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金属对金属髋关节表面置换中骨水泥型与非骨水泥型股骨部件的随机对照试验:一项骨密度研究。

A randomised controlled trial of cemented and cementless femoral components for metal-on-metal hip resurfacing: a bone mineral density study.

作者信息

Tice A, Kim P, Dinh L, Ryu J J, Beaulé P E

机构信息

University of Ottawa/The Ottawa Hospital, Ottawa, Ontario, Canada.

出版信息

Bone Joint J. 2015 Dec;97-B(12):1608-14. doi: 10.1302/0301-620X.97B12.36110.

Abstract

The primary purpose of this study of metal-on-metal (MoM) hip resurfacing was to compare the effect of using a cementless or cemented femoral component on the subsequent bone mineral density (BMD) of the femoral neck. This was a single-centre, prospective, double-blinded control trial which randomised 120 patients (105 men and 15 women) with a mean age of 49.4 years (21 to 68) to receive either a cemented or cementless femoral component. Follow-up was to two years. Outcome measures included total and six-point region-of-interest BMD of the femoral neck, radiological measurements of acetabular inclination, neck-shaft and stem-shaft angles, and functional outcome scores including the Harris hip score, the Western Ontario and McMaster Universities Osteoarthritis Index and the University of California at Los Angeles activity scale. In total, 17 patients were lost to follow-up leaving 103 patients at two years. There were no revisions in the cementless group and three revisions (5%) in the cemented group (two because of hip pain and one for pseudotumour). The total BMD was significantly higher in the cementless group at six months (p < 0.001) and one year (p = 0.01) than in the cemented group, although there was a loss of statistical significance in the difference at two years (p = 0.155). All patient outcomes improved significantly: there were no significant differences between the two groups. The results show better preservation of femoral neck BMD with a cementless femoral component after two years of follow-up. Further investigation is needed to establish whether this translates into improved survivorship.

摘要

本金属对金属(MoM)髋关节表面置换研究的主要目的是比较使用非骨水泥型或骨水泥型股骨部件对股骨颈后续骨密度(BMD)的影响。这是一项单中心、前瞻性、双盲对照试验,将120例平均年龄49.4岁(21至68岁)的患者(105例男性和15例女性)随机分为接受骨水泥型或非骨水泥型股骨部件两组。随访至两年。观察指标包括股骨颈的总体和六点感兴趣区域的骨密度、髋臼倾斜度、颈干角和柄干角的影像学测量,以及功能结局评分,包括Harris髋关节评分、西安大略和麦克马斯特大学骨关节炎指数以及加利福尼亚大学洛杉矶分校活动量表。共有17例患者失访,两年后剩余103例患者。非骨水泥组无翻修病例,骨水泥组有3例翻修(5%)(2例因髋关节疼痛,1例因假肿瘤)。非骨水泥组在6个月(p<0.001)和1年(p = 0.01)时的总体骨密度显著高于骨水泥组,尽管两年时差异的统计学意义消失(p = 0.155)。所有患者的结局均显著改善:两组之间无显著差异。结果显示,随访两年后,非骨水泥型股骨部件对股骨颈骨密度的保存效果更好。需要进一步研究以确定这是否转化为更好的假体生存率。

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