anterior cervicalcorpectomy partly，simple discectomy fusion and internal fixation；The main method of fixation is anteriorVertebral titanium plate system.The better clinical effect obtained by the vertebral titanium plate system,However, there is insufficient anterior plate: for example, a large volume of steel, inappropriate choicecould cause leakage of esophageal complications; complex plate, you need to play four vertebrae in nailingdown; cause greater probability o vertebral degeneration; due to steel components more easily causeinternal fixation loosening, back nail; steel without sustained pressure effect, may cause bone does not heal;longer operation time will increase laryngeal nerve, trachea, esophagus and other organ damage. So notonly shorten the operation time to find a more stable fixation can play a role, and internal fixation isessential to overcome these complications.With the rapid development of spinal surgery, the new products of internal fixation continual emerged,and our department use the unique memory and super-elasticity of nickel titanium alloy on the anteriorcervical fixation to do some relative research, and successfully applied to the anterior cervical spinaloperation.There are three types of the nickel titanium memory alloy fixator, immersed in0℃~5℃water, the memory alloy will become soft, which is shaped by a special positioning shaping clamp,andthen use a special insrument clampe into the upper and lower body firmly together of the intervertebralspace which is decompressed, then at36℃±2℃warm water immersion memory alloy, at this time itwill produce a large recovery force to rest ore the original shape, fixing the upper and lower body firmlytogether, avoiding vertebral about bolt, reduce vertebral injury, no fixed titanium bar used, reduce vertebralstability failure relatively.In clinical，the type of GYZ anterior cervical memory fixator reduce theoperation trauma, save operation time, and avoid unnecessary damage. Purpose：1.In the six cases of adult cervical specimens first completely mechanical load test, and then were usedGYZ fixer,anterior cervical plate fixation of the mechanical load, the obtained data compared with eechother, measured angle displacement parameters and displacement distance parameter, to evaluate therationality of the design;2.In clinical,through the follow-up observation of VAS, JOA, cervical NDI,imaging data, bone graft fusion time between the preoperative and postoperative,to evaluate clinical effectof the GYZ fixer.Methods：Select6cases fresh cervical specimens (C3-7) preservated in-20℃low temperature thawed inroom temperature, resection the muscle, reserve the ligament and complete joint capsule, the raw dataloaded obtained after the mechanical load tests, And then both embedded and fixed specimens, remove theC4/5discs and intervertebral bone grafting, fix the C4/5discs with GYZ fixation and demarcate them, alltest specimens fixed in MTS mechanical loading, high speed camera system acquisited the experimentalimage data, import into the software, the calculation of C4, C5vertebral body in flexion, extension, lateralloading loading flexion loading, rotary load point displacement parameters and displacement parameters(lateral displacement, displacement) obtained, and then anterior plate fix the C4, C5vertebrae formechanics loading, analysis of GYZ fixation in vitro specimen fixation stability, to evaluate the rationalityof preliminary design.In clinical, in our department there are46caes between2012May-2013December received anteriorcervical GYZ type fixator and after follow-up of mono segmental cervical disc herniation, an average of2.7years, aged18-65years old, mean (48.8±12.6), including28male cases and female18cases,segmental lesions8cases C3-4,14cases C4-5,20cases C5-6,4cases C6-7,evaluation was performed on allpatients condition changes of preoperative evaluation and cervical function were consistent with cervicalspondylosis operation standard, and met the inclusion criteria.The VAS score, JOA score, cervical NDIscale, imaging,and the time of bone graft fusion are obtained to value the postoperative symptoms. Throughthe comparison of the patient’s conditions before and after the operation and the cervical function,andevaluate deeply the effect of GYZ anterior compression fixator in clinical application. Results：Anteflexion loading displacement parameters flexion angle GYZ4.80±0.70, steel group4.60±0.06,the intact group4.49±0.52, compared with the steel，GYZ group the difference without statisticallysignificant （P＞0.05）;Compared with the intact: the difference was statistically significant（P<0.05）inAnteflexion loading displacement parameters; extension load extension angle displacement parameterGYZ2.39±0.69, the steel2.51±0.88,the intact2.49±0.10, compared with the steel，the GYZ thedifference was statistically significant（P＞0.05）;Compared with the intact:the difference was statisticallysignificant（P<0.05）;The left lateral flexion loading flexion angle displacement parameters in the GYZwere0.52±0.18, the steel0.50±0.10, the intact2.44±0.32, right lateral flexion angle displacementparameters in the GYZ were0.67±0.12, control group0.66±0.11, intact2.64±0.26, complete set oflateral displacement parameters in the GYZ group were1.19±0.18, control group1.16±0.18, intactgroup5.07±0.14, compared with the steel, GYZ:the difference among left right and lateral flexion loadingflexion angle displacement parameters without statistically significant（P＞0.05）;compared with the intactgroup: the difference was statistically significant（P<0.05）；Rotating load displacement parameters leftrotation angle GYZ0.56±0.08, steel group0.47±0.13, intact group2.04±0.19, right rotation angledisplacement parameters in the GYZwere0.44±0.10, steel group0.48±0.09, intact1.91±0.9, the antitorque value of GYZ was1.01±0.14, control group0.95±0.15, intact group3.95±0.15, compared withthe steel group GYZ:the difference was statistically significant（P＞0.05）;compared with the intact group:the difference was statistically significant（P<0.05）.Follow up with VAS scores, JOA score, cervical NDI score, radiographic evaluation after operation3weeks,6weeks,1year,2years,3years and fusion time to evaluate the degree of improvement insymptoms after surgery.Preoperation VAS score was7.1±5.6, JOA score8.9±0.8, cervical NDI score43.6±3.9, spinal cord compression in imaging.The incision of46case were healed by first intention, nocomplication such as cerebrospinal fluid leakage and nerve function damage. Operation time:40-60min,mean(48.24±39.56) min, bleeding50-220ml, mean (90.26±52.13) ml.All of46cases were followed upfor9-36months, average23months. At last follow-up after operation of cervical X-ray and all the GYZfixatords without loosening, interbody without obvious lucent zone between the upper and lower vertebrelinterface, trabecular bone healed well by bone graft, healing time was3.5-8.6months, average4.5months. At the last follow-up VAS score, JOA score, NDI score was2.8±1.2,15.8±1.5,18.1±4.2, andcompare with the preoperative7.1±5.6,8.9±0.8,43.6±3.9，these improved significantly, all thedifferences were statistically significant (t=6.3061p=0.056; t=4.032, p=0.039t=3.231, p=0.024).Conclusion：1. There is no statistical significance difference between the GYZ fixator and the anterior plate on thestability of the cervical.2. The designation of the GYZ fixator conforms with the anatomy and mechanics characteristics ofanterior cervical operation.3. Through the evaluation of the parameter of VAS,JOA and cervical dysfunction index scale andimaging,the clinical effect of GYZ fixator is reliable.4. Shorten the operation time, operated simply, fixed reliably, and reduce the postoperativecomplications, decrease the cost at the same time. |
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