Department of Orthopaedic Surgery and National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University, 37# Guoxue Road, Chengdu, 610041, Sichuan, People's Republic of China.
State Key Laboratory of Biotherapy, Collaborative Innovation Center for Biotherapy, Department of Gastrointestinal Surgery and Laboratory of Gastric Cancer, West China Hospital, Sichuan University, Chengdu, China.
Arch Orthop Trauma Surg. 2020 Aug;140(8):1097-1107. doi: 10.1007/s00402-020-03429-z. Epub 2020 Apr 18.
Unsatisfactory alignment in unicompartmental knee arthroplasty (UKA) is one potential cause of postoperative failure. Patient-specific instruments (PSIs) are designed to improve the alignment of the prostheses, but the effect of PSIs on the alignment or clinical outcome is controversial and lacks validated evidence. We conducted a meta-analysis and systematic review to determine the effect of PSIs on UKA outcomes for the first time.
A systematic literature search in MEDLINE, EMBASE, CNKI (Chinese database) and Cochrane Central Register of Controlled Trials (up to June 2019) was performed to collect studies that compared PSIs with conventional instruments. Two reviewers independently screened all the records on the basis of inclusion and exclusion criteria. Quality assessments with Cochrane's quality assessment tool or Newcastle-Ottawa scale (NOS) were conducted, the data were extracted, and statistical analyses were completed.
Ten studies with 444 knees were included. The meta-analysis confirmed that PSIs contributed to reduced errors in the alignment of the femoral compartment in the sagittal plane (mean difference = - 2.53, CI [- 3.14, - 1.99], P < 0.01) and the tibial compartment in both the coronal (mean difference = - 0.97, CI [- 1.44, - 0.49], P < 0.01) and the sagittal plane (mean difference = - 1.29, CI [- 1.81, - 0.76], P < 0.01). One study supported that PSIs reduced outliers in inexperienced surgeons; however, all studies investigating PSIs among experienced surgeons suggested that PSIs cannot reduce the percentage of outliers. There was no significant difference in the postoperative score (mean difference = - 0.06, CI [- 0.36, 0.23], P = 0.68) or rate of complications (RR = 1.02, CI [0.15, 6.79], P = 0.99) between PSIs and conventional instruments.
The findings of this study suggest PSIs could not reduce the percentage of outliers in UKA patients for experts, and postoperative scores and complication rates are not improved by PSIs, compared with conventional instruments. Based on this meta-analysis and systematic review, no practical benefit to UKAs in experts was detected in PSIs. The findings of this study also suggest that PSIs improved alignment of UKA and might be beneficial to inexperienced surgeons, but it is still unclear whether this improvement is clinically significant and the evidence of inexperienced surgeons is limited. Therefore, more high-quality RCTs are need to be carried out in the future.
单髁膝关节置换术(UKA)中不满意的对线是术后失败的一个潜在原因。患者特定器械(PSI)旨在改善假体的对线,但 PSI 对线或临床结果的影响仍存在争议,且缺乏经过验证的证据。我们首次进行了荟萃分析和系统评价,以确定 PSI 对 UKA 结果的影响。
在 MEDLINE、EMBASE、CNKI(中国数据库)和 Cochrane 对照试验中心注册库(截至 2019 年 6 月)中进行了系统的文献检索,以收集比较 PSI 与常规器械的研究。两名评审员根据纳入和排除标准独立筛选所有记录。使用 Cochrane 质量评估工具或纽卡斯尔-渥太华量表(NOS)进行质量评估,提取数据并进行统计分析。
共纳入 10 项研究,涉及 444 例膝关节。荟萃分析证实 PSI 有助于减少股骨间室在矢状面(平均差异=-2.53,CI [-3.14,-1.99],P<0.01)和胫骨间室在冠状面(平均差异=-0.97,CI [-1.44,-0.49],P<0.01)及矢状面(平均差异=-1.29,CI [-1.81,-0.76],P<0.01)的对线误差。一项研究支持 PSI 可减少经验不足的外科医生中的离群值;然而,所有研究均表明 PSI 并不能减少经验丰富的外科医生中的离群值百分比。PSI 和常规器械在术后评分(平均差异=-0.06,CI [-0.36,0.23],P=0.68)或并发症发生率(RR=1.02,CI [0.15,6.79],P=0.99)方面无显著差异。
本研究结果表明,PSI 并不能降低专家 UKA 患者的离群值百分比,与常规器械相比,PSI 并不能提高术后评分或降低并发症发生率。基于本次荟萃分析和系统评价,未发现 PSI 对专家的 UKA 有实际获益。本研究结果还表明,PSI 改善了 UKA 的对线,可能对经验不足的外科医生有益,但尚不清楚这种改善是否具有临床意义,且经验不足的外科医生的证据有限。因此,未来需要开展更多高质量的 RCT。