Eggerding Vincent, Reijman Max, Scholten Rob J P M, Verhaar Jan A N, Meuffels Duncan E
Department of Orthopaedics, Erasmus MC, University Medical Center, 's Gravendijkwal 230, Rotterdam, Netherlands, 3000 CA.
Cochrane Database Syst Rev. 2014 Sep 3;2014(9):CD007601. doi: 10.1002/14651858.CD007601.pub4.
Anterior cruciate ligament (ACL) reconstruction is one of the most frequently performed orthopaedic procedures. The most common technical cause of reconstruction failure is graft malpositioning. Computer-assisted surgery (CAS) aims to improve the accuracy of graft placement. Although posterior cruciate ligament (PCL) injury and reconstruction are far less common, PCL reconstruction has comparable difficulties relating to graft placement. This is an update of a Cochrane review first published in 2011.
To assess the effects of computer-assisted reconstruction surgery versus conventional operating techniques for ACL or PCL injuries in adults.
For this update, we searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (from 2010 to July 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 5, 2013), MEDLINE (from 2010 to July 2013), EMBASE (from 2010 to July 2013), CINAHL (from 2010 to July 2013), article references and prospective trial registers.
We included randomized controlled trials (RCTs) and quasi-randomized controlled trials that compared CAS for ACL or PCL reconstruction versus conventional operating techniques not involving CAS.
Two authors independently screened search results, assessed the risk of bias in the studies and extracted data. Where appropriate, we pooled data using risk ratios (RR) or mean differences (MD), both with 95% confidence intervals (CI).
The updated search resulted in the inclusion of one new study. This review now includes five RCTs with 366 participants. There were more female than male participants (70% were female); their ages ranged from 14 to 53 years. All trials involved ACL reconstructions performed by experienced surgeons.Assessing the studies' risk of bias was hampered by poor reporting of trial methods, and consequently several studies were judged to be 'unclear' for several types of bias. One trial presenting primary outcome data was at high risk of detection bias from lack of clinician blinding and attrition bias from an unaccounted loss to follow-up at two years.We found moderate quality evidence (three trials, 193 participants) of no clinically relevant difference between CAS and conventional surgery in International Knee Documentation Committee (IKDC) subjective scores (self-reported measure of knee function; scale of 0 to 100 where 100 was best function). Pooled data from two of these trials (120 participants) showed a small, but clinically irrelevant difference favouring CAS (MD 2.05, 95% CI -2.16 to 6.25). A third trial (73 participants) also found minimal difference in IKDC subjective scores (reported MD 0.2).We found low quality evidence (two trials, 120 participants) showing no difference between the two groups in Lysholm scores, also measured on a scale 0 to 100 where 100 is best function (MD 0.25, 95% CI -3.75 to 4.25). We found very low quality evidence (one trial, 40 participants) showing no difference between the two groups in Tegner scores. We found low quality evidence (three trials, 173 participants) showing the majority of participants in both groups were assessed as having normal or nearly normal knee function (86/87 with CAS versus 84/86 with no CAS; RR 1.01, 95% CI 0.96 to 1.06).Similarly, no differences were found for our secondary outcome measures of knee stability, loss in range of motion and tunnel placement. None of the trials reported on re-operation.No adverse post-surgical events were reported in two trials (133 participants); this outcome was not reported by the other three trials.CAS use was associated with longer operating times compared with conventional operating techniques: the mean difference in operating times reported in the studies ranged between 9 and 27 minutes.
AUTHORS' CONCLUSIONS: From the available evidence, we are unable to demonstrate or refute a favourable effect of CAS for cruciate ligament reconstructions of the knee compared with conventional reconstructions. However, the currently available evidence does not indicate that CAS in knee ligament reconstruction improves outcome. There is a need for improved reporting of future studies of this technology.
前交叉韧带（ACL）重建是最常开展的骨科手术之一。重建失败最常见的技术原因是移植物位置不当。计算机辅助手术（CAS）旨在提高移植物放置的准确性。虽然后交叉韧带（PCL）损伤和重建远不如前交叉韧带常见，但PCL重建在移植物放置方面也存在类似的困难。这是对2011年首次发表的Cochrane系统评价的更新。
评估计算机辅助重建手术与传统手术技术治疗成人ACL或PCL损伤的效果。
本次更新中，我们检索了Cochrane骨、关节与肌肉创伤组专业注册库（2010年至2013年7月）、Cochrane对照试验中心注册库（CENTRAL）（2013年第5期）、MEDLINE（2010年至2013年7月）、EMBASE（2010年至2013年7月）、CINAHL（2010年至2013年7月）、文章参考文献及前瞻性试验注册库。
我们纳入了比较ACL或PCL重建的CAS与不涉及CAS的传统手术技术的随机对照试验（RCT）和半随机对照试验。
两位作者独立筛选检索结果，评估研究中的偏倚风险并提取数据。在适当情况下，我们使用风险比（RR）或均值差（MD）合并数据，并给出95%置信区间（CI）。
更新检索后纳入了一项新研究。本系统评价现纳入5项RCT，共366名参与者。女性参与者多于男性（70%为女性）；年龄范围为14至53岁。所有试验均为经验丰富的外科医生进行的ACL重建。试验方法报告不佳妨碍了对研究偏倚风险的评估，因此几项研究在几种偏倚类型方面被判定为“不清楚”。一项呈现主要结局数据的试验因缺乏临床医生盲法存在较高的检测偏倚风险，且因两年随访中有未说明的失访存在损耗偏倚风险。我们发现中等质量证据（3项试验，193名参与者）表明，在国际膝关节文献委员会（IKDC）主观评分（膝关节功能的自我报告测量；0至100分，100分为最佳功能）方面，CAS与传统手术之间无临床相关差异。其中两项试验（120名参与者）的合并数据显示，CAS有微小但临床无关的优势（MD 2.05，95%CI -2.16至6.25）。第三项试验（73名参与者）也发现IKDC主观评分差异极小（报告的MD为0.2）。我们发现低质量证据（2项试验，120名参与者）表明两组在Lysholm评分方面无差异，Lysholm评分也是0至100分，100分为最佳功能（MD 0.25，95%CI -3.75至4.25）。我们发现极低质量证据（1项试验，40名参与者）表明两组在Tegner评分方面无差异。我们发现低质量证据（3项试验，173名参与者）表明两组中大多数参与者被评估为膝关节功能正常或接近正常（CAS组86/87，非CAS组84/86；RR 1.01，95%CI 0.96至1.06）。同样，在我们关于膝关节稳定性、活动范围丢失和隧道位置的次要结局指标方面未发现差异。所有试验均未报告再次手术情况。两项试验（133名参与者）未报告术后不良事件；其他三项试验未报告该结局。与传统手术技术相比，使用CAS与手术时间延长相关：研究报告的手术时间均值差在9至27分钟之间。
根据现有证据我们无法证实或反驳与传统重建相比，CAS对膝关节交叉韧带重建有有利影响。然而，目前可得证据并未表明膝关节韧带重建中使用CAS能改善结局。未来对该技术的研究需要改进报告。
