| BackgroundWith the acceleration of population aging,the prevalence of lumbar disc hernation was increasing year after year.The purposes of traditional lumbar decompression surgery and lumbar fusion surgery were nerve decompression and lumbar stability.Although the outcomes were satisfactory,there was part of patients still had low back pain postoperatively,and several surgical complications had been found during the follow-up.Such as discectomy surgery for lumbar disc herniation,because the normal structure of disc has been destroyed,the range of motion(ROM)was increasing and the facet joint had osteoarthritis et al.And the incident of complications was increasing with the prolonging of time.Otherwise,the surgical segment ROM completely lost after the lumbar fusion surgery,leading the adjacent segment ROM increasing,this may result in the acceleration of degeneration of adjacent segment.Because of improved understanding of lumbar kinematics,increasing number of surgeons now consider how to treat lumbar degenerative disease while maintaining ROM.New materials and techniques have led to the development of many non-fusion techniques and devices,and the most widely used techniques were posterior dynamic stabilization(PDS).The PDS could treat lumbar degenerative diseases and keep lumbar motion so that it had less influence on lumbar motion postoperatively.So far,there were various kinds of PDS devices,and Dynesys,Isobar and K-rod were widely used and reported,and Dynesys was most widely used,it had been reported to treat mono-level,multi-level lumbar degenerative diseases.However,there was still controversy about the advantages of PDS.First,Few article reported the clinical outcomes between the discectomy and PDS.In additional,the influence of adjacent segment by PDS comparing to Fusion surgery was unclear.At last,the influence of lumbar kinematics by PDS was still unclear.Especially,the kinematics of non-surgical segment and lumbar after multi-segment PDS fixation.Our study focus on lumbar degenerative diseases compared the clinical outcomes and radiological results between PDS and traditional lumbar surgery.In order to learn better about the advantages and disadvantages of PDS and clarify the relationship between the PDS and lumbar degeneration.MethodsPart IIt was perspective compared study,and it was approved by the Southwest Hospital Research Ethics Board and registered with the UMIN Clinical Trials Registry.Inclusion criteria : 1.Signed informed consent,2.Age between 18 and 60 years inclusive,3.Radiographic evidence of single level lumbar disc herniation,4.Scheduled for single-level lumbar discectomy with or without fusion or dynamic stabilization,5.Preoperative ODI ? 30,6.Clinical symptoms consistent with lumbar disc herniation determined by history or physical exam: Radicular back or lower extremity pain and/or Decreased muscular strength and/or Abnormal sensation,7.Involved disk at the spinal level between L2 and S1,8.Failed to gain adequate symptom relief from at least one month of adequate non-operative treatment,except in patients with severe symptoms that require immediate surgery(at surgeon's discretion),9.UCLA is level I,10.Absence of significant symptomatic adjacent segment disc herniation.Inclusion criteria:Exclusion criteria: 1.Cauda equina syndrome,2.Previous spinal surgery,except previous discectomy at the same segment,3.Patients with other lumbar conditions that will,in the opinion of the investigator,interfere with clinical outcomes(e.g.spinal structural deformities,spinal fractures,ankylosing spondylitis,spinal tuberculosis,spinal infection,spinal tumors,symptomatic cervical spinal disease),4.Osteoporosis defined as T-score ?-2.5.BMD will be measured by DEXA performed on lumbar spine,5.Systemic infection such as AIDS,HIV,and active hepatitis,6.Recent history(less than 3 years)of chemical substance dependency or significant psychosocial disturbance,which may impact the outcome or study participation,7.Participation in a clinical trial of another investigational drug or device within the past 30 days.The subjects were enrolled according to inclusion and exclusion criterions and signed the consent form.The subjects were divided into two groups: Group A: Lumbar Decompression and PDS fixation,Group B: Discectomy and the Group A was divided into three subgroups by using different PDS devices: A1 Dynesys PDS,A2 K-rod PDS and A3 Isobar PDS.All the groups` clinical outcomes and radiological outcomes were recorded and measured both preoperatively and follow-up.The clinical outcomes were evaluated by back and leg pain Numerical Rating Scale(NRS),Oswestry Disability Index(ODI)and SF-36 questionnaires.The radiological outcomes were evaluated by lumbar AP and Lateral X-ray,Flexion and Extension X-ray and lumbar MRI.The outcomes were successively measured and record at preoperatively and postoperative 1 month,3 months,6 months,12 months and 24 months.Part IIIt was perspective compared study,and it was approved by the Southwest Hospital Research Ethics Board and registered with the UMIN Clinical Trials Registry.Inclusion criteria : 1.Signed informed consent,2.Age between 18 and 60 years inclusive,3.Radiographic evidence of single level lumbar disc herniation,4.Scheduled for single-level lumbar discectomy with or without fusion or dynamic stabilization,5.Preoperative ODI ? 30,6.Clinical symptoms consistent with lumbar disc herniation determined by history or physical exam: Radicular back or lower extremity pain and/or Decreased muscular strength and/or Abnormal sensation,7.Involved disk at the spinal level between L2 and S1,8.Failed to gain adequate symptom relief from at least one month of adequate non-operative treatment,except in patients with severe symptoms that require immediate surgery(at surgeon's discretion),9.UCLA is level II or more severe,10.Absence of significant symptomatic adjacent segment disc herniation.Inclusion criteria : Exclusion criteria: 1.Cauda equina syndrome,2.Previous spinal surgery,except previous discectomy at the same segment,3.Patients with other lumbar conditions that will,in the opinion of the investigator,interfere with clinical outcomes(e.g.spinal structural deformities,spinal fractures,ankylosing spondylitis,spinal tuberculosis,spinal infection,spinal tumors,symptomatic cervical spinal disease),4.Osteoporosis defined as T-score ?