| Background: Ossification of the posterior longitudinal ligament(OPLL)is defined as ectopic bone formation of the posterior longitudinal ligament and can cause clinical manifestations by the compressed of spinal cord.Although pathogenesis of OPLL is closely related to a variety of genetic and environmental factors,its accurate physiopathologic mechanism is still unclear.Patients without obvious symptoms should be treated conservatively first,while patients who have developed symptoms of spinal cord compression should be considered for surgical intervention.A number of studies have shown that the size and shape of the ossified mass and compressed segments have a significant influence on the choice of the surgical method.Surgery is the only effective way to relieve OPLL compression and it is mainly divided into two types: anterior approach and posterior approach.The former has positive expected effects through direct decompression,but has high technical requirements for the operator,high surgical risks,high risk of spinal cord injury in the operation,as well as high occurrence of postoperative complications like cerebrospinal fluid leakage.The latter is relatively simpler through indirect decompression which is probably unsatisfactory.Besides,the progression of the ossified mass may lead to the recurrence of the spinal cord compression,severe surgical trauma,and other deficiencies.Most scholars believe that both surgical approaches improve the neurological function,and no significant difference has been found in the long-term clinical efficacy study.However,when the compression segments of the ossified mass ≥3,the surgeon is more inclined to choose the posterior approach.In order to remove compression and avoid aggravating spinal cord injury caused by the operation encroachment,we designed the surgical method of anterior cervical ossified posterior longitudinal ligament en bloc resection(ACOE),treated by which over 100 patients had good ourcomes in recent years.In order to evaluate the early clinical curative effect of the surgical method more scientifically,and differences between ACOE and posterior laminectomy and fusion,we designed a randomized controlled trial.40 cases were included and divided into groups in a mathematical random way.The ACOE surgery group and the posterior total laminectomy and fusion with bone graft and internal fixation(PTLF)surgery group.The basic data,function scores,surgical procedures,curative effect,complications and adverse events of all enrolled patients were recorded in detail and data were archived.Finally,the differences in curative effect of the two surgical methods were described through statistical analysis,in order to confirm the safety and effectiveness of ACOE,and define the indications of the two different surgical methods.This study was reviewed by the hospital ethics committee(2017SL015).Objective: A single center open randomized controlled trial was carried out,to discuss the early clinical curative effect of ACOE and PTLF in the treatment of OPLL,and confirm its safety and effectiveness.Methods: In accordance with the included and excluded criteria,and according to the actual situation of the single center,it was estimated that about 40 OPLL patients were enrolled in the group from July 2017 to September 2019.After signing the informed consent and filling in the case report forms,patients were randomly divided into ACOE group or PTLF group by mathematical random method.All surgeries were performed by the same surgeon.During follow-up,the basic epidemiological data,perioperative parameters,neurological function recovery,X-ray examination results,and complication incidence were statistically analyzed.SPSS25.0 statistical software was used for statistical analysis.Chi-square test was used for qualitative data and T test for quantitative data.P <0.05 was defined as statistically significant.Results: A total of 40 patients were enrolled in the clinical study,of which 22 patients underwent ACOE surgery and 18 patients underwent PTLF surgery.There was no significant difference in the epidemiological data such as gender and age between the two groups(p > 0.05)and all patients were followed up regularly for more than 6 months.The results showed that there was no statistical difference between surgery time and hospital stays in the two groups(p>0.05),but the amount of blood loss during surgery in ACOE group was significantly less than that in PTLF group(p<0.05).Postoperative JOA score and improvement rate,postoperative VAS score and reduction value,postoperative NDI index and improvement value,postoperative SF-36 life quality scale score and improvement value were all not statistically different between the two groups(p>0.05).The postoperative cervical spine curvature in ACOE group was significantly better than that in PTLF group(p<0.05),and the postoperative SVA value in PTLF group was higher(p<0.05).There was no statistical difference in postoperative range of motion between the two groups(p>0.05).There was no spinal cord or nerve injury in the two groups.There was no statistical difference in total complications and various types of complications between the two groups(p>0.05).Conclusion: The study results showed that both surgical methods obtained satisfing postoperative clinical results.The patients in ACOE group had less intraoperative blood loss.Both groups showed different degrees of improvement in postoperative neurological function,but there was no statistical difference.ACOE group had better correction and maintenance of cervical spine curvature,but the postoperative SVA value was higher in PTLF group.There was no statistical difference between two groups in terms of postoperative range of motion and occurrence of complications.Patients in ACOE group obtained ideal neurological function improvement and the safety during and after surgery could be fully guaranteed.It was an effective and safe method of anterior approach for OPLL.However,longer follow-up observation was still needed in case there will be recurrence or progression of the ossified mass,or new neurological function declined after surgery. |
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