Disc height and motion patterns in the lumbar spine in patients operated.docx
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Discheightandmotionpatternsinthelumbarspineinpatientsoperated
CONSORT清单评价RCT论文
论文
部分
条目
内容
评价
VAS
文题
摘要
1a
文题能识别是随机临床试验
Discheightandmotionpatternsinthelumbarspineinpatientsoperated
withtotaldiscreplacementorfusionfordiscogenicbackpain.
Resultsfromarandomizedcontrolledtrial
是
1b
结构式摘要,包括试验设计、方法、结果、结论几个部分
BACKGROUNDCONTEXT:
Fusionisconsideredthe‘‘goldstandard’’insurgicaltreatmentof
degenerateddiscdisease;theintendedpostoperativegoalisabsenceofmobility,buttreatmentmay
inducedegenerationinadjacentsegments.Totaldiscreplacement(TDR)aimstorestoreandmain-
tainmobilitybyreplacingapainfuldisc.Littleisknownaboutthedegreeandqualityofmobilityin
artificialdiscsinvivoandwhethermaintainedmobilityreducesthestressonadjacentsegmentsthat
isbelievedtooccurafterfusion.
PURPOSE:
Toseeifsurgicalgoalsforrespectivetreatmentshadbeenreached,ifclinicaloutcome
wasrelatedtothis,andifdifferencesindischeightattreatedsegmentsandadjacentsegmentmo-
tionpatternsbetweengroupsoccurred.
STUDYDESIGN:
ComparisonofX-raymeasurementsinarandomizedcontrolledtrialbetween
instrumentedposteriorfusionandTDRforchroniclowbackpain(CLBP)assumedtobediscogenic.
Resultswerecomparedwithclinicaloutcome.
PATIENTSAMPLE:
Thematerialconsistedof152patientssufferingfromCLBPassumedtobe
discogenic.Seventy-twopatientsweretreatedwithfusionand80withTDR.
OUTCOMEMEASURES:
ResultsofX-raymeasurementswerecomparedbetweengroupsand
relatedtoself-reportedclinicalresultsregardingbackpainanddisability.
METHODS:
Flexion-extensionX-rayswereanalyzedpreoperativelyand2yearspostoperatively
usingdistortion-compensatedRoentgenanalysis(DCRA)attreatedandadjacentlevels,andmobil-
ityafterfusionandTDRwasestimated.Changesindischeightandrangeofmotion(ROM)respec-
tivetranslationinadjacentsegmentswerecomparedbetweengroups.ResultsofDCRA
measurementswerealsocomparedwiththeclinicaloutcome.
RESULTS:
Preoperativeflexion-extensionROMwassimilarbetweenthefusionandTDRgroups,
andpreoperativedischeightsofsegmentstobetreatedwerebetweenoneandtwostandarddevi-
ationlessthanthatpreviouslyestablishedinanormativedatabase.Seventypercentoffusedpatients
hadnomobility,whereas85%ofTDRpatientsweremobile.Fulfillmentofsurgicalgoalswascor-
relatedtoneitherbackpainnordisability.FusedsegmentswerelowerandTDRsegmentswere
higherthannormativevaluespostoperatively.Therewerealsosignificantdifferencesatadjacent
segments,therebeingmoretranslationandflexion-extensioninthefusiongroupthaninthe
TDRgroup.
CONCLUSIONS:
ThisveryaccurateX-raymethod(DCRA)indicatesthatsurgicalgoalswere
reachedinmostpatients.This,however,wasnotcorrelatedtoclinicaloutcome.Differencesbe-
tweenthegroupsinpostoperativedischeightattreatedsegments,respectiveROM,andtranslation
引言
背景和
目的
2a
科学背景和对试验理由的解释
Forseveraldecades,fusionofthelumbarspinehasbeen
thestandardsurgicaltreatmentforpainfuldegenerativedisc
disease(DDD).However,incurrenttreatmentofotherjoint
diseases,fusionhasalmostbeencompletelyabandonedin
favorofartificialjoints.Therefore,itwouldappearlogical
toreplaceadegenerateddiscwithaprosthesis,because
fusionmightcreateincreasedmotion,degeneration,and
painatadjacentsegments.Inpatientssufferingfrom
DDD,adiscprosthesiscouldrelieveclinicalsymptoms,re-
storingmorphologyandkinematicsofthesegmentandalso
alignmentoftheintervertebraljointstomaintainphysiolog-
icalfunction.Furthermore,totaldiscreplacement(TDR)
couldreducepainwithoutincreasingstressandloadsin
adjacentsegments,oneofthesideeffectsassociatedwith
fusion[1–4].Resultsoflong-termandshort-termstudies
ofTDRindicategoodtoexcellentclinicaleffects[5–13].
