A prospective randomized study of Refobacin Bone Cement R versus Palacos R + G.

IF 4.9 1区医学 Q1 ORTHOPEDICS

Bone & Joint Journal Pub Date : 2024-05-01 DOI:10.1302/0301-620X.106B5.BJJ-2023-0999.R1

Vasileios Angelomenos, Maziar Mohaddes, Johan Kärrholm, Henrik Malchau, Bita Shareghi, Raed Itayem

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引用次数: 0

Abstract

Aims: Refobacin Bone Cement R and Palacos R + G bone cement were introduced to replace the original cement Refobacin Palacos R in 2005. Both cements were assumed to behave in a biomechanically similar fashion to the original cement. The primary aim of this study was to compare the migration of a polished triple-tapered femoral stem fixed with either Refobacin Bone Cement R or Palacos R + G bone cement. Repeated radiostereometric analysis was used to measure migration of the femoral head centre. The secondary aims were evaluation of cement mantle, stem positioning, and patient-reported outcome measures.

Methods: Overall, 75 patients were included in the study and 71 were available at two years postoperatively. Prior to surgery, they were randomized to one of the three combinations studied: Palacos cement with use of the Optivac mixing system, Refobacin with use of the Optivac system, and Refobacin with use of the Optipac system. Cemented MS30 stems and cemented Exceed acetabular components were used in all hips. Postoperative radiographs were used to assess the quality of the cement mantle according to Barrack et al, and the position and migration of the femoral stem. Harris Hip Score, Oxford Hip Score, Forgotten Joint Score, and University of California, Los Angeles Activity Scale were collected.

Results: Median distal migration (y-axis) at two years for the Refobacin-Optivac system was -0.79 mm (-2.01 to -0.09), for the Refobacin-Optipac system was -0.75 mm (-2.16 to 0.20), and for the Palacos-Optivac system was -1.01 mm (-4.31 to -0.29). No statistically significant differences were found between the groups. Secondary outcomes did not differ statistically between the groups at the two-year follow-up.

Conclusion: At two years, we found no significant differences in distal migration or clinical outcomes between the three groups. Our data indicate that Refobacin Bone Cement R and Palacos R + G are comparable in terms of stable fixation and early clinical outcomes.

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Refobacin 骨水泥 R 与 Palacos R + G 的前瞻性随机研究。

目的：Refobacin骨水泥R和Palacos R + G骨水泥于2005年推出，以取代原来的Refobacin Palacos R骨水泥。假定这两种骨水泥的生物力学行为与原来的骨水泥相似。本研究的主要目的是比较用Refobacin骨水泥R或Palacos R + G骨水泥固定的抛光三锥形股骨柄的移位情况。采用重复放射性立体计量分析法测量股骨头中心的移位情况。次要目的是评估骨水泥套、骨干定位和患者报告的结果：共有75名患者参与研究，其中71名患者在术后两年内接受了治疗。手术前，他们被随机分配到三种研究组合中的一种：使用Optivac混合系统的Palacos骨水泥、使用Optivac系统的Refobacin和使用Optipac系统的Refobacin。所有髋关节均使用了骨水泥 MS30 支架和骨水泥埃奇得髋臼组件。根据Barrack等人的方法，术后X光片用于评估骨水泥套的质量以及股骨柄的位置和移位情况。收集了哈里斯髋关节评分、牛津髋关节评分、遗忘关节评分和加州大学洛杉矶分校活动量表：结果：两年后，Refobacin-Optivac系统的中位远端移位（y轴）为-0.79毫米（-2.01至-0.09），Refobacin-Optipac系统为-0.75毫米（-2.16至0.20），Palacos-Optivac系统为-1.01毫米（-4.31至-0.29）。两组之间没有发现明显的统计学差异。在两年的随访中，各组的次要结果在统计学上没有差异：结论：两年后，我们发现三组患者的远端移位或临床结果无明显差异。我们的数据表明，Refobacin 骨水泥 R 和 Palacos R + G 在稳定固定和早期临床效果方面具有可比性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Bone & Joint Journal ORTHOPEDICS-SURGERY

CiteScore

9.40

自引率

10.90%

发文量

318

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