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

1、Disc height and motion patterns in the lumbar spine in patients operatedCONSORT 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Disc height and motion patterns in the lumbar spine in patients operatedwith total disc replacement or fusion for discogenic back pain.Results from a randomized controlled trial

2、是1b结构式摘要，包括试验设计、方法、结果、结论几个部分BACKGROUND CONTEXT: Fusion is considered the gold standard in surgical treatment ofdegenerated disc disease; the intended postoperative goal is absence of mobility, but treatment mayinduce degeneration in adjacent segments. Total disc replacement (TDR) aims to restore and

3、 main-tain mobility by replacing a painful disc. Little is known about the degree and quality of mobility inartificial discs in vivo and whether maintained mobility reduces the stress on adjacent segments thatis believed to occur after fusion.PURPOSE: To see if surgical goals for respective treatmen

4、ts had been reached, if clinical outcomewas related to this, and if differences in disc height at treated segments and adjacent segment mo-tion patterns between groups occurred.STUDY DESIGN: Comparison of X-ray measurements in a randomized controlled trial betweeninstrumented posterior fusion and TD

5、R for chronic low back pain (CLBP) assumed to be discogenic.Results were compared with clinical outcome.PATIENT SAMPLE: The material consisted of 152 patients suffering from CLBP assumed to bediscogenic. Seventy-two patients were treated with fusion and 80 with TDR.OUTCOME MEASURES: Results of X-ray

6、 measurements were compared between groups andrelated to self-reported clinical results regarding back pain and disability.METHODS: Flexion-extension X-rays were analyzed preoperatively and 2 years postoperativelyusing distortion-compensated Roentgen analysis (DCRA) at treated and adjacent levels, a

7、nd mobil-ity after fusion and TDR was estimated. Changes in disc height and range of motion (ROM) respec-tive translation in adjacent segments were compared between groups. Results of DCRAmeasurements were also compared with the clinical outcome.RESULTS: Preoperative flexion-extension ROM was simila

8、r between the fusion and TDR groups,and preoperative disc heights of segments to be treated were between one and two standard devi-ation less than that previously established in a normative database. Seventy percent of fused patientshad no mobility, whereas 85% of TDR patients were mobile. Fulfillme

9、nt of surgical goals was cor-related to neither back pain nor disability. Fused segments were lower and TDR segments werehigher than normative values postoperatively. There were also significant differences at adjacentsegments, there being more translation and flexion-extension in the fusion group t

10、han in theTDR group.CONCLUSIONS: This very accurate X-ray method (DCRA) indicates that surgical goals werereached in most patients. This, however, was not correlated to clinical outcome. Differences be-tween the groups in postoperative disc height at treated segments, respective ROM, and translation

11、引言背景和目的2a科学背景和对试验理由的解释For several decades, fusion of the lumbar spine has beenthe standard surgical treatment for painful degenerative discdisease (DDD). However, in current treatment of other jointdiseases, fusion has almost been completely abandoned infavor of artificial joints. Therefore, it woul

12、d appear logicalto replace a degenerated disc with a prosthesis, becausefusion might create increased motion, degeneration, andpain at adjacent segments. In patients suffering fromDDD, a disc prosthesis could relieve clinical symptoms, re-storing morphology and kinematics of the segment and alsoalig

13、nment of the intervertebral joints to maintain physiolog-ical function. Furthermore, total disc replacement (TDR)could reduce pain without increasing stress and loads inadjacent segments, one of the side effects associated withfusion 14. Results of long-term and short-term studiesof TDR indicate goo

14、d to excellent clinical effects 513.Only a few reports, however, examined whether the basicaim of arthroplastythat is, the maintenance or restorationof segmental mobilityis actually achieved. Furthermore,published findings are inconsistent and to some extent con-tradictory2b具体目的或假设This study has fou