Onlyafewreports,however,examinedwhetherthebasic
aimofarthroplasty—thatis,themaintenanceorrestoration
ofsegmentalmobility—isactuallyachieved.Furthermore,
publishedfindingsareinconsistentandtosomeextentcon-
tradictory
2b
具体目的或假设
Thisstudyhasfourmainaims:
1.Toevaluatewhethertheprimarysurgicalmechanical
goals—thatis,tocreateastablefusionortorestore/
maintainmobilityafterTDR—wereachieved.
2.Toevaluatewhethertherewasacorrelationbetween
clinicaloutcomeandsuccessfulfusionandsuccessful
TDR.
3.ToevaluatewhethertherewasanydifferenceinROM
inadjacentsegmentsafterspinalfusionandTDR.
4.Toevaluatewhethertherewasanychangeindisc
heightandalignmentoftreatedandadjacentseg-
mentsaftersurgeryandtocompareeffectsbetween
spinalfusionandTDR.
方法
试验
设计
3a
描述试验设计(诸如平行设计、析因设计)包括受试者分配入各组的比例
3b
试验开始后对试验方法所作的重要改变(如合格受试者的挑选标准),并说明原因
受试
者
4a
受试者的合格标准
InclusionandexclusioncriteriaareshowninTable1.
4b
资料收集的场所和地点
trialwasperformedatthe
StockholmSpineCenterinStockholm,Sweden[9]
干预
措施
5
详细描述各组干预措施的细节以使他人能够重复,包括它们实际上是在何时、如何实施的
结局
指标
6a
完整而确切的说明预先设定的主要和次要结局指标,包括它们是何时、如何测评的
Theprimaryoutcomemeasurewastheachievementof
postoperativemobilitygoals,measuredradiographically.
Thisoutcomewascomparedbetweenthefusionandthe
TDRgroups.Forfusion,theprimarysurgicalgoalwasthe
absenceofmobilityinalltreatedsegments;forTDR,the
goalwasrestoringandmaintainingmobilityinalltreated
segments.Secondaryoutcomemeasurestheclinicaloutcome
6b
试验开始后对结局指标是否有任何更改,并说明原因
样本量
7a
如何确定样本量
TheLehrformulawasusedtoprovidecrudeestimatesof
samplesize[24].With80%powerat5%significancelevel,thesizeofeachgroupwasestimatedat64patients.The
samplesizewasincreasedto72toallowforpotentialdropouts.
7b
必要时,解释中期分析和试验中止原则
随机方法
序列
产生
8a
产生随机分配序列的方法
8b
随机方法的类型,任何限定的细节(怎样分区组和各区组样本多少)
分配
隐藏
9
用于执行随机分配序列的机制(如编按序编码的封藏法),描述干预措施分配之前为隐藏序列号所采取的步骤
实施
10
谁产生随机分配序列,谁招募受试者,谁给受试者分配干预措施
盲法
11a
如果实施了盲法,分配干预措施之后对谁设盲(例如受试者、医护提供者、结局评估者),以及盲法是如何实施的
11b
如有必要,描述干预措施的相似之处
统计学方法
12a
用于比较各组主要和次要结局指标的统计学方法
Forcomparisonofflexion-extensionROMs,theactual
measureddegreeswererecordedanddifferencescalculated.Forthesecalculations,Studentttest,chi-square,
andFisherexacttest,Mann-WhitneyUtest,Pearsonprod-
uctmomentcorrelation,andtheSpearmanrankcorrelation
wereused.Alpha(pvalue)wassetto.05.
