Disc height and motion patterns in the lumbar spine in patients operated.docx

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Disc height and motion patterns in the lumbar spine in patients operated.docx

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Disc height and motion patterns in the lumbar spine in patients operated.docx

Discheightandmotionpatternsinthelumbarspineinpatientsoperated

CONSORT清单评价RCT论文

论文

部分

条目

内容

评价

VAS

文题

摘要

文题能识别是随机临床试验

Discheightandmotionpatternsinthelumbarspineinpatientsoperated

withtotaldiscreplacementorfusionfordiscogenicbackpain.

Resultsfromarandomizedcontrolledtrial

是

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

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

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

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

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

受试者的合格标准

InclusionandexclusioncriteriaareshowninTable1.

资料收集的场所和地点

trialwasperformedatthe

StockholmSpineCenterinStockholm,Sweden[9]

干预

措施

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

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

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

如何确定样本量

TheLehrformulawasusedtoprovidecrudeestimatesof

samplesize[24].With80%powerat5%significancelevel,thesizeofeachgroupwasestimatedat64patients.The

samplesizewasincreasedto72toallowforpotentialdropouts.

必要时，解释中期分析和试验中止原则

随机方法

序列

产生

产生随机分配序列的方法

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

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

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

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

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

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

各组出现的所有严重危害或意外效应

讨论

局限性

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

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