-2.5.BMD will be measured by DEXA performed on lumbar spine,5.Systemic infection such as AIDS,HIV,and active hepatitis,6.Recent history(less than 3 years)of chemical substance dependency or significant psychosocial disturbance,which may impact the outcome or study participation,7.Participation in a clinical trial of another investigational drug or device within the past 30 days.The subjects were enrolled according to inclusion and exclusion criterions and signed the consent form.The subjects were divided into two groups: Group A: Lumbar Decompression and Dynesys PDS,Group B: Transforaminal Lumbar Interbody Fusion(TLIF).All the groups` clinical outcomes and radiological outcomes were recorded and measured both preoperatively and follow-up.The clinical outcomes were evaluated by back and leg pain NRS,ODI and SF-36 questionnaires.The radiological outcomes were evaluated by lumbar AP and Lateral X-ray,Flexion and Extension X-ray and lumbar MRI.The outcomes were successively measured and record at preoperatively and postoperative 1 month,3 months,6 months,12 months and 24 months.Part IIIIncluded in this retrospective study were patients with L4-S1 disc herniation who underwent fusion or PDS from September 2010 to September 2014.Inclusion criteria were: ages 18-65 years;clinical symptoms consistent with lumbar degenerative disease(radicular back or lower extremity pain and/or decreased muscular strength and/or abnormal sensation);radiographic evidence of L4-5 and L5-S1 disc degenerative disease(instability,grade I degenerative spondylolisthesis,stenosis,or disc herniation);history of L4-S1 decompression and fusion or Dynesys? stabilization;no symptoms caused by non-surgical levels;at least had two years' follow-up.Exclusion criteria were: cauda equina syndrome;severe osteoporosis;dual-energy X-ray absorptiometry(DXA,previously DEXA)T-score <-3.0;metabolic bone disease,ankylosing spondylitis,spinal deformity,tuberculosis,infection,tumor,or deformity;systemic infection such as acquired immune deficiency syndrome(AIDS)or active hepatitis;mental illness,drug abuse,and/or alcoholism.Clinical outcomes were assessed by preoperative and postoperative Visual Analog Scale(VAS)and ODI.Preoperative and postoperative X-rays assessed ROM of the non-surgical and surgical levels and whole lumbar.MRI assessed degeneration of non-surgical levels.ResultsPart IIn our perspective study,the patients underwent both PDS or discectomy had good outcomes.Patients` back and leg pain relieved apparently,both of groups' patients' lumbar function recovered well.The Group A patients' back and leg pain obviously reduced postoperative 1 month and became stable after it.The Group B patients' back pain declined during 6 months after surgery,but the NRS of back pain increased during the 6 months to 24 months postoperatively.At the postoperative 24 months,there are significantly different between Group A1 and B.the ROM of surgical segment had been reserved in all three groups of Group A postoperatively.However,the Group B surgical segment ROM increased 14% at postoperative 24 months,and there was no surgical segment instability or spondylolisthesis has been found in the Group B.The Group A surgical level disc space height had no declined because PDS offer a good support for the surgical level.However,the surgical level disc height of Group B decreased about 17% at the 24 months follow-up.There is significantly different between Group A and Group B at the 24 months postoperatively.Otherwise,there was no complications in Group A,but there were two cases had recurrence disc herniation in Group B.Part IIIn our perspective study,the patients underwent both PDS or TLIF had good outcomes.Patients` back and leg pain relieved apparently,both of groups' patients' lumbar function recovered well.The Group A patients' back and leg pain obviously reduced postoperative 1 month and became stable after it.It is faster than Group B.The ROM of surgical segment had been reserved about 60% in the Group A postoperatively.Both groups ROM of above adjacent segment increased,the Group B ROM of above adjacent segment increased about 40%,which was much higher than Group A.The MRI results showed that there was 5 case`s surgical adjacent level degenerated accelerated,but no case has been found in Group A.Part IIIA total of 56 consecutive patients were divided into two groups: Group A,PDS;and Group B,fusion.Patient demographics and baseline characteristics were similar in the two groups.In both groups,there was a significant difference between preoperative and postoperative VAS and ODI scores(P<0.05).However,there was a significant difference in 6-month follow-up ODI between the two group(P<0.05).X-rays showed PDS patients partially maintained surgical level ROM,and non-surgical level ROM increased less than in the fusion group.MRI showed adjacent segment degeneration(ASD)in both groups,and patients whose preoperative L3-4 Pfirrmann classification was higher than grade 2 had more ASD than lower than grade 2.Conclusion1.All of three PDS which are Dynesys,Isobar and K-rod and discectomy surgery had good clinical outcomes.Comparing to the discectomy,the PDS surgery not only could relief the patients' pain but also could maintain the clinical outcome and avoid patients' pain becoming worse.2.The PDS could partly reserve the ROM of surgical segment postoperatively and maintain the surgical level disc height.However,the surgical segment ROM increased apparently and disc height decreased significantly after the discectomy surgery.And the PDS surgery reduced the rate of recurrence disc herniation.3.Both the Dynesys PDS and TLIF surgery had good clinical outcomes postoperatively.However,the patients underwent Dynesys PDS recovered faste r than the TLIF.4.Dynesys PDS could keep part ROM of surgical which would have less influence to the above adjacent segment.5.PDS can maintain surgical level ROM,and had less influence on whole and non-surgical level ROM.Following PDS,patients recovered faster and had a better lumbar function.It may be a better choice for multi-level lumbar degenerative diseases. |
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