Müller Jacobus H, Liebensteiner Michael, Kort Nanne, Stirling Patrick, Pilot Peter, Demey Guillaume
ReSurg SA, Rue Saint-Jean 22, 1260, Nyon, Switzerland.
Department of Orthopaedics and Traumatology, Medical University of Innsbruck, Anichstraße 35, 6020, Innsbruck, Austria.
Knee Surg Sports Traumatol Arthrosc. 2023 Apr;31(4):1230-1246. doi: 10.1007/s00167-021-06678-6. Epub 2021 Aug 25.
The purpose of this systematic review and meta-analysis was to collect, synthesise and critically appraise findings of clinical studies that report outcomes of custom total knee arthroplasty (TKA). The hypothesis was that, compared to off-the-shelf (OTS) TKA, custom TKA would yield better surgical, clinical and radiographic outcomes.
This systematic review and meta-analysis was performed in accordance with the guidelines of Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). On 8 February 2021, two authors independently searched and screened articles using MEDLINE®, Embase® and the Cochrane Library without restriction on date of publication. Findings from eligible articles were narratively synthesised and tabulated, and when ≥ 3 comparative studies reported the same outcome, results were pooled and summarised in forest plots. Quality assessments of the studies were done according to the guidelines of the Joanna Briggs Institute (JBI) Checklists.
A total of 15 articles were eligible for data extraction, of which 9 were case-control studies reporting on 929 custom versus 998 OTS TKA, 5 were case series reporting on results of 587 custom TKA, and 1 was a cross-sectional study reporting on results of 44 custom versus 132 OTS TKA. Five studies that compared early revision rates found the overall effect in favour of OTS TKA (odds ratio (OR), 0.4; p = n.s.) but the result did not reach statistical significance. Four studies found no statistically significant difference in KSS knee (standardised mean difference (SMD), - 0.10; p = n.s.) and function (SMD, 0.03; p = n.s.), and five studies found no statistically significant difference in range of motion (SMD, 0.02; p = n.s.). One study that compared bone-implant fit between custom and three OTS tibial components found no overhang but revealed under-coverage of up to 18% in knees with custom tibial baseplates.
Custom TKA demonstrated no significant benefits compared to OTS TKA in terms of pooled clinical outcomes, but had considerably higher early revision rates. The findings of the present systematic review and meta-analysis suggest the need for studies with better comparable groups and standardisation of reporting outcomes amongst studies, that could increase the quality of evidence and enable pooling of results in future meta-analyses.
Level IV.
本系统评价和荟萃分析旨在收集、综合并批判性评价报告定制全膝关节置换术（TKA）结果的临床研究结果。假设是，与现货（OTS）TKA相比，定制TKA将产生更好的手术、临床和影像学结果。
本系统评价和荟萃分析按照系统评价和荟萃分析的首选报告项目（PRISMA）指南进行。2021年2月8日，两位作者独立使用MEDLINE®、Embase®和Cochrane图书馆检索和筛选文章，对发表日期无限制。对符合条件的文章的结果进行叙述性综合和列表，当≥3项比较研究报告相同结果时，将结果汇总并汇总在森林图中。根据乔安娜·布里格斯研究所（JBI）清单指南对研究进行质量评估。
共有15篇文章符合数据提取条件，其中9篇为病例对照研究，报告了929例定制TKA与998例OTS TKA的情况，5篇为病例系列研究，报告了587例定制TKA的结果，1篇为横断面研究，报告了44例定制TKA与132例OTS TKA的结果。五项比较早期翻修率的研究发现总体效果有利于OTS TKA（优势比（OR），0.4；p=无统计学意义），但结果未达到统计学显著性。四项研究发现KSS膝关节（标准化平均差（SMD），-0.10；p=无统计学意义）和功能（SMD，0.03；p=无统计学意义）无统计学显著差异，五项研究发现活动范围无统计学显著差异（SMD，0.02；p=无统计学意义）。一项比较定制和三种OTS胫骨组件之间骨植入物贴合度的研究未发现悬垂，但发现定制胫骨基板的膝关节覆盖率低至18%。
与OTS TKA相比，定制TKA在汇总临床结果方面未显示出显著益处，但早期翻修率相当高。本系统评价和荟萃分析的结果表明，需要进行具有更好可比性的组的研究，并在研究之间对报告结果进行标准化，这可以提高证据质量，并使未来的荟萃分析能够汇总结果。
四级。