12b
附加分析的方法,诸如亚组分析和校正分析
Distortion-compensatedRoentgenanalysis.Whenperformingdistortion-compensatedRoentgen
analysis(DCRA),thecontoursofthelumbarvertebrae
arehandmappedanddigitized,andcomputerprograms
checkgeometricpropertiesofthecontours,objectivelylocatevertebral‘‘corners,’’andcalculatetheparametersfor
allsegmentsimagedonalateralradiograph.Inthisstudy,
theanalysisincludedvertebraeL1throughS1.Intheinstancesinwhichradiographsdidnotcovertheentirelum-
barspine,theidenticalnumberofvertebraewasmapped
anddigitizedfromthepreoperativeandpostoperativeradiographs.InDCRA,discheightandanteroposteriordisplacement(sagittalalignment)arecorrectedtostandard
anglesoflordosis.Forthepurposeofqualitycontrolinthis
study,heightsofthecranialandcaudalvertebraeoftheoperatedsegments,measuredfromthepreoperativeandpost-operativepairsofradiographs,werecompared.Foreach
vertebra,thefourheightvaluesdeterminedpreoperatively
andpostoperativelyinextensionandflexionshouldhave
coincidedwithinthelimitsofthemeasurementerror.
结果
受试者流程
13a
随机分配到各组的受试者例数,接收已知分配治疗的例数,以及纳入主要结局分析的例数
Inourclinicaloutcomestudy[9],46(64%)ofthe72
patientsinthefusiongroupand56(70%)ofthe80patients
intheTDRgroupreportedthattheyweretotallypainfreeor
muchbetteratthe2-yearfollow-up.
13b
随机分组后,各组脱落和被剔除的例数,并说明原因
募集
受试者
14a
招募期和随访时间的长短,并说明具体日期
Atthe2-yearpostoperativefollow-up
14b
为什么试验中断或停止
基线
资料
15
用一张表格列出每组受试者的基线数据,包括人口学资料和临床特征
Table2
Patientdemographics:
VAS,EQ-5D,ODIquestionnaire,LBP,meanvalues
纳入
分析例数
16
各组纳入每种分析的受试者数目(分母),以及是否按最初的分组分析
是
结果和估计值
17a
各组每一项主要和次要结局指标的结果,效应估计值及其精确性(如95%可信区间)
TheprecisionoftheDCRA
protocolhaspreviouslybeenvalidatedbyspecimenexperimentsandcomparisonwiththe‘‘goldstandard’stereophotogrammetricRoentgenanalysis[19].Thishases-
tablishedthestandarddeviation(SD)forDCRAmeasure-
menterrorwhenmeasuringflexion-extensionROM.The
SDrangesbetween1and2.3,thelargesterroroccurring
atL5–S1[19,21–23].Thus,theconfidenceintervalforthe
measurementerroris0þ1.96SD.Forthefusiongrouptaken
asawhole,theabsenceofmobilitywasdefinedasROMatthe
treatedsegmentbeinglessthantheconfidenceintervalforthe
measurementerrorofthemethod,whichis1.96timesthe
above-describedSDfromspecimenexperiments.
17b
对于二分类结局,建议同时提供相对效应值和绝对效应值
辅助
分析
18
所做的其他分析结果,包括亚组分析和校正分析,指出哪些是预先设定的,哪些是新尝试的分析
危害
19
各组出现的所有严重危害或意外效应
讨论
局限性
20
试验的局限性,报告潜在偏倚和不精确的原因,以及出现多种分析结果的原因
Fromdatagainedwiththeveryaccuratemethod
(DCRA)usedinthepresentstudy,weconcludethatthesur-
gicalgoalwasachievedin78%oftreatedsegmentsandin
70%ofpatientsinthefusiongroup.Likewise,restored/
maintainedmobilitywasachievedin89%oftreatedseg-
mentsandin85%ofTDRpatients.Clinicalandsurgical
outcomewasbetterintheTDRgroupcomparedwiththe
fusiongroup,butitwasnotpossibletodrawanyconclusion
toexplainthisdifference