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成人前交叉韧带断裂的双束与单束重建

Double-bundle versus single-bundle reconstruction for anterior cruciate ligament rupture in adults.

作者信息

Tiamklang Thavatchai, Sumanont Sermsak, Foocharoen Thanit, Laopaiboon Malinee

机构信息

Division of Orthopaedics, Khon Kaen Hospital, Khon Kaen, Thailand.

出版信息

Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD008413. doi: 10.1002/14651858.CD008413.pub2.

Abstract

BACKGROUND

Arthroscopic reconstruction for anterior cruciate ligament rupture is a common orthopaedic procedure. One area of controversy is whether the method of double-bundle reconstruction, which represents the 'more anatomical' approach, gives improved outcomes compared with the more traditional single-bundle reconstruction.

OBJECTIVES

To assess the effects of double-bundle versus single-bundle for anterior cruciate ligament reconstruction in adults with anterior cruciate ligament deficiency.

SEARCH METHODS

We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (to February 2012), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 2), MEDLINE (1966 to February week 3 2012) and EMBASE (1980 to 2012 Week 8). We also searched trial registers, conference proceedings, and contacted authors where necessary.

SELECTION CRITERIA

Randomised and quasi-randomised controlled clinical trials comparing double-bundle versus single-bundle reconstruction for anterior cruciate ligament (ACL) rupture in adults.

DATA COLLECTION AND ANALYSIS

Two review authors independently selected articles, assessed risk of bias and extracted data. We contacted investigators to obtain missing information. Where appropriate, results of comparable studies were pooled.

MAIN RESULTS

Seventeen trials were included. These involved 1433 people, mostly young physically active adults. All included trials had methodological weaknesses and were at risk of bias, notably selection bias from inadequate or lack of allocation concealment. Data for pooling individual outcomes were available for a maximum of nine trials and 54% of participants.There were no statistically or clinically significant differences between double-bundle and single-bundle reconstruction in the subjective functional knee scores (subjective IKDC score, Tegner activity score, Lysholm score) in the intermediate (six months up to two years since surgery) or long term (two to five years from surgery). For example, the long term results for the Lysholm score (0 to 100: best score) were: mean difference (MD) 0.12, 95% confidence interval (CI) -1.50 to 1.75; 5 trials, 263 participants). The only trial reporting on long term knee pain found no statistically significant differences between the two groups. There were no significant differences between the two groups in adverse effects and complications (e.g. infection reported by nine trials (7/285 versus 7/393; risk ratio (RR) 1.14, 95% CI 0.46 to 2.81); graft failure reported by six trials (1/169 versus 4/185; RR 0.45; 95% CI 0.07 to 2.90).Limited data from five trials found a better return to pre-injury level of activity after double-bundle reconstruction (147/162 versus 208/255; RR 1.15, 95% CI 1.07 to 1.25). At long term follow-up, there were statistically significant differences in favour of double-bundle reconstruction for IKDC knee examination (normal or nearly normal categories: 325/344 versus 386/429; RR 1.05, 95% CI 1.01 to 1.08; 9 trials), knee stability measured with KT-1000 arthrometer (MD -0.74 mm, 95% CI -1.10 to -0.37; 5 trials, 363 participants) and rotational knee stability tested by the pivot-shift test (normal or nearly normal categories: 293/298 versus 382/415; RR 1.06, 95% CI 1.02 to 1.09; 9 trials). There were also statistically significant differences in favour of double-bundle reconstruction for newly occurring meniscal injury (9/240 versus 24/358; RR 0.46, 95% CI 0.23 to 0.92; 6 trials) and traumatic ACL rupture (1/120 versus 8/149; RR 0.17, 95% CI 0.03 to 0.96; 3 trials). There were no statistically significant differences found between the two groups in range of motion (flexion and extension) deficits.

