Twoyear fusion and clinical outcomes in 224 patients.docx
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Twoyearfusionandclinicaloutcomesin224patients
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
Two-yearfusionandclinicaloutcomesin224patients
treatedwithasingle-levelinstrumentedposterolateralfusion
withiliaccrestbonegraft
否
1b
结构式摘要，包括试验设计、方法、结果、结论几个部分
BACKGROUNDCONTEXT:
Reportedfusionratesforspinefusionsusingiliaccrestbonegraft
（ICBG）varybetween40%and100%becauseofdifferentfusiontechniques,patientcomorbidity,
diagnosisandassessmentcriteria.
PURPOSE:
Wereporttwo-yearresultsofsingle-levelinstrumentedposterolateralfusionsevalu-
atedwithradiographs,fine-cutcomputedtomography（CT）scanswithreconstructionsandoutcome
measures.
STUDYDESIGN/SETTING:
Retrospectiveanalysisofdatafromaprospectivemulticenterran-
domizedclinicalcontrolledtrial.
PATIENTSAMPLE:
Patientswithvariousdegenerativediagnosesenrolledinthecontrolarmof
aFoodandDrugAdministration（FDA）-regulated,multicentertrialofsingle-leveldecompression
andposterolateralfusionfordegenerativelumbardisease.
OUTCOMEMEASURES:
ShortForm-36（SF-36）,OswestryDisabilityIndex（ODI）,Numeric
RatingScales（0–20）forback,leg,andgraftsitepain,CTscans,anteroposteriorandlateralflex-
ion/extensionradiographs.
METHODS:
PatientsenrolledinanFDA-regulated,multicentertrialat29siteswithdegenerative
lumbardiseasetreatedwithsingle-levelinstrumentedposterolateralfusionwithICBGwerein-
cludedintheanalysis.Demographicandsurgicaldatawerecollected.Clinicaloutcomeswerefol-
lowedusingstandardmetrics.Fusionwasassessedbyindependentradiologistsat6,12,and24
monthspostoperatively.Twofusioncriteriawerecompared:
anteroposteriorandflexion/extension
radiographstoassessmotionandbridgingbone,withCTscansasneededtoconfirmbridgingbone;
andCTscanassessmentforbridgingboneonly.
RESULTS:
Onehundredninety-fourof224subjects（86.6%）completedthestudy.Themeanop-
erativetimewas2.9hourswithabloodlossof448.6mL.Theaveragegraftvolumewas36.3mL.
Therewere21（9.4%）woundinfections,18（8.0%）incidentaldurotomies,3（1.3%）implantdis-
placements,2（0.9%）malpositionedimplants,and17（7.6%）graft-relatedcomplications.
Twenty-sevenpatients（13.9%）requiredreoperation,themajorityfornonunions.Fusionratesbased
onradiographswithselectiveCTsat6,12,and24monthswere65.3%,82.5%,and89.3%,respec-
tively.FusionratesbasedonbridgingboneonCTscanswere56.1%,71.5%,83.9%,respectively.
Two-yearimprovementforalloutcomemeasureswassignificant（p!
.001）
d
ODI25.3,SF-36Phys-
icalComponentScore（PCS）12.2,backpain7.9,andlegpain7.1.Twoyearspostoperatively,60%
ofpatientscomplainedofgraftsitepain（meanpainscore58.5）.
引言
背景和
目的
2a
科学背景和对试验理由的解释
Theuseofautogenousbonegrafthaslongbeenconsid-
eredthemostreliablemethodofobtainingasolidspinalfu-
sion.Ithasbeenalmostacenturysincethefirstautograft
fusionwasperformedbyAlbeeandHibbsin1911[1,2].
Subsequently,theuseoftricorticaliliaccrestautograft
foranteriorinterbodyfusionswasintroducedbyMercer
[3]in1936,followedbytheuseofautograftfibulardowels
forspondylolisthesisbySpeed[4].Thereportedfusion
ratesusingdifferentsurgicalandgraftingtechniquesvary
between40%and98%,withnosignificantimprovement
infusionratesoverthepasttwodecades[5],despitethein-
troductionofspinalinstrumentation.
Factorsthatargueagainsttheuseofautograftinclude
theextendedsurgicaltime,increasedbloodlossnecessary
toharvestbonegraft,andmoreimportantlythepersistent
painandmorbidityassociatedwiththeharvestingproce-
dure[6–10].Inanefforttoreducethemorbidityofthese
autograftharvest–relatedcomplications,otherautograft
techniques,surgicalapproaches,andbonegraftsubstitutes
withacceptablefusionrateshavebeenthesubjectofin-
tenseresearch[11–15].However,areliableandaccurate
estimateofautograftfusionrateisnecessarytoestablish
astandardforcomparingvarioustypesofbonegraftsubsti-
tutes（ie,ceramics,demineralizedbonematrix,andbone
morphogeneticproteins）.
