| BackgroundCervical disc disorder(CDD),which is also known as cervical spondylosis,has the tendency of younger year by year in the population.Anterior cervical discectomy and fusion(ACDF)and cervical artificial disc replacement(CADR)are acceptable surgical options for CDD patients with neurologic deficit,who underwent conservative treatment are invalid.However,review of the literature showed that the optimal surgical approach for the treatment of single-segmental CDD was still controversial.CADR is at least as effective as ACDF in some randomized studies.In the United States,studies of the costs and benefits of both procedures have been conducted: short-term cost-benefit analyses over 5 and 7 years suggest that CADR may be preferred treatment.According to the Food and Drug Administration,CADR significantly reduces hospital stays and out-of-pocket costs.However,several meta-analyses have found that ACDF can significantly reduce incidence of complications such as reoperation in CDD patients.There is a lack of relevant clinical guidance on how to choose the two surgical methods;At present,there are only a few references,but all studies come from abroad.Since CADR is included in DRG in the United States,then its medical cost is lower than ACDF.In China,material costs of CADR are higher than those of ACDF.With the increasing number of CDD patients year by year,how to balance the economic and surgical benefits has become an important thing for spine surgeons.Moreover,the medical insurance system in China(mainly the new rural cooperative medical care system)is different from that in the United States.We cannot draw a conclusion by referring to the research results in the United States.It's important to find how to achieve individualized treatment of single-segmental CDD and choose the best treatment plan.Thus,it is very important to study the cost-benefit analysis of anterior surgery for single-segmental CDD under the new rural cooperative medical care system in China or Henan.Objective1.To summarize clinical effect of Activ-c cervical intervertebral disc replacement on single segmental CDD for at least 5 years follow up.2.To analyze and discuss the epidemiology and risk factors of heterotopic ossification(HO)after CADR.3.Using the EAT-10 tool to evaluate the potential risk factors of postoperative(single-segmental ACDF and CADR)dysphagia and the degree of influence on dysphagia at different postoperative time points.4.To explore and analyze the differences between ACDF and CADR in the treatment for single-segmental CDD under the new rural cooperative medical care system and the economic benefit ratio of these patients,so as to provide a reference for clinicians' surgical decision from the economic benefit.Method1.A retrospective analysis was performed on patients with single-segmental CDD treated by ACDF or CADR who were admitted in the department of Orthopedics,the First Affiliated Hospital of Zhengzhou University from January2012 to December 2017.2.Hospital information system(HIS)was used to retrieve all the medical records of eligible single-segmental CDD patients admitted to department of Orthopedics in our hospital,including the demographic characteristics of the patients one by one,the information related to the operation,such as the operation time,complications,hospitalization costs and other information.All evaluation data for patients was collected,using telephone follow-up system,outpatient follow-up survey and other methods.3.Picture archiving and communication system(PACS)was used to measure and evaluate various imaging features of patients before and after surgery,such as phenomenon of postoperative heterotopic ossification from CADR,cervical curvature index(CCI),range of motion(ROM),Facet joint Angle,intervertebral disc Angle on surgical segment(IDA),cervical functional spinal unit Angle(CFSUA),T1-slope(T1S),cervical(C)2-7cobb Angle,etc.4.According to different surgical methods,eligible patients were divided into CADR group and ACDF group.According to whether HO was incorporated or not,CADR group was divided into HO group and non-HO group.Degree of postoperative dysphagia was evaluated referring to the EAT-10 tool.According to the clinical efficacy advantage,the advantage group of the treatment method was screened.Then economic benefit ratio was calculated for the advantage group.Result1.A total of 535 patients who underwent ACDF or CADR surgery were evaluated for long-term(5-year)follow up.At the end of 5-year follow-up,a total of243 patients were included in the study group,including 65 CADR patients(52.2%-rate of lost for follow-up)and178 ACDF patients(55.4%-rate of lost for follow-up).Baseline characteristics and preoperative clinical measurements were similar in both groups.The neurological success rate,VAS scores in the arm and neck,and JOA scores in the two