一种新型锥形楔形茎:多中心临床结果研究

D. Campbell, K. Sharpe, R. Cohen
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引用次数: 0

摘要

在过去的十年中,无水泥锥形楔形阀杆取得了很好的效果。远端植入与近端配合不足,以及未能实现生物固定导致大腿疼痛、松动和植入物失败。为了支持各种患者的形态,设计了一种新型锥形楔形茎,其远端形态减少,最大限度地增加了磨砂表面的近端接触。本研究的目的是分析该系统设计的临床结果。方法纳入前瞻性、上市后多中心研究的319例患者接受了新型锥形楔形茎。临床和患者报告的结果包括Harris髋关节评分(HHS)、下肢活动量表(LEAS)、Short Form 12 (SF12)和Euroqol 5D评分(EQ-5D)在术前至术后两年进行评估。结果研究人群中男性占53.3%,平均年龄62.4±9.3岁,BMI 29.8±4.5。迄今为止,有一例大腿疼痛发生率(0.3%)和0.63%的无菌修复率。术后两年人群Kaplan-Meier生存分析估计为97.87%,95% CI(93.98% - 99.25%)的全因修正生存率(图1)。从统计上看,术后6周疼痛、功能和生活质量得到显著改善,所有临床和患者报告的结果测量持续了一年(图2)。结论设计了一种新型锥形楔形柄,可以最大限度地近端配合各种患者的内侧和外侧形态。放射学研究表明,与较老的锥形楔形设计相比,根管设计具有更好的根管配合度。目前的研究显示,采用锥形楔柄髋关节置换术后,大腿疼痛和修复的发生率较低,功能、疼痛和生活质量均有改善。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A NOVEL TAPERED WEDGE STEM: MULTICENTRE CLINICAL OUTCOMES STUDY
Introduction Cementless tapered wedge stems have shown excellent results over the last decade. Distal potting with inadequate proximal fit, as well as failure to achieve biologic fixation has led to thigh pain, loosening and implant failure. To support a variety of patient morphologies a novel tapered wedge stem was designed with reduced distal morphology, maximizing the proximal contact of the grit blasted surface. The objective of the study was to analyze the clinical outcomes of this stem design. Methods Three hundred and nineteen patients enrolled into prospective, post-market multicenter studies received a novel tapered wedge stem. Clinical and patient-reported outcomes including the Harris Hip Score (HHS), Lower Extremity Activity Scale (LEAS), Short Form 12 (SF12), and Euroqol 5D Score (EQ-5D) were evaluated preoperative through two years postoperative. Results Demographics of the study population include 53.3% male patients with a mean age of 62.4 ± 9.3 years and BMI of 29.8 ± 4.5. To date, there has been one incidence of thigh pain (0.3%) and a 0.63% aseptic revision rate. Kaplan-Meier survivorship analysis for the population at two years postoperative estimated 97.87% with 95% CI (93.98% – 99.25%) survivorship to all cause revision ( Figure 1 ). Statistically significant improvements in pain, function, and quality of life were seen initially at six weeks postoperative and continued through one year in all of the clinical and patient reported outcome measures ( Figure 2 ). Conclusion A novel tapered wedge stem was designed to maximize proximal fit medially and laterally across a variety of patient morphologies. Radiographic studies have shown the stem design has significantly better canal fit compared to older tapered wedge designs. The current study exhibits low incidence of thigh pain and revisions, with improvements in function, pain and quality of life after hip arthroplasty with this tapered wedge stem.
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