Yu Bin-feng, Yang Guo-jing, Wang Wei-liang, Zhang Lei, Lin Xi-peng
Department of Orthopedics, The Third Affiliated Hospital of Wenzhou Medical College, Wenzhou, 325200, People's Republic of China.
J Orthop Surg Res. 2016 Mar 30;11:39. doi: 10.1186/s13018-016-0374-1.
Highly cross-linked polyethylene (HXLPE) has been reported as an effective material for decreasing polyethylene wear and osteolysis in total knee arthroplasty (TKA). Because no single study to date has been large enough to definitively determine the benefit of HXLPE in TKA, we conducted a meta-analysis to pool the results from randomized controlled trials (RCTs) and non-RCTs to make such a determination.
Potential candidate articles were identified by searching the Cochrane Library, Medline (1966-2015.10), PubMed (1966-2015.10), Embase (1980-2015.10), ScienceDirect (1985-2015.10), and other databases. "Gray studies" were identified from the included articles' reference lists. Pooled data were analyzed using RevMan 5.1.
Three RCTs and three non-RCTs were included in the meta-analysis. There were no significant differences between the groups in the total number of reoperations (P = 0.11), reoperations for prosthesis loosening (P = 0.08), radiolucent line (P = 0.20), osteolysis (P = 0.38), prosthesis loosening (P = 0.10), and mechanical failures related to the tibial polyethylene (P = 1.00). Similarly, no significant differences between the two groups were found in postoperative total knee score (P = 0.18) or functional score (P = 0.23).
The meta-analysis showed that compared with conventional polyethylene, HXLPE did not improve the clinical and radiographic outcomes in mid-term follow-up after TKA. Additional high-quality multicenter prospective RCTs with good design, large study populations and long-term follow-up will be necessary to further clarify the effect of HXLPE in TKA.
据报道,高度交联聚乙烯(HXLPE)是一种有效减少全膝关节置换术(TKA)中聚乙烯磨损和骨溶解的材料。由于迄今为止尚无一项单独研究规模大到足以明确确定HXLPE在TKA中的益处,我们进行了一项荟萃分析,汇总随机对照试验(RCT)和非RCT的结果以做出此类判定。
通过检索Cochrane图书馆、Medline(1966 - 2015.10)、PubMed(1966 - 2015.10)、Embase(1980 - 2015.10)、ScienceDirect(1985 - 2015.10)及其他数据库来识别潜在的候选文章。从纳入文章的参考文献列表中识别“灰色研究”。使用RevMan 5.1分析汇总数据。
荟萃分析纳入了3项RCT和3项非RCT。两组在再次手术总数(P = 0.11)、因假体松动进行的再次手术(P = 0.08)、透亮线(P = 0.20)、骨溶解(P = 0.38)、假体松动(P = 0.10)以及与胫骨聚乙烯相关的机械故障(P = 1.00)方面无显著差异。同样,两组在术后全膝关节评分(P = 0.18)或功能评分(P = 0.23)方面也未发现显著差异。
荟萃分析表明,与传统聚乙烯相比,HXLPE在TKA中期随访中并未改善临床和影像学结果。需要更多设计良好、研究人群庞大且长期随访的高质量多中心前瞻性RCT,以进一步阐明HXLPE在TKA中的作用。