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大金属头在薄型维生素 E 掺杂交联聚乙烯嵌件中的使用并未增加全髋关节置换术中聚乙烯的磨损:一项随机对照试验的 5 年结果。

The Use of Large Metal Heads in Thin Vitamin E-Doped Cross-Linked Polyethylene Inserts Does Not Increase Polyethylene Wear in Total Hip Arthroplasty: 5-Year Results From a Randomized Controlled Trial.

机构信息

Department of Orthopaedics, Region of Västra Götaland, Sahlgrenska University Hospital, Mölndal, Sweden; Institute of Clinical Sciences, Department of Orthopaedics, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.

Department of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark; Faculty of Health Sciences, Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.

出版信息

J Arthroplasty. 2024 Jul;39(7):1804-1810. doi: 10.1016/j.arth.2024.02.008. Epub 2024 Feb 11.

Abstract

BACKGROUND

Vitamin E-doped cross-linked polyethylene (VEPE) has encouraged the use of larger heads in thinner liners in total hip arthroplasty (THA). However, there are concerns about wear and mechanical failure of the thin liner, especially when metal heads are used. The aim of this randomized controlled trial was to investigate if the use of a large metal head in thin VEPE liner would increase polyethylene wear compared with a standard 32-mm metal head and to compare periacetabular radiolucencies and patient-reported outcomes in THA.

METHODS

There were 96 candidates for uncemented THA who were randomly allocated to either the largest possible metal head (36 to 44 mm) that could be fitted in the thinnest available VEPE liner (intervention group) or a standard 32-mm metal head (control group). The primary outcome was proximal head penetration, measured with a model-based radiostereometric analysis. Secondary outcomes were periacetabular radiolucencies and patient-reported outcomes. The midterm results of the trial at 5 years are presented.

RESULTS

The median total proximal head penetration (interquartile range) was -0.04 mm (-0.12 to 0.02) in the intervention group and -0.03 mm (-0.14 to 0.05) in the control group (P = .691). The rates of periacetabular radiolucencies were 1 of 44 and 4 of 42 (P = .197), respectively. Patient-reported hip function and health-related quality of life did not differ between the groups, but participants in the intervention group reported a higher level of activity (median University of California Level of Activity score 7 versus 6, P = .020). There were 5 revisions caused by dislocations (2), periprosthetic fracture (1), stem subsidence (1), or iliopsoas impingement (1).

CONCLUSIONS

Large metal heads in thin VEPE liners did not increase liner wear and were not associated with liner failure 5 years after THA.

摘要

背景

维生素 E 交联聚乙烯(VEPE)的应用鼓励在全髋关节置换术(THA)中使用更大的股骨头和更薄的衬垫。然而,人们对薄衬垫的磨损和机械失效存在担忧,尤其是在使用金属股骨头时。本随机对照试验的目的是研究在最薄的 VEPE 衬垫中使用大金属股骨头是否会比标准 32mm 金属股骨头增加聚乙烯磨损,并比较 THA 术后的髋臼周围透亮区和患者报告的结果。

方法

共有 96 名候选者接受非骨水泥 THA,他们被随机分配到可装入最薄可用 VEPE 衬垫的最大金属股骨头(36 至 44mm)(干预组)或标准 32mm 金属股骨头(对照组)。主要结局是通过基于模型的放射立体测量分析测量的近侧股骨头穿透。次要结局是髋臼周围透亮区和患者报告的结果。本文报告了试验的 5 年中期结果。

结果

干预组的中位数总近侧股骨头穿透(四分位距)为-0.04mm(-0.12 至 0.02),对照组为-0.03mm(-0.14 至 0.05)(P=0.691)。髋臼周围透亮区的发生率分别为 1/44 和 4/42(P=0.197)。两组患者的髋关节功能和健康相关生活质量无差异,但干预组患者的活动水平更高(中位数加利福尼亚大学活动水平评分 7 分与 6 分,P=0.020)。共有 5 例因脱位(2 例)、假体周围骨折(1 例)、柄下沉(1 例)或髂腰肌撞击(1 例)而进行了翻修。

结论

在 THA 后 5 年,薄 VEPE 衬垫中的大金属股骨头并未增加衬垫磨损,也与衬垫失效无关。

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