AUTHORS' CONCLUSIONS: There is insufficient evidence to determine the relative effectiveness of double-bundle and single-bundle reconstruction for anterior cruciate ligament rupture in adults, although there is limited evidence that double-bundle ACL reconstruction has some superior results in objective measurements of knee stability and protection against repeat ACL rupture or a new meniscal injury. High quality, large and appropriately reported randomised controlled trials of double-bundle versus single-bundle reconstruction for anterior cruciate ligament rupture in adults appear justified.

摘要

背景

前交叉韧带断裂的关节镜重建是一种常见的骨科手术。一个存在争议的领域是,代表“更符合解剖学原理”方法的双束重建与更传统的单束重建相比,是否能带来更好的治疗效果。

目的

评估双束重建与单束重建对前交叉韧带缺失的成年患者进行前交叉韧带重建的效果。

检索方法

我们检索了Cochrane骨、关节与肌肉创伤组专业注册库(截至2012年2月)、Cochrane对照试验中心注册库(CENTRAL)(《Cochrane图书馆》2012年第2期)、MEDLINE(1966年至2012年2月第3周)和EMBASE(1980年至2012年第8周)。我们还检索了试验注册库、会议论文集,并在必要时联系了作者。

入选标准

比较双束重建与单束重建治疗成年患者前交叉韧带(ACL)断裂的随机和半随机对照临床试验。

数据收集与分析

两位综述作者独立选择文章、评估偏倚风险并提取数据。我们联系研究者以获取缺失信息。在适当情况下,合并可比研究的结果。

主要结果

纳入了17项试验。这些试验涉及1433人,大多数是身体活跃的年轻成年人。所有纳入试验都存在方法学缺陷且有偏倚风险,尤其是因分配隐藏不足或缺乏而导致的选择偏倚。最多有9项试验和54%的参与者可获得合并个体结果的数据。在中期(术后6个月至2年)或长期(术后2至5年),双束重建与单束重建在主观膝关节功能评分(主观国际膝关节文献委员会(IKDC)评分、泰格纳活动评分、莱肖尔姆评分)方面无统计学或临床显著差异。例如,莱肖尔姆评分(0至100分:最高分)的长期结果为:平均差(MD)0.12,95%置信区间(CI)-1.50至1.75;5项试验,263名参与者)。唯一一项报告长期膝关节疼痛的试验发现两组之间无统计学显著差异。两组在不良反应和并发症方面无显著差异(例如,9项试验报告的感染情况(7/285对7/393;风险比(RR)1.14,95%CI 0.46至2.81);6项试验报告的移植物失败情况(1/169对4/185;RR 0.45;95%CI 0.07至2.90)。来自5项试验的有限数据发现,双束重建后恢复到伤前活动水平的情况更好(147/162对208/255;RR 1.15,95%CI 1.07至1.25)。在长期随访中,IKDC膝关节检查(正常或接近正常类别:325/344对386/429;RR 1.05,95%CI 1.01至1.08;9项试验)、使用KT-1000关节测量仪测量的膝关节稳定性(MD -0.74 mm,95%CI -1.10至-0.37;5项试验,363名参与者)以及通过轴移试验测试的膝关节旋转稳定性(正常或接近正常类别:293/298对382/415;RR 1.06,95%CI 1.02至1.09;9项试验)方面,双束重建有统计学显著优势。在新出现的半月板损伤(9/240对24/358;RR 0.46,95%CI 0.23至0.92;6项试验)和创伤性ACL断裂(1/120对8/149;RR 0.17,95%CI 0.03至0.96;3项试验)方面,双束重建也有统计学显著优势。两组在活动范围(屈伸)缺陷方面无统计学显著差异。

作者结论

尚无足够证据确定双束重建与单束重建对成年前交叉韧带断裂的相对有效性,尽管有有限证据表明双束ACL重建在膝关节稳定性的客观测量以及预防再次ACL断裂或新的半月板损伤方面有一些更优结果。开展高质量、大规模且报告恰当的比较双束重建与单束重建治疗成年前交叉韧带断裂的随机对照试验似乎是合理的。

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