原发性全髋关节置换术中四边形非骨水泥股骨假体与缩短型假体的放射稳定性比较:一项前瞻性随机对照试验。

IF 3.1 Q1 ORTHOPEDICS
Florian Kruse, Alix Addi, Philippe Anract, David Biau
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引用次数: 0

摘要

目的:无水泥股骨内固定广泛应用于全髋关节置换术(THA),越来越多的人对短股骨假体设计感兴趣。这些股骨假体旨在保护近端骨,促进生理负荷转移,并促进微创入路。其中,“缩短的”股骨假体源自传统柄,保留骨干延伸,可能在植入物定位方面具有优势。然而,关于其机械可靠性的临床证据仍然有限。本研究旨在比较在骨关节炎患者接受THA治疗时,缩短的非骨水泥四边形股骨假体与常规长度股骨假体的两年放射学稳定性。方法:我们于2018年1月至2021年12月进行了一项前瞻性、单盲、随机、非劣效性试验。接受原发性THA的患者被随机分配接受常规长度的四边形股骨假体或其缩短版本。主要终点是两年时的股骨成分迁移,用Ein Bild伦琴分析-股骨成分分析(EBRA-FCA)进行评估。次要结果包括术中和术后并发症发生率,以及12个月时的12项牛津髋关节评分(OHS)。结果:共纳入143例髋关节,其中139例(70例为常规长度,69例为缩短长度)纳入临床分析。对98个髋关节(每组49个髋关节)进行了按方案放射学分析。两年后,缩短股骨假体组的平均股骨假体偏移量为0.94 mm (SD 0.49),而常规长度组的平均股骨假体偏移量为0.86 mm (SD 0.52)。90% CI的上限(-0.09至0.25)低于预定的1 mm的非劣效性界限。并发症发生率和功能结局无显著差异(p < 0.05)。结论:在两年时,缩短的四边形股骨假体的放射学结果与常规长度的假体相比是一致的。虽然没有完全达到计划的样本量,但结果仍在预定的非劣效性范围内。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Radiological stability of a quadrangular uncemented femoral component compared with its shortened version in primary total hip arthroplasty : a prospective randomized controlled trial.

Aims: Cementless femoral fixation is widely used in total hip arthroplasty (THA), with increasing interest in shorter femoral component designs. These femoral components aim to preserve proximal bone, promote physiological load transfer, and facilitate minimally invasive approaches. Among these, 'shortened' femoral components, derived from conventional stems and retaining a diaphyseal extension, may offer advantages in terms of implant positioning. However, clinical evidence regarding their mechanical reliability remains limited. This study aimed to compare the two-year radiological stability of a shortened uncemented quadrangular femoral component with that of its conventional-length counterpart in patients undergoing THA for osteoarthritis.

Methods: We conducted a prospective, single-blind, randomized, noninferiority trial between January 2018 and December 2021. Patients undergoing primary THA were randomly assigned to receive either the conventional-length quadrangular femoral component or its shortened version. The primary outcome was femoral component migration at two years, assessed with Ein Bild Roentgen analyze - femoral component analysis (EBRA-FCA). Secondary outcomes included intraoperative and postoperative complication rates, as well as the 12-item Oxford Hip Score (OHS) at 12 months.

Results: A total of 143 hips were randomized, with 139 (70 conventional-length, 69 shortened) included in the clinical analysis. Per-protocol radiological analysis was carried out on 98 hips (49 hips per group). At two years, mean femoral component migration was 0.94 mm (SD 0.49) in the shortened-femoral component group and 0.86 mm (SD 0.52) in the conventional-length group. The upper bound of the 90% CI (-0.09 to 0.25) was below the prespecified noninferiority margin of 1 mm. No significant differences were observed in complication rates or functional outcomes (p > 0.05).

Conclusion: At two years, radiological outcomes of the shortened quadrangular femoral component were consistent with noninferiority compared with the conventional-length version. Although the planned sample size was not fully reached, the findings remained within the prespecified noninferiority margin.

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来源期刊
Bone & Joint Open
Bone & Joint Open ORTHOPEDICS-
CiteScore
5.10
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8 weeks
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