2b
具体目的或假设
Thepurposeofthisstudyisto
reportonthefusionrate,asdeterminedbyfine-cutcom-
putedtomography（CT）scanswithsagittalandcoronal
reconstructionsincombinationwithplainradiographs,for
alargeseriesofsingle-levelinstrumentedposterolateral
spinalfusionsusingiliaccrestbonegraft（ICBG）.Depend-
ingonthevariabilityoffusionratebysurgeon,center,and
diagnosis,thisinformationmayallowmoreaccurateexpec-
tations,onthepartofbothsurgeonsandpatients,astothe
relativesuccessofalternativesurgicalfusiontechniques.
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
Theindicationsforsurgeryweresymptomatic,single-level
lumbosacraldegenerativediseasefromL2–L3toL5–S1of
atleast6months’durationthathadnotrespondedtonon-
operativecare.Clinicalsymptomswerelowbackpainwith
orwithoutradicularlegpain.Radiographicstudiescon-
firmedinstability（angulation$5
and/ortranslation
$4mm）,osteophyteformation,decreaseddischeight,
thickeningofligamentoustissue,discdegenerationorher-
niation,orfacetjointdegeneration.Additionalenrollment
criteriawereagrade1orlessspondylolisthesis,noprevi-
ousfusion,andaminimumpreoperativeOswestryDisabil-
ityIndex（ODI）scoreof30.Exclusioncriteriaincluded
apreviousattemptatfusionattheintendedsurgicallevel,
significantosteoporosis（basedonprevioushistoryorless
thantwostandarddeviationsbelownormalondual-energy
X-rayabsorptiometryscanforsubjectswithriskfactorsfor
osteoporosis）,autoimmunedisease,malignancy,infection,
pregnancy,ortheinabilitytoobtainiliaccrestautograft
becauseofapreviousharvest.
4b
资料收集的场所和地点
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
Allpatientsunderwentastandardopenmidlineposterior
approachandweretreatedwithasingle-levelinstrumented
fusionusingCDHorizon（MedtronicSofamorDanek,
Memphis,TN,USA）pediclescrewandrodinstrumentation.Bonegraftfromtheiliaccrestwasobtainedinastandardopenfashion,morselized,andplacedonthe
decorticatedbonysurfaceofthetransverseprocessesand
alongtheparsinterarticularis.Fusionofthefacetjoint
wasnotspecificallyrequiredbytheprotocol.Thevolume
ofgraftharvestedwasrecorded.Anylocalbonegraftobtainedfromthedecompressionwasdiscarded.Nosupplementalinterbodyfusionswereperformed.
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
OutcomemeasuresconsistingoftheODI[16],MedicalOutcomesStudyShortForm-36（SF-36）[17],backpain,legpain,
andbonegraftsitepainnumericratingscalescores
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
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
TheradiographsandCTscanswereevaluatedbytwoindependentradiologistswhowereblindedtowhichpatientgrouptheywereevaluating
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
12b
附加分析的方法，诸如亚组分析和校正分析
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
Table2
Descriptivecharacteristicsofdegeneration
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
Two-year
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
Table1
Demographicandcharacteristicsofdegenerativedisease
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）
Theproportionofpatientstakingweaknarcoticmedica-
tionissignificantlylessat2yearscomparedwithpreoper-
ative（51.8%vs.31.7%,p5.001）.Also,theproportionof
patientstakingstrongnarcoticmedicationissignificantly
lessat2yearscomparedwithpreoperative（18.4%vs.
9.9%,p5.016）.Ofthe224subjects,41.1%wereworking
beforesurgery.At24months,48.4%wereabletoreturn
towork.Two-yearimprovementforalloutcomemeasureswassignificant（p!
.001）
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
Thereareseverallimitationstothisstudy.Thespecific
pathologiesthatrequiredsurgicalinterventionwerevaried
inthepatientpopulation.Localbonegraftharvestedduring
thedecompressionwasdiscarded.Althoughthisisalmost
alwaysneverdoneinclinicalpractice,itwasnecessaryto
dosointhisstudytoaccuratelyevaluatetheefficacyofus-
ingICBGalonetoachievefusion,asthevolumeandqual-
ityofbonegraftharvestedlocallyvarieswidely.The
performanceandradiographicevaluationoffacetfusion
wasnotspecifiedintheprotocol,whichmayunderestimate
thefusionrate.Asinclinicalpractice,mostofthepatients
hadaconcomitantdecompression.Thus,theimprovement
inclinicaloutcomesmaybereflectivenotonlyofthesuc-
cessofthefusion,butofthedecompressionsurgeryas
well.Theratingofthepainfromthedonorsiteishighly
subjectiveandmaybedifficulttodifferentiatefromre-
ferredpainorpainfromthesacro-iliacjoint.
可推
广性
21
实验结果被推广的可能性（外部可靠性，实用性）
AutogenousICBGhaslongbeenconsideredthe
升级会员 