Department of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.
BMC Musculoskelet Disord. 2021 Sep 12;22(1):781. doi: 10.1186/s12891-021-04671-1.
The metal-on-metal large-diameter-head (MoM-LDH) hip replacements increased in popularity during the start of the twenty-first century. Subsequently reports raised concerns regarding adverse reactions due to elevated chromium (Cr) and cobalt (Co) concentrations as well as high rates of other complications and revisions. The purpose was to compare Harris Hip Score and SF-36 at 5-years follow up following MoM-LDH total hip arthroplasty (MoM-LDH-THA) or MoM hip resurfacing (MoM-HR).
The study was conducted between November 2006 to January 2012 in a tertiary health care center in Denmark. Patients with primary or secondary osteoarthritis were randomly assigned to receive a Magnum (MoM-LDH-THA) or a Recap (MoM-HR) prosthesis. Randomization was computer generated and allocation was concealed in an opaque envelope. Neither patients nor care provider were blinded. Primary outcome was Harris Hip Score at 5-years follow up.
Seventy-five were included and allocated to the MoM-LDH-THA (n = 39) and MoM-HR (n = 36) group. The study was prematurely stopped due to numerous reports of adverse events in patients with MoM hip replacements. Thirty-three in the MoM-LDH-THA and 25 in the MoM-HR group were available for primary outcome analysis. Median Harris Hip Score was 100 (IQR: 98-100) for MoM-LDH-THA and 100 (IQR: 93-100) for MoM-HR (p = 0.486). SF-36 score was high in both groups with no significant difference between groups.
Harris Hip Score and SF-36 score was excellent in both groups with no significant difference at 5-years follow up. Our findings suggest that there is no clinical important difference between the two prostheses implanted 5 years after implantation.
ClinicalTrials.gov, NCT04585022 , Registered 23 September 2020 - Retrospectively registered. This study was not prospectively registered in a clinical trial database since it was not an entirely implemented standard procedure in the international orthopedic society when the study was planned.
在 21 世纪初，大直径金属对金属头（MoM-LDH）髋关节置换物的使用日益普及。随后，有报道称由于铬（Cr）和钴（Co）浓度升高以及其他并发症和翻修率高，出现了不良反应的担忧。目的是比较 MoM-LDH 全髋关节置换术（MoM-LDH-THA）或 MoM 髋关节表面置换术（MoM-HR）后 5 年的 Harris 髋关节评分和 SF-36。
该研究于 2006 年 11 月至 2012 年 1 月在丹麦的一家三级保健中心进行。患有原发性或继发性骨关节炎的患者被随机分配接受 Magnum（MoM-LDH-THA）或 Recap（MoM-HR）假体。随机化由计算机生成，分配在不透明的信封中隐藏。患者和护理提供者均未设盲。主要结局为 5 年随访时的 Harris 髋关节评分。
共纳入 75 例患者，随机分配至 MoM-LDH-THA（n=39）和 MoM-HR（n=36）组。由于 MoM 髋关节置换术患者出现大量不良事件报告，该研究提前停止。MoM-LDH-THA 组 33 例和 MoM-HR 组 25 例可进行主要结局分析。MoM-LDH-THA 组的中位数 Harris 髋关节评分为 100（IQR：98-100），MoM-HR 组为 100（IQR：93-100）（p=0.486）。两组的 SF-36 评分均较高，组间无显著差异。
两组的 Harris 髋关节评分和 SF-36 评分均较好，5 年随访时无显著差异。我们的研究结果表明，两种假体在植入后 5 年时没有临床重要差异。
ClinicalTrials.gov，NCT04585022，2020 年 9 月 23 日注册 - 回顾性注册。由于在研究计划时，该研究并不是国际骨科协会的标准程序，因此该研究并未在临床试验数据库中进行前瞻性注册。
