Banci Lorenzo, Balato Giovanni, Salari Paolo, Baldini Andrea
Permedica Orthopaedics S.P.A, Via Como 38, Merate, 23807, Lecco, Italy.
Department of Public Health, Section of Orthopaedic Surgery, "Federico II" University, Naples, Italy.
Knee Surg Sports Traumatol Arthrosc. 2023 Mar;31(3):839-851. doi: 10.1007/s00167-021-06775-6. Epub 2021 Oct 29.
Nitride-based ceramic coatings, such as titanium nitride (TiN) and titanium niobium nitride (TiNbN), have been introduced in total knee arthroplasty (TKA) to enhance the mechanical properties and biocompatibility of knee components, harden the metal surface and reduce CoCrMo exposure and metal ion release. However, the theoretical advantages of these ceramic coatings in TKA have yet to be fully elucidated. This systematic review aimed to provide clinical evidence on mid-term outcomes of ceramic-coated knee prostheses in comparison with uncoated standard CoCrMo knee prostheses in primary TKA. The hypothesis was that ceramic-coated implants can be used in primary TKA with no inferior outcomes compared to uncoated CoCrMo implants.
A systematic review of the literature was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to find all clinical studies regarding primary TKA with ceramic-coated knee prostheses. MEDLINE (PubMed), Embase and Cochrane Library were searched from 1990 to October 2020 to identify relevant studies for the first qualitative analysis. Using PICOS eligibility criteria, a subgroup of the selected studies was used to perform a meta-analysis.
Fifteen studies were included in this systematic review, of which six were included in the meta-analysis: 3 randomized controlled trials, 2 retrospective comparative studies and 1 prospective cross-sectional study. Pooled data overall included 321 coated TKAs vs. 359 uncoated TKAs and a mean follow-up of 4.6 years (range, 2-10 years). No significant difference in the implant survival risk ratio with revision or reoperation due to any reason was found between coated and uncoated TKAs, even considering the RCT study subgroup with a risk ratio of 1.02 (P = 0.34). No significant differences were found for postoperative complications, clinical scores, or metal blood concentrations at 1 year.
The findings of this systematic review and meta-analysis support the statement that ceramic-coated TKAs are not inferior to uncoated TKAs, showing comparable survival rates, complication rates and clinical outcomes. There is strong evidence that ceramic-coated TKA does not improve the clinical results or survival rate in comparison with uncoated TKA.
II, Therapeutic.
氮化物基陶瓷涂层，如氮化钛（TiN）和氮化钛铌（TiNbN），已被应用于全膝关节置换术（TKA）中，以增强膝关节组件的机械性能和生物相容性，硬化金属表面，减少钴铬钼暴露和金属离子释放。然而，这些陶瓷涂层在TKA中的理论优势尚未完全阐明。本系统评价旨在提供陶瓷涂层膝关节假体与未涂层的标准钴铬钼膝关节假体在初次TKA中的中期结果的临床证据。假设是陶瓷涂层植入物在初次TKA中的应用效果不低于未涂层的钴铬钼植入物。
根据系统评价和Meta分析的首选报告项目（PRISMA）指南对文献进行系统评价，以查找所有关于陶瓷涂层膝关节假体初次TKA的临床研究。检索1990年至2020年10月的MEDLINE（PubMed）、Embase和Cochrane图书馆，以确定相关研究进行首次定性分析。使用PICOS纳入标准，对所选研究的一个亚组进行Meta分析。
本系统评价纳入了15项研究，其中6项纳入Meta分析：3项随机对照试验、2项回顾性比较研究和1项前瞻性横断面研究。汇总数据总体包括321例涂层TKA与359例未涂层TKA，平均随访4.6年（范围2 - 10年）。即使考虑风险比为1.02（P = 0.34）的RCT研究亚组，涂层和未涂层TKA之间因任何原因进行翻修或再次手术的植入物生存风险比也没有显著差异。术后1年的并发症、临床评分或金属血浓度均无显著差异。
本系统评价和Meta分析的结果支持以下观点：陶瓷涂层TKA不劣于未涂层TKA，显示出相当的生存率、并发症发生率和临床结果。有强有力的证据表明，与未涂层TKA相比，陶瓷涂层TKA并不能改善临床结果或生存率。
II，治疗性。