groups were similar(P>0.05).At 60 months-follow-up,patients in the CADR group were better than those in the ACDF group in terms of the mean NDI(%)score,Physical component summary(PCS)in SF-36,ROM in the surgical segment,CCI and global range of motion(GROM)(P<0.05).2.At 5 years-follow-up,the incidence of HO in the CADR group was 16.9%,and the HO group was similar to the non-HO group in terms of improving neurological function and alleviating pain(P>0.05).Among the preoperative correlation factors,age(older)was significantly correlated with the occurrence of HO(rs=0.632,P=0.000).Low T1-S was also a high risk factor for HO(rs=0.714,P=0.000).The results of CFSUA were similar to T1-S(rs=0.563,P=0.000),and the smaller CFSUA may be one risk factor for HO.T1-S has a weak positive correlation with CFSUA(rs=0.266,P=0.032).Among the postoperative related factors,the significant decreasing in Facet Angle may be one of the high-risk factors for HO(rs=0.478,P=0.000).Decreasing in IDA Angle is similar to the result of Facet Angle.It may also be a risk factor for HO(rs=0.506,P=0.000).3.A total of 179 patients were assessed for dysphagia.These items were associated with early postoperative dysphagia(1day),such as younger(less than 50 years old)patients(OR=1.05,95%CI=1.02-1.08),female(OR=2.99,95%CI=1.48-6.10),increased operation time(more than 90 minutes)(OR=1.11,95%CI=1.09-1.13),treatment by ACDF(OR=3.02,95%CI =1.69-7.03)and T1-S(°)was more than 30(OR=3.11,95%CI =1.89-7.12).T1-S(°)over 30 was associated with dysphagia at 2 weeks after surgery(OR=3.58,95%CI=11.54-8.21).At 6 weeks postoperatively,a history of post-anesthetic vomiting(OR=3.93,95%CI =1.08-13.96)was associated with a greater risk of dysphagia,and c5/6 level surgery(OR=0.32,95%CI =0.12-0.79)was associated with lower risk of dysphagia.At 3 months postoperatively,ACDF(OR=4.03,95%CI =1.36-9.35)remained an increased risk factor for dysphagia.Higher T1-S(OR=4.63,95%CI =1.12-11.36)and higher ASA scores(OR=7.96,95%CI =1.55-39.90)were associated with higher incidence of dysphagia in the late postoperative period(12 months),while c5/6 level surgery(OR=0.29,95%CI =0.11-0.76)was associated with lower risk of late postoperative dysphagia.4.Economic benefit ratio analysis was performed on 87 patients with the new rural cooperative medical care payment method,and a total of two clinical efficacy differential indicators were screened out: NDI(%)and JOA score.NDI(%)score within 3 months after surgery,CADR group was the advantage group.1 day after surgery,the overall benefit-economy ratio(H)of the dominant group was 1.44.At 2weeks after surgery,H was 1.17.One month after surgery,H was 1.14.Three months after surgery,the H value was 1.11.The differential benefit-to-economy ratio(I)showed the same trend after surgery,and I ratio was 7.30 reaching its maximum value at one day after surgery.JOA score within 1 month after surgery showed that the CADR group was the advantage group.The overall benefit-economy ratio(H)of the CADR group was 1.81 at one day after surgery.At 2 weeks after surgery,H was 1.65.The H was 1.62 at one month after surgery.The differential benefit-to-economy ratio(I)was 12.56 at one day after surgery and 58.48 two weeks after surgery.At 1 month after surgery,I ratio was 63.56.A treatment decision tree is established according to the benefits and expenses.Conclusion1.CADR could achieve similar clinical efficacy to ACDF in the treatment of single-segmental CDD,and was more advantageous in reducing NDI.CADR could maintain the ROM of the operative segment and the overall cervical curvature,and did not increase the activity of the adjacent segment.2.HO did not affect the cervical curvature and global range of motion on CADR patients.Clinical efficacy of CADR could still be preserved.Smaller T1-S,decreased intervertebral disc Angle(IDA),and decreased Facet Angle might be risk factors for the occurrence of HO after CADR.3.EAT-10 could be used for quantitative analysis of dysphagia after single-segment ACDF or CADR.T1-S ?30°,age ?50 years,female,prolonged operation time,surgical method of ACDF,history of vomiting after anesthesia and high ASA score were all risk factors for postoperative dysphagia of single-segmental ACDF or CADR.4.According to surgical indications,both ACDF and CADR could be chosen for treating patients with single-segmentel CDD.Both of them could obtain good clinical efficacy,and the patients paid the same out-of-pocket cost.Using same cost,CADR group was able to gain more therapeutic advantages in decreasing NDI(%)and improving JOA in the short term.Therapeutic benefits could be affected by wage of patients.5.Referring to the treatment decision tree,the best clinical advice can be given to patients with single-segment CDD according to surgical benefits and expenses. |
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