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近端多孔涂层与全多孔涂层股骨柄:一项多中心随机试验。

Proximally versus fully porous-coated femoral stems: a multicenter randomized trial.

机构信息

London Health Sciences Centre, University of Western Ontario, 339 Windermere Road, London, ON, N6A 5A5, Canada.

出版信息

Clin Orthop Relat Res. 2010 Feb;468(2):424-32. doi: 10.1007/s11999-009-1092-3.

Abstract

UNLABELLED

There are two broad-based categories of cementless femoral component designs: proximally porous-coated and fully porous-coated. While both have been widely used, there remains debate regarding differences in clinical outcome scores, relative incidence of thigh pain, and development of stress shielding. We investigated these variables in a multicenter prospective randomized blinded clinical trial of 388 patients from three centers: 198 patients had a proximally porous-coated tapered cementless femoral component and 190 patients had a fully porous-coated cementless femoral component. A minimum followup of 2 years (mean, 6.7 years; range, 2.0-8.65 years) was available in 367 of the 388 patients (95%). We observed no differences in age at surgery, body mass index, or preoperative clinical outcome scores (WOMAC, SF-12, Harris hip score, UCLA activity, thigh pain) with the two groups. We determined serial bone density changes in a subcohort of 72 patients from two of the three centers. The postoperative clinical outcome scores were similar at all followup intervals, and we observed no differences in the incidence of thigh pain at any time. Bone density reduction in Gruen Zone 7 was greater with the fully coated stem than the proximally coated stem (24% versus 15% reduction, respectively). Both fully and proximally coated stems performed well, with no clinical differences at 2 years' followup, except in bone mineral density evaluations.

LEVEL OF EVIDENCE

Level I, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

摘要

未加标签

无水泥股骨部件设计有两大基础类别:近端多孔涂层和全多孔涂层。虽然两者都得到了广泛应用,但在临床结果评分、大腿疼痛的相对发生率以及应力遮挡的发展方面仍存在争议。我们在来自三个中心的 388 名患者的多中心前瞻性随机双盲临床试验中研究了这些变量:198 名患者使用近端多孔涂层锥形无水泥股骨部件,190 名患者使用全多孔涂层无水泥股骨部件。388 名患者中的 367 名(95%)有至少 2 年(平均 6.7 年;范围 2.0-8.65 年)的随访。我们观察到两组之间在手术时的年龄、体重指数或术前临床结果评分(WOMAC、SF-12、Harris 髋关节评分、UCLA 活动、大腿疼痛)方面没有差异。我们在来自三个中心中的两个中心的 72 名患者的亚组中确定了连续的骨密度变化。在所有随访间隔,术后临床结果评分相似,我们在任何时候都没有观察到大腿疼痛发生率的差异。在 Gruen 区域 7 中,全涂层的股骨柄的骨密度减少比近端涂层的股骨柄更多(分别为 24%和 15%的减少)。全涂层和近端涂层的股骨柄都表现良好,除了在骨矿物质密度评估方面,在 2 年的随访中没有临床差异。

证据水平

I 级,治疗研究。有关证据水平的完整描述,请参见作者指南。

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