15、r main aims:1. To evaluate whether the primary surgical mechanicalgoalsthat is, to create a stable fusion or to restore/maintain mobility after TDRwere achieved.2. To evaluate whether there was a correlation betweenclinical outcome and successful fusion and successfulTDR.3. To evaluate whether there

16、 was any difference in ROMin adjacent segments after spinal fusion and TDR.4. To evaluate whether there was any change in discheight and alignment of treated and adjacent seg-ments after surgery and to compare effects betweenspinal fusion and TDR.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

17、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Inclusion and exclusion criteria are shown in Table 1.4b资料收集的场所和地点trial was performed at theStockholm Spine Center in Stockholm, 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The primary outcome measure was the ach

18、ievement ofpostoperative mobility goals, measured radiographically.This outcome was compared between the fusion and theTDR groups. For fusion, the primary surgical goal was theabsence of mobility in all treated segments; for TDR, thegoal was restoring and maintaining mobility in all treatedsegments.

19、 Secondary outcome measures the clinical outcome6b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The Lehr formula was used to provide crude estimates ofsample size 24. With 80% power at 5% significance level,the size of each group was estimated at 64 patients. Thesample size was increased to 72 to allow for pot

20、ential dropouts.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For comparison of flexio

21、n-extension ROMs, the actualmeasured degrees were recorded and differences calculated. For these calculations, Student t test, chi-square,and Fisher exact test, Mann-Whitney U test, Pearson prod-uct moment correlation, and the Spearman rank correlationwere used. Alpha (p value) was set to .05.12b附加分

22、析的方法，诸如亚组分析和校正分析Distortion-compensated Roentgen analysis. When performing distortion-compensated Roentgenanalysis (DCRA), the contours of the lumbar vertebraeare hand mapped and digitized, and computer programscheck geometric properties of the contours, objectively locate vertebral corners, and calc

23、ulate the parameters forall segments imaged on a lateral radiograph. In this study,the analysis included vertebrae L1 through S1. In the instances in which radiographs did not cover the entire lum-bar spine, the identical number of vertebrae was mappedand digitized from the preoperative and postoper

24、ative radiographs. In DCRA, disc height and anteroposterior displacement (sagittal alignment) are corrected to standardangles of lordosis. For the purpose of quality control in thisstudy, heights of the cranial and caudal vertebrae of the operated segments, measured from the preoperative and post-op

25、erative pairs of radiographs, were compared. For eachvertebra, the four height values determined preoperativelyand postoperatively in extension and flexion should havecoincided within the limits of the measurement error.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In our clinical outcome study 9

26、, 46 (64%) of the 72patients in the fusion group and 56 (70%) of the 80 patientsin the TDR group reported that they were totally pain free ormuch better at the 2-year follow-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 At the 2-year postoperative follow-up14b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

27、基线数据，包括人口学资料和临床特征Table 2Patient demographics: VAS, EQ-5D, ODI questionnaire, LBP, mean values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）The precision of the DCRAprotocol has previously been validated by specimen experiments and comparison with the gold sta

28、ndard stereophotogrammetric Roentgen analysis 19. This has es-tablished the standard deviation (SD) for DCRA measure-ment error when measuring flexion-extension ROM. TheSD ranges between 1 and 2.3 , the largest error occurringat L5S1 19,2123. Thus, the confidence interval for themeasurement error is

29、 01.96 SD. For the fusion group takenas a whole, the absence of mobility was defined as ROM at thetreated segment being less than the confidence interval for themeasurement error of the method, which is 1.96 times theabove-described SD from specimen experiments.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

30、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From data gained with the very accurate method(DCRA) used in the present study, we conclude that the sur-gical goal was achieved in 78% of treated segments and in70% of patients in the fusion group. Likewise, restored/maintained mobility was achieved in 89% of treated seg-ments and in 85% of TDR patients. Clinical and surgicaloutcome was better in the TDR group compared with thefusion group, but it was not possible to draw any conclusionto explain this difference