Prospective randomized study of the Charite artificial disc data from two investigational center

《Prospective randomized study of the Charite artificial disc data from two investigational center》由会员上传分享，免费在线阅读，更多相关内容在教育资源-天天文库。

1、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ProspectiverandomizedstudyoftheCharite´artificialdisc:datafromtwoinvestigationalcenters否1b结构式摘要，包括试验设计、方法、结果、结论几个部分BACKGROUNDCONTEXT:Fordecadestherehasbeenadesiretorestoremotionofapainfuldegeneratedspinalsegment.ArtificialdiscshavebeenusedinEuro

2、peforalmost20years.Inthefewreportsavailableintheliterature,theresultshavebeenpromising.However,therehavebeennoprospectiverandomizedstudiescomparingartificialdiscswithspinalfusion.PURPOSE:ThepurposeofthisstudywastodetermineifpatientswithsymptomaticdegenerativediscdiseasetreatedwithCharite´art

3、ificialdisc(DePuySpine,Raynham,MA)arthroplastywouldshowsignificantimprovementinfunctionaloutcomemeasuresandtocomparetheseresultstofusion.STUDYDESIGN/SETTING:Thiswasaprospectiverandomizedclinicaltrialcomparingtotaldiscreplacementwithanteriorlumbarinterbodyfusionusingcages.Thedatareportedwerec

4、ollectedfromtwospinespecialtycentersparticipatinginaFoodandDrugAdministrationregulatedtrial.新疆中医医院医学统计咨询室制第10页共10页METHODS:Aconsecutiveseriesof144patientswererandomizedusinga2:1ratioofCharite´versusBAK(ZimmerSpine,Minneapolis,MN).Allpatientswerebeingtreatedforsingle-leveldiscogenicpainconfirm

5、edbyplainradiography,magneticresonanceimagingandprovocativediscography.Datawerecollectedatdesignatedfollow-upperiodsforupto24months.RESULTS:Themeanagewas40.1years(range,21to56years).Forty-fourcaseshadBAKanteriorinterbodyfusion,and100caseswererandomizedtoCharite´discreplacement.Themeanoperati

6、ngtimewas76.2minutes(range,54to137minutes)fortheCharite´cases.Themeanestimatedbloodlosswas196.2cc(range,50to1,800cc).Mostpatientsweredischargedin1to2dayswithasoftcorsetandreturnedtonormalactivitieswithin3weeksiftheyunderwentthediscreplacement.ThemeanOswestryDisabilityIndexscorefortheBAKgroup

7、was69.612.8preoperativelyand27.526.4at24-monthfollow-up(p.001)ThecorrespondingmeanOswestryscorefortheCharite´discpatientswas70.9preoperativelyand30.0at24-monthfollow-up(p.001).CONCLUSIONS:Inthisprospectiverandomizedstudy,bothsurgicalgroupsimproveds